News & Analysis as of

Clinical Trials Patents

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Samsung Bioepis Biosimilar Updates

by Goodwin on

We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

by Miles & Stockbridge P.C. on

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications...more

Clinical Trials as Prior Art: PTAB Denies Bass IPR Petition With Only a "Hope" of Efficacy

by Foley & Lardner LLP on

In the most recent loss for Kyle Bass’ hedge fund in IPR proceedings, the Board denied institution of an IPR based on a petition filed by Coalition for Affordable Drugs V LLC (CFAD) against Biogen MA Inc. IPR2015-01136, Paper...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

by Ropes & Gray LLP on

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

News from Abroad: Research Exemptions and Active Ingredient Manufacture

After a series of papers, reports and consultations on the scope of the research exemptions to patent infringement stretching over 10 years, section 60 of the Patents Act 1977 was finally amended on 1 October 2014 by the...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

Federal Circuit Clarifies Standards for a Clinical Trial to Be Public Use

In 2007, Dey L.P., Dey Inc., and their parent company Mylan, Inc. (collectively, "Dey") sued Sunovion Pharmaceutical, Inc. ("Sunovion"; formerly known as Sepracor, Inc.) for infringement of five of Dey's patents....more

Federal Circuit Holds That Third Party Clinical Trial May Not Constitute Public Use

by Foley & Lardner LLP on

In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial...more

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