4-Aminopyridine: Acorda Win & Loss

May 3, 2017

Acorda won at the PTAB but lost in the US District Court.

Acorda Therapeutics, Inc. is fighting is to extend the life of their 4-aminopyridine formulations and methods.

160px-4-aminopyridine.svg

Acorda will retain market exclusivity to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg at least through July 2018.

The US District Court in Delaware ruled that Acorda’s four patents set to expire between 2025 and 2027 are invalid.  A few weeks earlier, the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld the four patents challenged via the inter partes review (IPR) process [U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent)]. These patents, if valid and enforceable, are calculated to expire in 2025, 2025, 2026 and 2027, respectively.

ACORDA THERAPEUTICS, INC., et al. v. ROXANE LABORATORIES, INC., et al.

Case #: 14-882
Judge: Chief Judge Leonard P. Stark

Next?: Acorda will appeal. Meanwhile Acorda announced restructuring and layoffs

http://www.4-traders.com/ACORDA-THERAPEUTICS-INC-8238/news/Acorda-Therapeutics-Implements-Corporate-Restructuring-to-Align-Cost-Structure-with-Focus-on-Promi-24209186/

http://cen.acs.org/articles/95/i15/Troubled-biotechs-cut-jobs.html

Fierce Pharma

http://www.fiercepharma.com/pharma/court-nixes-4-acorda-patents-teeing-up-amprya-generics-for-2018

Acorda press releases

03/31/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/US-District-Court-Issues-Decision-to-Invalidate-Four-AMPYRA-Patents-Company-Will-Appeal-Ruling/default.aspx

03/09/2017: http://ir.acorda.com/investors/investor-news/investor-news-details/2017/Patent-Trials-and-Appeal-Board-PTAB-Upholds-Four-AMPYRA-Patents/default.aspx

Nucleophilic Covalent Drugs

May 1, 2017

Prof. Kate Carroll of Scripps Research Institute extended covalent drug discovery to cysteine-oxidized proteins by developing a library of nucleophilic drug candidates. For example, Prof. Carroll provided pyrolidinedione nucleophiles that react with protein tyrosine phosphatases.

See J.AmChem.Soc. 2017, DOI:10.1021/jacs.7b01791

http://pubs.acs.org/doi/10.1021/cen-09517-notw7

US 2016/0195532 “Targeted Covalent Probes and Inhibitors of Proteins Containing Redox-Sensitive Cysteines”

 

 

Patent-Related Notes from C&EN

April – 2017

Syngenta Patents Infringed:

Syngenta says a U.S. district court has found that the agrochemical maker Willowood infringed two Syngenta patents relating to the fungicide azoxystrobin. Damages for the infringement will be assessed at a trial later this year.

Solvay won a patent infringement lawsuit in China:

Solvay has won a patent infringement lawsuit in China against the Yantai-based firm Sunshow Specialty Chemical. The suit involved an ultraviolet stabilizer for thermoplastic olefins produced by Solvay’s Cytec Industries subsidiary.

10% of NIH Grants Directly Lead to Patents

According to Science (2017, DOI: 10.1126/science.aal0010), 10% of NIH Grants Directly Lead to Patents. Meanwhile, 30% of NIH grants are cited in patent applictions.   (See “By the numbers” – C&EN, 2017, 95 (14), pp 21–21April 3, 2017.)

The applied value of public investments in biomedical research

Abstract

Scientists and policy-makers have long argued that public investments in science have practical applications. Using data on patents linked to U.S. National Institutes of Health (NIH) grants over a 27-year period, we provide a large-scale accounting of linkages between public research investments and subsequent patenting. We find that about 10% of NIH grants generate a patent directly but 30% generate articles that are subsequently cited by patents. Although policy-makers often focus on direct patenting by academic scientists, the bulk of the effect of NIH research on patenting appears to be indirect. We also find no systematic relationship between the “basic” versus “applied” research focus of a grant and its propensity to be cited by a patent.

Steadymed wins IPR Challenge of United Therapeutics’s Remodulin® Product-by-Process Patent Claims

Final Decision – March 31, 2017

IPR2016-00006

STEADYMED LTD., (Petitioner)  v. UNITED THERAPEUTICS CORPORATION, (Patent Owner)

U.S. Patent No. 8,497,393 B2 “Process to Prepare Treprostinil, the Active Ingredient in Remodulin®”

Link to PDF: https://ptabdata.uspto.gov/ptab-api/documents/663936/native

Concert Pharma Sells Deuterated Version of Ivacaftor to Vertex

Vertex acquired rights to Concert Pharmaceuticals’s cystic fibrosis drug CTP-656. The drug is a deuterated version of Vertex’s own compound ivacaftor, which it sells under the name Kalydeco.

CTP-656 Currently in Phase II clinical trials. The deal avoided a potential litigation between the two companies.

CTP-656

CTP-656

Links:

BioSpace: “Vertex (VRTX) Inks Deal Worth $250 Million for Concert Pharma (CNCE)’s Cystic Fibrosis Drug”

C&EN: “Vertex Buys Concert’s Cystic Fibrosis Drug”

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