Pharmaceutical Industry Life Sciences

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PTAB Life Sciences Report -- Part I December 2016

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

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

"Two Court of Chancery Deal Litigation Decisions Provide Helpful Guidance"

Chelsea Therapeutics: Post-Closing Bad Faith Claim a ‘Rare Bird’ in Delaware Absent Allegations of Self-Interestedness or Lack of Independence - In In re Chelsea Therapeutics International LTD Stockholders Litigation,...more

Competition law scrutiny of patent settlements - a new focus in Australia?

Settlement agreements in patent disputes between pharmaceutical companies may soon face greater competition law scrutiny in Australia. The Productivity Commission has put ‘pay for delay’ patent settlements between originator...more

Sanofi & Verily Launch a Diabetes Joint Venture

Sanofi, a French multinational pharmaceutical company, and Verily Life Sciences LLC (formerly Google Life Sciences), Alphabet’s U.S.-based company devoted to the study of life sciences, recently announced the launch of Onduo,...more

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

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

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