Valgancyclovir Hearings and the Need for More Transparency

The parties to the opposition involved Roche (the patentee, represented by Pravin Anand of Anand and Anand) and the following opponents:

i) Cipla (represented by Majumdar and Company)
ii) Bakul Pharma (represented by Majumdar and Company)
iii) Matrix Labs (represented by Feroz Ali)
iv) Indian Network for People Living with HIV/AIDS (INP+ (represented by Anand Grover)
v) Tamilnadu Networking People with HIV/AIDS (TNNP+ (represented by Anand Grover)
vi) Ranbaxy (represented by Lakshmikumaran of Lakshmikumaran and Sridharan)

Quality of Opposition Decisions?

With this stellar line up, one hopes that the final order will be a well reasoned one. In an earlier post, we mulled the likelihood of sound decisions coming out of the customs office, if such office were the beneficiary of an “adversarial” process, in which high caliber attorneys participated. Given that the patent office has significantly greater institutional competence in dealing with patent matters (unlike the customs office), it is more likely that an adversarial process will lead to better quality decisions.

Unfortunately, it may be a while before we get such a “sound” decision in the Valgancyclovir case. The matter was not really “heard”, as several opponents alleged that the affidavit evidence filed by Roche (about 1000 pages in all!) was taken on record without intimating them. As a result of this, they claimed that they did not think it necessary to file any reply to Roche’s evidence.

Two of the opponents also contended that the affidavits filed by Roche were not properly notarised. As for the first objection, the patent office stated that Roche’s evidence had been taken on record. However, in order to offset any inconvenience to the opponents, the office offered more time to the opponents to file their replies.

As for the second objection, it is not clear if the patent office will treat the improper notarisation as a substantive error, meriting a dismissal of Roche’s evidence or as a mere technical error that could be corrected.

Likely Delays?

In the light of these delays, one wonders if the proceedings are likely to be completed within 8 weeks time (from date of filing of rejoinder affidavit by patient groups), as directed by the Supreme Court of India. The Supreme Court order permitted patient groups to take part in the post grant opposition proceedings, as an exception, without delving into whether or not they had locus standi to do so.

It is not clear as to who would benefit from the delay. On the one hand, since the patent has already been granted, any delays in the post grant proceedings would benefit Roche. On the other other, since Roche has a pending patent infringement suit against Cipla and no injunction has been granted to restrain Cipla, any delays would benefit Cipla, as they are free to introduce generic versions of their drug in the interim. As to whether they have done so in practice is not known to me.

Post Grant Opposition: Proposal for Reform

Under section 25 (3) and (4) of the Patents Act (and the corresponding rules), the opposition procedure is to be conducted in the following manner:

i) The Controller constitutes an opposition board, to whom copies of the opposition and the reply (by patentee) are forwarded. The Board is to consist of 3 members and the Controller appoints one of them as Chairman. Based on the written submissions, the Board forms an opinion, which is then communicated to the Controller. This opinion of the Board is not communicated to the parties or the public.

ii) The Controller reviews the opinion of the Board and offers an opportunity for hearing to the parties concerned. He/she then issues a final decision which is then communicated to the parties. This decision is then appealable to the IPAB (Intellectual Property Appellate Board).

The above process appears to be an unduly long winded and inefficient one. Wouldn’t it be far simpler to constitute a Board (with 2 Controllers and one examiner) to review the matter once and for all? In other words, the Board reviews the written submissions and also hears the parties. At the end of this consolidated process, a decision issues. Given that Controllers do not anyway examine patent applications in the first instance, couldn’t we make better use of their talents during opposition proceedings?

I recommend that the Board consist of two controllers and not one for the reason that if the Board were to be otherwise (consisting of 1 Controller + 2 Examiners), we might have no possibility of dissent, as examiners might tend to defer to the Controller.

A two stage process, with an initial review and opinion by the Board and a denovo review of this by the Controller, seems a waste of time and resources. And to this extent, a Board that reviews the post grant opposition at the first instance and issues the final decision as well might make for a quicker and more efficient process.

Secondly, the post grant process needs to be conducted in a manner that provides against any sort of bias. For one, the Board should not consist of any examiner or Controller that was in any way involved with the prosecution of the patent at any of the earlier stages. The patent rules provide for this, but are worded to apply only to examiners: it should be amended to extend to Controllers as well.

Secondly, it would be far better to have the opposition decided by an office that is different from the granting office. In other words, if the Chennai office granted the patent, the opposition must be reviewed and decided by the Mumbai office. Given the possibility of officers within a single office being close to one another, one cannot rule out the possibility that a Controller from Chennai may be disinclined to overrule the earlier grant of the patent by his fellow officer from the same office. Given that most of us are susceptible to what is commonly termed a “confirmation bias”, one must provide for a variety of measures to retain the independence and objectivity of officials who decide patent oppositions.

Thirdly, and perhaps most importantly, the opinion of the Board to the Controller must be made public. In the pegasus post grant opposition, Deputy Controller, Madhusudhanan went out of his way to not only mention that he disagreed with the Board, but also to spell out their opinion and why he disagreed with it. It is a very well reasoned decision and I will bring you a separate post on this shortly.

Need for More Transparency

Can we hope for this sort of transparency with other Controllers that decide post grant proceedings? Wouldn’t it be far better if our CG, PH Kurian issues an order stipulating that all such opinions shall be made public? In fact, this was one of the requests in our petition calling for more patent information to be made public. We collected more than 250 signatures and we want to thank our many readers for their continued support to this cause.

Having begun the “transparency” mission in 2006, I am still singing the same song…not least because of my firm firm belief that greater transparency is the one of the most effective ways in which we can hope to improve the functioning of the Indian patent office.