Delhi HC issues favourable order to Novartis on its divisional patent application for dry eye disease drug

New Delhi, August 25, 2022:

The Delhi High Court has set aside an order by the Patent Office dismissing a patent application of Swiss pharma major Novartis AG, for its composition for the treatment of dry eye disease, and remanded the matter back for considering the divisional application on its own merits.

The patent application was filed by Sarcode Corporation, which developed the dry eye drug lifitegrast ophthalmic solution Xiidra.

The decision comes after the Patent Office, in an order on September 28, 2020, rejected Novartis’ divisional application for the Lymphocyte Function Associated Antigen-1 (LFA-1 antagonist), on the ground that the subject matter of the granted claims of a parent application filed in 2007 and the subject matter of the divisional application belong to the same broad class and group of inventions, both linked so as to form a single inventive concept.

The divisional application was filed in September 19, 2014, after the Patent Office, while considering a national phase application (parent application) of the company, raised objections that the claims show plurality of distinct inventions each independently belonging to a different method of treatment. The company amended the set of claims for the national phase application, with claims to three specific compounds. It then filed the patent application which has come under dispute at present, as a divisional application.

The Patent Office, while considering the divisional application, raised an objection that the claims were already granted in the parent application. The company then filed an amended set of claims in which it limited the claims to one of the compounds. However, the Patent Office rejected the application concluding that “the subject matter of the compounds of the granted claims of parent application and subject matter of the claims in divisional application belong to the same broad class and belong to a group of inventions linked so as to form a single inventive concept…”

Justice Prathiba M Singh, after hearing both the parties, concluded that the divisional application is a valid one and it deserves to be examined in accordance with law.

“Accordingly, the impugned order is set aside. The matter is remanded back to the Patent Office for considering the divisional application on its own merits in respect of the other objections under Sections 2(1)(j), 2(1)(ja), 3(d), 3(e), 3(i) and 59 of the Act which were not gone into,” said the Order issued on August 23.

“Insofar as the issue of whether it is a valid divisional or not is concerned, this Court holds that the divisional application is a valid divisional application. The appeal, along with all pending applications is allowed in the above terms,” added the Order.

Xiidra, claimed as the first prescription treatment approved by both signs and symptoms of dry eye disease with a mechanism of action that target inflammation, was acquired from Sarcode by UK-originated biopharma company Shire, which was in turn acquired by Japanese drug major Takeda Pharma in January, 2019.

Takeda, as part of its strategy to focus on optimising its portfolio around the key business areas that are core to its long-term growth, sold Xiidra 5% product to Novartis for $3.4 billion upfront in cash and up to an additional $1.9 billion in potential milestone payments, in July, 2019.Pharmabiz