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First patent war in India’s diabetes market gets intense

A file photo of a Glenmark R&D centre in Mumbai. Glenamark’s generic drugs are about 20% cheaper than Merck’s Januvia and Janumet, which sell for Rs1,290 and Rs1,980, respectively, for a month’s dose.  (A file photo of a Glenmark R&D centre in Mumbai. Glenamark’s generic drugs are about 20% cheaper than Merck’s Januvia and Janumet, which sell for Rs1,290 and Rs1,980, respectively, for a month’s dose. )Premium
A file photo of a Glenmark R&D centre in Mumbai. Glenamark’s generic drugs are about 20% cheaper than Merck’s Januvia and Janumet, which sell for Rs1,290 and Rs1,980, respectively, for a month’s dose.
(A file photo of a Glenmark R&D centre in Mumbai. Glenamark’s generic drugs are about 20% cheaper than Merck’s Januvia and Janumet, which sell for Rs1,290 and Rs1,980, respectively, for a month’s dose. )

HC has rejected interim relief to Merck against Glenmark saying it had not made a strong case for an injunction

Mumbai: The first patent war in India’s 3,000-crore diabetes market grew more intense with the Delhi high court’s decision on Friday to reject an interim relief sought by US drug maker Merck Sharp and Dohme Corp. (formerly Merck and Co. Inc.) against Glenmark Pharmaceuticals Ltd.

The latest patent litigation triggered by Glenmark launching generic versions of Merck’s top-selling anti-diabetes drugs Januvia and Janumet in the domestic market has the potential to become more complex than other similar cases related to anti-HIV and anti-cancer drugs, say legal experts.

The Delhi high court said Merck, though it holds a patent in India for the base drug sitagliptin used in treating type 2 diabetes, had not made a strong case for an injunction.

The court order, reviewed by Mint after it was posted on the website of Delhi high court on Saturday, shows the court’s analysis of this complicated matter, where it see merits in arguments from both sides.

Glenmark launched copies of Januvia and Janumet in India under brand names Zita and Zita-Met, respectively, in the last week of March. The generic drugs are about 20% cheaper than Merck’s Januvia and Janumet, which sell for 1,290 and 1,980, respectively, for a month’s dose. The patent litigation on the diabetes drugs is significant in the Indian context as the country has the world’s second largest diabetic population after China, and the market is growing by at least 10% every year, according to market research data of IMS Health, a pharma market research company.

“The matter is complex in this case as Glenmark’s argument in the case was that it hasn’t infringed any existing patents in India on these products—Januvia (sitagliptin phosphate, a salt of sitagliptin) and Janumet (a combination of sitagliptin and another diabetes drug metformin)," said a patent lawyer, declining to be identified.

“But this may not be a valid point in this case since Merck’s patent in India covers the basic molecule sitagliptin. One cannot make a salt form or derivative without first making the basic molecule," said Shamnad Basheer, a patent law expert and professor at the National University of Juridical Sciences, Kolkata.

The derivative or salt form, therefore, will necessarily infringe the parent patent covering sitagliptin, he said.

“It is a basic principle of patent law that in order to determine infringement, one must compare the plaintiff’s patent with the defendant’s product and see if the defendant’s product falls within the scope of the claims. And not compare the plaintiff’s product against the defendant’s product, as many Indian courts appear to be doing," he said.

But since Merck has patented sitagliptin phosphate as a separate invention in many countries and had tried filing this in India earlier, it could not successfully argue whether its patent for sitagliptin (granted in India) is not different from the other, the court order shows. Merck’s patent application in India for sitagliptin phosphate after it secured the patent for sitagliptin in 2007 was abandoned after it faced a pre-grant opposition.

“The court has held that plaintiff (Merck) has not disclosed that it had abandoned the patent for sitagliptin phosphate in India," said a lawyer representing Glenmark.

On this ground, Glenmark argued that the patent for sitagliptin and sitagliptin phosphate are different and Merck itself had admitted in the US and Europe that these are covered by different patents. Merck was unable to explain its own admissions of “new discovery" made in its sitagliptin phosphate application at the court, Glenmark’s lawyer said in a statement on Friday.

Besides, he said, Merck did not have any response to Glenmark’s argument that several other firms too were manufacturing sitagliptin phosphate active pharma ingredients in India, and an injunction targeting only Glenmark would be unfair.

Several bulk drug manufacturers in India produce and supply sitagliptin to Merck and other licensed companies abroad.

Unlike earlier patent infringement cases between foreign patent holders and local generic firms, the Merck-Glenmark matter cannot have a strong public interest cause, said an industry expert. “On the pricing front, Merck’s strategy in India has been comparatively reasonable," said this person, who too did not want to be identified.

Merck, while launching Januvia and Janumet in India in 2008, adopted a differential pricing strategy. The drugs prices in India are roughly 1/5th of their prices in the US and some other regions.

“This was probably the first case of differential pricing in India and in which price was arrived at after surveys of the same being within the reach of the people in need of the said medicine. The plaintiffs (Merck) also have a patient access programme for patients," the court observed.

Merck has also licensed the products to local drug maker Sun Pharmaceuticals Ltd, which has a large sales network in the country, for increased market penetration and access to these drugs for patients.

Merck was granted a patent for sitagliptin in India in 2007. The patent did not have any opposition at the time of application or after the grant. The drug, invented by Merck in 2001, was first filed for patent internationally in 2002, and currently under patent protection in 102 countries including India. The Indian patent was applied for in 2004.

Since India’s intellectual property law allows opposition to a patent claim both pre- and post-grant periods, any party that wants to challenge a patent had the opportunity to seek its invalidation. Thus, the court, although it declined to stay Glenmark’s sales and manufacturing of these copy versions, asked it to diligently maintain accounts of the manufacture, production and sales of the products and to file the information every quarter before the court with an advance copy to the counsel for the plaintiffs (Merck). The court emphasized that, “Needless to state that any observation contained herein shall not have any bearing on the final decision of the matter."

Glenmark on Friday said it was happy with the outcome of the court case. “We maintain that our Zita and Zita-Met do not infringe any of Merck’s patents in India," it said.

Merck in a statement said it was upset with the denial of an interim relief, and that it would explore all options to protect its rights in India.

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