The Federal Circuit recently issued a decision in SoftView LLC v. Apple Inc. clarifying the scope of patent owner estoppel set forth in 37 C.F.R. § 42.73(d)(3)(i). 2024 WL 3543902 (Fed. Cir. July 26, 2024). The regulation...more
On July 9, 2024, Director Vidal reversed and remanded a denial of institution of inter partes review (IPR) relating to three Spin Master patents. See Prime Time Toys LLC v. Spin Master, Inc., IPR Nos. 2023-01339, 2023-01348,...more
The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
7/30/2024
/ Biosimilars ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform
The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Director Vidal recently vacated three discretionary denials of institution after finding that the three petitioners did not have a “significant relationship” with a prior petitioner. American Honda Motor Co., Inc. v. Neo...more
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more
1/26/2024
/ En Banc Review ,
Intellectual Property Protection ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing
USPTO Director Kathi Vidal recently designated precedential section II.E.3 of Penumbra, Inc. v. RapidPulse, Inc. and clarified that the priority analysis for an AIA reference patent as prior art is different than for a...more
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
12/20/2023
/ Bayh-Dole Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health and Safety ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
March-in-Rights ,
NIST ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs
In its second-ever Final Written Decision in a derivation proceeding, the Patent Trial and Appeal Board (“PTAB”) determined that a patent application for a biocidal composition and method of producing said biocidal...more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
In Short -
The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
The Federal Circuit recently held, in Cupp Computing AS v. Trend Micro Inc., that a disclaimer in an inter partes review (IPR) proceeding is not binding on the USPTO in the same proceeding in which the disclaimer is made....more
In Short: -
The Situation: President Biden and members of Congress have called for reform of certain patenting practices at the United States Patent and Trademark Office ("USPTO") under the premise that changes to the...more
The PTAB recently issued a rare decision instituting a derivation proceeding, in Global Health Solutions LLC v. Selner, DER2017-00031 (“GHC”). The GHC institution decision provides several lessons for future petitioners...more
A podcast from JAMS featuring Steven Bauer and Sarah Geers on how ADR can play a pivotal role in resolving IP-related disputes in the life sciences industry -
In this podcast, Steven Bauer, mediator and arbitrator at...more
4/1/2022
/ Arbitration ,
Arbitrators ,
Dispute Resolution ,
Intellectual Property Litigation ,
Inventors ,
Life Sciences ,
Mediation ,
Mediators ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Trade Secrets
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
2/16/2022
/ Competition ,
Data Management ,
Deceptive Intent ,
Drug Pricing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Monopolization ,
Patient Access ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
USPTO
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Although it may seem counterintuitive, the PTAB has jurisdiction over expired patents, and patent owners may need to defend their expired patents in inter partes review. The PTAB recently reiterated this in Apple, Inc. v....more
12/22/2021
/ Apple ,
Article III ,
Claim Construction ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Lack of Jurisdiction ,
Patent Expiration ,
Patent Trial and Appeal Board ,
Patent-in-Suit ,
Patents ,
Standing
Jones Day partners Meredith Wilkes, Patricia Campbell, and Sarah Geers discuss the implementation of the Trademark Modernization Act, the recent decision in Thaler v Hirshfeld – a case involving protections for works created...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
We recently reported on bipartisan legislation introduced by Senators Patrick Leahy (D) and John Cornyn (R) to significantly revamp certain features of the America Invents Act (AIA), ten years after its debut. This proposed...more
10/22/2021
/ America Invents Act ,
Estoppel ,
Injury-in-Fact ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Inventions ,
Patent Trial and Appeal Board ,
Patents ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Standing ,
USPTO
In Baker Hughes Oilfield v. Hirshfeld, the Federal Circuit held that the PTAB violated the Administrative Procedure Act (“APA”) by finding certain instituted claims obvious on grounds it had indicated in its institution that...more
Background -
On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
9/21/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Induced Infringement ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a). In this case,...more
Claims added or amended during inter partes review (“IPR”) do not become part of a patent until the Patent Office officially says so by issuing an IPR certificate under 35 U.S.C. § 318(b). The patentee needs more than a Final...more