Novartis AG manufactures pharmaceutical and consumer healthcare products. The Company uses innovative science and digital technologies to create transformative treatments in areas of great medical need. Novartis offers patent protected prescription medicine and generic pharmaceuticals and biosimilars.
In India, the Pharmaceutical business of Novartis AG is focused on Multifocal lens having reduced chromatic aberrations, Alkynyl nucleoside analogs as inhibitors of human rhinovirus, Alkynyl nucleoside analogs as inhibitors of human rhinovirus, Apparatuses and methods for parameter adjustment in surgical procedures.
Novartis AG filed patent application numbered 1331/DELNP/2015 that is titled as IMPROVED PROCESS FOR MANUFACTURING 5-(2,6-DI-4-MORPHOLINYL-4-PYRIMIDINYL)-4-TRIFLUORO-METHYLPYRIDIN-2-AMINE. This Patent Application has been granted as Patent Number 318015.
The invention covers Chemical compound. This invention discloses improved processes for manufacturing a compound, 5-(2,6-Di-4-morpholinyl-4-pyrimidinyl)-4-trifluoromethylpyridin-2-amine, its monohydrochloride salt and intermediates thereof.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act Section 3(d) of the Patents Act, 1970 claimed compounds appears to be mere derivative of the known compounds as described in prior art D1-D2. The claimed compounds shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
As a response, It is respectfully submit that section 3(d) is not applicable unless the known compound in the prior art has known efficacy. With regard to the Learned Controller’s objection that claims 1 to 4 and 7 to 16 relate to mere use of a known process, we respectfully submit that the claimed process relates to new improved process with particular steps (such as different solvents, reagents, improved yield and purity compared with the prior art).
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.
