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Federal Rules of Civil Procedure Pharmaceutical Industry

Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

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The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

Dechert LLP

Dechert Re:Torts - Issue 15

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Previous editions of Re:Torts (It’s (Still) Important Enough to Get It Right; Opioid Public Nuisance Question) have covered decisions that addressed whether various states permit public nuisance claims in connection with the...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

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As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Husch Blackwell LLP

False Claims Act Update: A Mid-Year Review (2023)

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The Supreme Court issued a number of headline-grabbing decisions this term on topics like religious accommodation, LGBTQ protections, and consideration of race in college admissions. These decisions are wide-reaching and...more

WilmerHale

CAFC Patent Cases - May 2021 #2

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Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

WilmerHale

CAFC Patent Cases, 10/26/20 – 11/09/20

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Precedential Federal Circuit Opinions: In Re NITRO FLUIDS L.L.C. [ORDER] (2020-0142, 10/28/28) (REYNA, WALLACH, and CHEN)  - Reyna, J.  The Court considered a petition for a writ of mandamus seeking transfer from the...more

Carlton Fields

More Alike Than Different: Sixth Circuit Instructs MDL Court to Find Efficiencies Within Federal Rules Governing Individual Cases

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Judges presiding over multidistrict litigations, known as MDLs, must walk a tightrope between individual and collective needs. ...more

Goodwin

Pfizer Moves to Dismiss Amgen’s Suit Over Proposed Neulasta Biosimilar

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As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more

Mintz - Intellectual Property Viewpoints

Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...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

King & Spalding

Litigants in Opioid MDL Propose First Ever “Negotiating Class”

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In late June, thirty-nine cities and counties advancing claims in the opioid multidistrict litigation moved to certify a “negotiating class” solely for the purpose of reaching a settlement....more

Goodwin

More Discovery Rulings in AbbVie v. BI

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We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret issued an order on additional...more

Goodwin

Biologic and Biosimilar Litigation Updates

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In an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues are...more

Obermayer Rebmann Maxwell & Hippel LLP

Supreme Court Punts on False Claims Act Specificity Requirement

Last week the Supreme Court of the United States rejected a petition for a writ of certiorari in Medical Device Business Services, Inc. et al. v. United States ex rel. Nagrol et al. In this case, the petitioner asked the...more

Bricker Graydon LLP

CMS imposes massive cuts on 340B program; Hospital associations’ legal challenge dismissed

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On November 1, 2017, CMS issued a final rule that became effective January 1, 2018, under which hospitals serving a disproportionate share of low-income patients (DSH hospitals) will receive nearly 27 percent less in...more

McDermott Will & Emery

NJ Court Grants Exceptional Case Fees Based on Speculative Infringement Suit

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The US District Court for the District of New Jersey awarded Luitpold more than $210,000 in fees and costs under 35 USC § 285 after granting its motion for judgment on the pleading under Fed. R. Civ. P. 12(c) (ANDA Update,...more

Jones Day

Sixth Circuit Reinforces "Stringent" Pleading Standard in False Claims Act Cases

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The Sixth Circuit's recent decision in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co. reinforced Federal Rule of Civil Procedure 9(b)'s requirement that plaintiffs plead fraud "with particularity" in False Claims Act cases....more

Goodwin

Update: Amgen v. Hospira

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As we previously reported, on September 22, 2017, a Delaware federal jury awarded Amgen $70 million in damages after finding that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the ’298 patent). Five days later,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016)

Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Butler Snow LLP

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

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The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

McDermott Will & Emery

Supreme Court: Claim Construction Is Subject to Hybrid Review - Teva Pharmaceuticals USA v. Sandoz, Inc.

In a 7–2 decision penned by Justice Breyer, the Supreme Court of the United States overturned the de novo standard as the sole standard of review issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz,...more

K&L Gates LLP

Teva and Its Potential Impact on Patent Litigation

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The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not...more

Foley & Lardner LLP

Why Did the Supreme Court GVR the Shire Lialda Case?

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On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more

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