Vern Norviel

Vern Norviel

Wilson Sonsini Goodrich & Rosati

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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

7/24/2015 - Appeals Biosimilars BPCIA Commercial Marketing Counterclaims Disclosure FDA First Impression Notice Provisions Patents Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz v Amgen Unfair Competition

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

7/17/2015 - ANDA FDA Generic Drugs Healthcare Orange Book Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

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

6/30/2015 - China Gilead Sciences Patent Prosecution Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Popular SIPO

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

6/24/2015 - Diagnostic Tests DOJ Emerging Growth Companies Enforcement Actions Equity Financing False Claims Act FDA Healthcare Human Genome Project IPO Life Sciences Manufacturers Medical Devices Myriad Patent Infringement Patents Personalized Medicine Venture Capital

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

6/3/2015 - ANDA FDA Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Product Exclusivity

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

3/25/2015 - Biosimilars BPCIA FDA Patents Pharmaceutical Manufacturers Pharmaceutical Patents Popular Sandoz Sandoz v Amgen

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

3/17/2015 - Biologics Clinical Trials Drug Manufacturers FDA Informed Consent Medical Devices Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

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

1/16/2015 - FDA Laboratory Developed Tests Proposed Regulation Regulatory Agenda

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

12/17/2014 - Alice Corporation CLS Bank v Alice Corp DNA Mayo v. Prometheus Myriad Myriad-Mayo Patent-Eligible Subject Matter Patents Product of Nature Doctrine USPTO

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

8/7/2014 - Clinical Laboratories Enforcement Guidance FDA Laboratory Developed Tests Medical Devices

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

5/1/2014 - Digital Health Healthcare IPO Patents SBIRs Startups Venture Funding

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

2/27/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

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

6/12/2013 - America Invents Act Civil Monetary Penalty CMS Final Rules Mayo Foundation for Medical Ed Mayo v. Prometheus Patent Reform Patents Sunshine Act Venture Capital

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