Enaltec Labs Private Limited operates as a pharma company. The Company provides generic formulators and pharmaceutical products. Enaltec Labs serves customers worldwide.
In India, the Pharmaceutical business of Enaltec Labs Private Limited is focused on polymorphic form of alcaftadine, composition and process.
Enaltec Labs Private Limited filed patent application numbered 1266/MUM/2011 that is titled NOVEL POLYMORPHIC FORM OF DRONEDARONE HYDROCHLORIDE. This Patent Application has been granted as as Patent number 317078.
The invention covers chemical compound. The invention relates to novel polymorphic form of dronedarone hydrochloride hereinafter referred as crystalline form II. The present invention further relates to processes for preparing crystalline form II of dronedarone hydrochloride and pharmecutical composition thereof.
During patent examination, the patent examiner raised objections under Section 3(d) of Indian Patents Act that since the cited documents (D1-D2) disclose the crystalline form of dronedarone and the use of the compound is also for similar activity. Hence the present compounds are considered derivative of the known compound as cited without any distinguishing improved efficacy with reference to the cited ones.
As a response to the said objection, the applicant has cancelled the claim 10 to expediate the process.
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.
