Last year, we had blogged on a writ petition filed by Glochem Industries against the grant of a patent to Cadila healthcare pursuant to a pre-grant opposition filed by Glochem. Cadila’s application (now a patent) concerned Crystalline form of Clopidogrel Besylate, which is used to prevent clotting of blood and in treatment of cardiac ailments.
A regular reader of SpicyIP, Sandeep K. Rathod, recently brought to our notice the decision of the Deputy Controller of Patents (Mumbai Office) in a review petition filed by Ind Swift Industries under Section 77 of the Patents Act. The petition called for review of the Deputy Controller’s decision in an unsuccessful pre-grant opposition to Cadila’s application by Ind Swift industries.
Prior claiming, lack of an inventive step and Section 3(d) were again raised in the review petition by Ind Swift.
Prior Claiming under Section 13(1)(b)
Ind Swift cited an Indian Patent Application (Let’s call it Application X) to raise the ground of prior claiming under Section 13(1)(b) of the Act. Section 13(1)(b) permits the use of an earlier filed but later published Indian complete specification to allege anticipation of a particular patent application. In this case, Cadila’s application was filed on April 25th, 2003 and Application X was published in 2005, but filed in February 2003.
Ind Swift contended that X was earlier cited by Cadila to oppose a European patent application 1480985 as relevant prior art. Consequently, according to Ind Swift, Cadila could not conveniently dismiss Application X as irrelevant for the purposes of evaluating its own patent application; more so, when Cadila itself had taken the view that Application X disclosed an industrially suitable procedure to synthesize pharmaceutically acceptable salts such as besylate and the need for a crystalline form of the salt.
Consequently, since in the European proceedings, Cadila had taken the view that a salt of benzenesulfonic acid with Clopidogrel which had a crystalline form was not novel and hence unpatentable, its own patent application too had to be held unpatentable.
The Deputy Controller took the view that Section 13(1)(b) requires “prior claiming” as opposed to mere lack of novelty. In other words, if Ind Swift’s purpose was to assail the claim of novelty in Cadila’s application, it could have relied upon Section 13(2) because the provision permits use of patent and non-patent literature to prove anticipation. He held that Application X did not “claim” the embodiments of Cadila’s application and therefore, Section 13(1)(b) did not apply to the case.
One wonders if the Deputy Controller would have taken a view in favour of Cadila if Section 13(2) had been raised instead of Section 13(1)(b)…
Inventive Step
Ind Swift contended that Cadila’s application was obvious in light of the teachings in US4847265. The Deputy Controller affirmed the view taken in the decision and held the application to be non-obvious. According to him, the US patent disclosed various salts of Clopidogrel, most of which were amorphous, and hence difficult to handle. On the contrary, Cadila’s application dealt with the crystalline form of Clopidogrel besylate which the US patent implicitly acknowledged as difficult to manufacture. Therefore, since the US patent dealt with amorphous salts, a case for obviousness had not been made out against Cadila’s application.
Section 3(d)
Ind Swift cited a couple of documents on studies which compared the efficacy of crystalline clopidogrel besylate with clopidogrel bisulphate and clopidogrel hydrogen sulphate and concluded that there was no “overall significant difference” in the antiplatelet effect of the crystalline form.
The Deputy Controller however affirmed the decision given in the pre-grant proceedings based on the material submitted by Cadila during the examination and opposition proceedings. He endorsed the view taken in the pre-grant order, wherein it was held that crystalline clopidogrel besylate “has superior beneficial properties, which greatly enhance its commercial value”.
Comparing clopidogrel bisulphate and crystalline clopidogrel besylate, he observed that the concentration of the inactive metabolite increased over a period in the former thereby reducing the therapeutic efficacy of the drug. On the contrary, no inactive metabolite was detected in crystalline clopidogrel besylate claimed by Cadila, which increased the shelf life of the drug.
On the issue of stability, he observed that the pure crystalline form remained stable and free-flowing after 2 months even when compared to solvated forms of crystalline clopidogrel besylate. Also, the pure crystalline form was found to be less cardiotoxic than the solvated form.
In view of the above, the Deputy Controller held that Cadila’s application did not attract Section 3(d).
In this decision, the Deputy Controller avoids, or probably desists from discussing numerical limits to be set in understanding what constitutes “enhanced efficacy”. He seems to take an approach, where a host of characteristics which contribute to enhanced efficacy of the drug, would be relevant for the purposes of evaluating it on the anvil of Section 3(d). Importantly, such factors could include enhanced shelf-life of the drug as opposed to pure therapeutic efficacy of a certain dosage.
I am not sure how much of a departure this is from the jurisprudence evolved on Section 3(d) thus far, but it doesn’t seem to be inconsistent either.
We would like to hear the opinion of our readers on the decision.
We thank Sandeep Rathod for bringing this decision to our notice.
Please ask the then Deputy Controller to see through the real glasses of 3(d) unless his palms were greased/ or eyes were blurred……..
This reflects a very true case of being biased to desi pharma companies….
But, I will reserve by judgments till I can bring forth more orders of this nature in favor of desi pharma compnaies….
I too think there is some thing amiss here.
All in the practice know how the previous controller gave the order at last moment and has been placed under vigilance enquiry (enquiry is public domain news – not my gossip).
Additionally, though I usually like the way Ruchi madame writes her orders, in the current case, I do not see the logic clearly – partly because the original order of Hafeez in this case is NOT in public domain and hence the over reliance on an order that is not in public domain is slightly uncomfortable.
Finally, I do have a problem with the logic here – from what I understand (and I may be completely wrong) is that the Applicant proved bio-equivalence for this ‘new’ salt with the currently marketed salt. If its bio-equivalent, then how was enhanced efficacy established??
Regards,
Freq. Anon.
The Application has matured into a patent – IN242111.