Intellectual Property & Patents

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry’s future, but, in the US, some argue it is becoming increasingly difficult to do.

Shashank Upadhye, Esq., managing partner at Amin Talati Upadhye, will discuss intellectual property/patent issues for active pharmaceutical ingredients and abbreviated new drug applications at CPhI North America in Philadelphia, PA, on Tuesday, April 24, 2018.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

Gene therapies highlight FDA new drug approvals in 2017.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

The US Department of Justice reports that AmerisourceBergen has pled guilty to illegally distributing misbranded oncology drugs and will pay a $260-million penalty.

The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

The company was granted patent rights to the use of CRISPR in a genomic integration method for eukaryotic cells.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.

The dispute over who has the rights to key CRISPR-Cas9 patents continues. On April 12, 2017 the University of California, Berkeley, in conjunction with the University of Vienna and Emmanuelle Charpentier, filed an appeal to overturn an earlier decision by the United States Patent Trial and Appeal Board (PTAB).

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the company to keep patents for their CRISPR-Cas9 gene-editing technology.

Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.

The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company’s leading multiple sclerosis treatment.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.