News & Analysis as of

Pharmaceutical Industry Non-Disclosure Agreement

McDonnell Boehnen Hulbert & Berghoff LLP

H. Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)*

The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past...more

Axinn, Veltrop & Harkrider LLP

FTC Throws Down the Gauntlet on Improper Orange Book Listings

The FTC recently issued a policy statement warning drug manufacturers that it “intends to scrutinize improper Orange Book listings” and “use its full legal authority” to “tak[e] actions against companies and individuals that...more

Proskauer - Life Sciences

When Nondisclosure Agreements and Pharmaceutical Trade Secrets Intersect

In the United States, the scale of trade secret theft is estimated to be between $180 billion and $450 billion annually. Among the targets of this theft are pharmaceutical companies, which are some of the most...more

Fisher Phillips

Protecting Against the Risk of Trade Secret Exposure Arising from Biotech Industry Collaboration

Fisher Phillips on

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

Patrick Malone & Associates P.C. | DC Injury...

Courts, by too readily sealing records, contributed to opioid crisis, report finds

The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...more

Robins Kaplan LLP

Financial Daily Dose 7.1.2019 | Top Story: US and China Pledge to Resume Trade Talks

Robins Kaplan LLP on

The US and China agreed to resume trade talks after a  7-week hiatus, “averting for now an escalation of their multibillion-dollar tariff war that has roiled global markets and threatened the future of the world’s two largest...more

Goodwin

Federal Circuit Addresses Standing in Decision on Appeal from PTAB

Goodwin on

Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Robins Kaplan LLP

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

Robins Kaplan LLP on

Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...more

Orrick - Trade Secrets Group

Former Employee Allegedly Coughs Up Cold Remedy Formula: Broad Non-Disclosure Agreement Largely Ineffective

A New Jersey appellate court’s decision last week in UCB Mfg., Inc. v. Tris Pharma, Inc., serves as a cautionary tale for employers when drafting confidentiality agreements to protect their trade secrets and confidential...more

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