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Gibbons Law Alert

Tagged: PA Patent Rules

Expert Report Cannot Be Used for Previously Undisclosed Invalidity Theories

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Posted in Patent

On March 8, 2022

The United States District Court for the Central District of California recently granted a plaintiff’s motion to strike portions of the defendant’s expert report for the untimely disclosure of new invalidity theories that were not previously disclosed in the defendant’s invalidity contentions. In Nichia Corporation v. Feit Electric Company, Inc., the plaintiff sought to strike from the defendant’s expert report: (1) an entirely new reference; (2) two new obviousness theories based on combinations of references not included in the defendant’s final invalidity contentions; and (3) a new written description argument. In ruling, the court highlighted the district’s Standing Patent Rules’ emphasis on “early notice” of infringement and validity contentions, that amendments to contentions require diligence by the moving party and that new infringement and invalidity theories cannot be introduced through expert reports. The Standing Patent Rules that the parties were following were initially set forth by Judge Guilford of the Central District of California. It has been noted that “Judge Guilford’s Standing Patent Rules are similar to the Local Patent Rules adopted by the Northern District of California.” Mort. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1321(Fed. Cir. 2016). And, relatedly, the District of New Jersey “adopted verbatim [its] Local Patent Rules from the Northern District of California.” TFH Publ’n, Inc....

Northern District of California Relies on the Safe Harbor Defense of Section 271(e)(1) to Resolve Infringement Cases Early

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Posted in Biotech / Pharmaceuticals

On November 30, 2020

Two recent decisions from the Northern District of California show courts’ willingness to dispose of cases early in litigation through the safe harbor defense. The safe harbor of Section 271(e)(1) allows competitors, before the expiration of a patent, to engage in otherwise infringing activities if the use is “reasonably related to” obtaining regulatory approval. These two decisions provide pre-litigation and litigation guidance for life science companies that manufacture regulated products such as drugs and medical devices. The Supreme Court has construed the safe harbor to apply to drugs as well as medical devices and other products subject to Food and Drug Administration (FDA) approval. Section 271(e)(1) of the Patent Act provides that: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” In Carl Zeiss Meditec v. Topcon Medical Systems, the N.D. Cal. granted with prejudice a motion to dismiss the plaintiff’s patent infringement claim based on product testing as barred by the safe harbor of § 271(e)(1). Carl Zeiss alleged that software testing by Topcon...

NJ District Courts Bar Defendants’ Indefiniteness Argument During Claim Construction Because Not Alleged in Invalidity Contentions

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Posted in Patent

On June 17, 2014

We previously reported that New Jersey District Court Judges will limit a patent infringement defendant’s discovery to the claims and defenses identified in its Invalidity Contentions served under Local Patent Rule 3.3. For the same reasons, a defendant may be barred from taking certain positions during claim construction. In an opinion issued last week, Judge Jose L. Linares held in Auxilium Pharmaceuticals, Inc. & FCB I LLC v. Watson Laboratories, Inc., No. 12-3084 (JLL) that a defendant that does “not raise an indefiniteness defense in its invalidity contentions . . . cannot seek a determination that the patents-at-issue are invalid for indefiniteness through claim construction.”

NJIPLA Pharmaceutical/Chemical Patent Practice Program

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Posted in Patent

On December 3, 2012

The 26th Annual New Jersey Intellectual Property Law Association (NJIPLA) Pharmaceutical/Chemical Patent Practice Update will feature the Honorable Faith S. Hochberg of the United States District Court for the District of New Jersey, who will provide a judge’s perspective on emerging issues under the AIA. The program will take place on December 5, 2012, from 12:00 – 5:15 p.m. at the Woodbridge Hilton in Iselin, New Jersey. The program offers 4.5 NJ and NY CLE credits, and 4.0 PA CLE credits, and will also provide a look at Already v. Nike, antitrust pitfalls in product improvements, and new issues regarding biotech patents.

CAFC Chief Judge Rader on Curbing E-Discovery, Part II

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Posted in E-Discovery / Patent

On April 13, 2012

In succession to remarks he made this past Fall about the soaring costs of electronic discovery in IP cases and unveiling the Model Order Regarding E-Discovery in Patent Cases, Federal Circuit Chief Judge Randall Rader recently told the ABA Section of IP Law that both the bar and the bench together, must continue to rein in the high costs of e-discovery. Chief Judge Rader suggested that attorneys’ need to limit their e-discovery requests and courts should consider implementing rules to facilitate efficient and cost effective discovery, as many have begun to do.

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