Raising the bar for post-grant oppositions: Lessons on procedure and evidence post the Valcyte ‘post-grant opposition’

The recent decision of the Patent Office in the post-grant opposition against Roche’s patent for Valcyte has spurred some interesting discussions on this blog. Most of these discussions, however, have centred on an analysis of the decision from a pure patent law perspective. In this post I would like to raise some policy and practical questions on the issues of procedure and evidence that are followed in post-grant oppositions. Before that however I would like to briefly comment on the constitutionality of the post-grant opposition mechanism.

Image from here.

A. Is it ‘arbitrary & unreasonable’ for the procedure followed in a post-grant opposition to be different from the procedure followed in a revocation proceeding?

To put it very briefly, the entire aim of this portion of the post, is to prove that is unconstitutional for the Patents Act to prescribe different procedures for challenging a patent in different forums. While the analysis below is restricted to a comparison between the Patent Office and the High Court, the same analysis could extend to even revocation proceedings before the IPAB.

Currently the procedure followed by the Patent Office in a post-grant opposition (u/s 25) is as laid down in the Patent Rules, 2003. The post-grant opposition mechanism is initiated by the opponent issuing a notice of opposition under Rule 55A. On receipt of the notice the Controller is required under Rule 56 to set up an Opposition Board consisting of 3 members, one of whom is required to be an examiner. The Opposition Board then considers all the grounds of the opposition, the patentee’s reply statement, along with any evidence filed by either party and the Board then submits a detailed report to the Controller on each ground of opposition. Subsequent to this the Controller fixes a hearing at which both parties present oral arguments after which he renders a decision.

The procedure followed in a revocation proceeding before the High Court is governed by the Code of Civil Procedure, 1908 and has little resemblance to the procedure followed by the Patent Office in a post-grant opposition. Some of the main differences are as follows:

(i)There is no Board of Opposition advising a judge in a revocation proceeding;
(ii)The eligbility criteria for being a judge of the High Court and a controller in the patent office are completely different – in effect you have two differently qualified people deciding identical issues;
(iii)The procedure followed by the High Court is laid down in the Code of Civil Procedure and is much more rigorous than the post-grant procedure which is prescribed by the Patent Office Rules. A revocation trial in the High Court would have additional stages such as the ‘framing of issues’ wherein the Court delineates the facts in dispute and clearly assigns the burden of proof to either party. For example if the opponent was opposing a patent on the grounds that the patentee has failed to demonstrate increased efficacy under Section 3(d) then in that case the onus of proof should ideally be on the opponent to prove the same. To this end, the opponent will have to lead evidence. The patentee’s only duty is to find flaws in the evidence led by the opponent.

Article 14 of the Constitution and ‘equal protection’: Article 14 of the Constitution which ensures the ‘Right to Equality’ to all citizens is one of the most sacred fundamental rights in the Constitution. One of the basic principles of Article 14 is the right to ‘equal protection’, which incidentally is borrowed from the ’14th ‘ Amendment to the U.S. Constitution. The ‘Equal Protection’ doctrine allows the legislature to reasonably classify different subject matter into different classes and to treat each class differently provided that such classification bears a rational nexus to the objectives of the statute. This is the supporting legal framework for reservations in educational institutes i.e. the legislature is well within its right to classify the population into forward and backward communities and to give preferential treatment to the backward community. The state however will have to treat all subject within each class equally. Any discrimination between the members of the same class will be ultra vires Article 14 and struck down as unconstitutional.

Both a revocation proceeding before the High Court and a post-grant opposition before the patent office are aimed at the same result – to ensure the knocking down of patent from the register of patents. Since both proceedings result in an identical result, they both fall into the same class and there is no reasonable basis to differentiate between the two. Once it is established that both proceedings fall within the same class, then in that case there is no reasonable basis to establish two different procedures for the same class of proceedings. Any attempt to to do so would be arbitrary, unreasonable and unconstitutional.

To briefly summarize the above: It is unconstitutional for Parliament to have provided for two different procedures to strike down a patent.

B. Issues of procedure in the Valcyte post-grant opposition:

(i)Rule 56(3) of the Patent Rules: This Rule clearly states that “The examiner, who has dealt with the application for patent during the proceeding for grant of patent thereon shall not be eligible as member of Opposition Board as specified in sub-rule (2) for that application.” While I am yet to receive final confirmation on this, it appears that in regards, Patent No: 207232 for Valcyte, the examiner who handled the application was also a member of the Opposition Board. From a perusal of both the pre-grant opposition order and the post grant opposition order it appears that the Examiner of Patents Dr. Bindu Jacob was on the Panel hearing arguments in both proceedings. Since the pre-grant opposition is essentially dealing with the patent application, it is but curious as to how the same examiner was a member of even the Board of Opposition despite the express prohibition in the Rules. It is even more curious as to why neither party objected to this violation of the Rules.

(ii)Same Controller heard both the pre-grant opposition and the post-grant opposition: Both the pre-grant opposition and the post-grant opposition were heard by the same Controller – Dr. S.P. Subramaniyan. Basically the decision to grant the patent was made by the same person who ended up revoking the patent. This is strikingly odd since it is highly irregular for any institution to allow the same person to hear arguments against his previous orders. In fact you may even say it is against the principles of natural justice. This is precisely the same reason that Mr. Chandrashekran (IPAB) was not allowed to hear the Novartis, Glivec, appeal to the IPAB. The fact that neither party objected to Dr.S.P Subramaniyan hearing the dispute, speaks very highly of the credibility enjoyed by him in the eyes of the IP Bar. Nevertheless institutions are built on rules and not personalities. To that extent this is an unhealthy precedent and I’m informed that there are already some Patent Office circulars aimed at avoiding such a repetition. Once again it is strange that neither party objected to him adjudicating the dispute.

(iii)The recommendations of the Opposition Board: Under Section 25(3) of the Patent Act, the Controller is mandated by law to constitute an Opposition Board. The role of the Opposition board is to consider the written pleadings and evidence of both parties and to submit a report of its recommendations to the Controller who is hearing the Opposition. As per Rule 62(5) of the Patent Rules, “After hearing the party or parties desirous of being heard, or if neither party desires to be heard, then without a hearing, and after taking into consideration the recommendation of Opposition Board, the Controller shall decide the opposition and notify his decision to the parties giving reason therefor.” The Controller is then bound by the law to consider the recommendations of the Opposition Board. Although he is not bound by the recommendations of the Opposition Board he will still be bound to take into consideration the recommendation of the Report, meaning that he will have to give reasons for disagreeing with the Opposition Board. I briefly perused the Order of the Controller in the Valcyte post-grant opposition and I could not find even a single reference to the Recommendations of the Opposition Board. Contrast this with the brilliantly detailed Order passed by Mr. T.V.Madhusudhan in the post-grant opposition against Roche’s Pegasus patent. In his Order, Mr. Madhusudhan clearly reproduces the recommendations of the Opposition Board after which he also gives cogent reasons for either agreeing or disagreeing with their recommendations.

Since the Valcyte Order is bereft of such reasoning, would it be possible for the aggreived party to seek the setting aside of the Order on the grounds that the decision has not been rendered as per the procedure laid down by the law?

C. Issues of evidence in the Valcyte post-grant opposition: – ‘Its not what you know, its what you can prove’

The question of evidence in patent trials is always pretty dodgy. This is partially due to the reason that the requirement to lead evidence arises only when there is a dispute of fact. Obviousness however is usually a mixed question of ‘fact and law’. The question therefore being whether expert opinion should be limited to questions of fact or whether it can extend beyond that to an opinion on the law. Moreover if such opinion is introduced, should the Controller be bound to consider the same in his decision. In the context of the Valcyte post-grant opposition there are more specific issues that arise and are as follows:

(i) The Opponents’ Section 8 arguments: The Opponents Section 8 argument which basically demands the patent to be revoked on the ground that the patentee had failed to specifically disclose office actions for the corresponding patent application in foreign patent office such as the USPTO. This ground is probably one of the easiest grounds on which one can oppose a patent. The Controller however was compelled to reject this argument on the ground that the evidence led by the opponents in this regard was not duly authenticated. The Opponents surprisingly presented only a printout of the USPTO prosecution history of the corresponding patent. The Evidence Act 1872 clearly specifies the manner in which a document is to be proved under Indian law. For example a computer printout is inadmissible unless it is accompanied by a Section 65B affidavit by a technical expert testifying that the printout is authentic and not tampered with. In the case of a foreign document the Evidence Act prescribes a procedure to get such documents authenticated. It is surprising that the Opponents missed these points in such a high stakes matter. It maybe prudent that the Patent Agent examination be revised from next year to include even the law of evidence as a compulsory subject.

(ii) Cross-examination of witnesses: This is more of a comment on the legal strategies followed by either party. The post-grant Order makes reference to evidence affidavits filed by Roche. Although the Order does not clarify, I received independent confirmation that even the Opponents filed several evidence affidavits in opposition to Roche’s evidence affidavits. The question that I would like to pose to our readers is whether or not cross-examination makes a difference in a revocation action. Under S.79 of the Patents Act, the Controller has the power to allow for cross-examination of any witnesses. Therefore both parties had a right to cross-examine each other’s witnesses on the evidence affidavit that they had previously submitted. In my opinion cross-examination can make all the difference in a revocation trial, especially for the patentee. It is only in cross-examination that the patentee can pose direct questions to the opponent, through his witnesses and therefore attempt to put in perspective the testimony of the expert witness. At the end of the day obviousness is mostly a question of probability. The degree of probability in a witness’s opinion can be adequately clarified only through a good cross-examination. A crucial admission by the opponent’s witness during cross-examination can alter the entire nature of a trial. This is precisely the reasons that a trial is so crucial in the common law system. Given the stakes at hand and the fact that Roche already had a patent in its hand, it is doubt able as to why exactly they did not opt for cross-examination of the opponent’s witnesses. Better safe than sorry!

Conclusions: While the Valcyte post-grant opposition had been commended for its reasoning on the issue of obviousness there is still a lot to be done to raise the level of adjudication before the Patent Office. This burden however rests not only on the patent office but also the legal practitioners appearing before it. It is their duty to guide the patent office in its actions. To that extent the success and failure of the Patent Office will have to necessarily be shared by legal practitioners. While there are other issues that I wanted to discuss in this post, I will save it for another day which is not a Sunday.