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Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

Gireesh Babu, New Delhi
Saturday, April 1, 2023, 08:00 Hrs  [IST]

A Single Bench of the Delhi High Court has refused to grant interim injunction in favour of German pharma major Boehringer Ingelheim against the Indian generic manufacturers in a patent litigation on the former’s diabetes drug linagliptin, noting that prima facie the patent is vulnerable to revocation and the company has made an attempt towards evergreening the invention and re-monopolising the same.

The Court has also ordered the company to pay Rs. 2 lakh each to the Indian generic manufacturers, which are in litigation with the company on the patent, and the same amount to Delhi High Court Legal Services Committee in four weeks on account of detriment caused to the public interest. It has also vacated the pro-tem arrangements arrived between Boehringer Ingelheim and some of the Indian players regarding the drug, and the interim injunctions passed in favour of Boehringer Ingelheim earlier.

Refusing to grant interim injunction, the Court ordered that there shall be no impediment on the manufacture and sale of products with linagliptin as the active pharmaceutical ingredients on account of the species patent and the defendants are permitted to manufacture and sell these products, if so advised, subject to necessary approvals. However, the defendant companies (the generic manufacturers in litigation) have to maintain complete accounts of manufacture and sale of the products under dispute and file statement of accounts on a half yearly basis.

The dispute is in connection with the patent rights of Boehringer Ingelheim for its drug linagliptin, sold under the brand Trajenta and Trajenta Duo in India from the years 2012 and 2014, respectively.

The company had a patent granted for the Markus formula, as a genus patent, for which the term was explored on February 21, 2022. Several Indian companies launched the product following the patent expiry, but the originator company claimed that the product is covered under a patent granted on October 5, 2010 for a term of 20 years with effect from August 18, 2003.

This led to patent infringement litigation and in the Court has issued the order on March 29 on six suits filed by the company against Alkem Laboratories, Micro Labs Ltd, Natco Pharma Ltd, Mankind Pharma Ltd, and Vee Excel Drugs and Pharmaceuticals Pvt Ltd and others.

The Judge observed that the facts in the present batch of cases are very similar to the facts in a litigation between AstraZeneca and some of the Indian companies related to the patent of another diabetes drug dapagliflozin.

In a detailed order on March 29, 2023, Justice Amit Bansal observed that the company sought reliefs claiming that the drug is covered under the genus patent and the species patent till the time the genus patent was expired and only after the expiry of this patent, the company made the assertions that the drug is covered only in the species patent. The company has also filed the sales details of linagliptin in its Form 27 submissions, which are periodic filings with the Patent Office regarding the working of the patent, for both the genus and species patents.

“Having obtained all these benefits based on the assertion that linagliptin is claimed and covered in genus patent, now it does not lie in the mouth of the plaintiffs to take a stand to the contrary. The plaintiffs cannot be allowed to approbate and reprobate,” said the Order. The court observed that in prima facie view, the drug was disclosed, claimed and covered under the genus patent as well as the species patent.

Had linagliptin not been disclosed or claimed in the genus patent, the plaintiffs (Boehringer Ingelheim) could not have made a claim for infringement of the genus patent in two of the cases filed in 2019. Therefore, at an interlocutory stage at least, the requirements with regard to prior claiming under Section 64(1)(a) of the Patents Act are satisfied in the present case, said the Judge.

“In the present case also, the plaintiffs by filing multiple patents for different aspects of the same product are seeking to extend the term of the patent beyond twenty years, granted in respect of the genus patent, which expired on 21st February 2022,” he said.

“In my considered view, the action of attempting to patent both the genus and species patent would amount to evergreening or layering of patent protection, which is impermissible under the Indian Patent Law. Section 3(d) of the Patents Act has been incorporated in the statute to ensure that such action of evergreening and layering is prevented. In view of my findings above, it would not be necessary to consider other grounds of revocation raised in the suits, which shall be considered at the stage of the trial,” added the Order.

The company is not manufacturing the drug in India and have licensed the suit patent to Lupin and Eli Lilly, for which royalties are payable by the said entities to the plaintiffs.

“Clearly, the intention of the plaintiffs is to monetise the said invention. Therefore, the present case is one where monetary damages can be calculated and awarded to the plaintiffs, in the event, the plaintiffs succeed in the present suits. It is a settled position of law that where monetary damages are the adequate compensation for the plaintiffs, an interim injunction should not be granted,” it added.

Drawing similarity to the AstraZeneca case, which went through both the single bench and division bench of the Delhi High Court, the Judge observed that the drug linagliptin is used for treatment of diabetes, which is a widely prevalent disease in India and is considered as a co-morbidity factor in the cases of Coronavirus infection.

“Therefore, the public interest also demands that large segments of the population should have easy and affordable access to an anti-diabetes drug. Undeniably, the products of the defendants (generic manufacturers) are significantly cheaper than that of the plaintiffs and taking into account that linagliptin is a daily-use drug, affordability plays a major role in its access to wide sections of the public,” observed the Court. The Judge also observed that in exception to a couple of cases all the other generic manufacturers waited till the expiry of the genus patent to launch their products in the market.

All the six suits are listed before the Joint Registrar of the High Court in May, 2023, for further proceedings.


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