Patent

Patenting Pegasus: From Flights of Fancy to Firmer Legal Moorings?


By most accounts, India’s specialised IP tribunal, the IPAB (Intellectual Property Appellate Body) has undergone a significant face lift. From being seen as a lethargic and all too incompetent body, subject to flights of legal fancy and with a penchant for meticulously reproducing counsel submissions, sans any legal analysis of their own, many practitioners and IP stakeholders now swear by the proficiency of the IPAB. 

We’ll bring some you data soon to back up this common perception that after the advent of the inimitable Justice Prabha Sridevan, the IPAB has taken a turn for the better, and a significant one at that. She’s known to wield the IPAB with a strong stick, refusing wanton adjournments and bearing down heavily on ill prepared counsels. As I’ve stated often in this blog, given the adversarial nature of India’s legal system, the quality of our jurisprudence is often contingent on the caliber of arguments advanced by counsels. By forcing counsels to up their game, Justice Sridevan and her team at the IPAB are invariably effectuating a quality upgrade in our jurisprudence!

Given this wonderful new perception surrounding the IPAB, I was rather surprised to see a news item that appeared to suggest that the IPAB was back to its good ole days (and ways). In the context of a patent dispute involving Pegasus, India’s first patented drug that survived a post grant challenge and was now before the IPAB, Pharmabiz noted that:

“The hearing in the post grant opposition against the patent granted to Roche for Pegasys (Peg intergferon alpha 2B), a key drug used for Hepatitis-C treatment, has been adjourned by the Intellectual Property Appellate Board (IPAB) in Chennai without fixing any new date for next hearing.

The crucial hearing on the case was held by the IPAB on two days on July 30 and 31. Though the argument in the case was not complete, the hearing was adjourned by the Board without fixing any new date for the next hearing of the case which is crucial for the civil society as the treatment for hepatitis-C is currently very expensive and out of reach of people due to the patent on this drug.”


I checked immediately with the IPAB and they clarified that this was blatantly false! There was indeed a next date of hearing; and this date (September 6th) was fixed after consultations with both sets of counsels: Anand Grover appearing for Sankalp, a patient group challenging the validity of the Pegasus patent and Rahul Balaji, appearing as counsel for patent firm, De Penning and De Penning, which is representing Roche in this matter. 

A real pity that Wockhardt, one of the post grant challengers (along with Sankalp) backed out of this dispute (not surprising, given Wockdhardt’s severe financial woes). Wockhardts’ absence puts enormous pressure on Sankalp to defend their right to standing in this dispute: one of the cardinal issues in this dispute before the IPAB is whether or not Sankalp is a “person interested” under the Patents Act and therefore eligible to file a post grant opposition. 

As I’d noted in a previous post reviewing a patent office decision, where the term “person interested” was liberally interpreted:


“What I liked most about the decision is the fact that the IPO has finally opened up the meaning of “person interested” in section 25 (2). It placed emphasis on the term “includes” in the definition of “person interested” and held that a person interested could include a patient group that was interested in opposing bad patents that resulted in increased drug prices. This will certainly engender more oppositions from civil society and patient groups and is a welcome development.”


Pegasus is an important case in many ways, not least of which is the fact that it scores two firsts in the annals of Indian patent history. It is India’s first granted pharmaceutical product patent. It is also India’s first post grant opposition case, with the Controller (Madhusudhanan) upholding the validity of the patent after reviewing more than 50 pieces of prior art! While one may disagree with his analysis and conclusions, his decision cannot be faulted for being a non speaking one.

As with most other patented drugs, Pegasus raises stark issues of pricing and access. From most accounts, Pegasys (Pegylated interferon alfa-2a), a drug used to treat Hepatitis C costs about Rs 4.36 lakh (available at a discounted price of Rs 3,14,496) for a 6 month treatment. It is usually taken in combination with Ribavarin, which costs another Rs 47,160. 

One wonders why pharmaceutical patentees refuse to drop prices, despite being at the receiving end of high court orders (Roche vs Cipla, where Justice Bhat refused to grant an injunction on the grounds of the excessive price differential between the patented drug and the allegedly infringing generic) and compulsory licensing decisions. However, this issue should not concern the IPAB which is limited to examining the technological proficiency of the invention: whether or not it is patentable.


Pegasus offers considerable scope for the IPAB to place our patent jurisprudence on firmer legal moorings and resuscitate it from a more fanciful past.


ps: while Roche committed to dropping prices for two of its drugs (Herceptin and Mabthera) in the aftermath of the Natco vs Bayer compulsory licensing decision, it is yet to announce any price cuts for Pegasus.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

2 comments.

  1. Avatarrajeev

    Dr . Basheer,
    Nice that the jurisprudence through IPAB is up. But reading your article it was ironically noticed that you need to have a ‘person interested’ in ameliorating the system to interpret ‘person interested ‘ term u/ s 25(2) of the ACT. Presently Justice Sridevan fits the ‘person interested’
    But how will the interpretation of ‘person interested ‘ u/s 25(2) be if a not so interested person comes to adjudicate in the system. Then there may be no person who would be found having a interest in the opposition.
    R.K.jain
    Patent agent

    Reply

Leave a Reply

Your email address will not be published.