Intellectual Property & Patents

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

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

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

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

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

Waters’ acquisition of Prosolia’s DESI technology boosts its mass spectrometry imaging portfolio.

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

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.

Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.

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

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.

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 patent was filed for a chewing gum composition with controlled release of cannabinoids and opioid agonists, and antagonists for addiction or dependence treatment.

The agency released its report on pilot project to involve patients in the assessment of medicines.

A new study from the United States National Institutes of Health (NIH) found that pairing the antidepressant amitriptyline with drugs designed to treat central nervous system diseases, enhances drug delivery to the brain by inhibiting the blood-brain barrier in rats. The blood-brain barrier serves as a natural, protective boundary, preventing most drugs from entering the brain. The research, performed in rats, appeared online April 27, 2017 in the Journal of Cerebral Blood Flow and Metabolism.

UC Berkeley appealed the February 2017 decision that determined Harvard and MIT’s Broad Institute and Berkeley’s CRISPR-Cas9 technologies were separately patentable.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

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

In a recent deal with the Federal Trade Commission, Endo agreed to refrain from entering into future pay-for-delay agreements for ten years.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.