Intellectual Property & Patents

Spark Therapeutics and Selecta entered a license agreement for Selecta’s gene-therapy co-administration technology.

Through a license agreement with the Broad Institute, Charles River Laboratories will now be offering gene-editing engineering technology.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

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

Pharmaceutical manufacturers should not be protected from antitrust litigation simply because FTC chooses not to pursue a lawsuit, the agency wrote in a recent amicus brief.

In 2016, Amgen will simultaneously fight off biosimilar competitors to its legacy products and prepare to file its own follow-on products with regulators.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen's in the market.

Novartis settles its litigation with the US subsidiary of Sun Pharma regarding Gleevec.

Pfizer settles its litigation against Teva Pharmaceuticals regarding Pfizer's patent covering the use of Viagra.

The little-known exception to the patent term extension law is potentially valuable but easy to miss.

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders

The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed (now part of Takeda) sought to enforce the patent for its blockbuster acid reflux medicine.

The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.