The Delhi High Court rejects Boehringer Ingelheim’s request for a temporary restraining order, and generic linagliptin production is permitted.

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In a patent dispute involving the former’s diabetes drug linagliptin, a single judge of the Delhi High Court declined to grant an interim injunction in favour of German pharmaceutical giant Boehringer Ingelheim against Indian generic manufacturers, noting that the patent is presumptively voidable and the company has made efforts to evergreen the invention and re-monopolize it. As compensation for harm done to the public interest, the court further ordered the business to pay Rs. 2 lakh apiece to the Indian generic manufacturers who are battling the company over the patent as well as the same sum to the Delhi High Court Legal Services Committee in four weeks. Also, the pro-tem agreements reached about the medicine between Boehringer Ingelheim and select Indian players as well as the earlier issued interim injunctions in Boehringer Ingelheim’s favour have been revoked.

The Court refused to issue an interim injunction, instead ordering that the species patent shall not prevent the manufacture and sale of products containing linagliptin as the active pharmaceutical ingredient, and that the defendants are free to manufacture and sell these products, if advised and subject to required approvals. The generic manufacturers who are the defendants in the lawsuit, however, are required to keep thorough records of the creation and sale of the disputed goods and provide statement of accounts at least once every six months. 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.

On February 21, 2022, the business had the Markus formula given a patent as a genus patent, for which the term was investigated. Following the expiration of the patent, the product was introduced by a number of Indian companies, but the company that invented it asserted that the invention was protected by a patent issued on October 5, 2010, which had a 20-year duration beginning on August 18, 2003. The corporation filed six lawsuits against Alkem Laboratories, Micro Labs Ltd, Natco Pharma Ltd, Mankind Pharma Ltd, Vee Excel Medicines and Pharmaceuticals Pvt Ltd, and other parties as a result of this patent infringement case, and on March 29, the court issued an order regarding those six lawsuits.

The judge noted that the conditions in the current group of lawsuits are extremely similar to the facts of a dispute between AstraZeneca and other Indian companies over the patent of another diabetes medication, dapagliflozin. On March 29, 2023, Justice Amit Bansal issued a detailed order in which he noted that the company had requested relief, claiming that the drug was protected by both the genus and species patents up until the genus patent’s expiration, and that it was only after the genus patent’s expiration that the company asserted that the drug was only protected by the species patent. In its Form 27 submissions, which are routine communications with the Patent Office regarding the operation of the patent for both the genus and species patents, the company has also included sales information for linagliptin.

“After obtaining all of these advantages on the basis of the allegation that linagliptin is protected by a genus patent, the plaintiffs are not in a position to assert the opposite at this time,” the statement continued. It was stated in the Order that the Plaintiffs could not be allowed to approve and reprobate. The court noted that the medicine appeared to be disclosed, claimed, and protected by both the genus and species patents at first glance. The plaintiffs (Boehringer Ingelheim) could not have alleged infringement of the genus patent in two of the actions brought in 2019 if linagliptin was not disclosed or claimed in the genus patent. The conditions with regard to prior claiming under Section 64(1)(a) of the Patents Act are thereby met in the current case, at least at the interlocutory stage, according to the Judge.

“In the present case also, the plaintiffs by filing additional patents for various elements of the same product are seeking to extend the term of the patent beyond twenty years, issued in respect of the genus patent, which expired on February 21, 2022,” he stated. “In my opinion, trying to obtain a patent for both the genus and the species would amount to evergreening or layering of patent protection, which is prohibited under Indian law. The Patents Act’s Section 3(d) has been inserted into the law to make sure that evergreening and layering are not permitted. The Order continued, “In light of my findings above, it would not be required to assess other grounds for revocation asserted in the lawsuits, which shall be taken into account at the trial stage.

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. “It is clear that the plaintiffs want to profit from the invention in question. Therefore in the event that the plaintiffs prevail in the current lawsuits, monetary damages can be determined and granted to the plaintiffs in the current case. It has long been accepted law that interim injunctions should not be granted when monetary damages would be an adequate form of compensation for the plaintiffs. The judge compared the situation to the AstraZeneca case, which was heard by both the single bench and division bench of the Delhi High Court. The judge noted that the drug linagliptin is used to treat diabetes, which is a condition that is very common in India and is thought to be a co-morbidity in cases of Coronavirus infection.

“As a result, the public interest also requires that a substantial portion of the population have quick and inexpensive access to a diabetes medication. Unquestionably, the products of the defendants (generic manufacturers) are much less expensive than those of the plaintiffs, and given that linagliptin is a daily-use medication, price plays a key role in the public’s capacity to acquire it, the Court noted. The Judge further noted that, with the exception of a few cases, all other generic producers had delayed releasing their goods onto the market until after the genus patent had expired.

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