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Science Group Sues FDA Over New Laboratory-Developed Test Rule

On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more

WIPO Member States Adopt New Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge

On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making....more

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Teva v. GSK: The “Skinny” Label Case Pending Before the Supreme Court

On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more

Natural Alternatives International, Inc. v. Creative Compounds, LLC.: Dietary Supplement Containing A Natural Product Incorporated...

In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of...more

Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more

Proposed Legislation: The Hatch-Waxman Integrity Act

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Bayer and Monsanto Deal Gets Blessed

Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its...more

Seattle Genetics Acquires Cascadian Therapeutics, Continuing a Strong 2018 Start in Biotech Mergers and Acquisitions

On January 31, two Seattle biotech companies, Seattle Genetics and Cascadian Therapeutics, announced a merger agreement under which Seattle Genetics will acquire Cascadian Therapeutics for $614 million. The announcement...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena

The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more

Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

Melinta Therapeutics Receives FDA Approval for Baxdela in Skin Infections

On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approval...more

Tesaro Receives Early FDA Approval for Ovarian Cancer Drug Zejula

On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more

Matching Claim Language with Label Language Ensnares Infringers

On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of...more

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more

Getting the Most from Biotech Patents in Europe Without Breaking the Bank: Selecting the Right Countries for Validation

Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries. Such a decision may have long-term business and legal consequences. ...more

Federal Circuit Relies on Robust Disclosure to Save Priority Date

On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written...more

Navigating the Patent Minefield

In This Presentation: • Patent infringement suits – Costly – Risk of preliminary injunction – Time consuming – Risk of customers being sued – Damages • Lost profit or reasonable royalty • Treble...more

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