Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
Be careful of showing your claimed inventions at tradeshows. On February 15, 2023, the Federal Circuit (“CAFC”) affirmed a summary judgment ruling that, by merely showcasing an embodying device at an industry event (the...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
Presidential administrations have affected intellectual property (IP) policy since the very beginning of United States history. In his first State of the Union address in 1790, President George Washington addressed patents....more
In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more
PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more
As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more
Section 112 of the Patent Act as codified, entitled "Specification" in the statute, specifies the amount of disclosure required to support a patent claim (among other requirements). Section 112(a) contains three...more
In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more
Last week, the Federal Circuit overturned an obviousness determination in an inter partes review by the Patent Trial and Appeal Board in OSI Pharmaceuticals LLC v. Apotex Inc. The Court also reaffirmed its holdings in...more
Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more
On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...more
Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...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
The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...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
A patent can provide incredible benefits. When a patent is infringed, the patent owner may be entitled to damages from the infringer. Also, the patent owner may be able to receive an injunction against the infringer,...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
Helsinn Healthcare (“Helsinn”) is the maker of certain treatments for chemotherapy-induced nausea (the “Palonosetron Products”). During the development process, Helsinn entered into two third party agreements for distribution...more
When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more