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Pharmaceutical Industry

Breaking News: FDA Approves Samsung Bioepis’s Biosimilar of REMICADE®

by Goodwin on

Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s...more

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

by Foley & Lardner LLP on

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Just How Predictable Must the Invention Be to Lose Patent Protection? Depends on the Inventive Concept

by Bennett Jones LLP on

Only a true invention can be patented; a patent claim to an invention is not valid if the invention was obvious. Assessing obviousness can be thought of as bridging the gap between two cliffs: on one side is the existing...more

Celltrion Files for Approval to Sell Herzuma (Trastuzumab) in Japan

by Goodwin on

Celltrion announced last week that it has filed for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of breast and gastric cancers...more

Pharmaceutical Compound Nonobvious Absent Evidence Suggesting Specific Modification to Prior Art Compound

by Jones Day on

The PTAB issued a final written decision in IPR2016-00204, upholding the validity of claims 1–13 of Patent RE38,551 E (“the ’551 patent”), which covers the antiepileptic drug VIMPAT® (lacosamide)....more

Novartis AG v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2017)

Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Fed Circ Affirms Conflicting Invalidity Determinations from District Court and PTAB

by Jones Day on

As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

New FCC Chair Ajit Pai is wasting little time in reversing Obama-era regulatory efforts meant to restrict media firms and telecomm companies, and he’s got his sights set on net neutrality next....more

Brexit – the end of parallel imports from the UK?

by Hogan Lovells on

The United Kingdom's unprecedented vote to leave the EU will undoubtedly cause a broad range of legal issues in the future. This post focuses on the consequences of Brexit on parallel imports - a field of significant...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

House and Senate Committees Release Draft Bill that Reauthorizes the User Fee Program for Biosimilars

by Goodwin on

The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

by Hogan Lovells on

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Klaus Kleinfeld is out as CEO of Alcoa-subsidiary Arconic. Kleinfeld’s two-year tenure was marked by problems, and Kleinfeld did himself no favor with an un-Board-authorized letter that he sent to activist-investor Elliott...more

Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday April 18 2017

by Hogan Lovells on

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

The Risk Management Process in Compliance

by Thomas Fox on

An exploration of risk forecasting, risk assessment and risk-based monitoring for the compliance profession. ...more

Vast – Or at Least Half-Vast – Conspiracy Claim Dismissed

by Reed Smith on

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and...more

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