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Tag You’re It: Chief Judge Swain sua sponte Transfers Pro Se Patent Infringement Complaint to Delaware

Chief United States District Judge Laura Taylor Swain (S.D.N.Y.) recently transferred an action for patent infringement brought pro se by Rachel Ohana (“Ohana”) against Mars Petcare US, Inc. (“Mars Petcare”) to the United...more

Show Me the Papers!: Judge Aaron Grants Motion to Compel Document Discovery from Third-Party

United States Magistrate Judge Stewart D. Aaron (S.D.N.Y.) recently granted a motion by Samsung Electronics Co. Ltd and Samsung Electronics America, Inc. (collectively “Samsung”) to compel non-party Microchip Technology...more

How Much Searching is “Non-Exhaustive”?: Judge Gardephe Invalidates Claims as Indefinite

On April 24, 2024, United States District Court Judge Paul G. Gardephe (S.D.N.Y.) construed claims of three patents asserted by Network-1 Technologies, Inc. against Google LLC and YouTube, LLC. The court found the asserted...more

Nothing to See Here: Judge Reznik Finds that Privilege with a Patent Prosecuting Attorney Belongs to the Assignee, Not the...

On November 22, 2023, United States Magistrate Judge Victoria Reznik (S.D.N.Y.) provided some rare insight into “the applicability and scope of the attorney-client privilege as it relates to patent counsel.” Op. at 1. Judge...more

Judge Oetken Construes “Analog”: Can Anything be Truly Digital?

On September 5, 2023, United States District Judge J. Paul Oetken (S.D.N.Y.) construed several terms raised by Plaintiff Dynamics, Inc.(“Dynamics”) and Defendant Samsung Electronics Co., Ltd. (“Samsung”), including “Analog...more

Judge Schofield Finds Assertion of “Weak” Patent Claims Not Exceptional for Purposes of Awarding Attorney’s Fees under 35 U.S.C. §...

On January 23, 2023, United States District Judge Lorna G. Schofield (S.D.N.Y.) denied Maropost Marketing Cloud, Inc.’s (“Maropost”) motion to declare its dispute with Zeta Global Corp. (“Zeta”) exceptional for purposes of...more

Fiduciary Duties Waivable by Contract, Precluding Claims

The U.S. Bankruptcy Court in Manhattan recently reminded us why Delaware choice-of-law provisions are so popular in limited partnership and other agreements.  In an adversary proceeding, Judge David S. Jones held that...more

Federal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® Dispute

According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant),...more

Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License

The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more

Magistrate Judge Reyes Recommends Dismissal of DJ Action Against Assignee That Never Owned The Patent-In-Suit

On February 9, 2021, United States Magistrate Judge Ramon E. Reyes, Jr. (E.D.N.Y.) recommended that Sell Below Cost USA LLC’s (“Sell Below”) DJ complaint against Blue Island Holding Group (US) Inc. (“Blue Island”) that United...more

Federal Circuit Axes Amgen Antibody Patents, Finding Lack of Enablement

The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional requirements”—in this case, claims to antibodies defined by their function—“can...more

FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma

On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed or refractory large B-cell lymphoma.”  Juno, a Bristol-Myers Squibb Company,...more

2021 Biosimilar Approval and Litigation Update

The last two years saw the launch of several biosimilars.  Looking ahead to 2021, several others may be on the horizon.  In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products.  Eight of the...more

Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case

The Federal Circuit has spoken.  In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc.  A case watched closely by the biotechnology and pharmaceutical industries, the Federal...more

Judge Ramos Finds Forum Selection Clause of NDA Implicates Confidentiality and Not IP Rights and Allows IPRs to Proceed

On January 19, 2021, United States District Judge Edgardo Ramos (S.D.N.Y.) denied Kannuu Pty Ltd. (“Kannuu”)’s motion for preliminary injunction and instead granted Samsung Electronics Co., Ltd. (“Samsung”)’s motion to stay...more

Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue

Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman...more

Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases

Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more

For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA...

On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more

FDA Issues Updated Guidance on Emergency Use Authorization for COVID-19 Vaccines

On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June. The updated guidance, which is being...more

USPTO’s Revised Patent Eligibility Guidance Aims for Greater Clarity and Consistency

On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about...more

The Patent-Eligibility Question: Aatrix, Berkheimer and Beyond

Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing...more

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