Page 149 - CW E-Magazine (1-4-2025)

Pharmaceuticals

PATENT FIGHT
Delhi High Court rejects Roche’s plea to block

Natco Pharma on Risdiplam patent

The Delhi High Court has rejected and unencumbered, along with its mar- oral prescription medicine indicated for
Swiss multinational F. Hoffmann- ket value, before this court within four the treatment of spinal muscular atro-
La Roche AG’s petition seeking to weeks, the judge said. phy in patients two months of age or
temporarily restrain Natco Pharma older.
from infringing its product patent for The Hyderabad-based generic manu-
Risdiplam compound used for treating facturer was also directed to maintain Roche had come across the listing of
spinal muscular atrophy. complete accounts of the manufacture, Risdiplam on Natco Pharma’s website
sale and supply of the products and also under the “APIs under development”
The court noted that the Roche’s fi le statements of accounts before the section. Further investigation revealed
approved drug Risdiplam, which is court on quarterly basis, duly supported that Natco was preparing for commer-
marketed under the name ‘Evrysdi,’ by affi davit. Natco Pharma shall also cial production of Risdiplam API, it said.
is not available at an affordable price, fi le the annual statements of sales of Moreover, the domestic pharma company
thus the public interest would be to out- their products, duly authenticated by its was found to have fi led a patent applica-
weigh the need for grant of injunction auditor, the court directed in its 95-page tion in September, 2022 under the title,
(restraint order). judgement. “Improved process for the preparation
of Risdiplam and its intermediates” for
Roche had sought interim injunc- Roche’s registered patent, which manufacturing of Risdiplam, Roche told
tion against Natco Pharma to restrain is a “species patent” for the product the court, while alleging infringement of
infringement of its patent titled “com- ‘Risdiplam,’ relates to compounds its rights in the patent.
pounds for treating spinal muscular which are survival motor neuron used in
atrophy”. The multinational company the treatment of spinal muscular atrophy. Natco argued that the Patents Act
claimed that its suit patent has a term Risdiplam is the active pharmaceuti- does not bestow presumptive validity
of 20 years from May 11, 2015 and cal ingredient in the Swiss fi rm’s com- on a patent, even if it has been granted
expires on May 11, 2035. mercial product marketed worldwide, pursuant to a failed pre-grant opposi-
including India, under the brand name tion, or even if it survives a post-grant
Stating that the court is not inclined Evrysdi (risdiplam). Risdiplam is an opposition.
to grant any injunction in favour of
Roche, Justice Mini Pushkarna in her Wanbury to launch new iron
interim order held that Natco Pharma
“has prima facie raised a credible chal- supplement and API
lenge to the validity of the suit patent,”
thus it is not inclined to accept Roche’s Wanbury has announced that it better absorption compared to existing
plea Justice. Further, balance of con- will launch two new products – a iron salts in the market.
venience is also against the plaintiffs branded formulation called Wanbury
and is in favour of the defendant, she C-RED and an active pharmaceutical The ketamine hydrochloride API,
added. ingredient (API) – ketamine hydro- developed through Wanbury’s in-house
chloride. R&D team, complies with major pharma-
However, the court said that Roche copeia standards, including USP and
can be compensated in damages. Wanbury C-RED is a liposomal iron EP. The company stated that the API
“Nonetheless, it is clarifi ed that in case supplement targeting the gynaecology has an annual demand exceeding 200
the plaintiffs (Roche) ultimately succeed segment, specifi cally designed to im- tonnes for both human and veterinary
in the trial, the defendant (Natco) prove haemoglobin levels, particularly markets and is primarily used to induce
shall be liable to pay damages to the during pregnancy. The company claims sleep before and during surgeries. Wan-
plaintiffs. For this purpose, Natco this formulation prevents gastric irri- bury will export ketamine to European
shall fi le its list of assets, encumbered tation and constipation while ensuring markets.

Chemical Weekly April 1, 2025 149

Contents Index to Advertisers Index to Products Advertised