Roche vs CIPLA: Update


Heated arguments between Arun Jaitley (representing CIPLA) and Abhishek Singhvi (representing Roche) yesterday. The key issue was the validity of the patent. Jaitley cited a number of case law etc to establish that since this is a new patent, the validity attack should be taken seriously. He also argued that the Indian Patent Act does not grant a presumption of validity–a point that we discussed in our earliest posts on the Bilcare patent matter.

Hearings will continue today as well. It could well be a week or two before we see a final decision (on whether Roche is entitled to a temporary injunction against CIPLA). For our earlier posts on this case, see here and here.

As one of our blog readers (Ashutosh) pointed out to me, this case will have extensive political overtones given that it pits Arun Jaitley (ex law minister and BJP leader) against Abhishek Singhvi (Congress spokesperson).

I’ve heard that Jaitley was more persuasive yesterday, and it could well be that his advocacy skills could see CIPLA win. However, CIPLA’s initially flawed strategy of going to press and openly declaring that they will infringe may swing the matter in favour of Roche. CIPLA never bothered to participate in the pre-grant opposition or file a post grant opposition challenging the patent—and yet goes ahead and develops a product based on Roche’s molecule and gains regulatory approval. This fact may again tilt the case in favour of Roche.

Perhaps the judge may temporarily injunct CIPLA and stay the proceedings till such time as the post grant opposition mechanism is pursued and exhausted. This might be a sensible way out, given that in the Bilcare case, we had a court suggesting that the patent was invalid (while denying a temporary injunction) and the patent office later affirming the validity of the patent in a post grant opposition!! It seems like the Roche CIPLA case is proceeding in a similar direction. Though the outcome is uncertain and we have to wait and watch.

The Pricing Issue

A number of press statements discuss the pricing issue (i.e. Roche drugs cost around Rs 1.5 lakhs) in the context of this patent case–and CIPLA too makes these statements. And I believe that CIPLA’s counsel harped on this too in the court. It seems non-sensical to me that a court would invalidate a patent on the ground the price of the patented drug is too high!!

These are two separate issues and it is important that we keep them distinct. If Roche’s patent is an otherwise valid one (it meets all the patentability criteria under the Indian patent regime), one cannot simply knock it off on the ground that the patent is used to charge high prices.

Patent Grant vs Use

As Spicy IP has been reiterating, there is a distinction between the “grant” of a patent and it’s “use”. In an earlier post in the context of Novartis’ Gleevec, we noted:

“Patents are not ‘bad’ per se, as most of these statements make them out to be. Rather, as with most other things in life, they are susceptible to abuse. In this regard, it is important to strike a distinction between the grant of a patent and the regulation of its ‘use’. Assuming that the Novartis patent issues, there are plenty of built-in safeguards in India’s patent regime to ensure that the prices remain in check.”

To elaborate further:

At the grant stage, one merely looks to whether or not the claimed invention is a good one to protect via patents i.e. whether it is a technical advancement of some sort that furthers the cause of science and technology in some way. The patent may then issue and the patentee may either use the patent in a good way or can abuse it (by charging excessive prices etc).

If the patentee abuses the patent right by charging excessively, then there are various mechanisms within the Indian Patent Act itself that can be deployed to address the situation. Notably, there is a compulsory licensing provision that clearly states that a CL will issue if the patented product is sold at an unreasonably high price. Unfortunately, this kicks in only 3 years after the patent has been granted. In the meantime, we have the NPPA (National Pharma Pricing Authority) and price controls–something SpicyIP has been blogging about for a while. Lastly, Roche itself may voluntarily bring down the prices or have differential pricing schemes to have drugs at cheaper prices to those with lower income levels.

In short, the key issue is whether or not, Roche’s Erlotinib is a valid patent under the Indian Patent Act i.e. is it “new”, “non obvious”, useful and does it demonstrate increased efficacy over and above an earlier known substance (Gefitinib?). If it is valid, then we ought to respect it and CIPLA ought to be injuncted. If the patentee (Roche) uses the patent to charge high prices for its drug (Tarceva), then the price controller should step in and ask them to reduce prices.

Some facts on the Roche Patent

Sandeep Rathod who runs the excellent “genericpharmaceuticals” blog has some good factual data on the Erlotinib patents on his blog. He recently brought this to my notice. Please see here. In particular, these are the details that Sandeep has dug out:

1. Details of Roche patent involved in Litigation:

Granted patent: IN196774
Grant Publication: 14/Sep/2007
Application: 537/DEL/1996
Applicant: Pfizer [for ‘537]
Corresponding patent: US5747498 [Orange Book listed]
US expiry: 30/Mar/2015

2. Second Patent Application for Erlotinib

A later patent application for Erlotinib was filed in India (IN/PCT/2002/00507/DEL). This corresponds with US patent 6900221 (the ‘221 patent).

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. AvatarAnonymous

    The Patent Act On India nowhere talks about the “pricing issue”.Patent is a monopoly in itself.Although it is agreed that public interest is prime factor, but it wont be just to pretermit the efforts made by of Roche in research and development of erlotinib.

    Reply

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