5 Key Takeaways | Rolling with the Legal Punches: Resetting Patent Strategy to Address Changes in the Law
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
Section 112 of the Patent Act contains multiple requirements that relate to the adequacy of an inventor’s disclosure within a patent application. The Supreme Court has offered some clarity to inventors seeking to patent...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
On July 24, in United Therapeutics Corporation v. Liquidia Technologies, Inc., the Federal Circuit addressed whether safety and efficacy are required for pharmaceutical method claims to be sufficiently enabled and supported...more
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more
Without any comments, the Supreme Court has denied Juno Therapeutics’ Petition for Rehearing, which requested that the Court hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC....more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Circuit Judges Moore, Linn, and Hughes presiding; Opinion by Moore, J.; Dissenting Opinion by Linn, J.)...more
ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more
The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C....more
NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC. Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Minnesota. Summary: Providing examples in the claim language and...more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. Judges Cunningham and Stoll did not participate in the decision, which...more
In Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 21-1070, slip op. at 7 (Fed. Cir. Jan. 3, 2022), the defendant posed two distinct written-description challenges to Novartis’s patent claims, regarding (1) a daily...more
Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) - In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that...more
In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more
When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim? This is a question that comes readily to mind...more
NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more
Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC. Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia. Summary: A specification may not...more
The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more