Just Can't Catch a Break - US Court of Appeals Decides That AI Cannot be an Inventor of Patents

Artificial intelligence's road to recognition as a legal entity keeps hitting obstacle after obstacle, and as things stand it looks like right's in AI created works or inventions will be questionable without proper legislative intervention. Despite the continuous stumbling blocks, it seems that some inventors are very interested in continuing the fight, so yet another important decision has been reached on AI inventorship of patents in the US. The Court of Appeals recently handed down its decision on the matter, which continues on the near never-ending line of decisions across the globe that have been discussed on this blog before many times (for example here, here and here). 

The case of Stephen Thaler v Katherine Vidal concerned the DABUS AI system, which will be very familiar to the readers of this blog by now. DABUS was created by Mr Thaler and set out to create a number of inventions, and subsequently Mr Thaler applied for patents for some of these inventions (at issue specifically applications 16/524,350 and 16/524,532). In these applications Mr Thaler listed DABUS as the sole inventor. Mr Thaler also handled all of the filing formalities for DABUS, including a number of documents setting out why it is the inventor of the inventions. The USPTO rejected both applications due to them lacking a valid inventor and therefore being incomplete. The District Court, on appeal, found that "an 'inventor' under the Patent Act must be an 'individual' and the plain meaning of 'individual' as used in the statute is a natural person", and Mr Thaler therefore appealed to the Court of Appeals. 

Justice Stark noted that the sole issue in the case is whether an AI software system can be an "inventor" under the Patent Act. 

The Patent Act expressly sets out that inventors are 'individuals', which is means "the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention". The key here is the word individual, which Justice Stark highlighted to meaning "...a human being" (as decided by the Supreme Court in Mohamad v Palestinian Authority). Unless defined otherwise by statute this remains the definition, as is the case under the Patent Act. 

When not inventing, AI likes to take it easy with
a little light gardening in the evenings

Despite the wording 'whoever' being used in the Patent Act, the fact remains that these provisions are still subject to the above, i.e. that an inventor be a human being. Mr Thaler also noted that AI software programs should qualify as 'inventors' since otherwise patentability would depend on "the manner in which the invention was made". Justice Stark rejected this position, specifying that this isn't about inventorship, and also that that inventions may still be non-obvious even if they are discovered during 'routine' testing or experimentation. 

Existing precedent supports this position, with, for example, the decision in the University of Utah v Max-Planck setting out that "inventors must be natural persons and cannot be corporations or sovereigns", and in Beech Aircraft Corp v EDO Corp where it was decided that "only natural persons can be 'inventors'". Justice Stark noted that, while they deal with a different question (i.e. corporate ownership), the cases nonetheless support the position that the plain meaning of 'inventor' in the Patent Act is limited to natural persons.

Justice Stark then touched on Mr Thaler's various arguments to round out their decision. Mr Thaler had argued that inventions generated by AI should be patentable in order to encourage innovation and public disclosure. Justice Stark determined this to be purely speculative and lacking in basis under the Patent Act. Mr Thaler also argued constitutional avoidance where permitting AI programs to be inventors would support the constitutional purpose of patents "to promote the progress of science and the useful arts" and that not recognizing AI as an inventor undermines such progress, raising potential constitutional concerns that we should avoid. Justice Stark also readily rejected this position, setting out that the lack of AI inventorship would be unconstitutional, since Congress has decided to legislative limiting inventorship to human beings. 

The Court of Appeals therefore rejected Mr Thaler's appeal. 

The decision was, by no means, a surprise and continues the trajectory of rejection that AI inventorship has faced over the last several years (despite the South African CIPC registering DABUS' inventions as patents, being the only jurisdiction to do so so far). It remains to be seen whether Mr Thaler will want to try and take the matter to the Supreme Court, but it would seem unlikely to be picked up due to the sheer clarity of the matter in the US. A future involving AI inventorship would clearly require further steps from legislatures across the board, but currently there seems to be very little appetite to do so.

The EPO Are Not 'Board' of AI Yet - EPO Board of Appeal Weighs in on Whether Artificial Intelligence Can Be an Inventor

The progression of AI in the world of IP rights keeps trundling along, with many national and international bodies having already weighed in on whether AI can be an inventor for the purpose of patent law or not (discussed on this blog before). The answer seems to have been a resounding "no", however, following an earlier decision by the EPO, the EPO Board of Appeal has now issued its decision in the ever-continuing DABUS saga, which does shed some further light on the matter and does show that the current legislative framework does seem robust enough on the matter of AI (though this writer would think that specific legislative updates are still a must).

The case of Designation of inventor/DABUS (case J 0008/20) concerned two patent applications filed at the EPO (namely EP18275163 and EP18275174). The applications didn't list an inventor for the patents, but, following a clarification by the applicant, Stephen Thaler, the inventor was noted to be "DABUS". DABUS is an AI created by Mr Thaler. The EPO Receiving Section rejected both applications on the grounds that the designated inventor, DABUS, didn't meet the requirements for an inventor, that being a need for them to be a 'natural person'. Mr Thaler subsequently appealed both decisions to the Board of Appeal.

The appeal was brought on three separate grounds: (i) whether an applicant can designate an entity which is not a natural person as the inventor under Article 81 of the European Patent Convention; (ii) to comply with the EPC is it enough for an applicant to file any declaration irrespective of its content, or does the latter need to satisfy specific requirements; and (iii) whether and to what extent the EPO can examine and object to statements filed under Article 81.

To set the scene, Article 81 requires that an inventor be designated for all patent applications, and any deficient designation of an inventor can be amended under Rule 21 of the EPC. Further, Article 61 of the EPC notes that "[t]he right to a European patent shall belong to the inventor or his successor in title" (the latter being a legal successor in the title of the rights), and the rights of any employee, if they are the inventor, will be determined by the national legislation where they are employed. 

The Board of Appeal first dealt with the main request in the matter, i.e. whether an AI can be an inventor of a patent. The Board firmly rejected this point, as they determined that "[u]nder the EPC the designated inventor has to be a person with legal capacity", so adopting a simpler, ordinary meaning approach in deciding what an 'inventor' is. What the provisions around designating an inventor seek to do are to confer and protect the rights of the inventor, facilitate the enforcement of potential compensation claims provided under domestic law, and identify a legal basis for entitlement to the application. The Board clearly set out that "[d]esignating a machine without legal capacity can serve neither of these purposes". 

The Board also noted that there is no practice or agreement that would allow for the Board to overcome this specific language. The appellant also advanced an argument of fairness allowing for AI to be an inventor of a patent; however, the Board immediately rejected this argument as well. 

The Board therefore confirmed that the Receiving Section's decision was correct in raising an objection to the applications. 

In summarizing its position, the Board decided that "…the main request does not comply with the EPC, because a machine is not an inventor within the meaning of the EPC. For this reason alone it is not allowable". 

The Board then turned to the auxiliary request, i.e. whether the first sentence of Article 81 does not apply where the application does not relate to a human-made invention. The Board swiftly sided with the request and agreed that the part of Article 81 would not apply in that instance, since the provisions were drafted to confer specific rights on the inventor, so where no human inventor can be identified, then Article 81 does not apply. 

The appellant had provided a statement with this request noting that they had derived the right to the European patent as owner and creator of the machine. The Board disagreed and stated that the statement didn't bring them within the remit of Article 60, since there is no legal situation or transaction which would have made him successor in title of an inventor. 

The Board did consider two referrals that were requested to be made to the Enlarged Board, however, the referrals were rejected. 

In discussing why no referral was needed, the Board turned to matters surrounding Article 52 of the EPC, which specifies that an invention is one which is novel, industrially applicable and involves an inventive step is patentable. The appellant argued that the provision only relates to human-made inventions, and the Board agreed with this position. How a particular invention was made doesn't play a part in the patent system, so therefore it is possible that AI-generated inventions too are patentable under Article 52. However, this position can't co-exist with Article 60, so you would have inventions that are patentable under Article 52, but for which no rights are provided under Article 60. 

The Board also considered the requirement to file a statement of origin of the right to a European patent where the inventor and the applicant differ. The Board noted that this is only a formal requirement, and only informs the public of the origin of the right, but that it would be disproportionate to deny protection to patentable subject-matter for failing to fulfil such a formal requirement. 

Additionally, they noted that, as the lawmakers only had human-made inventions in mind when drafting Article 60, so it is possible that no statement on the origin of the right is required where the application concerns an invention developed by a machine. 

The crux of why Mr Thaler's applications have failed in light of the above is that there is nothing preventing him from listing himself as the inventor in relation to both applications. The Board highlighted that there is no case law "…which would prevent the user or the owner of a device involved in an inventive activity to designate himself as inventor under European patent law".

The decision is yet another among many that highlight the issues of AI inventorship and why there is simply a need for evolution in the law to accommodate AI inventions somehow. However, as noted by the Board, the creator of the AI could be listed as the inventor, bypassing this issue, however, it seems that Mr Thaler was deadset on setting a new precedent and allowing for direct ownership by the AI systems. This presents the problem of enforcement and/or remuneration, and undoubtedly these would be handled by the creator themselves, rendering this problem almost moot in this writer's view. We will see if the case progresses to the Enlarged Board, but it seems that Mr Thaler is in no way done with the DABUS saga as things stand. 

It’s a Sword! It’s a Shield! It’s Res Judicata! - The dilemma of patent validity in South Africa

We're really grateful for the extremely comprehensive article below on a very important case in South Africa, which was brilliantly written by Sfiso Nxumalo. He is a South African lawyer, currently reading for the Bachelor of Civil Law degree at the University of Oxford. He worked at Bowmans as a candidate attorney, and also worked as a law clerk at the South African Constitutional Court before reading for the BCL. You can find his LinkedIn profile here. 

Introduction

On 9 May 2019, the South African Constitutional Court, the highest appellate court in South Africa, heard its first ever patent litigation case in Ascendis Animal Health (Pty) Limited v Merck Sharpe Dohme Corporation. The case required the Constitutional Court to interpret the South African Patent Act 57 of 1978 and decide the correct approach to proceedings concerning the (in)validity of patents. 

The legal issue before the Constitutional Court was significant, namely: are the different grounds of challenging the validity of a patent separate and distinct causes of action or are they one cause of action. In addressing this issue, the Court also had to consider whether the bifurcated nature of the patent litigation affected the main issue. More precisely, does it matter if the challenge of (in)validity of patents is raised in patent revocation proceedings (as a ‘sword’) or in patent infringement proceedings (as a ‘shield’)? 

Unfortunately, the Court was evenly split in its decision (usually 11 justices sit on the bench – but the Court had one justice missing due to other judicial commitments). Thus, the first patent case to be heard by the apex Court of South Africa is of very little jurisprudential value. However, the want of jurisprudential value should not stop us from engaging some of the key issues in the case. 

Facts

In June 2011, Ascendis Animal Health (Pty) Limited (the applicant) initiated revocation proceedings against Merck Sharp Dohme Corporation and Merial Limited (the respondents) for the annulment and repeal of the Patent 1998/10975 (the patent) in terms of section 61(1) of the Patents Act 57 of 1978 (the Act) because the invention was not patentable under section 25 of the Act as the invention was not new and it lacked an inventive step. These were the revocation proceedings. 

While the revocation proceedings were taking place, the respondents in October 2011 instituted proceedings against the applicant for infringing the patent. The respondents argued that, since August 2011, the applicant had made, sold, used, offered for sale and/or imported an anti-parasitic formulation under the trademark entitled Ivermax LA Platinum and had infringed the patent. This was the infringement action. 

The infringement action was stayed awaiting the conclusion of the revocation proceedings. The applicant challenged the patent exclusively on the ground of novelty. At first instance, the Commissioner of Patents found in favour of the applicant and revoked the patent for its lack of novelty. 

On appeal the Supreme Court of Appeal overturned the decision of the Commissioner of Patents and found in favour of the respondents. After this decision, the applicant sought to amend its plea in the infringement action, to remove the defence of novelty (since it lost this case in the revocation proceedings) and sought to include an additional defence – inutility. In response, the respondents sought to amend their pleadings in the same proceedings and argue that all the defences by the respondent were res judicata (already decided by a court) since the question of the validity of the patent had been definitively decided and upheld by the Supreme Court of Appeal.

In hearing the infringement action, the Commissioner of Patents granted the respondents’ amendment and held that the grounds on which an applicant may rely on to attack the validity of a patent are not separate causes of action. It held that the applicant had effectively abandoned the obviousness claim as a basis of invalidity in the revocation proceedings and that it had not formally elected to reserve the right to rely on a separate cause of action. This is the decision the applicants subsequently appealed to the highest court. 

The Constitutional Court’s decision

Five justices of the Court in a judgment penned by Justice Khampepe upheld the appeal and ordered that the parties’ pleadings should be allowed to be amended. The other five justices in a judgment penned by Justice Cameron, held that they would dismiss the appeal. The effect of this is that there is no majority decision and the decision of the Commissioner of Patents stands. The issues are discussed in more detail below.

(i) Are the grounds of challenging the validity of the patent single or distinct and separate causes of action

Justice Khampepe held that the grounds on which a patent may be challenged under section 61 of the Act (such as novelty, utility and obviousness) are concrete, distinct and separate causes of action. She opined that a cause of action comprises every fact that would be necessary for the plaintiff to prove in order to support his right to judgment of the Court. A cause of action, she emphasised, comprises facta probanda (the facts required to be proved) as opposed to the facta probantia (the facts by means of which they are proved, i.e. particulars or evidence). She then strongly reasoned that each ground of revocation are separate, distinct and independent causes of action because the facta probanda that need to be proven for each ground are markedly different. She then explained that although the legal conclusion that results from claims of either novelty, obviousness or inutility may be the same (i.e. the finding of a patent’s invalidity), it does not mean that they all represent a single cause of action. The facts required to prove a claim of novelty, inutility and obviousness are disparate as the elements constituting each ground are dissimilar. 

A compelling point is raised by Justice Khampepe when she reminds us that South Africa is a non-examination state, i.e. the state does not check whether an invention is novel before it is registered as a patent. As a result, South Africa relies on private parties to challenge the artificial monopolies created by way of registering a patent.

In the opposing judgment, Justice Cameron held that the default position should be that a previously unsuccessful patent validity claim should bar an applicant from raising the validity of the patent as a defence in an infringement action. He posited that the question is essentially the validity of the patent and this was definitively decided by the Supreme Court of Appeal and thus the matter was res judicata or is barred by issue estoppel. In his opinion, all the grounds constituted a single cause of action. 

While Justice Cameron’s argument that there is a need to stabilise our patent litigation system is attractive, it does not overcome Justice Khampepe’s reminder that South Africa relies on private parties to litigate the validity of patents. If the state relies on private parties to litigate, such parties should not be subjected to burdensome procedural requirements seeing that their litigation, while it may be driven by profit, benefits the public. Of greater consequence, allowing parties to challenge patents ensures competition in key industries and thus benefits the larger public. This does not mean that piecemeal litigation should be permitted and encouraged. In this author’s opinion the different grounds of validity claims are separate causes of actions and parties should bring as many claims known to them at the time of instituting proceedings. Should they later bring another ground, it should not be barred based on res judicata or issue estoppel. To my mind, this is a lesser evil, compared to a complete bar, which would mean that parties have one shot at challenging a patent, and should they fail, the patent holder gains a product monopoly. Justice Cameron’s conclusion is striking because it seems to go further than just bar the litigant party. He seems to suggest that res judicata could be relaxed even regarding different parties litigating over the same ‘issue’. 

(ii) Are the defences raised in the infringement action res judicata

On this issue, Justice Khampepe held that the defences were not res judicata. She described the scheme of the Act in great detail and she then distinguished between revocation proceedings and infringement actions. Justice Khampepe considered that, in revocation proceedings, evidence is provided by way of affidavit, whereas in an infringement action, evidence is given orally. In addition, the remedies available in these proceedings are different – revocation proceedings remove the patent from the register of patents, thus making it a remedy in rem (against a thing); whereas an invalidity defence in an infringement action does not remove the patent from the register but simply renders it unenforceable against the person challenging it, thus making it a remedy in personam (against a person). She then found that ‘the findings in the revocation proceedings have a final effect on the infringement action for causes which have not actually been adjudicated upon in revocation proceedings.’ In other words, in revocation proceedings the grounds of patent validity are a sword; and in infringement actions such grounds are a shield. And in her view this matters because it would lead to the dual proceedings being nugatory and of no effect because a finding on the revocation proceedings could be carried over to the infringement action.

In plain terms, Justice Cameron argued that the dispute is essentially about the validity of the patent. Once a court of appeal has ruled on the validity of a patent, the applicant is estopped from bringing the same issue of patent validity (regardless of the ground) in the infringement proceedings. He opined that same cause of action can be interpreted widely to include the same issue (the issue being the validity of the patent). 

Again, Justice Khampepe’s incisive approach is appealing. There seems to be stark differences between the two proceedings. In this author’s view, a statutory basis for the differences indicate that the legislature intended for them to be serve different functions (i.e. a sword and shield). The applicant of course will be barred from raising the same grounds that have been decided before in revocation proceedings. In my mind, requiring parties to bring all their claims at the in one suit might have adverse effects on the patent litigation going forward.

Conclusion

No patent litigation regime is without disadvantages, and the law should be applied with a purposive approach that serves the (national) objectives of patents. While there was no binding decision by the Constitutional Court, its importance lies in its detailed discussion of the South African patent system. 

Artificial Intelligence Cannot be an Inventor of Patents, Says USPTO (and the UKIPO and EPO)

Artificial intelligence is a topic that is near and dear to this writer's heart, and something that has the potential to hugely impact the world of intellectual property law. Whether it is in relation to the possibility of copyright protection being afforded to copyright works by AI, or even inventions devised by the same, both the legislatures and judiciaries of the world will have to tackle these questions more deeply as the technology evolves and becomes more commonplace. However, recently many national governing bodies dealing with IP have handed down decisions relating to artificial intelligence and patents, which will undoubtedly shape the direction we will be heading.

First off, the USPTO handed down its decision in Re FlashPoint IP Ltd, where it had to consider whether AI can be an inventor under US law, and therefore could own patents for those inventions. The case concerned applications for a patent relating to devices and methods for attracting enhanced attention (Application No. 16/524,350), which was created by DABUS - an AI that was created by Stephen Thaler. DABUS was solely listed as the inventor for the invention in question (with Mr Thaler being listed as its representative and assignee for the rights). At first instance, the USPTO rejected the application due to a lack of an inventor, and Mr Thaler subsequently appealed the decision. The Commissioner of Patents then handed down its opinion earlier this Summer.

Pursuant to 35 USC 115, an application for a patent has to include the name of the inventor of that invention being claimed, with "inventor" being defined as "the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention". The Commissioner then noted that the entirety of the law around this concept only speaks of 'natural persons', i.e. humans, and that the declaration at the end of the application requires a declaration from a person. In brief, the legislation seems to therefore preclude any non-human inventors from applying for patents. 

Furthermore, the Commissioner considered the decision in the University of Utah v Max-Planck-Gesellschaft, where the US Federal Court determined that 'inventors' of patents are the individuals that conceived the invention, which seems to, again, not include non-human inventors. Similarly, in the same case, the Court noted that "...only natural persons can be 'inventors'". The Commissioner then concluded that, based on the above precedent and interpretation of the provisions, AI cannot itself be an inventor. Additionally, even if applicants list a natural person as the inventor, when they have not invented the invention in question, the application will fail due to that person not fulfilling the inventorship criteria under the legislation. 

Mr Thaler also applied for patents in relation to the same invention in both the UKIPO and the EPO. 

The UKIPO handed down its decision in relation to Thaler's applications GB1816909.4 and GB1818161.0 in December 2019. Again, the rejection of the applications concerned the naming of DABUS as the inventor of the inventions, which, according to the UKIPO, does not fulfill the requirements of the UK legislation for registration. 

According to s. 7 of the Patents Act 1977, a patent can only be granted to the inventor of the invention, with an 'inventor' being defined as "...the actual deviser of the invention". Additionally, if no inventor is named in an application, s. 13 requires that the applicant identify the “person or persons whom he believes to be the inventor or inventors” in the application - clearly referring to persons and not non-human inventors. The UKIPO quickly determined that this indeed did require a natural person as the inventor. 

Finally we'll look at the decision from the EPO in late January 2020, specifically concerning applications EP18275163 and EP18275174. In its decision, the EPO determined that "...the inventor designated in a European patent must be a natural person", which was a standard that was intentionally applicable and supported by decisions in national European bodies (as above in the UK). The requirement for an inventor is also mandatory in relation to EP applications, and without proper legal personality the owner of the rights in the patents would be unable to exercise them, including any AI machines. With this in mind, the applications didn't meet the requirements of the EPO, and the applications were rejected. 

The above decisions highlight the current issues with AI and the legislative frameworks that require human inventors or creators for works to be able to be protected. Whether this changes in the future remains to be seen, but it would probably be more likely that the current scheme remains and AI is relegated to supporting human inventors in the creation of inventions, allowing for patentability and protection. Without this human end-point it would be improbable for AI to be the inventor of inventions barring a shift in legislative attitudes. 

We All Knew That - UK Supreme Court Rules on Patent Obviousness

Patents afford great protection for inventions, but have high threshold in order to ensure that few patents that disclose nothing new are issued. AS one can imagine from common sense, anything that is patented needs to not be obvious, as this would allow for the protection of something that lacks sufficient invention to merit protection. After all, if it is obvious, how can you claim you've invented or found it? Even with this is mind, what makes a patent 'obvious'? In a long awaited decision by the UK Supreme Court, the matter was (finally) put to bed, at least in the UK.

The case of Actavis Group PTC EHF v ICOS Corporation concerned a dosage patent owned by ICOS (EP1173181), which related to the use of tadalafil (more commonly known as Cialis) in a dosage form for the treatment of sexual dysfunction. The patent was exclusively licenced to Eli Lilly. Actavis initiated proceedings to revoke the patent, arguing that it was obvious (among other points), with the matter ultimately ending up with the Supreme Court.

The main point of contention in the case is section 3 of the Patents Act 1977, which sets out that "…an invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art". Put differently, an inventive step (a necessary component for being able to patent something) cannot include something that is 'obvious' to a person skilled in the art, having considered anything that forms the state of the art in which they are skilled in.

Typically the courts follow two tests on determining obviousness; (i) the Windsurfing/Pozzolli structure; and (ii) the EPO's problem-and-solution method.

The question of obviousness, as set out in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc., concerns an undetermined set of factors in the light of all the relevant circumstances. These may include "…the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success".

Lord Hodge then set out a number of factors that he considered were relevant to the case at hand. Without diving deeply into each one of them (totaling at nine different factors), they included:

• whether it was obvious to undertake a specific piece of research, at the priority date, which had a reasonable or fair prospect of success;
• the routine nature of the research and any established practice of following such research through to a particular point;
• the burden and cost of the research programme; and
• the necessity for and the nature of the value judgments which the skilled team would have in the course of a testing programme.

Additionally, as the patent concerned is a dosage patent for the drug, one has to also take into consideration whether the specific dosage is indeed obvious.

The Court finally moved onto consider whether the patent in question was obvious. This began with the acknowledgement that it was obvious for the skilled team to pursue the pre-clinical and clinical research in order to implement the patent. The target for the research was also indeed to identify the appropriate dosage regime for tadalafil in the treatment of erectile dysfunction. The dosages tested would have included doses that were as low as described in the patent. This would, contrary to the decision at first instance, point to the patent being obvious more than not.

Clearly, as discussed by the Court, the approach to finding the correct dose would've been a 'no brainer' for the relevant skilled experts, and the patent was determined to be obvious. This was not contradicted even if following the EPO's problem-and-solution method.

In short, the Court found that "…the Court of Appeal was entitled to interfere with the trial judge’s assessment of obviousness and to hold that the… patent was invalid for lacking an inventive step".

The decision took a long hard look at the tests surrounding obviousness, and will clearly help further assessments of the same question in the future. The decision does also allow for the acceptance of routine or well-established inquiry as patentable subject matter, even if in this instance the dosage was obvious. 

A Point of Direction - UK Supreme Court Considers Direct and Indirect Patent Infringement

Due to the limited monopoly period in patents, infringement can be very problematic for the rightsholder, and would need to be dealt with as quickly as possible to maintain the competitive edge the patent provides. What remains tricky is establishing whether a competing product infringes on the patent, be it directly or indirectly. Drawing the line in the sand for the two types of infringement is very important, and judicial consideration on both might not be as clear as one hopes. In an attempt to clarify the position, the UK Supreme Court took on a case that involves two rivals in the pharmaceutical business.

The case of Eli Lilly v Actavis UK Ltd dealt with the chemical Pemetrexed, developed by Eli Lilly, used for the treatment of cancerous tumors. Used solely by itself the drug can be harmful, even fatal, and hence is not used as an anti-cancer drug. The side-effects of the drug could, however, be negated by using it in combination with vitamin B12 or folic acid and used for its original purpose. Eli Lilly has sold the combination drug, called Alimta, since 2004. The company also patented this combination drug in the EU (patent no. 1313508) including designations in France, Italy and Spain. Actavis proposed the launch of competing products that used pemetrexed together with vitamin B12, but, instead of using the same active ingredient Actavis would've used a different, albeit similar combination (differing from the patent claims). Eli Lilly alleged that the products would directly or indirectly infringe on their patent, with the matter ultimately reaching the Supreme Court in July.

The focal point of the matter is the use of a particular pemetrexed diacid or a pemetrexed salt with vitamin B12, which is specified in claim 1 of the patent, while Actavis uses a slightly different salt. Article 69 of the European Patent Convention sets out the extent of a patent's protection, which "…shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims". A combination of the claims and its associated description should be used to determine the patent's remit of protection, i.e. could it include more compounds than the one set out in claim 1. The relevant provision for the infringement of patents in the UK is section 60 of the Patents Act 1977, which is governed by the above provision in the EPC.

After discussing the precedential history of patent infringement in both the UK and Europe, Lord Justice Neuberger, handing down the Court's unanimous decision, set out the proper test on patent infringement. In his view, to assess patent infringement matters, one has to look at two issues through the eyes of the person skilled in the relevant art. Namely, "...(i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial". He further specified that the second issue should viewed as not merely identifying what the words of the claim would mean to the skilled person, but also considering the extent if any to which the scope of protection afforded by the claim should extend beyond that meaning.

Lord Justice Neuberger then moved onto discussing the two issues above in more depth.

The first issue, in his view, is a straightforward application of claim interpretation, considering that the ingredients used by Actavis would not fall within the expression "pemetrexed disodium" in claim 1.

Steve wasn't a big fan of taking Pemetrexed 

The second issue proved to be trickier. Lord Justice Neuberger saw that, to determine what would amount to an 'immaterial' variation of the invention, it would be helpful to look at the three questions set out in Improver Corpn v Remington Consumer Products Ltd. These ask "i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent? ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention? iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?"

The judge then turned to answering the above three questions.

For the first question Lord Justice Neuberger quickly determined that both drugs work in the same way as the patented invention, ultimately comprising of a medicament containing the pemetrexed anion and vitamin B12. The drug will achieve substantially the same result, in the same way, as the invention.

In the light of the second question, Lord Justice Neuberger considered that the skilled person would appreciate that each of the Actavis products would work in precisely the same way as pemetrexed disodium when included in a medicament with vitamin B12. The use of different free acids or salts would not change this outcome, as they were clearly established as at the priority date of the patent, and the skilled person would clearly investigate their effects as a part of routine. A test for knowing whether the drugs work or not would, in his mind, is too strict.

In answering the third question, Lord Justice Neuberger diverged from the Court of Appeal's decision. He considered that the skilled person would understand that the use of ' pemetrexed disodium' would not limit infringement to only that particular salt – this just happened to be the one used during experimentation. He concluded that it is unlikely that any other pemetrexed salts or pemetrexed free acid would have been excluded from the scope of protection.

Lord Justice Neuberger ultimately saw that the patent had been directly infringed by Actavis. He affirmed his position even in the light of the patent's prosecution history, as reliance on it should be reserved to limited instances and not every matter concerning infringement. The judge also considered direct infringement in France, Italy and Spain, and concluded that the patent had been infringed in these jurisdictions as well.

Finally, the Court looked at whether the patent had also been indirectly infringed had they determined the patent to not have been directly infringed, also set out in section 60 of the Patents Act 1977. The parties argued about the manufacture and administration of the drugs, diverging on whether both contribute to infringement or not. Ultimately Lord Justice Neuberger determined that Actavis would have indirectly infringed Eli Lilly's patent if they knew, or it was obvious given the circumstances, that the drug would be used by dissolving it into a saline solution

The Supreme Court's decision in the case will be very influential, and redefines how direct infringement in particular is assessed. It'll be interesting to see how the new tests are applied to different types of patents, not just pharmaceuticals, and whether it will make proving infringement easier or more difficult.

Printing on the Wall - US Supreme Court Rules on Patent Exhaustion

Discussed on this blog only a few weeks ago, the US Supreme Court decision in Lexmark can have huge ramifications for both patent holders and sellers of those products all over the world. When and if at all patent rights exhaust after the sale of a product, be it in the US or abroad, is an important question and will set clear boundaries for both buyers and sellers, potentially impacting the price and availability of products and services all over the world. Many IP practitioners have been waiting for the decision by the Supreme Court, who released it only some weeks ago.

By way of a brief primer, the case of Impression Products Inc. v Lexmark International Inc. concerned the resale of printer ink cartridges, for which Lexmark owned several patents, which they also designed and manufactured. Impression Products bought used cartridges both abroad and in the US, refilled them and resold them; however, Lexmark set conditions on the cartridges during their sale, preventing their reuse and resale by other companies. Lexmark took Impression to court, and the matter ended up with the Supreme Court, who were set to decide a major point of patent law, as to when patent rights have been exhausted (if at all) after the sale of the product containing the patent rights.

The first question the Court tackled was whether the sale of the cartridges in the US did indeed exhaust their rights in the patented aspects of the goods. 35 USC section 154(a) confers the right to make and sell patented products, but the provision does not set any express limitations on the right. However, case law has established that "[w]hen a patentee chooses to sell an item, that product “is no longer within the limits of the monopoly” and instead becomes the “private, individual property” of the purchaser, with the rights and benefits that come along with ownership". The law therefore has limits on the control that a patent holder can exert on products within their monopoly. After discussing the historical context of patent exhaustion, the Court swiftly determined that "…Lexmark cannot bring a patent infringement suit against Impression Products to enforce the single-use/no-resale provision accompanying its Return Program cartridges. Once sold, the Return Program cartridges passed outside of the patent monopoly, and whatever rights Lexmark retained are a matter of the contracts with its purchasers, not the patent law".

This rationalisation makes sense to this writer, since a near perpetual, inexhaustible patent right in products, even post-sale, could have huge ramifications on the resale market, and potentially even anti-competitive uses (which the prevention of the resale of cartridges by a competitor could be construed as). The Court summarised its position on this: "…patent exhaustion is uniform and automatic. Once a patentee decides to sell—whether on its own or through a licensee—that sale exhausts its patent rights, regardless of any post-sale restrictions the patentee purports to impose, either directly or through a license".

The Court then moved onto the issue of the importation and sale of cartridges bought abroad. This question has not been addressed much under patent legislation, but has been discussed in the Supreme Court decision in Kirtsaeng, which established that the first sale of a copyright protected work would exhaust the rights in that work, even if imported from abroad and sold in the US (having been initially made and sold lawfully).

The Supreme Court faced the wrath of
patent holders after the decision

Under the common law concept of exhaustion, as discussed in Kirtsaeng, there is no territorial restriction on the fact. A sale abroad would be, arguably, exhaustion of rights within the US, and would therefore allow the importation of those goods into the US without infringement. According to the court, the copyright concept of exhaustion would not be distinguishable from patent exhaustion, as this would "…differentiating the patent exhaustion and copyright first sale doctrines would make little theoretical or practical sense [as] …the two “share a strong similarity and identity of purpose". The person buying the goods abroad is not buying the patented rights, according to the court, and that "…exhaustion is triggered by the patentee’s decision to give that item up and receive whatever fee it decides is appropriate". The court therefore concluded that Lexmark's rights were exhausted when the cartridges were sold abroad, and Impression would not be infringing their rights by importing the goods to the US.

Justice Ginsburg was the only judge to dissent. In her view, patent rights were purely territorial, and that "…[b]ecause a sale abroad operates independently of the US patent system, it makes little sense to say that such a sale exhausts an inventor’s US patent rights". This would open the door for competitors to potentially sell those patented products in the US with no legal recourse by the patent holder. Arguably, Justice Ginsburg's perspective is wholly justifiable, and this writer would raise concerns over this fact as well. If patent rights are fully exhausted in the event of a foreign sale, there would be very few restrictions on doing exactly the above by competitors. Finally, she disagreed with the majority's application of Kirtsaeng with patent rights, as "…[a]lthough there may be a “historical kinship” between patent law and copyright law… the two “are not identical twins". The legislative framework for copyright and patents does differ, and a straightforward application of copyright concepts to patents might not be possible as the law stands today.

The decision is a very important one, and will have clear and strong implications to patent holders who rely on the retention of rights in the US, irrespective of where the products were sold. Time will only tell whether this opens the Pandora's Box of reselling "infringing" products in the US; however, this writer is certain that other avenues will be used for the sale of patented products, such as contractual vehicles, rather than relying on pure rights retention.

A Lack of Patent Exhaustion - Discussing the Lexmark Case Ahead of US Supreme Court Hearing

Many IP rights give their owners a great deal or rights and capabilities to restrict the use of their rights by other parties, and arguably, rightfully so, as the creation is indeed theirs. Even though this might be the case at face value, the use and exploitation of those rights should still have certain limitations, for example, from preventing an author from allowing certain people from reading their book after they have purchased a copy. This doctrine is called the exhaustion of rights, which means that after a certain point, the rights held by the author or owner of a technology cease to apply, allowing for the party to use their products as they please. Exhaustion of rights is still a developing area of law, and an up-coming case in the US Supreme Court has been primed to tackle this in relation to patents, with the case having ramifications both ways irrespective of the decision. Looking ahead to the decision, it is important to discuss the Court of Appeal case decided over a year ago.

The case of Lexmark International Inc. v Impression Products Inc. dealt with the sale of refilled ink cartridges for computer printers by Impression, who purchased used cartridges from abroad to refill and resell in the US (having a third-party circumvent the protection mechanism preventing reuse in the cartridges). Lexmark holds patents in relation to these cartridges, and most of the cartridges had strict single-use/resale restrictions set by Lexmark both in the US and abroad. Impression had not sought permission to resell the cartridges in the US, and Lexmark subsequently took the company to court for patent infringement.

Under 35 USC section 271, only the patent holder is authorized to sell and import patented inventions in the US. Impression argued that the rights (undisputed to be valid and enforceable) had been exhausted after the first sale of the cartridges to the original consumer, and therefore their resale and importation would not be an infringement of the rights.  The Court disagreed, and saw that "...a patentee may preserve its § 271 rights when itself selling a patented article, through clearly communicated, otherwise-lawful restrictions, as it may do when contracting out the manufacturing and sale". This would therefore allow Lexmark to assert its rights post-sale as per the stickers on the cartridges.

The Court focussed on the aspect of the provision that restricts the sale of the patented 'without authorization', as the lack authorization of resale through the sticker clearly leaves the buyer without rights. Conversely, the sale of an article without the reservation of rights would, arguably, have the right to resale the item. It all comes down to the language used during the sale process. The Court summarized their position, where "...[a] sale made under a clearly communicated, otherwise-lawful restriction as to post-sale use or resale does not confer on the buyer and a subsequent purchaser the "authority" to engage in the use or resale that the restriction precludes", following the decision in Mallinckrodt Inc. v Medipart, Inc.. This means that the patent owning party would retain the rights in the item if expressly and clearly communicated at the time of purchase, provided that no law or policy is violated through the retention of rights.



Patent exhaustion is a real plight! (Source: Good Little Robot)

The legislative position is not any different, according to the Court, from the common law position as set out in Kirtsaeng v John Wiley & Sons (discussed more here), which restricted the rights in items that have been sold (albeit in relation to copyright and not patent rights). The ultimate seller of patent rights can retain some rights in the sold items, which differs from copyright that does not offer the same varying set of rights.

The second question the Court had to grapple with was whether the sale of the items abroad conferred any authority to Impression to import the cartridges to the US and sell them there. Ultimately, following the Jazz Photo Corp. v International Trade Commission case, the Court determined that no legal rule to this effect existed. For there to be an ability to do so, Impression would have to have a licence, implied or direct, to do so, which in the case they did not have. Similarly to the above, the decision in Kirtsaeng does not apply in this instance either (where copyright protected works were bought abroad and imported for sale in the US), as the law in copyright affords an equivocal right to resell the items, which patent legislation does not give.

Ultimately, Impression's case failed and the Court found that they had indeed infringed Lexmark's rights.

Both Judge Dyk and Hughes dissented from the judgment, raising opposing views on both the applicability of Mallinckrodt and Jazz Photo.

In their view, in relation to the first argument of patent exhaustion, the decision in Quanta Computer Inc. v LG Electronics Inc. applies, which sets out that "...the initial authorized sale of a patented item terminates all patent rights to that item". The moment the item involving the patent has been sold with authorization, all rights in the patented aspect cease to apply, even in relation to resale. Additionally, in relation to the second argument, once the item was sold abroad (with no restrictions as to US patent rights), the rights in the patent works are exhausted. This is even more poignant, according to the judges, due to the sale by the patent rightsholder, and not a mere licensee.

The case, once decided by the Supreme Court, could potentially have huge implications to the sale and resale of goods incorporation patent rights in the US. Should the Supreme Court side with Lexmark, it could cause a huge cooling on the resale of products in the US, and an upswing on the incorporation of stricter sale terms in relation to patent rights in any given goods. This could cause prices to rise and items to be less readily available to consumers. On the opposite side, should the Supreme Court agree with Impression, patent rights could be hugely devalued in the US, especially when it comes to the sale of goods at first instance. This could mean higher up-front costs to protect against the loss on resales, but also release a whole swathe of second-hand markets for patent goods, particularly from abroad should the rights have been exhausted. No matter which way the case goes, it will be very important to both consumers and patentees alike, and shape the future of patent exhaustion for years to come.

Source: Gizmodo

A Big Bite of the Apple - Supreme Court Decides the Fate of Design Patents

The two titans of technology, Apple and Samsung, have fought long and hard over many aspects of intellectual property law, especially ones relating to the design of the (now ancient, at least in smartphone terms) iPhone. The two companies have fought legal battles all over the world since 2011, with varying results for both parties. After a monstrous $1.05 billion award of damages to Apple in earlier cases by a jury, the matter ended up with the Supreme Court, who were destined to look at an aspect of design patents often overlooked by the judiciary, even if it was merely from a damages perspective. The Supreme Court handed down its judgment in early December.

The case of Samsung Electronics Co. v Apple Inc., dealt with design patents owned by Apple on aspects of the iPhone, in particular a black rectangular design (D618,677), the same with a bezel on a surrounding rim (D593,087), and a colourful grid of 16 icons on a black screen (D604,305). Samsung employed similar design aspects in its various smartphones (including the Galaxy S line), and Apple took them to court for infringement in the aforementioned design patents. What the Supreme Court were tasked to determine was the infringement, and subsequent award for damages for infringement, under section 289 of the US Patent Act.

The above section provides a remedy for damages when "[a] person who manufactures or sells “any article of manufacture to which [a patented] design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit". While this is more straightforward in instances of whole infringement of a simple, single article, it is more difficult, as admitted by Justice Sotomayor (handing down the Court's unanimous judgment), in cases with complex, multi-component items and subsequent profits using the infringing elements.

Complexity comes with a need for introspection

What remains key is the liability for the infringing articles where the designs have been applied, which has been traditionally set at "…the extent of his total profit, but not less than $250". This then means you have to initially identify the 'article of manufacture' to which the infringed design has been applied, and then calculate the infringer's total profit made on that article of manufacture.  The Court therefore had to decide "…whether, in the case of a multicomponent product, the relevant “article of manufacture” must always be the end product sold to the consumer or whether it can also be a component of that product". This would either enable the patent holder to claim all profits made by selling the Samsung smartphones (i.e. the whole phone), or restrict the damages that can be claimed (i.e. only allowing damages for the particular designs used, and not the whole phone) by the rightsholder.

The Supreme Court left quite a bit unanswered in relation to the question of when an article of manufacture would be the whole product, or simply a component thereof, which, at least to this writer's mind, is a huge part of this matter and many others involving complex technology. Arguably, as the decision will be sent to the Federal Court for a rethink, the lower rungs will have to fill this space; however, there is a chance that an agreement will not be reached (yet again) by the lower courts, and the Supreme Court will have to address this matter in the future.

Justice Sotomayor saw that, after a simple reading of the term 'article of manufacture' that it would encompass both an individual component of a product, or the product as a whole. Design patents can be acquired for both, and while a component has to be embodied in an article, the designs can themselves only cover those components.p

The Supreme Court ended up saying very little in their judgment, and the future of design patents, especially in the smart device space, will remain very unclear. Whether the Federal Court comes up with a good test for the above remains to be seen, but this writer for one thinks the Supreme Court should've added more meat to their decision. Although they did highlight some issues with the parties' briefs, one would have concieved that some more guidance was to be given. Either way, the decision is important, and sets the scene for Apple and Samsung to compete more for the future of their devices and their designs.

Source: IPKat

A New Era - What Does the Donald Trump Presidency Potentially Mean for IP?

Now that the dust has settled in the long and arduous process that is the American presidential race, it is time to look ahead to the future and the possible implications of the Donald Trump presidency. While it can be appreciated that the next 4 (or even 8) years will be ones of change one way or the other, this writer is not concerned with the wider implications, but only of those impacting intellectual property law. The 45th president's particular focus on this area of law still remains very murky; however, his position has been stated in some amount of press and campaign materials, which will form a basis for this discussion.

In his own policy manifesto for his campaign, Mr Trump set out that he will "...use every lawful presidential power to remedy trade disputes if China does not stop its illegal activities, including its theft of American trade secrets - including the application of tariffs consistent with Section 201 and 301 of the Trade Act of 1974 and Section 232 of the Trade Expansion Act of 1962". Clearly his approach echoes largely a trade-based plan, rather than the change of laws and regulations surrounding IP in the United States. Arguably, these are quite strong deterrents for the infringement of intellectual property rights in China, but these measures have had little effect before due to the massive presence of Chinese manufacturing in the world stage (although the country has taken significant steps forward to better enforce IP rights). Recent changes to the Chinese IP law landscape have possibly mitigated the current issues highlighted by the Trump campaign, but this will undoubtedly not deter him should the president want to go after China in a more direct fashion.

Aside from legislative or policy changes, his 100 day plan encompasses withdrawal from the Trans-Pacific Partnership and the renegotiation of bilateral trade agreements, many of which will touch on IP in one way or another. This will have drastic effects on US trade relations, but the implications for IP will be minimal.

The face of an uncertain future for IP

Some have argued that, per his close ties to the entertainment industry, that copyright regulations would be tightened and copyright enforcement made stricter, with higher sentencing and easier claims by rightsholders (in this writer's thinking anyway). Similarly, his position on copyright might impact the regulation of the Internet, with broad-ranging implications should it be used as a weapon to combat against those who infringe copyright online. Overall Donald Trump has been quite quiet in his views on intellectual property and what his concrete plans are during his presidency.

This can be compared with Hillary Clinton's Initiative on Technology & Innovation, which set out a myriad of action points in this sphere, but specifically targeted copyright as a sub-point. In her initiative she set out to "...modernize the copyright system through reforms that facilitate access to out-of-print and orphan works, while protecting the innovation incentives in the system.  It should also promote open-licensing arrangements for copyrighted material supported by federal grant funding". Her plan seemed to focus more on accessibility than enforcement, but echoes vagueness, as expected in a political campaign. Similarly, she aimed to take on patents with "...reforms to the patent system to reduce excessive patent litigation and strengthen the capacity of the Patent and Trademark Office". Clearly this was to reduce frivolous patent litigation by patent trolls, but more particular reforms were left to be sorted if she were ultimately elected. Mrs Clinton was overall much more up-front with her plans and vision for IP, but even so it left much to decipher as to what might actually happen, rather than what might.

As one can appreciate the future developments of this coming presidency are unknown, and while candidates often give indications as to their stances or policy intentions, these don't necessarily stick once they reach the Oval Office. This writer will remain optimistic, but does wonder whether a more pro-rightsholder position will become the norm, with a clear reduction in fair use and other legitimate uses of copyright materials, especially in an online environment. Odds are the trajectory that IP legislation was already headed will most likely remain the same irrespective of who the president is, as a swooping overhaul of this would lead to too much uncertainty and possibly a negative impact in IP and innovation as a whole (with the rapid pace of technological development making things even worse if not kept up with). While the media has calmed down after the election, it will surely be quite the next 4 years to come.

Can You Patent Embryonic Stem Cells? - The ECJ Ends the Fight, For Now

As was discussed quite extensively on this very blog some months ago, the genesis of human life and its formidable times are a topic riddled with controversy and a myriad of viewpoints, yet the topic has not come to contention much in the judiciary. Since the opinion of Attorney General Villalon, discussed by this very writer in the link above, the actual decision of the European Court of Justice has been anticipated by many, especially in light of the potential future of stem cell research in the EU. The ECJ's decision is hugely important in a world-wide context, potentially seeing a precedent which will either hinder or enable other similar jurisdictions to allow or disallow similar patents, even in light of the Myriad Genetics saga in the US.

The case in question, International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, for the uninitiated, deals with two patent applications, filed by the International Stem Cell Corporation, relating to stem cells; more specifically "...methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the claimed methods, and... the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and product-by-process claims to synthetic cornea or corneal tissue produced by these methods". To put things into more simplistic terms, the applications (GB0621068.6 and GB0621069.4) relate to the usability of stem cells or their production from oocytes (female egg cells). A more detailed expression of the facts and the prior judgments can be found in this writer's article discussing the Attorney General's opinion.

A parent's dream, endless potential (Source: Bizarro Comics)

The Court was therefore faced with the same question posed to the Attorney General: "...whether Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and development to a certain stage have been stimulated by parthenogenesis constitutes a ‘human embryo’ within the meaning of that provision" and be unpatentable under the Directive. The interpretation of the Article in question hinges heavily, as discussed by the Attorney General, on the ECJ's earlier decision in Oliver Brüstle v Greenpeace, where the Court saw that "...any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article... since that fertilisation is such as to commence the process of development of a human being". This is a key distinction, as the cells in ISCC's applications would not be capable of development into a human being. Even with this in mind the Court saw that "...a non-fertilised human ovum must be classified as a ‘human embryo’" as the cells, when harvested, are still capable of being fertilized and possess the potential to develop into a human foeatus, thus falling within the meaning of a 'human embryo'.

The Attorney General saw things differently in his interpretation of the law, and the Court in the case in hand agreed with him: "...a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being" to fall under the definition of a 'human embryo', contrary to Brüstle. ISCC's patents cover the use of cells in a state where they cannot possibly be fertilized and multiply, thus not, under the Court's current considerations, be classified as a 'human ebryo', and be exempt from patenting. The Court then summarized its position very well: "...where a non-fertilised human ovum does not fulfil that condition, the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a ‘human embryo’... [and] [b]y contrast, where such an ovum does have the inherent capacity of developing into a human being, it should... be treated in the same way as a fertilised human ovum, at all stages of its development".

In the end the ECJ rejected the notion that ISCC's patents would encompass a 'human embryo', and accepted the patenting of stem cells, so long as they are truly incapable of development, either inherently or through genetic manipulation (which ISCC indicated it would be doing to the cells in their applications). What this decision demonstrates is a much more open approach to patenting stem cells, and in this writer's opinion, represtents a healthy and morally correct approach to stem cells and patents, especially in light of potential future developments in the field and a correct application of the law. 

Whether the courts will face any new cases dealing with different, potentially more nuanced and 'grey' approaches to stem cells or genetics in general in the future remains to be seen, but the potential dvelopment in the area is exciting, both from a human perspective and a legal one as well. 

Source: IPKat

Genetic Patents Saga Continues - Next Stop, Canada

After the Myriad Genetics saga has been experienced on both sides of the world, in the US and Australia (both discussed on this very blog quite extensively: US here and here; Australia here), the fight seemed to be over and the decision, at least for now, settled. With the Australian case having been appealed to the High Court of Australia, most IP practitioners and academics awaited the conclusion of the patent's road in Australia, a new challenge in the field of genetic patents has begun in the colder of the North American powerhouses; Canada. The Myriad Genetics patents have not been challenged in Canada, although the Provinces themselves have rejected them and refuse to enforce the patents, and this case would be an important stepping stone in completely answering the question of the patentability of genetic material, at least in North America.

The challenge is being mounted by Children's Hospital of Eastern Ontario (more commonly known as CHEO), however taking the fight to (finally) someone else but Myriad Genetics. The question relates to patents covering the testing and/or assessment of Long QT Syndrome, which, as explained by the Mayo Clinic: "...is a heart rhythm disorder that can potentially cause fast, chaotic heartbeats. These rapid heartbeats may trigger a sudden fainting spell or seizure. In some cases, your heart may beat erratically for so long that it can cause sudden death". One does not catch Long QT, as it is a genetic disorder, which requires identification prior to treatment. CHEO were prevented from conducting their own genetic analyses on-site, as the University of Utah holds the patents for the testing of this genetic disorder, much akin to the Myriad Genetic Patent (Canadian patents 2240737, 2336236, 2337491, 2369812 and 2416545 respectively). Due to the mandatory outside testing at the University of Utah, CHEO's costs to diagnose this disorder are nearly double when compared to internal testing, resulting in increased costs and potentially even diagnosis times; again, very similar to the problems with the Myriad Genetics case.

The Canadian Patent Act reflects the US legislation quite heavily in relation to patentable subject matter. Under section 2 of the Canadian Patents Act an 'invention' is defined as "...any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter". A nearly identical definition is set out in 35 USC section 101 in the United States. The relevance of this is very important, as the Supreme Court's rejection of genetic patents in the US will undoubtedly influence the Canadian courts going forward.

Even genes have it tough under today's beauty standards (Source: Dan Collins)

Under the Canadian Patents Act section 27 both scientific methods and abstract theorems are not patentable, although an application of such can potentially be patented. One has to note the omission of an express exclusion of naturally occurring subject matter, which is included in many other jurisdictions. The argument raised by CHEO therefore hangs on whether a naturally occurring phenomena can be patented under section 2, if it is deemed to be a sufficiently marked departure from the naturally occurring thing itself. One has to wonder why the Canadian legislature has left this exclusion out of the law, as it is very much the standard all over the common law.

As for potentially applicable case law the pickings are quite slim. The case of Harvard College v Canada (Commissioner of Patents), the Canadian Supreme Court saw that, even though section 2 is very broad in its wording, it does not include "....anything under the sun that is made by man", and can be therefore limited in its scope. The Harvard case effectively dismissed the patentability of 'higher lifeforms', which has been argued to encompass plants as well as animals, such as the genetically modified mice in question in the case itself, it still remains a useful examination of some of the wording the Federal Court will face. Whether one can include genes in the term 'higher lifeforms' remains to be seen, and in this writer's opinion, it will be a tough argument to press, but a possible one due to the complexity and higher level of function which genes serve in the human body. In Monsanto Canada Inc. v Schmeiser the Supreme Court looked at patents relating to genetically modified crops. The case largely focused on infringement, rather than the patentability of genetically modified crops, but as the Supreme Court did briefly bring the fact to light, it still might be used as a starting point to defend the patentability of other genes; even human genes.

This writer for one will await the emergence of this case in the courts, and wonders if the decision will be different to that of the US Supreme Court. Arguably the Canadian courts should hold that patents are not eligible for patent protection; however, as recently seen in the Full Federal Court of Australia as mentioned above, things are not always as straightforward as you might think. Yet, due to the sheer similarities of the Canadian and US law, and the significant influence of its North American brethren in the South, one can imagine things going CHEO's way on this one. As the case was filed in the very early parts of November a judgment will be a long ways away, but this will be one to look forward to in 2015.

Source: Ars Technica

Can You Own a Recipe? When Food Meets Intellectual Property Law

Food is quite important to all of us, and not just because of its nourishing quality and necessity for life, but also for the sheer enjoyment of a dish which has been prepared with care and love. This writer for one will freely admit that he loves to both cook and eat (often the latter more than the former), which prompted me with a thought in the process of seeking out recipes to make: can you own a recipe, or if anything, are recipes protectable under intellectual property law? Upon initial thinking the question seems to beg an answer, since recipes are undeniably creations of great creative efforts, planning, knowledge and skill, which, prima facie at least, should afford it some level of protection. This aside, food is ubiquitous to all cultures, peoples, and as said above, a necessity, which would render their protection draconian or even preventative of the enjoyment of cultural aspects for the larger masses should recipes be isolated to only a select few. The question indeed deserves an answer, and I shall endeavor to do so below, separating the matter into each type of intellectual property.

Recipes and Copyright

Often people's first memories of recipes is a dusty old tome which their grandparents have kept and compiled over the years, containing family recipes and secrets from generations ago. Whether it is Gordon Ramsay or your lovely grandma, recipes take effort and skill to create and compile, being put into tangible form either on paper or online. Under the UK Copyright, Designs and Patents Act 1988, and similarly its US, Australian and Canadian counterparts, copyright protection is afforded to original literary works; however this protection is given to the expression of those literary ideas, not the ideas themselves (expanded more on this very blog here and here). Recipes, therefore, potentially could be protected under copyright should they be expressed in a very specific or original manner; however the ideas of the recipes themselves (for example the concept of a pancake) cannot be protected by copyright.

Some recipes are more 'original' than others

This was specifically discussed by the Australian IPO (link leads to an external PDF file), which this writer thinks is an accurate representation of the laws' applicability in most common law countries: "[t]he owner of copyright in a recipe has certain limited rights to control the manner in which their written recipe is used. This does not include, for example, preventing people from making the dish, or from writing their own descriptions of how to make it". To expand on this, the individual or entity can protect their recipe to an extent, but cannot prevent others from making that particular dish or writing down their version of the recipe. As expression is protected, and not ideas, mere techniques, information on ingredients or methods or the 'idea' of an overall recipe cannot be protected.

Copyright leaves recipes quite exposed, but does offer some level of protection should someone try to use your recipe which has been published in a book or in another protectable form. However should they want to publish their own version or efforts, even writing down a specific recipe in their own words after following someone cooking it, they are free to do so.

Recipes and Trademarks

The names of dishes can be quite valuable, especially if they gain a high level of traction. A famous dish can be highly desirable to protect in name, and under the UK Trade Marks Act 1994 (and similarly under its American, Australian and Canadian counterparts) a sign, an indicator of a goods' origin, can be protected, which easily encompasses the names of dishes or recipes. A recent example of this is the fabled Cronut, a mixture between a croissant and a donut, which became seemingly huge overnight. Arguably the recipe for a Cronut can be very valuable, and many have shared their takes on the item, but what truly brings protectability to the doughy foodstuff is its name - something its creator trademarked promptly. As illustrated above the idea of a Cronut is not protectable as is, but the name does prevent others from selling the item under the recognizable moniker, which is very often more valuable than attempting to prevent the use of a recipe. 

This is not to say protecting a dish or a recipe can result in a positive outcome. Last year a Vietnamese restaurant in London faced some backlash after it asserted its trademark on the dish "Pho", albeit used in the restaurant's name rather than as a means to protect a specific recipe. Whether it is a food related name or a distinct recipe with an elaborate or distinct name, trademarks do serve as a great tool to protect recipes, yet are limited to only truly distinct cases, as one cannot simply just trademark a common recipe or dish.

Recipes and Patents

The more interesting choice of the three was an option this writer had never even considered; patenting a recipe. More often than not patents protect inventions, which encompasses a very wide array of things, but one would never think of a recipe as an 'invention' no matter how inventive the approach can be. Nevertheless, this is still quite possible, although any aspiring food patent seeker will be fighting an uphill battle at best.

Intricate methods of cooking often lead to mixed results

Under the UK Patents Act 1977 for an invention to be patentable it has to fulfill certain criteria: it has to be something new; involve an inventive step; and be capable of industrial application. On the face of things a recipe could be exactly that, and fall under each category; however one can imagine this would pertain more to an industrial recipe, rather than a single kitchen in a single restaurant. A good example of a food related patent is Cadbury's patent for chocolate that doesn't melt (and for the sake of balance Nestle's equivalent is here). The recipe clearly calls for a specific method of creation, a way to make the recipe, rather than the recipe itself. Chocolate is way too common for it to be afforded patent protection, but a novel way to produce chocolate could easily be patented if it falls under all of the requirements. For a great in depth look at the matter in the US, please do read Gene Quinn's article, which covers recipe patents under US law very comprehensively.

Patents are a tougher sell as a method for protecting recipes, but are still quite viable and an option should you dish be created in a very unconventional, new way, and possibly include a more industrial approach rather than one which relates to looks or flavor alone. It won't protect the recipe per say, but it will protect the method through which that recipe is produced.

Conclusion

In short, can you own a recipe? Yes and no. To own a recipe in its most truest sense, it seems nearly impossible under current intellectual property laws, and rightfully so, since no nation would want to deprive its citizens of the multifaceted world that is the culinary world. One can easily own an aspect or two to a recipe, for example its name or a specific structure if it entails a strict layering process for example, or even a printed recipe, but the limits the law imposes on those rights are very strict and nuanced. Being able to buy a lasagna outside of a certain restaurant in Italy is truly a blessing for us all, and we can take that availability for granted.

A message to all aspiring chefs and current culinary professionals: focus on the quality of your product rather than its protectability under intellectual property law.