Patent

A “Madhu” Victory for Merck: Busting the Patent Bias Myth!


Ants-eat-sugary-foodDoes India Suffer a Patent Bias?

Clearly not! At least if one were to go by the Delhi High Courts’ recent ruling vindicating Merck’s patent (covering an anti diabetic drug, Sitagliptin) and restraining Glenmark from manufacturing and selling a generic version of the same.  Will the Modi government now please flaunt this decision to our US counterparts who’ve been ranting against the Indian IP system?

Here is a Mint piece by Shreeja Sen and others highlighting the salient aspects of this decision; one that constitutes an important milestone for Indian drug and IP law. And here is a link to the original decision.

Patent Infringement Jurisprudence Comes of Age!

A quick read of the decision suggests that it’s a fairly robust one, at least on the patent infringement count. Readers may recall my rant against the Roche vs Cipla judgment (Re: anticancer drug, Erlotinib) on one count: that the court simply failed to construe the claim and came up with the ridiculous proposition that in a patent infringement suit, one must compare the plaintiffs’ product (drug) with that of the defendants’ product (drug).

Thankfully, the Merck court in this case has effectively reversed that erroneous proposition and rightly held that the comparison ought to be between the plaintiffs’ patent and the defendants’ product. And if the product impinges on any of the plaintiff’s claim, it will be held to infringe!

As Madhulika’s series of posts on this case demonstrate, Glenmark had essentially argued that the Merck patent covered only the Sitagliptin free base, and that  their product (Sitagliptin phosphate monohydrate) did not impinge upon this claim over the free base. I’ve never really understood this argument, since how could one possibly make the salt form or any variant without necessarily making the base form? Or have I got my chemistry all wrong?

The court (Justice AK Pathak) rightly held held as below:

 “Thus, use of Sitagliptin Free base alone in Sitagliptin Phosphate Monohydrate tablet by the defendant itself amounts to infringement of the suit patent.”

and later:

“From the above discussions, I am of the view that plaintiffs have succeeded in proving that suit patent discloses Sitagliptin Phosphate Monohydrate generically. Sitagliptin Free Base is also disclosed. It is the Sitagliptin Free Base which is the DPP-IV inhibitor and phosphate salt is used for delivery of Sitagliptin in the body. Sitagliptin Phosphate Monohydrate has enhanced properties in the sense that it has improved chemical and physical characteristics, but the active moiety is Sitagliptin.”

A Market for Patent Experts?

A large part of this case appears to have turned on the credibility of the “ expert” witnesses ushered into court by the respective parties to testify on their behalf. The judge makes it amply clear that, when compared with the plaintiffs witness (PW2), he found the defendants’ witness (DW2) unreliable,  Here is an extract:

“The stand taken by DW2 in his affidavit is in conflict with what has been stated in Ex. DW2/P-1 of which DW2 is one of the inventor. That apart, I find that DW2 has taken shifting stand. He has not been able to specify as regards to what happens in the human body when Sitagliptin Phosphate Monohydrate is consumed.

It is also evident that Prof. Nangia has personal interest in Sitagliptin, being one of the inventors of Ex. DW2/P1, inasmuch as, he has given evasive replies to the questions which were inconvenient to the defendant. Accordingly, I find PW2 to be more trustworthy and reliable witness in the chemical, biological and medicinal field.”

Going forward, patent litigants have to pay great heed to the expert witnesses that they hire. And it is in this regard, that I am extremely proud of the fact that one of my former students at NUJS, Ashish Arun spotted this “expert” witness opportunity way early in the game and now runs a product/service called Expert Witness Guru, that offers a terrific database of expert witnesses and how they have generally fared in litigation/cases (whether they were able to swing the cases for those that hired them or not)

Patent Validity

I’ve not assessed the “validity” aspect of this decision (since Glenmark had challenged the patent validity and interestingly also alleged that the disclosure of the Sitagliptin free base was not “sufficient”). Balaji will bring you a detailed assessment on this count. For our previous posts on this, see Madhulika’s stellar analysis here.

Public Interest and Drug Pricing?

As I note in my comments to the Mint (and as quoted in their piece here):

“On the aspect of pricing of generic drugs, Basheer said that in this particular case, the difference between the prices was not that significant from a public health perspective given the availability of substitutes. So, in terms of public interest, the injunction could not have been refused.

“Also if the government finds the prices still high, it can regulate through the price regulator. Patent decisions should not be the vehicle for price regulation,” he said”

Also see Madhulika’s post here highlighting the significance (or otherwise) of the cost differential between the originator and the generic drug and the availability of substitutes etc .

Dispensing with Interim Injunctions: Expedited Patent Trials

As we noted in an earlier blog post, the Supreme Court ordered that the patent trial in this case be expedited. And that the recording of evidence before the trial court finish in a months time!

Pursuant to this, the patent trial and hearings concluded in under three months!

This suggests the workability of our favourite policy prescription (touted multiple times on this blog): that no interim injunctions be granted in complex patent cases, but that these disputes be taken directly to trial and finished expeditiously. For those interested, this policy prescription is outlined elaborately in this academic piece here and in this shorter piece in the Mint here.

ps: “Madhu” (as used in the title) is the sanskrit/hindi term for “sweet”. And harks back to an ancient ayurvedic tale of how diabetes was first discovered when a circumspect physician observed ants flocking towards the urine of those with high sugar levels. And the disease therefore came to be known as Madhu-meha. Only fitting therefore that most of our Sitagplitin posts were covered by the insightful Madhu-lika!

pps: image from here.

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. AvatarSHAKLAIN KHURSHID

    Comparison on Plaintiff patent and Defendants Product is fair enough to conclude. I appreciate this basis to conclude on patent infringement law suit.

    Regards
    Shaklain Khurshid

    Reply

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