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Expert Testimony Pharmaceutical Industry

Faegre Drinker Biddle & Reath LLP

Amended FRE 702 Arrives in MDL Practice: S.D.N.Y. Excludes Plaintiffs’ Experts in Acetaminophen MDL

The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role...more

Akin Gump Strauss Hauer & Feld LLP

Results from Phase I and II Clinical Trials and Pending Phase III Clinical Trial Insufficient to Render Obvious Method of Treating...

In an ANDA case in the District of Delaware, the court has rejected an obviousness challenge to a patented method of increasing survival in patients having prostate cancer. The court found that early clinical trial results...more

McDonnell Boehnen Hulbert & Berghoff LLP

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2022)

Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more

Akin Gump Strauss Hauer & Feld LLP

Discussion of Inventors’ Path in Expert’s Obviousness Opinion Warrants Partial Exclusion in Bench Trial

In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more

Bradley Arant Boult Cummings LLP

30(b)(6) vs. 702 – Is Your Witness a Party or an Expert?

Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more

Haug Partners LLP

Is Silence Disclosure? The Federal Circuit Clarifies its Position on Negative Claim Limitations

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In Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 21-1070, slip op. at 7 (Fed. Cir. Jan. 3, 2022), the defendant posed two distinct written-description challenges to Novartis’s patent claims, regarding (1) a daily...more

Snell & Wilmer

Federal Circuit Upholds a Silent Written Description

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In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

Butler Snow LLP

The Case for Non-Retained Expert Witnesses

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It’s not easy getting a drug or device to market. From concept to launch, it takes years of work and the involvement of countless professionals from the engineering, medicine and regulatory disciplines. If the product becomes...more

Foley Hoag LLP

Product Liability Update - May 2020

Foley Hoag LLP on

Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...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

Smart & Biggar

Seedlings’ LifeCard patent found invalid and not infringed by Pfizer’s EpiPen

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Update: On July 28, 2021, the Federal Court of Appeal dismissed Seedling’s appeal from Justice Grammond’s decision: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154 (see article here). On January 2,...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 3

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Summer is winding down, and Fall texted to say she is on her way. This means that Pro Te: Solutio is returning for its third edition of 2019. As always, our authors have taken the time to research and address current issues...more

McDermott Will & Emery

Equivalent Disclosure Used to Satisfy Written Description Requirement

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Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more

Foley & Lardner LLP

The Senate Holds Hearings On The State Of Patent Eligibility In America

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Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more

McCarter & English, LLP

McCarter Plays Key Role In New Jersey Supreme Court’s Landmark In Re: Accutane Decision Regarding Expert Admissibility Standards

Until now, the perception that New Jersey law on expert admissibility was weaker than the Daubert standard used in federal courts and many other states - combined with New Jersey being home to so many pharmaceutical and...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Product Liability Insights - Issue 1, 2018

Welcome to our inaugural issue of Product Lines—our e-newsletter focusing on toxic torts and products liability news and issues. As we all know, there are many issues that arise in this complex area of the law every day. We...more

Foley & Lardner LLP

Claim Construction Of An Enantiomeric Chemical Structure

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In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Harris Beach PLLC

Significant New York Drug and Device 2017 Product Liability Decisions

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To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more

Goodwin

Amgen v. Hospira: Litigation Update

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With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit®...more

Holland & Knight LLP

Healthcare Law Update: September 2017

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OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

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