False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the...more
In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more
On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. ...more
Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written...more
In an appeal decided last month, the Federal Circuit affirmed a decision by the District Court for the Southern District of Indiana finding claim 20 of U.S. Patent No. 8,435,944 to be invalid as obvious. The panel also...more
The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more
In something of an anticlimax, Federal Circuit Judge William Bryson, sitting by designation on the bench of the U.S. District Court for the Eastern District of Texas, granted Allergan's motion to join the St. Regis Mohawk...more
In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more
On May 1st, the Federal Circuit ruled that the America Invents Act (AIA) did not change the statutory meaning of “on sale” where the existence of a sale was publicly announced prior to patenting, even if the sale did not...more
Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more
The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey -...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of California. ...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC 1:15-cv-06700; filed July 30, 2015 in the Northern District...more
Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more
There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more
The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more