Science and society

The Patent Chronicle

April 18, 2017

Medco looses infringement contest on Bivalirudin formulation patents

Decision: District court ruled that Mylan’s proposed Abbreviated New Drug Application (ANDA) on the clotting inhibitor did not infringe the Medco’s patents in question. At the same time, Mylan lost the battle seeking invalidation of the Medco patents.

Reason: “Efficient mixing” was as an essential process in the Medco patents for producing batch consistency in Bivalirudin formulations. Mylan’s method was found not to use “efficient mixing” steps in their process as “efficient mixing” was found to be narrowly construed in the one example in the patent, leaving the patent weak.

Impact: Mylan would produce formulations of Bivalirudin without infringing on the Medco patents. Multiple dependable sources for the formulation could turn out to be good for the patients.

https://twitter.com/JakeHoldreith/status/850344410382577664

Novartis loses a major Gilenya patent

Decision: USPTO’s Patent Trial and Appeal Board ruled one Novartis patent on Gilenya used to treat MS invalid for being obvious.

Reason: Torrent Pharma, Apotex, and Mylan had initiated an Inter Partes Review, a post-grant review process, in the USPTO. It sought to invalidate the Novartis patent on grounds of obviousness. The components of the drug were Fingolimod and Mannitol. The former was already known to be useful to treat automimmune disorders such as MS.

Impact: The patent covering the MS oral drug earns billions for Novartis. Novartis has altogether four patents covering the MS drug. This particular one would have shielded the drug from generics till 2026. With this loss, the doors open to generics in 2019.

UC Berkeley’s CRISPR fight proceeds to the next level

Decision: UC Berkeley files an appeal to the USPTO’s Patent Trial and Appeal Board’s decision in the Federal Circuit.

Reason: USPTO had ruled no interference on UC Berkeley’s CRISPR patent by Broad Institute’s CRISPR patent. Inventors of the UC Berkeley’s patent believe they have a broad patent that Broad’s patent infringes.

Impact: In the absence of cross-licensing agreements, it will end up being a long and expensive battle that will become a head ache for everyone, if Broad or UC Berkeley decide to go after the licensees from the other group.

Why the University of California Is Appealing the #CRISPR Patent Decision https://t.co/VhCE1m5VOy

— 𝐦𝐢𝐜𝐡𝐚𝐞𝐥 𝐭. 𝐜𝐨𝐥𝐨𝐫𝐠𝐞 (@CAM2Go) April 18, 2017

Coalition for affordable drugs nears end.

Decision: Bass, the founder of Hayman Capital Management, closed the funding that supported the Coalition.

Reason: Lack of success in getting patents owned by the Big Pharma invalidated at the USPTO. For last one and a half years, the coalition has not filed a new case. It had success in only in 3 out of 14 medicines that it targeted.

Impact: According to some, the Coalition brought increased awareness about high drug prices and what to do about it. It appears that generic manufacturers themselves have taken over this task and have found success in several cases. Therefore, the absence of the Coalition at the forefront of the fight to lower drug prices wont be felt.

Regardless of the actual motivations, the long story of PTAB, Kyle Bass and the Coalition for Affordable Drugs is ve…https://t.co/rV4EF9e3Sf

— Mike K (@Mkleader2) March 29, 2017

Two Goliaths vs many Davids on Eliquis face off

Decision: Over the last two weeks, Pfizer and BMS filed sixteen lawsuits together against 13 generic drug manufacturers of Eliquis.

Reason: Generic manufacturers have been piling up to grab a share of the drug’s multibillion-dollar deep vein thrombosis and pulmonary embolism market. They have abbreviated new drug applications (ANDAs) with the FDA to make and sell Apixaban, a generic for Eliquis.

Impact: Will depend on the ruling of the Delaware court where the lawsuits have been filed.

Roxane to foot defendant’s legal fees as lawsuit is ruled exceptionally meritless

Decision: NJ District Court ruled, “Roxane pursued an infringement claim for which it lacked any legal or factual support”. “Roxane has been unable to point to any colorable factual or legal support for its position. It is indeed an exceptional case.”

Reason: A motion was brought by the defendants Camber Pharmaceuticals Inc. and InvaGen Pharmaceuticals Inc. in the District Court to declare the case “exceptional”. Precedent allows the recovery of legal fees by prevailing party in exceptional cases. The case centered on capsule size. According to the plaintiff, the size of capsules of Calcium acetate made by the defendants were within the definition of the size of capsules claimed. The court ruled it was not.

Impact: Probably good for the patients as multiple sources for the end-stage kidney failure drug could keep prices down.

Drugmaker Must Pay Opponents' Fees After Patent Suit Held 'Meritless' https://t.co/fHiWUHQqYP via @NJLJ

— Charles Toutant (@ctoutantNJLJ) April 14, 2017

About the author:

Authored by Dr Syam Anand, PhD (Indian Institute of Science, IISc; Post-Doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years experience in diverse areas of Science with domain knowledge in Life Sciences and Intellectual Property. Dr. Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems and make common people curious and interested in understanding their worlds.

https://www.linkedin.com/in/syamprasadanand

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