Life Sciences Pharmaceutical Industry

News & Analysis as of

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Donations and Grants in China: Compliance Controls Beyond T&E

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

PTAB Life Sciences Report - September 2016 #2

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Medtronic Xomed, Inc. v. Neurovision Medical Products, Inc. - PTAB Petition: ...more

Blog: Federal Court Gives Teeth to Operational Efforts Covenant in Sanofi/Genzyme Earn-Out Dispute

We keep a close eye on developing cases regarding earn-outs and contingent payment rights in light of the prevalent use of these arrangements in life sciences deals and their increasing use in non-life sciences deals. On...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

PTAB Life Sciences Report - September 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH - PTAB Petition: IPR2016-01665;...more

PTAB Life Sciences Report - August 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Illumina, Inc. v. Scripps Research Institute - PTAB Petition: IPR2016-01619; filed...more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

PTAB Life Sciences Report

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents....more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

PwC Report: 2017 Will Be Year of Equilibrium for Medical Costs

A report issued by PwC's Health Research Institute (HRI) in June projects next year's medical cost trend (i.e., the projected percentage increase in the cost to treat patients) to be 6.5%, which is level to the medical cost...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

The Life Sciences Report - Summer 2016

The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World - In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more

FDA Regulatory and Compliance Monthly Recap – May 2016

FDA draft guidance provides recommendations on use of electronic health record data in clinical trials - The draft guidance provides recommendations on deciding whether and how to use EHRs as a source of data in clinical...more

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

MoFo BioMeter, Volume 5, Issue 1

The full-year 2015 BioMeter paints the picture of a strong year for biotechnology, but deeper analysis shows a cautionary trend. The average BioMeter value for the entire year across all transactions reporting up-front...more

Q1 2016 IPO Market Review

The first quarter of 2016 produced a meager eight IPOs with gross proceeds of $667 million. Only once over the prior 12 years has the first quarter produced a lower tally—there were only two new offerings in the glum...more

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

A Look at Tax Issues of the Life Sciences and Tech Industries

Wolters Kluwer had the opportunity this past week to sit down with Pepper Hamilton LLP partners Todd Reinstein, Washington, D.C., and Joan Arnold, Philadelphia, to discuss current tax issues particularly relevant to the life...more

Legislative Developments in Post-Grant Proceedings

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

Celltrion Opposes Expedited Trial and Delayed Launch Date

On Monday, Celltrion filed a response to the letter Janssen submitted to the Court on April 12 requesting an expedited trial schedule. Celltrion maintains that Janssen improperly argues the merits of Janssen’s claim of...more

Alert: Life Sciences Company Hit with $4 Million SEC Penalty

On March 29, the US Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay a $4 million penalty to settle fraud charges that it failed to...more

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