MannKind Corporation functions as a biopharmaceutical enterprise. The Company targets the growth and marketing of therapeutic commodities like diabetes, cancer, inflammatory, and autoimmune ailments. MannKind is well-known for leading the investigational product candidate in the technosphere insulin network.
In India, the business of MannKind Corporation focuses on methods for the synthesis of activated ethylfumarates and their use as intermediates, reactor for producing pharmaceutical particles in a precipitation process, IRE-1? Inhibitors, Laser diffraction with inhaler enclosed in a positive pressure chamber, and Powder dispenser modules and powder dispenser assemblies.
MannKind Corporation filed a patent application numbered 4130/DELNP/2013 that is titled COMPOSITION COMPRISING A SEROTONIN RECEPTOR AGONIST AND A DIKETOPIPERAZINE FOR TREATING MIGRAINES. The patent has been filed in the field of Pharmaceuticals. This Patent Application has been granted as Patent Number 352198. This invention relates to a pharmaceutical composition for the treatment of symptoms associated with migraine comprising an effective amount of a serotonin receptor agonist, an aliphatic amino acid, and a diketopiperazine or a salt thereof.
During the patent examination, the Patent Examiner raised objections under Section 3(d) of the Patents (Amended) Act, 2005 stating that the claims define a combination of known compounds. In the absence of experimental data, it is not clear if the claimed composition provides an enhancement of the known efficacy i.e., demonstrate a greater technical effect and/or differ significantly in properties w.r.t the constituents. In order to overcome this objection, the compounds must have unexpected properties when compared with the structurally closest composition from the prior art.
As a response, the Applicant submitted that the objection raised by the Controller lacks clarity. The Controller in the objection has not identified “specific known substance” in the documents that are being relied upon. The Controller has wrongly taken the substances in isolation and has failed to establish that the combination, as described in the instant application, i.e., the formulation is known.
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.
