Pharma and biotech patents: a law unto themselves -- and a litigation conference to match?

Cloning: a plus for biotech

This Kat, who loves patent law but is no scientist, has been reading, with interest, enjoyment and increasing understanding, the recent blogposts by guest Kat Suleman Ali on the topic of biotech patents. Suleman started the year with "Biotech inventions: controversies, case law, uncertainties and financing" (here), and this was followed a week later by "The ethics of biotech patenting: a dialogue about monopolies, human dignity and the cost of medicines". Then, to cap it all, last Sunday he posted "Biotech patent case law: why is it different, idiosyncratic and always changing?", in which he wrote:

"Biotech case law has its own concepts. Partly this is because many of its inventions follow from the discovery of properties of molecules or biological systems, and specific case law is needed to guide on the appropriate claim scope based on such contributions. That means biotech practice has its own particular ways of looking at inventive step and sufficiency, and these can be technology-specific. The concept of ‘reasonable expectation of success’ takes into account the inherent unpredictability of biological systems. ‘Sufficiency’ is usually an important determinant of claim scope. ‘Plausibility’ can be used to assess the quality of the data in the specification. The patenting of inventions relating to plants can be surprisingly complicated, and some medical inventions simply won’t fit into the claim formats available in Europe.  ...

Cute, but is it patentable

Parts of biotech case law are tied to the capabilities of the relevant technologies. As it becomes easier to characterise and manipulate molecules, ‘enablement’ seems to be becoming stricter, even though in theory this should not change over time. One consequence of this is that functional definitions are becoming less acceptable. In 2001 the Trilateral Study on ‘Reach Through Claims’ led to functional definitions of molecules no longer being acceptable in many claims. The European Patent Office (EPO) is now becoming stricter on how antibodies are defined, requiring more structural definition of the antibody in addition to a functional definition. Similarly more structural data now needs to be provided for mutant sequences defined with reference to particular functions".

Claim formats and the interpretation of claims are matters that lie at the heart of patent litigation and can make or break it. If a claim is too wide or too narrow, the patent may be fatally flawed. If it can't be understood, or if a clear meaning for it can't be projected upon the blank canvas of the mind of the hypothetical person skilled in the art, litigation may resolve nothing.  This sort of thing can happen in every area of technology, but the pharma/bio sector seems to be particularly prone to it.

This Kat appreciates things that help to remind him why a one-law-fits-all-sectors approach is convenient for legislators and for anyone who has to cram the whole of intellectual property law into a single university or college syllabus, but why it's not so convenient in practice.  In the field of copyright, it's quite easy to see why the rules governing authors' works apply differently where the work is a novel, a movie or a piece of software. Likewise in trade mark law sectorally different demands are easy for even a layman to appreciate: after all, the branding of foods and medicines has an entirely different significance to the branding of fashion goods. But how far does the same apply to patents, and why?

Bearing this question in mind, it was with fresh eyes that this Kat took a look at the programme for event organiser C5's 7th Forum, "Pharma & Biotech Patent Litigation". This Forum -- really a fully-fledged two-day conference -- takes place on Thursday 19 and Friday 20 March 2015 at the Hotel Okura, Amsterdam. Good news for readers of this weblog is that C5, in a fit of kindness, are offering readers of this blog a 10% reduction on the registration fee if they quote the VIP Katcode 630IPKAT10.  The feeling that one gets is that the pharma and biotech sector is so different from other areas of innovation, with its regulatory and health issues, genericity, orphan drugs, coaching of expert witnesses, research and experimentation, public policy perspectives, patent term extension possibilities and personal medicine opportunities that a good case could be made for starting afresh and building a sui generis scheme for all pharma and biotech products and processes. But that's another matter, best left for the future ...

Needless to say, there are plenty of Katfriends on the programme. These include, but are definitely not limited to, Galit Gonen (Vice President & General Counsel Europe, TEVA Pharmaceuticals, and winner of Legal 500 Intellectual Property and In-House Counsel of the Year Awards). Galit is speaking in cross-border litigation strategies, including strategies for responding to enforcement proceedings. Then there's Camilla Balleny (Partner, Carpmaels & Ransford LLP) on how to secure supplementary protection certificate protection in the face of constant twists, turns and apparent anomalies resulting from a stream of rulings from the Court of Justice of the European Union [there's no end of them, it seems: you can check them out on The SPC Blog, here] and elsewhere. Merpel, noting that the Kat has so far mentioned only women, reminds him to name at least a token male, so he opts for Simon Cohen (Partner, Taylor Wessing) and Sam Granata (a judge in the Commercial Court, Antwerp).

You can check out the Forum website for further particulars and registration details by clicking here. There's also a pre-conference workshop, which is as good an excuse as any for experiencing an extra dose of Amsterdam's pharma and biotech delights if you click here.