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China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more

The Importance of Label Licenses to Life Sciences Companies After Lexmark

On May 30, 2017, in Impression Products, Inc. v. Lexmark International, Inc., the U.S. Supreme Court held that a domestic or foreign sale of a patented product exhausts all U.S. patent rights in that product. The case was...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

USPTO Updates Patent Examiners on Recent Subject Matter Eligibility Decisions

On November 2, 2016, the U.S. Patent and Trademark Office (USPTO) issued a memorandum ("November 2016 Memo") to its patent examiners, updating them on recent subject matter eligibility decisions from the U.S. Court of Appeals...more

The Life Sciences Report - Winter 2016

Ten Considerations for Companies Evaluating a Pre-Negotiated Acquisition - In recent years, there has been a shift in the research and development strategy of large pharmaceutical and medical device companies from...more

New Law Remedies Partial Loss of Drug Marketing Exclusivity Period Caused by U.S. DEA Scheduling Delays

When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...more

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

Rejection of Gilead Patent Raises Issues for Companies Seeking Pharmaceutical Patent Protection in China

Chinese patent prosecution recently made worldwide headlines when the press announced that the Chinese Patent Office (SIPO) rejected a Gilead Sovaldi prodrug patent. Sovaldi (sofosbuvir) is a breakthrough drug used to treat...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

District Court Decision Opens Door to Five-Year NCE Exclusivity for Single Components of Previously FDA-Approved Multi-Component...

On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more

District Court Denies Amgen's Bid to Block Sale of Blockbuster Biosimilar Drug

On March 19, 2015, Judge Seeborg of the Northern District of California handed a significant victory to Sandoz's efforts to bring the first biosimilar product to market by denying Amgen's partial judgment on the pleadings and...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed...

On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more

USPTO Issues New Guidance with Fewer Limitations on the Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed...more

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

The Life Sciences Report - Spring 2013

In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more

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