University of Miami Wins Appeal at IPAB over Cancer Drug Patent ‘Coenzyme Q10 Formulations and Methods of Use’

For the fourth time in past two months the IPAB allowed an appeal against the order of the Controller and granted patent in favor of the appellant. The IPAB through order dated 25th August, 2020, (pdf) allowed an appeal against the Controller of Patents’ (Respondent) rejection of  the University of Miami’s (Appellant) application over a pharmaceutical composition comprising “Topical Co-enzyme Q10 (CoQ 10) Formulations and Methods of use” for treatment of cancer. Among other reasons, the Controller had deemed that by introducing changes to the principle claim, the appellant “changed the direction of the invention” as under the specification on record. And that as per the present disclosure, the specification lacks technical data to establish enhancement of efficacy and thus is not patentable under section 3(d).

The Board, hearing the appeal ex-parte, overruled the Controller’s 2015 order and held that it had been passed “without applying the relevant laws”. The Board termed the order to be “vague” and regarded the claims of the appellant to be novel and inventive. Notably, the Board ruled that filing of additional documents to overcome objections is allowed under Indian patent law. In this post I will discuss the specific aspect of the dispute surrounding filing of additional documents/ data by the appellant and the respective stance of Controller and the Board on the same.

The Bench which granted the present order consisted Justice Manmohan Singh (Chairman) and Dr. Onkar Nath Singh (Technical Member (PVPAT)). It is noteworthy that despite the supposed appointment of a Technical Member (Patents) (pdf), the patent matter was heard by the Technical Member (PVPAT).

Background

The facts of the present disputes aren’t laid down clearly in either of the orders and therefore, I’d suggest the readers to go through the orders once. However, I have made an attempt to cover the relevant portion of the factual matrix here. The appellant filed the National Phase Application on 25th July 2006 (application no. 2090/KOLNP/2006). The composition was explained to comprise CoQ 10 and a pharmaceutically acceptable carrier (in this case liposomes).

Of the 37 initial claims (pdf), the first examination report (FER) raised objections to 25 claims, stating that 24 claims attracted application of Section 3(i) and that the first claim did not sufficiently define the invention. Consequently the appellant amended those claims and revised the first claim by limiting it to be directed to liposomal composition for the treatment of cancer comprising 0.01 to 30% w/w CoQ10 and a liposome for topical and intravenous administration. The appellant submitted further information under Section 8, before the hearing, on three different occasions- 25th December, 2011, 2nd September 2013 and 22nd July, 2013, post the publication of the application on 18th May, 2007. The appellant had also filed experts affidavit on 27th February, 2014.

Controller’s Order for Rejecting the Application

After holding the hearing on 2nd August, 2013, the Controller put forward a short 1 page order on 27th February, 2015, rejecting the application on three grounds:

1. That the additional documents submitted by the appellant to explain the post research scenario, were grossly substantive and result of further research on the specification on record – thus barred by Section 59 of the Act
2.  The revision of claim, combining the carrier liposome with active drug molecule, (CoQ10) and evidence for enhancement of activity (as proposed by further documents) was beyond the scope of specification made and was not added to the specification within the stipulated time.
3. That the specification on record lacks technical data to prove enhancement of efficacy and thus the ‘invention’ can not be acknowledged to involve an inventive step and is not patentable under section 3(d) of the ’Act.

Additionally, The Controller’s order also stated that use of liposome as a carrier is already known in the art. The order further stated that even though the Controller held that the revised claim was beyond the scope of the specification and not added in time, the Controller also said that the revised claim is barred by section 3(i) (method of treatment) and thus registration of the patent in such case cannot be allowed.

Analysis of the IPAB’s Decision

Since no representation on behalf of the Controller was made, the Board solely relied on the arguments made in the appeal filed by the appellant and reiterated the same, in the order.

The Board accepted the appellant’s arguments that the Controller violated principles of Natural Justice by not making an objection on the basis of section 3 (i) and not specifying the reasons for rejecting the application on ground of sections 3 (d) and 3 (i). The order of the Controller was found to be a non speaking order. As per established law, (Board decision in Order no. 08/ 2014 (side note: I wasn’t able to locate this order)) the order must include details regarding grounds for refusal, and reasons for the same.

On the issue of the expert affidavits being disregarded by the Controller, the Board said there was again a violation of Natural Justice, holding that the  additional documents to be merely supportive of the original claim, and that these claims were within the scope of application, as filed originally. The Board relied on three rulings given by US courts namely Genetics Institute, LLC. v. Novartis Vaccines And Diagnostics, In re Khelghatian, Knoll Pharmaceuticals Company, Inc. v. Teva Pharmaceuticals USA, Inc. to rule that “Filing of additional documents, data and evidence in support of the invention, to overcome the objection raised and to attack a specific objection is something which is allowed under the Patent Law on not only India but also other foreign jurisdiction”. The Board, however, didn’t mention either an Indian case law or any provision under the Patent Act, Rules to elaborate on the above.

It must also be highlighted here that the Controller under its order objected to such filing documents/ data after the “stipulated time period,” and not the filing per se. Interestingly, the Board nowhere accepts or rejects this observation of the Controller and neither does it clarify if such additional documents can be filed beyond the prescribed time period. Looking at Rule 28 A r/w Rule 28 (7) of the Patent Rules, it is clearly stipulated that “In all cases of hearing, written submissions and the relevant documents, if any, shall be filed within fifteen days from the date of hearing.” In the present case the appellant had filed the affidavits of the experts on 27th February, 2014, six months after the hearing had taken place (2nd August, 2013).

Considering the facts of the present case where neither the Controller nor the appellant adhered to the prescribed timelines, one would expect that the Board would have taken a strict stance on this issue as it has done recently in the case concerning revocation of Ibrutinib, covered by Adyasha here. However, no such observation was made by the Board.

Side Notes

Another broader observation from not just this order but some other recent orders as well is  that the Board quizzed the Controller for not acknowledging the foreign registration over the similar invention. It recently made a similar observation in Health Protection Agency v. Controller General of Patents (pdf) and in the recent Ibrutunib order (aforementioned post by Adyasha) as well. I’m not aware if this is part of a larger trend, but, it must be mentioned here that the Board  in Novartis v. Union of India, rejected this notion stating “... we can not accept the argument that patent grant in other countries would have any persuasive value on the grant/refusal of patents in India.” The Supreme Court too in the appeal, indirectly acknowledged this.

A trend which has crept in the litigation proceedings before the Board is that no representation of the office of the Controller is made in crucial hearings. In this appeal too, the Board in para 32 of the order observed that “No one appeared when the appeal was heard. No written argument was filed by the respondent. We have gone through the record as well as the facts stated in the appeal. The said facts and legal issues are not rebutted on behalf of the respondent.”

This is not the first time when no representation on behalf of the Controller is made before the IPAB. In fact on a preliminary search on the patent orders section of the IPAB website one can see that out of the total 51 orders present on the website (where are the other orders?), passed across the benches of the board, no representation on behalf of the Controller was made in any of the cases! 11 out of these 51 orders were orders concerned with appeal against the rejection of patent applications by the controller and the Board granted patents in all 11. In almost all the orders (barring few which were concerned with adjournment or withdrawal of applications), dealing with substantial issues, the Board observed that no written representation has been made by the Controller in any of them. One wonders why despite rejecting the applications and after giving reasons for it, the office of the Controller hasn’t made any representation before the Board in any of the appeals.