API and IP Newsletter
Contents
Automated chemistry: The machines that can discover new drugs
Novartis backs Epsilogen's bid to turn 'Cinderella antibody' into a new class of cancer drug
FDA approvals in February 2022
FDA approved PYRUKYND in February 2022.
The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4 (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3)
Mitapivat is a pyruvate kinase activator that acts by allosterically binding to the pyruvate kinase tetramer and increasing pyruvate kinase (PK) activity. The red blood cell (RBC) form of pyruvate kinase (PK-R) is mutated in PK deficiency, which leads to reduced adenosine triphosphate (ATP), shortened RBC lifespan, and chronic haemolysis.
Below are the important patent families
WO 2011/002817 (Compound VIII-8)
WO 2016/201227 (Use of mitapivat) and
WO2019104134A1 relates to several polymorphs.
RM (cyclopropylmethyl)piperazine, is being imported by Jubilant Biosys and TCG, these companies must be working on developing API.
General information
Automated chemistry: The machines that can discover new drugs
These days, though, chemists are beginning to think that the legwork could be automated, allowing us to quickly make large libraries of new molecules and test their properties. To this end, Andy Cooper at the University of Liverpool, UK, and his team have built a robot chemist
News here.
Novartis backs Epsilogen's bid to turn 'Cinderella antibody' into new class of cancer drug
Novartis has thrown its weight behind a “Cinderella antibody,” leading a 30.8 million pound sterling ($40.9 million) series B round that positions Epsilogen to try to create “a brand new category of pharmaceutical within within cancer.”
London-based Epsilogen’s primary focus is an immunoglobulin E (IgE) antibody that targets the folate receptor alpha antigen. While researchers discovered IgE antibodies in 1966, and biologics pioneers considered them at the birth of the biotech industry, Epsilogen claims its candidate is the world’s first IgE antibody to enter the clinic.
Epsilogen CEO Tim Wilson, who coined the term “Cinderella antibody,” framed the near-total dominance of IgG antibodies up to this point as a result of “folklore problems with IgE” that have “prevented people paying attention” to recent advances in understanding of the potential benefits of the antibodies.
News here.
Intellectual Property
Naproxen and Esomeprazole Magnesium delayed-release tablets (Vimovo)
About couple of weeks ago we understood few legal terms. Let us understand some legal terms in this article too.
Claim preclusion. What is issue preclusion?
It relates to closely related issues, where “issue preclusion” OR “collateral estoppel” prevents someone from re-litigating a particular issue once a court has ruled on it.
What is summary judgement in USA?
In law, a summary judgment is a judgment entered by a court for one party and against another party summarily, i.e., without a full trial.
Here is the case where New Jersey district court granted summary judgment motion and found two patents invalid under issue preclusion. Dr. Reddy’s (DRL) moved the Court for summary judgment on issue preclusion and claim preclusion based on previous litigation concerning patents, US 6,926,907 and US 8,557,285. These patents found invalid earlier.
The two patents presently at issue descend from US 6,926,907 are US 8,858,996 and US 9,161,920.
This case is related to Vimovo. Vimovo (naproxen/esomeprazole magnesium) is the brand name for fixed-dose combination of enteric-coated naproxen, and IR esomeprazole magnesium in a single delayed-release tablet. Pozen, Inc. developed Vimovo in collaboration with AstraZeneca. On 30 April 2010, the FDA approved Vimovo
Vimovo is currently commercialized in the U.S. by Horizon Pharma and by AstraZeneca
On 20 November 2012, Dr. Reddy’s Laboratories (DRL) provided notice to Patentee that it filed a second ANDA relating to the Vimovo product. As it had done with respect to the earlier ANDA, DRL provided to the FDA a Paragraph IV certification in which it certified to FDA that the ‘907 patent was invalid, unenforceable or will not be infringed by DRL’s generic Vimovo product.
Based on this ANDA filing, Patentee brought a second patent infringement action against DRL, (DRL-II), alleging that DRL has infringed the ‘907 patent.
Less than six months after Magistrate Judge Arpert issued his decision, Patentee filed the instant motion to amend.
In this second motion, Patentee is seeking to file substantially the same amended invalidity responses as they sought in the earlier motion.
Patentee tried to argue, the claim that the filing of DRL- II provides good cause for granting this motion in DRL-I. According to patentee, the changed procedural and scheduling posture due to DRL’s second ANDA and the effect an invalidity holding in “DRL I” will have on “DRL II” provides good cause for the requested amendment.
The Court said, Patentee never really explain exactly how the filing of DRL II is such a change in circumstances that it would justify altering the earlier ruling. And hence, on 25 February 2022 the NJ District Court granted DRL’s request for summary judgment invalidating the ‘996 and ‘920 patents.
Horizon intends to appeal the District Court’s ruling to the Federal Circuit Court of Appeals. Here
Generic Launches:
On 18 February 2020, the FDA granted final approval for DRL’s generic version of VIMOVO.
On 27 February 2020, DRL had launched its generic version of VIMOVO in the United States
In March 2020 Lupin launched Authorized Generics.
Naproxen and Esomeprazole Magnesium delayed-release tablets (RLD: Vimovo) had an annual sale of approximately USD 400 million in the US (IQVIA MAT January 2020). Here
