Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
More than 500 sequentially accessed files downloaded to a personal thumb drive, and a description in a verified complaint of the purported confidential information and trade secrets implicated, were the key components of the...more
In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...more
Biotechnology companies in the healthcare/pharmaceutical realm are in an exceptionally competitive field, with many companies competing against each other for a chance to market similar innovative therapeutics. These...more
Before enactment of the America Invents Act (AIA) in 2011, it was understood that an inventor’s secret commercialization of an invention through sale or use can operate like prior art against that inventor’s subsequent patent...more
On January 22, 2019, the U.S. Supreme Court affirmed the U.S. Court of Appeals for the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229 (Jan. 22, 2019)....more
Addressing whether the on-sale bar of America Invents Act (AIA) 35 USC § 102(a)(1) applies to confidential sales where specific details are not made public, the Supreme Court of the United States found that the post-AIA...more
If the term "happy hour" in this article's title caught your attention, you may be disappointed by what comes next. This article is actually about limitations on patent protection, which I would argue is just as...more
Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more
The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act...more
Prior to the Leahy-Smith America Invents Act (“AIA”), the patent statute (35 U.S.C. § 102(b)) prohibited patenting an invention that was “on sale in this country, more than one year prior to the date of the application for...more
Inventors should not delay the filing of their patent applications, and preferably should file within one year of any commercialization of the invention, as confirmed by the Supreme Court on January 22, 2019....more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of 35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the...more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc, the United States Supreme Court held that a prior public sale of a patented product could destroy the novelty of a patent for that product even though there was no...more
U.S. patent law states that any invention that was “on sale in this country, more than one year prior to the date of the application for patent” is not eligible for patent protection. The Supreme Court recently confirmed...more
The America Invents Act (“AIA”), also called the Patent Reform Act of 2011, was enacted to overhaul the U.S. patent system and harmonize the domestic patent laws with those in the rest of the world. The AIA also created new...more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court affirmed the Federal Circuit’s decision that the sale of an invention to a party who is contractually obligated to keep the invention...more
In a unanimous decision, the United States Supreme Court has held that inventors are barred from obtaining patents on inventions that were “on sale” more than one year prior to a patent application even if the sale is subject...more
With Helsinn, the Supreme Court confirms that secret sales trigger the on sale bar, just as before the America Invents Act. Patent applicants should be cognizant of all commercial activity related to an invention to ensure...more
The US Supreme Court issued a decision in Helsinn Healthcare S.A. v Teva Pharmaceuticals, USA, Inc., holding that the on-sale bar of AIA 35 USC §102(a)(1) applies to confidential sales where specific details are not made...more
The Supreme Court unanimously finds that the AIA's "on sale" statutory language did not alter the pre-AIA "on-sale" bar. On January 22, 2019, the U.S. Supreme Court held that the America Invents Act ("AIA") did not change...more
This week, the Supreme Court issued a decision holding that a secret sale qualifies as prior art. At issue was whether the America Invents Act (AIA) changed the “on sale” bar to patentability to exempt secret sales as prior...more
US patent law has long held that inventions put on sale or placed in public use may not be patented if those sales or uses occurred more than one year before filing for patent protection. These rules apply to all forms of...more
The U.S. Supreme Court has issued a unanimous decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. regarding the impact of new language in the America Invents Act (AIA), 35 U.S.C. § 102, on the "on-sale bar."...more
Can a confidential agreement between a pharmaceutical company and a distributor constitute a patent-invalidating offer for sale of a pharmaceutical product, even if information about the product is never revealed to the...more
Our Intellectual Property Group examines the Supreme Court’s unanimous Helsinn v. Teva ruling that clarifies the meaning of “on sale” in the America Invents Act....more