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.

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