Menarini Asia-Pacific is a subordinate of the prominent Italian pharmaceutical corporation Menarini Group. They use their international resources for domestic customer insights to provide medical innovations to hospitals and healthcare providers. They observe broad portfolios of branded healthcare products and licensed brands from foremost biotech companies.
Menarini Asia-Pacific Holdings Pte Ltd filed a patent application numbered 7070/DELNP/2015 that is titled PHARMACEUTICAL COMPOSITIONS CONTAINING DEXKETOPROFEN AND TRAMADOL. The patent has been filed in the field of Pharmaceuticals. This Patent Application has been granted as Patent Number 353041. This invention provides a pharmaceutical composition in a solid oral dosage form, containing a combination of the two active pharmaceutical ingredients, dexketoprofen as a salt with organic bases and tramadol as a salt with inorganic acids, wherein the organic base is trometamol, the inorganic acid is hydrochloric acid, a filler which is microcrystalline cellulose, a binder selected from the group consisting of maize starch, maize starch pre-gelatinized and hypromellose, or mixtures thereof, a pharmaceutically acceptable excipient wherein the two active ingredients form a homogeneous mixture in which said active ingredients are intimately mixed.
During the Patent Examination, the Patent Examiner raised objections under Section 3(d) of the Patents (Amendment) Act, 2005. It was pointed out that the claims compound used in composition as claimed are only a new form of the known compound and considered as same substance as per the act because any enhancement in known efficacy in comparison to the prior art compound has not been exemplified.
As a response, the Applicant submitted that the amended claims discloses a composition and not a compound and said composition is neither a mere new form of a known substance nor what is claimed is a new use of a known substance. Therefore, said composition does not come within the ambit of Section 3(d).
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.
