On 29th June, 2015, Justice Manmohan Singh of the Delhi High Court upheld BMS’ patent for anti-cancer drug Dasatinib (marketed as Sprycel). Read the judgment here.
The tussle between US-based multinational Bristol-Myers Squibb and BDR Pharma, a mid-sized Bombay based company over Dasatinib goes back several years. It first came into the limelight in 2013 when BDR filed for a compulsory license for Dasatinib, citing the exorbitant price of the drug at present. However, the application was rejected as the authorities found that BDR had not acted in good faith during the negotiations for a voluntary license preceding the application. Subsequently, there was news that the Health Ministry was keen on a compulsory license under S.92 of the Patent Act, which allows the Government to initiate CL proceedings on its own. This also seems to have fizzled out.
However, it appears that in 2009, BMS filed a suit for a qua timet injunction against BDR as it suspected that BDR was planning on marketing dasatinib, based on the fact that the latter had applied to the DCGI for the requisite approvals. BDR in turn alleged (among several other minor claims) that the patent in dasatinib is invalid as it doesn’t pass the non-obviousness test and that in any event, the public interest lies in granting an alternative remedy such as ongoing royalties instead of an injunction. Among the arguments for invalidity of the patent was under S.3(d).
However, the S.3(d) analysis in the judgment is convoluted. The judgment does not disclose the exact arguments raised by BDR apart from that the patented compound in question is a mere derivative of a previously-known compound. The relevant paragraph of the Court’s analysis is reproduced below:
“…assuming for the sake that the defendants plea that the suit patent compound is a derivate of the known compound, still Section 3 (d) cannot be pressed in to service till the time the compound involved in the patent is efficacious. It is true that the plaintiffs have not proved this position by way in vitro or in vivo tests to show the efficacy, but that is the stage of the evidence to show and prove that the product is indeed efficacious in nature. At this prima facie stage, the wholistic reading of the plaints along side the written statement and the attendant circumstances where in the defendants are also equally inclined to launch this product itself shows that the efficacy is involved in the product in treating the ailment”
Such an understanding of S.3(d) is extremely puzzling: The provision, the intention behind which is to prevent ‘evergreening’ of patents by patenting minor modifications to previously patented inventions, does not deal with the overall efficacy of the invention itself. It is quite clear that the provision requires that the compound display enhanced efficacy over the previously known compound. The present judgment has very conveniently interpreted S.3(d) to only require that the patent be efficacious. While it can be conceded that it could be difficult to prove or disprove enhanced efficacy (which has to further be therapeutic efficacy for pharma compounds) at a prima facie stage, it is still a powerful tool in the hands of anyone who is interested in preventing evergreening of important patents and promoting access to medical care. The fact that such a simplistic reading was undertaken by the Court is indeed unfortunate.
BDR also argued that the drug in question is important in the treatment of Leukemia and is exorbitantly priced at Rs.1,67,000 for a month’s course , putting it outside the reach of the majority of the Indian population. Therefore, they argued, in infringement proceedings, the public interest lies in avoiding interim injunctions and granting other reliefs such as royalties, so that patients may benefit from cheaper drugs in the market. Our readers may recall that the same legal strategy was followed recently by Cipla against Novartis with respect to the Onbrez patent (read Spicyip coverage of the same here). Justice Manmohan Singh who adjudicated that decision as well held that where there the patent is prima facie valid and infringement is established with no credible defense, public interest cannot be a valid consideration for not granting an injunction. He alluded to the decision in the present case and held that the same reasoning applies here as well. The considerations here are slightly different as this is a qua timet injunction, i.e. it is based on an expectation of harm rather than actual harm. However, BDR has conceded that it plans on launching the drug in India.
Overall, it is puzzling why BDR would argue that it should get away by paying royalties pending an infringement litigation, especially when the mechanism of Compulsory Licensing under S.84 of the patents act serves the same purpose. It is true that Sprycel is exorbitantly priced in India and that it is a drug that can potentially save lives. The compulsory license provisions in the Indian Patent Act exist to serve exactly such situations. BDR’s previous attempt at a CL was rejected only because it did not negotiate for a voluntary license in a bonafide manner. We wonder what stops the company from re-negotiating and applying for a CL again.
Spadika, are we all NOT reading too much into an order that on O.39 aspect? Let’s face it, the strategies / submissions adopted by companies are not always reflected in the Orders and for the Judge too has made comment as Obiter which are being taken up by reporters/ media and not all of the Order is touching at the core points.
In the present, the Order was making an interim injunction final, till the completion of Trial. As you would note, BDR’s conduct has not necessarily been completely understandable in the Dasatinib context.
(1) If one tries to obtain a compulsory license and upon failing in getting the same, challenges the validity of the patent, wouldn’t that be barred by principle of estoppel? I know that the public interest involved in such cases is enormous and technicalities shouldn’t supersede the substance but I just want to know if it is a possibility.
(2) When a patent is invalidated, what happens to the consumers who spent large sums of money for purchase of the patented articles during the validity of the patent?
This is the most boring judgement that I’ve ever read. The Judge had a great opportunity to lay down some jurisprudence on the seeking license = acknowledging validity estoppel issue. However, instead of tackling this issue which will certainly keep coming up, he simply side-stepped it because he had already found the patent to be prima facie valid!
I don’t think that you can ever be estopped (in personam) from challenging a monopoly right (in rem). But at the interim stage it should certainly be a valid consideration.