News & Analysis as of

Estoppel in the Context of Inter Partes Review Proceedings - Apotex Inc. v. Wyeth LLC

The Patent Trial and Appeal Board (PTAB or Board) interpreted the estoppel provision of 35 U.S.C. § 315(e)(1) to deny institution of inter partes review in a second petition by the same petitioner against the challenged...more

PTAB Limits Scope Of Estoppel To Not Include Grounds Denied As Redundant

In a recent Inter Partes Review (“IPR”) institution decision, Apotex v Wyeth (IPR2015-00873, Paper No. 8), the USPTO’s Patent Trial and Appeal Board (the “Board”) found that some previously-asserted grounds of invalidity were...more

PTO Has Broad Discretion in Considering Extraordinary Situations for Patent Term Adjustment - Daiichi Sankyo Co. Ltd. v. Michelle...

Addressing the U.S. Patent Office’s (USPTO) discretion in connection with patent term adjustments, the U.S. Court of Appeals for the Federal Circuit agreed with the district court that the USPTO acted within its discretion in...more

Federal Circuit Upholds USPTO Post-Wyeth Patent Term Adjustment Procedures

In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to...more

Innovator Liability Finds Sweet Home In Ala.

Earlier this month, the Supreme Court of Alabama confirmed its January 2013 holding in Weeks v. Wyeth Inc. that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Though the recent ruling puts...more

Alabama Supreme Court Reaffirms That Plaintiffs Who Use Generic Drugs Can Recover From Brand-Name Manufacturers

On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless...more

Pennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties

On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face...more

S.D.N.Y. Prosecutors Get Martoma, but Probably No Closer to Steve Cohen

Lst Thursday, a jury in the Southern District of New York convicted Mathew Martoma in what is in dollar terms the largest insider trading case in captivity. As we’ve discussed before, Martoma had been accused of paying a...more

Lance v. Wyeth: A New Cause of Action in Pennsylvania?

Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs....more

Liability for Pharmaceutical Manufacturers Expands for the First Time to Include Design Defect Claims

Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Federal Circuit Finds Wyeth Restenosis Claims Invalid as Not Enabled

In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112....more

Wyeth v. Abbott Laboratories (Fed. Cir. 2013)

When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Federal Circuit May Have More To Say On Patent Term Adjustment (PTA) As USPTO Appeals Exelixis v. Kappos

Executive Summary: Three years removed from the Federal Circuit’s decision in Wyeth v. Kappos, patentees are seeking additional extensions of patent term based on the recent decision issued in Exelixis v. Kappos, which could...more

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