From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Friday, 23 January 2015

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.

24 comments:

Anonymous said...

A very interesting proposal to start afresh and have a sui generis scheme for pharma/biotech.

Imagine all the different things that would need to be discussed and all the different parties that would contribute. Strangely I think the UK is very well placed do that, being very good at drafting detailed legislation and having open debate. The US can be a bit trigger happy with legislation sometimes.

Anonymous said...

I certainly hope that the Kat has not stopped with merely reading Dr. Suliman's articles...

The "but our area is 'different' " meme has been largely discredited - the resulting fragmentation would yield a hopeless - and never ending - mess.

One additional aspect to that mess is that the future innovations simply cannot be known a priori in order for legislation to nicely tie those innovations into nice bundled packages. Innovation simply does not work that way.

Anonymous said...

WIPO and OECD are always discussing emerging issues in all IP areas, including biotech. The material they publish would be a good place to start if one wanted to set up the system again (see for example http://www.oecd.org/env/ehs/biotrack/Biotech%20Update%20No%2028%20--%2019%20%20Dec%202014%20.pdf). Clearly, achieving consensus would be a challenge.

Anonymous said...

At the moment we have a patent system where millions of pounds of R&D can be rendered unprotectable because of prior art document such as a speculative proposal in a conference abstract 2 years ago. That seems silly. If we believe in the basic idea of patents protecting the fruits of R&D there are better ways of doing it than exist now. There must be new rules we can set up that protect R&D results per se.

Anonymous said...

Anonymous @ 12:28,

I think that your view is not quite accurate enough.

If that proposal were truly and merely speculative, then it would not be considered prior art for lack of enablement.

Conversely, if the proposal is deemed enabling, then it cannot be considered speculative.

AFAIK, science fiction is not yet considered prior art anywhere in the world for any patent system. Please provide a proper citation for a legal holding to the contrary if such exists.

Anonymous said...

If an idea has been disclosed there is no just reason for a monopoly. Live with it.

Anonymous said...

Anonymous @ 17:48,

Your statement is simply too broad to sustain.

To wit, the mere disclosure of an idea without enablement is NOT enough to block the "monopoly" of a patent.

If it were, the ideas present in science fiction would eliminate patents. Such a notion is simply anathema to innovation, and bespeaks a lack of understanding of this area of law.

Anonymous said...

Anon at 12:28 data per se is hard to protect. People have defined 'cognitive units' of knowledge and Google has had the idea of pages devoted to 'knols' which are meant to be units of knowledge. Monopolies on knols is an interesting idea.

Anonymous said...

Patents, or colloquially "monopolies" (they are different things) on anything totally or purely in the mind are de facto unenforceable.

It only mucks up the conversation to entertain such "thoughts."

Anonymous said...

to anon at 18:53.

When I say the idea has been disclosed, I am referring to an enabling disclosure. I get the differences between the world of science fiction and reality and don't ever feel a need to add extra explanation or caveats to my comments, for those that don't.

Anonymous said...

Gee anon at 18:53 did you see that comment from the Kat posted next Wednesday? Sure you did! I am te poster of the very recently dated comment, but I posted this later one first. I think my understanding is correct this time.

Anonymous said...

Anonymous @ 16:05 - if indeed you refer to an enabling disclosure, then your statement is a contradiction.

You cannot have an enabling disclosure and be speculative at the same time (that was kind of the point of the jab at you).

As to Anonymous @ 16:10, you will have to be a bit more precise - what exactly is a comment (posted by anybody) - next Wednesday...?

lighthearted said...

I don't want to second guess what Anonymous meant by the Wednesday comment but I notice from Wikipedia: 'See You Next Wednesday is a recurring gag in most of the films directed by John Landis, usually referring to a fictional film that is rarely seen and never in its entirety. Each instance of See You Next Wednesday in Landis's films seems to be a completely different film.'

Also I quite liked the 'knols' idea mentioned by another Anonymous. It would solve the old problem of trading in IP and then a 'knol' could be given a specific value.

Anonymous said...

May as well have poked me with a wet fish for all the impact you are having. Even then, you miss your target as there was no mention of 'speculative' in my comment. Unless the blog fairies added it to the words you can see. Pesky fairies! not to worry as I am sure you are right sometimes.

I won't bother trying to explain the next wednesday thing to you as I am just not able enough to do so.

For the other sensible commentator: I have ever heard of 'see you next wednesday', but find the coincidence rather spooky.

Anonymous said...

I think if one is going to think seriously about a new sui generis right for biotech/pharma products one needs to write a list of what is good and bad about the present system. The nice thing about patents is that they fit so well into the free marketplace. A research firm can decide on what R&D to do, how to patent it and how to commercialise it. If it fails and goes bankrupt that is how the system works, and the taxpayer did not suffer. Also I cannot see another way of protecting biotech/pharma inventions, apart from very specific SPC-type rights which are suited to late stage R&D. There's no way that pharma companies would be able to do the blue-sky thinking involved given how entrenched they are in the present system. So perhaps we need to rely on academics to make suggestions.

Anonymous said...

Or perhaps not. Why do you assume pharma companies are 'entrenched' and unable do 'blue sky thinking'?

It may surprise you, but the best pharma companies employ very bright people.

In the IP arena it is the academics who unable to "blue-sky-think". Stuck in the "analysis-of-what-others-have-done" mode. I believe this was the topic of a blog posting several months ago.

The patent system works perfectly well for pharma to cover the R&D phase and in many cases it works well to provide a monopoly of sufficient period (with SPC/PTE) to recoup the investment. Additional rights that already exist and work well are orphan designations and data exclusivity.

Further sui generis protection, where deemed appropriate, would just need to be extensions of these existing exclusivity provisions.

I'm sure those who work in other technology areas would believe the patent system suits the pharma industry much more than their own.

Anonymous said...

Since I do not work in the bio-tech area, my knowledge of the law in this regard is severely limited. Having had a quick browse of this decision

http://www.bailii.org/eu/cases/EUECJ/2015/T14012.html

the provisions for orphan medicinal products seem to be at least very close to the idea of a sui generis protection.

Anonymous said...

Anon @ 13:16 are you saying there has been an exhaustive recent study of all possible new rights we could have and it has been concluded we don't need any more? I've not seen something like that published anywhere.

Anonymous said...

Anonymous at 10:57,

You had me nodding in agreement up until your last sentence.

I think that academics are the very last people that we need to rely on - at least the vast numbers of such related to the current Ivory Tower groupthink on patents and property.

There is a much smaller group focusing on innovation that are worthwhile to listen to, but by and large they are not the same vocal group currently involved in the patent debate.

Anonymous said...

To Anon of Saturday 24th @ 1420 - re Science Fiction as prior art. Here is an article indicating that Bob Heinlein's description of the water bed in Stranger in a Strange Land was cited by the USPTO against a later patent application:
http://www.techrepublic.com/article/geek-trivia-strange-waterbedfellows/

(Admittedly, this is cited all over the web, but I can't find a reliable source for it).

Anonymous said...

I've seen a case of a European Examiner citing 'Brave New World' against a claim that might have covered changing human behaviour. Can't find it now though.

Anonymous said...

Anon at 14:16

No, I am not saying that. I was responding directly to the previous comment at 10:57. Obviously, if i was saying that you've caught me out, but then I didn't know I was debating with the Oracle. The EPO could do with you services in the search section.

Anon at another time.

Anonymous said...

What a strange discussion I have come across. Am I to conclude that science fiction is not prior art, even if it constitutes and enabling disclosure, because such ideas are merely speculative, with such future predictions forming the foundations of the sci fi genre? With sci fi being a portal into the future, might the citing of such disclosures by an examiner be barred as hindsight analysis?

Anonymous said...

last anonymous,

I think that you have fallen into the definition trap.

"Science fiction" - if it constitutes an[d] enabling disclosure - is by definition NOT fiction.

These are mutually exclusive sets.

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