Pharmaceutical and Biotech Patent Ligitation: An Interview with Vineet Kohli, Merck

Vineet Kohli, Assistant Patent Counsel at Merck & Co., Inc., reflects on the recent impacts in the law in regards to patenting antibodies, and developments for the strategies of internal business units.

Pharma IQ: Is there anything in the industry in the moment that you’re finding particularly of interest?

V Kohli: There have been a number of interesting cases in the area of patent law in general, but some of them have specific impact with respect to biologics, and by that I mean the large molecules such as antibodies. There has been the case, our case, that has changed the landscape with respect to the finding of obviousness and it has had a substantial impact on a number of applications, irrespective of the subject matter, in terms of allowance. Allowance rates have indeed gone down as a result of KSR.

There was another interesting case that had an impact on biologics, which is In re Kubin, where the Court of Appeal, for the first time, appears to have taken the position that methods of identifying or isolating or recombinant genetic methods may indeed make DNA base or /small protein bases mentioned indeed obvious, which is a departure from In re Deuel. Then there have also been two cases: one of them is the ARIAD case, which basically deals with written description/possession; and the last one, in terms of antibodies, would be In re Sullivan, where the Court of Appeal has taken the position that, indeed, secondary considerations are important when it comes to deciding whether or not a specific antibody is obvious over another in the prior art.

So I think all of these four cases have created more of a stringent requirement, not only for written description, subparagraph 112 of the US Code, but also under obviousness in terms of: you can no longer try to disclaim your antibody claims. And I should also mention that there was another case that was decided a few years ago but also has an impact on antibodies, which is Noelle v Lederman, where the Court of Appeals took the position that if you’re the first one to have identified an antibody of a specific antigen specifically, then you can get a broad claim to the antibody itself.

Pharma IQ:
What do you see as the major challenges for your industry at the moment, and how do you believe we could possibly overcome those?

V Kohli:
I think the two challenges that I see, going forward, irrespective of what subject matter you’re trying to claim or what field it is you’re practising in, are going to be written descriptions, which would be the first bucket; and the second bucket, in my opinion, will be obviousness.

I think, in terms of chemical cases, formulation cases, combination treatments and what have you, it’s going to be much more difficult to be able to obtain claims to those unless you’ve shown some unexpected property. And I think in the biologics area the same applies to antibodies as well. So if in the past you were relying just upon a sequence dissimilarity between yours and that of the prior art, I think today, in that same area, you also have to now consider providing some unexpected properties where perhaps your antibody has a higher affinity or has a higher half-life or some form of unexpected properties that perhaps was not as critical before but it is now.

Pharma IQ:
With regards to patenting antibodies you’ve been mentioning, what are the main pieces of case law that are impacting patenting in this area right now?

V Kohli:
I think the four cases that come to my mind are, number one, KSR, which is the obviousness case, which is the so-called Big Mama of all obviousness cases. The second is In re Kubin. I think even though In re Kubin applied to cDNA in protein, I think the implications are that perhaps it may get a little… some practitioners, at least in the US, have taken the position that perhaps it may also have an impact on antibodies patent claims. And then, when you look at In re Kubin in light of In re Sullivan, there’s some light at the end of the tunnel in that you may be able to forget… so some antibody claims may be sequence-specific or CDR-specific, but perhaps it’s an issue of some unexpected properties.

The last case, I think, that has an impact on getting broad antibody patent claims, although there’ll be some conflict with ARIAD in terms of it in description, is the Noelle v Lederman case, where, if you are the first one to have identified and characterised a novel antigen, the courts have taken the position, as has the Patent Office in its written description manual, that it will allow you to claim any antibodies without antigens by the mere fact that possession of the antigen gives you possession of the antibody. So it does have an implication in that if you are coming into the field with a novel antigen you may be able to get much broader claims than someone who’s coming into the field with an antibody to a known antigen.

Pharma IQ:
How does each of these cases impact the strategies of the internal business units?

V Kohli:
I think it forces you or at least impels you to go back and talk to your clients and ask them for more specific data per se in terms of trying to get broad claims allowed, on one hand, assuming it’s a known antigen. On the other hand, if you want to get much broader claims then you have to somehow convince management of your company, whether big or small, to perhaps expend some more research expenses in terms of identifying novel antigens so you can get claims to a broad antibody. And I have seen some patent claims, from at least one biotech company from California, where, if you look at the patent claims, the novelty resides in possession of the novel antigen and therefore they’re now trying to get very broad claims to any antibody that binds to that antigen.


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