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Pillsbury - Propel

Protecting IP During Joint Development Projects: Agree on More than Non-Disclosure

Pillsbury - Propel on

As industry and markets have progressed, the technology they create has seen a commensurate increase in complexity. In practice, this results in the hyper-specialization of businesses so that they may continue to innovate at...more

Mintz - Intellectual Property Viewpoints

Janssen v. Celltrion, Damages: “Patent Dance” May Determine Availability of Lost Profits

On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price...more

Mintz - Intellectual Property Viewpoints

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Foley & Lardner LLP

Will The Avastin Biosimilar Patent Dance Go On?

Foley & Lardner LLP on

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

Knobbe Martens

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

Polsinelli

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

Polsinelli on

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

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