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Evidence Pharmaceutical Industry

Morgan Lewis - As Prescribed

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 18, No. 1

Robins Kaplan LLP on

Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Knobbe Martens

Low-Bar for Corroboration

Knobbe Martens on

MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board - Summary: Federal Circuit confirms low bar for evidence corroborating prior inventorship...more

Foley Hoag LLP

Product Liability Update - April 2023

Foley Hoag LLP on

MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Knobbe Martens

Is Evidence of Generic Industry Skepticism Enough to Preclude a Finding of a Motivation to Combine?

Knobbe Martens on

AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more

Oberheiden P.C.

PBM Audit Defense: Key Strategies for Pharmacies in 2023

Oberheiden P.C. on

Pharmacy benefit manager (PBM) audits are becoming increasingly dangerous for pharmacies. While the role of the PBM was initially to reduce costs for all parties involved, abusive PBM practices have led to the opposite in...more

Faegre Drinker Biddle & Reath LLP

Eastern District of Pennsylvania Issues Lone Pine Order in Zostavax MDL

Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is...more

Holland & Knight LLP

Healthcare Law Update: October 2021

Holland & Knight LLP on

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

HaystackID

[Webcast Transcript] Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

HaystackID on

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters...more

Smart & Biggar

Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

Smart & Biggar on

Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

Hanzo

FDA Regulatory Compliance: Can You Prove What Your Website Said?

Hanzo on

If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming...more

Smart & Biggar

Federal Court denies stay of decision issuing NOC for RUZURGI

Smart & Biggar on

On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more

Akin Gump Strauss Hauer & Feld LLP

District Court: Prosecution History Context Defeats Written Description Requirement

The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more

Faegre Drinker Biddle & Reath LLP

Northern District of California Excludes Expert Testimony and Grants Summary Judgment in Abilify Case

Applying basic scientific principles to exclude an expert’s unfounded and unsupported opinions, the U.S. District Court for the Northern District of California has granted summary judgment to the maker of the antipsychotic...more

Hogan Lovells

International Products Law Review 2020: Issue 76

Hogan Lovells on

We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more

Smart & Biggar

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal

Smart & Biggar on

As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more

Foley & Lardner LLP

A Fresh Look At The Lead Compound Analysis

Foley & Lardner LLP on

I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Remands for New Trial Based on District Court’s Improper Exclusion of Advice-of-Counsel Testimony

In United States v. Scully, 16-3073-cr (Pooler, Lynch, Cogan[1]), the Second Circuit vacated the defendant’s conviction for various offenses, including mail and wire fraud, conspiracy to defraud the United States, the sale of...more

Farrell Fritz, P.C.

Second Circuit Vacates Conviction of Pharmaceutical Distributor on Advice-of-Counsel Defense

Farrell Fritz, P.C. on

Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more

Proskauer - New England IP Blog

Jury Verdict Overturned in Pepcid® Dispute After Court Finds Insufficient Evidence of Infringement

Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more

Troutman Pepper

PTAB Can Rely on New Evidence Introduced by Petitioner in its Reply

Troutman Pepper on

In a decision last month, the Court of Appeals for the Federal Circuit gave petitioners in AIA proceedings yet another weapon to invalidate patents – by affirming a Patent Trial and Appeal Board (PTAB) decision that relied,...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for December 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Knobbe Martens

Third Circuit Upholds Dismissal of Doryx ‘Product Hopping’ Suit

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On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2016)

The Federal Circuit affirmed the decision by the Patent Trial and Appeals Board (PTAB) in an inter partes review (IPR) that the claims of Genzyme's U.S Patent Nos. 7,351,410 and 7,655,226 were obvious, in Genzyme Therapeutic...more

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