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.