Page 153 - CW E-Magazine (15-7-2025)

Pharmaceuticals Pharmaceuticals

DIVERSIFICATION SIMILAR BRAND NAME

Godavari Biorefi neries’ European patent for Delhi HC upholds restraining order on Rajasthan

anticancer molecule validated in key jurisdictions Aushdhalaya’s ‘Liv-333’

Mumbai-based bio-based chemicals Phase-1a clinical trials to assess safety The division bench of the Delhi companies on whether cost and dam-
firm, Godavari Biorefineries Ltd. in human patients with advanced solid High Court has upheld its single judge ages can be imposed on Rajasthan
(GBL), has announced that its Euro- tumours as well as in healthy volun- order to restrain Rajasthan Aushdha- Aushdhalaya, as directed by the single
pean patent for a novel anti-cancer teers. laya from making and selling medi- judge.
molecule has been validated in Spain, cines under the name ‘Liv-333’ or any
the United Kingdom, and as a ‘unitary The company’s clinical-stage bio- other name similar to Himalaya Global Himalaya claimed to have come to
patent’ covering multiple EU member tech division, Sathgen Therapeutics, Holdings and Himalaya Wellness Co’s know in January last year of several
states. Unitary patents make it possible is involved in advancing novel cancer trademark ‘Liv.52’, which is used as a listings of the mark ‘Liv-333’, as well
to get patent protection in up to 25 EU and antiviral therapies. With a lead liver tonic. as the logo by Rajasthan Herbal Inter-
member states by submitting a single molecule undergoing clinical trials national under which the latter was
request to the European Patent Offi ce and global patent protection, GBL is A bench comprising Justices C. Himalaya, of the mark ‘Liv.52’, dates selling preparations for liver treatment
(EPO). The patented molecule has demon- deepening its investment in transla- Hari Shankar and Ajay Digpaul said back to July 1957, it said. “Given the in capsule and tablet forms.
strated effi cacy against both cancer tional research that addresses some of that “We, in fact, are of the view that reputation that the mark has amassed
“This development highlights cells and cancer stem cells, marking a the world’s most urgent health chal- the adoption, by the appellant (Rajasthan over time, there is every likelihood After cease and desist notice,
GBL’s growing diversifi cation into promising advance toward more targe- lenges. Aushdhalaya), of a mark which was a of other infringers having themselves Himalaya moved the court to restrain
advanced scientifi c domains, com- ted and effective cancer therapies. It has portmanteau of ‘Liv’ as an abbrevia- adopted identical, or similar, marks, to Rajasthan Aushdhalaya from using the
plementing its leadership in ethanol, shown potential in the treatment of vari- “This patent validation marks a tion for liver and a number thereafter, capitalise on the respondents’ goodwill mark. In May last year, the single judge
bio-based chemicals, and renewable ous cancers, including breast and pros- signifi cant milestone in our journey cannot be treated as innocent,” adding and reputation. The mere fact that other bench while issuing summons granted
materials produced from agricultural tate cancer, with encouraging effi cacy toward advancing original, high-quality that the obvious intent appears to have infringers are also coexisting cannot, ex-parte restraint order asking Rajasthan
feedstock,” the company informed in a and safety profi les in preclinical animal scientifi c research,” said Dr. Sangeeta been to come close to the mark ‘Liv.52’ quite obviously, provide a license to the Aushdhalaya from using the mark ‘Liv-
press note. studies. The molecule is currently in Srivastava, Executive Director, GBL. which was being used by the respondent appellant, to infringe,” the order stated. 333’, or any other mark which was
(Himalaya). identical or deceptively similar to the
REGULATORY COMPLIANCE
However, the division bench respondents registered ‘Liv.52’ trade-
Sun Pharma working to fully resolve compliance Moreover, the registration, by sought response from the Himalaya mark.
DIVESTMENT
issues at three plants facing USFDA action
Nectar to sell API, formulations & menthol
Sun Pharmaceutical Industries aims was accorded an Offi cial Action Indi- sales in the current fi nancial year, with
to bolster compliance across its manu- cated (OAI) status in FY24, he noted. enhanced focus on speciality products. businesses to Ceph Lifesciences
facturing operations and work towards The company aims to expand its
achieving full regulatory resolution “We have completed the imple- product pipeline of global speciality Nectar Lifesciences said it will regulatory filing. Additionally, the Sanjiv Goyal said. Nectar Lifesciences
at the three facilities facing USFDA mentation of Corrective and Preventive products, he added. The drug major sell its active pharmaceutical in- company has entered into an Asset said the transaction forms a part of
action, according to Chairman and MD Action (CAPA) in the Halol facility, invested $154-mn on speciality pro- gredients (APIs) and formulations Purchase Agreement (APA) for the its long-term strategy to streamline
Dilip Shanghvi. which is currently awaiting USFDA ducts R&D in FY25. Sun Pharma along with menthol business assets sale of its menthol business assets to operations, strengthen its financial
inspection, and we are in the process reported consolidated revenues of to Ceph Lifesciences Pvt. Ltd., for Ceph Lifesciences for Rs. 20-crore, position, and unlock value for share-
In his address to shareholders in its of implementing CAPA at the Mohali Rs. 52,041-crore in FY25, with the share Rs. 1,290-crore. marking a comprehensive restruc- holders.
annual report for 2024-25, Mr. Shanghvi and Dadra facilities,” he added. Besides of global speciality business increa- turing move aligned with its future
said the company is facing US Food these three, all facilities remain compli- sing from 18% in FY24 to 20% in The company has signed a defi ni- strategy, it added. “The proceeds from the sale will be
and Drug Administration (USFDA) ant with global regulatory standards, FY25 sales. tive Business Transfer Agreement used to repay existing debt, invest in
compliance-related issues at three of its including those of the USFDA, (BTA) for the sale of its core busi- “By divesting mature segments of new and emerging business areas and
facilities. The company is facing an Mr. Shanghvi said. “We anticipate mid to high sin- ness division, comprising the manu- our business, we are laying the foun- reward shareholders, subject to appli-
import alert for the Halol facility and also gle-digit consolidated topline growth facture, distribution, and marketing dation for a focused and agile organi- cable approvals,” the company said.
is in receipt of non-compliance letter On the business front, he noted in FY26, and expect our global specia- of APIs and formulations to Ceph sation geared towards innovation and Besides, the proceeds will also be used
for the Mohali facility, he stated. Addi- that the company expects its R&D lity business to continue on its growth Lifesciences for Rs. 1,270-crore on long-term value creation,” Nectar to fund future corporate and growth
tionally, the company’s Dadra facility investment to be in the range of 6-8% of path,” Mr. Shanghvi said. a slump sale basis, Nectar said in a Lifesciences’ Promoter and Chairman initiatives, it added.

152 Chemical Weekly July 15, 2025 Chemical Weekly July 15, 2025 153

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