Ever filed a patent application and have a rejection issued without any explanations? With the recent IPAB order, hopefully we won’t be having more of that anymore.
In this case the patentee/appellant (Plough Schering now Merck) had filed a patent application claiming a particular crystalline form of a thrombin receptor antagonist, Vorapaxar. In 2009, the patent office passed an order rejecting the patent application under Section 15 citing lack of inventive step and lack of proof regarding therapeutic efficacy of the crystalline form. The IPAB opined that the patent office had not sufficiently articulated reasons for refusing the patent and set aside the order. The IPAB then directed the patent office to consider the matter afresh by affording sufficient reasonable opportunity to the applicant/appellant to substantiate/amend their claims. The IPAB order can be accessed here.
Image from here
The patentee had filed a patent application 2491/CHENP/2006 claiming a particular crystalline polymorph of a bisulfate salt of Vorapaxar characterized by X-ray diffraction. Vorapaxar is a thrombin receptor antagonist used in the treatment of acute coronary syndrome chest pain and is touted to become a blockbuster drug as the FDA panel recently voted in favor of approval. I couldn’t access the complete specification but the corresponding PCT application discloses that the crystalline polymorphic form is more stable and has improved thermodynamic properties over the parent compound. The Assistant Controller passed an order on June 2009 refusing the patent application on the grounds of lack of inventive step [Section 2(i) (j) (a)] and lack of evidence of enhanced therapeutic efficacy of the crystalline form [Section 3(d)].
The counsel for the patentee/appellant argued that the claims and contents raised by the appellants weren’t properly considered by the Controller and that the order did not sufficiently articulate reasons for refusal of the patent. The counsel for the Controller however contended that enough reasons were included in the order.
The IPAB order
The IPAB criticized the patent office order stating that it was very cryptic and a non-speaking one. The IPAB opined that the claims raised by the appellant were not considered in their entirety by the patent office. It also reasoned that Section 15 of the patents act affords opportunity to the applicant to make amendment in the application or to refuse the application on failure to submit any amendments.
Section 15 reads hereunder:
“Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not comply with the requirements of this Act or of any rules made thereunder, the Controller may refuse the application or may require the application, specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the application on failure to do so.”
The IPAB further added stating “The reading of the above said provisions makes it abundantly clear that the learned Controller ought not to have mechanically refused the application and on the other hand he could have exercised discretion to give opportunity to the applicant/appellant by making amendments in the application.”
I partially agree with the IPAB’s order and think that the patent office decisions leave much to be desired in terms of articulation skills and analytical rigor (read our previous posts on this here and here).
Having said that I also feel that, when an applicant submits a patent application with a claim for a crystalline polymorph form, they should have substantiated the claims with proof of enhanced therapeutic efficacy in the specification in the initial stages itself. After all, the Supreme Court in the Novartis decision (see Prashant’s analysis of the Novartis decision over here) made it abundantly clear that efficacy in the context of Section 3(d) should be construed as therapeutic efficacy. “What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.” For more on Section3 (d) and interpretation of the term efficacy, please read Shamnad’s paper here.
A note of caution: Foreign patent applicants.
Section 3(d) is unique to the Indian patent act. Foreign applicants typically seek patent protection by filing PCT applications designating India. Since proof of efficacy for patent applications relating to crystalline form of pharmaceutical drugs is a uniquely Indian requirement, oftentimes the specification does not include data showing proof of enhanced therapeutic efficacy and arenot specifically tailored to suit Indian patent law requirements. As a result lot of patent applications (belonging to foreign MNC’s/ applicants) end up getting refused/invalidated. Proof of enhanced therapeutic efficacy for Section 3(d) is indeed an onerous requirement, but any slackness in compliance can adversely affect the validity of the resultant patent.