Page 146 - CW E-Magazine (10-9-2024)

Pharmaceuticals

EXPERT VIEWS
CSIR-NCL roundtable deliberates on patenting of

inventions from biotechnology and medtech

On August 30, 2024, CSIR-NCL,
in partnership with the Offi ce of the
Controller General of Patents, Designs,
and Trade Marks (CGPDTM) and the
Danish Patent and Trademark Offi ce
(DKPTO), held a roundtable in Pune
focused on “Patenting of inventions
from biotechnology and biomedical
fi elds”. The event aimed to examine
and compare patent practices in these
sectors in India and Denmark, identi- butions since the 1940s and initiatives dations for clear biotech and medtech
fying challenges and opportunities like the Turmeric battle, Traditional examination guidelines in India, publi-
and assessing whether existing patent Knowledge Digital Library (TKDL) cising of commercialisable technolo-
examination processes require moderni- and creation of Venture Centre, NCL’s gies by the Indian Patent Offi ce, and
sation to keep pace with technological business incubator, which have sup- more discussions on biological mate-
advancements. ported the creation of 15 spin-offs. The rial deposition and National Biodiversity
roundtable concluded with recommen- Authority requirements.
The event, hosted by the Intellectual Alkem inks licensing pact with Takeda to
Property Group of NCL, witnessed
participation from all four Indian Patent introduce Vonoprazan in India
Offi ces, Danish Patent Offi ce examiners, Alkem Laboratories said it has “The company has a formidable
and representatives from CSIR labs inked a patent licensing pact with Takeda presence in the gastrointestinal segment
involved in biotech and medtech Pharmaceutical Company to commer- and this non-exclusive patent licence
intellectual property. Prof. Dr. Unnat cialise Vonoprazan in India. The medi- with Takeda will help us offer a pro-
Pandit, Controller General of Patents, cation (in strengths of 10 and 20 mg) duct with novel mechanism of action
Designs & Trademark Offi ce of India, is indicated in the treatment of refl ux for a large number of patients in India
and Dr. Louise Boisen, IPR Counsellor esophagitis (RE) and other indications who are suffering from gastro-related
at The Royal Danish Embassy in India, such as gastric ulcers and duodenal ailments,” Alkem Laboratories’ CEO
initiated the discussions, and the event ulcers, among others. Mr. Vikas Gupta said in a statement.
was moderated by Dr. Nitin Tewari,
Head of the Intellectual Property Group Zydus Lifesciences gets warning letter
at CSIR-NCL. from USFDA for its Jarod injectable unit

Indian Patent Offi ce examiners Zydus Lifesciences said it has to submit its response to the letter in
discussed the examination processes received a warning letter from USFDA 15 days. Zydus said the warning Letter
and requirements for biotech patents relating to its injectables manufactu- does not contain any data integrity rela-
in India, referencing recent case laws. ring facility at Jarod near Vadodara. The ted violations. “The company will take
They also addressed non-patentable warning letter is an escalation of the all necessary steps to work with USFDA
subject matter under the Indian Patents offi cial action indicated (OAI) classifi - towards earliest remediation of the
Act. Danish patent examiners provided cation of the inspection conducted by above facility,” Zydus said in a state-
insights into biotech and medtech the US regulatory agency from April ment to stock exchanges. The warning
patenting in Denmark and under the 15 to April 23, 2024. The warning letter letter doesn’t impact existing supplies
European Patent Convention. Dr. Tewari summarises violations with respect to from the manufacturing site but restricts
emphasised CSIR-NCL’s longstanding Current Good Manufacturing Practice new launches, which is critical for busi-
IP culture, highlighting signifi cant contri- (cGMP) regulations. The company has ness growth in US market.

146 Chemical Weekly September 10, 2024

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