Skinning Bad Pharma Patents: UK Shows the Way

In a very well reasoned decision, a UK court invalidated a pharmaceutical patent that merely combined two existing medicinal substances (along with a third solvent).

Given that Indian patent law tracks UK case law quite closely (perhaps even more so than it does US law), this decision from Justice Birss will be of great interest to our readers.

The main patent in issue claimed a “Non-aqueous pharmaceutical composition for dermal use to treat psoriasis comprising a vitamin, a corticosteroid and a solvent component”. The judge found in favour of invalidity owing to the sheer obviousness of combining two existing substances (a corticosteroid and a vitamin D analog) that were already in use for treating Psoriasis (a debilitating skin condition).

Prior to the patent in question, patients typically took the corticosteroid in the morning and the vitamin D analog at night. The patentee merely combined these two and added a solvent. The court found that there was a clear motivation to combine, and that the skilled person in the art would have found it fairly obvious to experiment with a limited range of substances to get to the formulation in question (taking care of issues such as differential PH value etc).

I wonder why the US never makes any noise about UK patent invalidations? No Congressional enquiries, no press statements, no ITC hearings, no Special 301! These special privileges appear reserved only for India! In any case, now that we have a joint policy making body (the IP working group of the US: India trade policy forum), perhaps India might be stripped of these privileges in the near future? Provided of course it does away with the notorious Section 3(d) and begins pegging its patent grant rates to the US. Come to think of it, we could simply outsource our patent examination to the US (a reverse kind of outsourcing, if you will). This will save our government tons of money in administering an overworked and under-resourced patent office. And more importantly, keep the US happy…think of all the wonderful FDI that would miraculously flow in and help India transcend its “developing” country status.

Anyway, back to the decision: its a well reasoned one and more importantly, a well written one. Perhaps some of our judges might draw a lesson or two…particularly the long winded ones who meander endlessly, extracting long passages from ancient case law for well established legal propositions and meticulously reproducing all of counsels’ tedious arguments complete with citations and case law extracts.

Also for those interested, the judge deals extensively with the evidence proffered by both sets of “experts” and his assessment of it. Given that the “expert” market is on the rise in India, there are some important lessons in there for prospective experts and the clients/lawyers that wish to engage them.

ps: The joint US India “IP working group” comment is in jest. I personally think its way too early to prejudge what this forum will do. None of us know the composition of this body, whether it will have adequate Indian representation, whether it will consult with all stakeholders and the level of finality that its decisions will have.

pps: Many thanks to the wonderful Hal Wegner for sharing this UK patent decision.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

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