India’s First Compulsory Licence: Open Ended?

While dismissing the SLP (special leave petition) of Bayer, the Supreme Court noted that:

“In the facts of the present case, we are not inclined to interfere. The Special Leave Petition is dismissed, keeping all questions of law open.”

What exactly does this mean? Honestly, it left me a bit puzzled. Wasn’t it the job of the highest court of the land to apply its mind to questions of law? If so, why did it leave it “open”?

And if issues of law remain unresolved, why did it go on to dismiss the SLP? A dismissal of the SLP would appear to suggest that the apex court was reasonably satisfied with the interpretation proffered by the IPO and the IPAB. And therefore decided not to interfere. But if this was so, why did it then leave the questions of law open? Particularly when a determination of legal issues are likely to impact the final decision in this case? As I noted on a facebook exchange with a friend (who explained that the court may have not wished to venture forth into a broader application of legal principles beyond the specific facts of the Nexavar case):

“As I understand it, the purpose of the SC is to lay down legal norms of interpretation that presumably should apply beyond the narrow facts of a particular case. For by this logic, it would mean that each case would necessarily have to be agitated all the way to the Supreme Court and back for each fact situation. Surely that is not an optimal use of the SC time and does not make for good policy. The issues of law in this case deserved determination (determining when a patented invention is excessively priced or not available and whether a patent is worked or not) far beyond the specifics of this case alone. And I think this precisely is the job of the apex court. To offer broad interpretative guidance which can then be applied across a range of fact situations.”

Or am I missing something here? Grateful if those of you in the know would be kind enough to clarify (preferably in the comments section of the blog, or if that proves too tedious, please shoot me an email). Thanks!

Which brings me to the next issue. Most of our generic majors have railed against the CL regime, complaining that the system is uncertain and legally cumbersome With this latest SC ruling, one hopes that their unfounded fears are laid to rest. This is a fairly simple regime to operationalize and avail of. After all, Natco filed its application in late 2011 and won at all forums, with the final forum (Supreme Court) deciding the issue within a mere 3 years of the commencement of the dispute. One cannot hope for any better. Given this scenario, will more of our generic companies stop making lame excuses and activate the CL regime? Rather than continue to rely on government largesse in operating Section 92? Why on earth would you depend on government largesse when you have an entitlement under the law? As we noted in an earlier post, when compared with section 92, section 84 is a matter of legal entitlement. One hopes that with the Supreme Court verdict, we see many more CL applications. Unless of course the real reason for the lack of CL applications under section 84 is the increasing tide of partnerships and collaborations between drug multinationals and our home grown generics, an aspect I highlighted in this editorial some months ago.

For more details on this latest SC dismissal of Bayer’s SLP, see:

1. Lawyers’s Collective has a detailed description of what transpired in the Supreme Court.

2. Amy Kazmin and Andrew Ward’s piece in the Financial Times. (See also this piece by Amy Kazmin on India assuming a frontline position in IP battles)

3. CH Unni’s piece in the Mint.

4. Rupali Mukherjee’s piece in the Times of India.

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5 thoughts on “India’s First Compulsory Licence: Open Ended?”

  1. I agree..

    Generally, a practicing lawyer would know that such gnomic orders with such gnomic phrases are very common while dismissing the SLPs by the Hon’ble Apex Court.

  2. The Bench had indeed delved into the the prima facie and ex-facie merits of the SLP before coming to an conclusion that the particular leave may not be granted . The Order pronounced was very caliberated given the fact that of late of over the period of years Supreme Court has been admitting SLP and then subsequently arriving at the findings that the Civi Appeals/Criminal Appeals need set aside or upheold the High Court Judgement/Decree. Every admitted Appeal before the Supreme Court leads to avoidable precedent leading to no one’s benefit . Leaving the questions of Law open in such an intricate matter leaves complete freedom to the IPAB and the controller General of Patents to decide future CL applications without concerns of any Binding but not fully comprehensive precedents . Justice Nariman having been a member of the Bombay High Court Bar was fully aware of the consequences had this SLP would have been admitted or any other observations/remarks passed even while dismissing it on the threshold .

    Advocate Suvro .

  3. An application for compulsory licence (CL) has been filed on 29-06-2015 for Saxagliptin patent also- IN 206543 (IN/PCT/2002/01154/MUM)

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