Gibbons Law Alert

Gibbons Law Alert

Author: Christopher H. Strate

District of Delaware Court Dismisses, with Prejudice, Claims Withdrawn Pursuant to Case Narrowing Order

by and

Posted in Pharmaceuticals

On November 18, 2024

In Exeltis USA Inc. v. Lupin Ltd., the United States District Court for the District of Delaware recently ruled, over the plaintiffs’ objection, that claims dismissed by the plaintiffs in response to the District Court’s case narrowing order were dismissed with prejudice. Exeltis is a Hatch-Waxman litigation involving patents covering Exeltis’s SLYND® product. During the case, the court entered a case narrowing order that required the plaintiffs to reduce the number of asserted claims and the defendants to reduce the number of invalidity defenses. The parties complied with the order, and the plaintiffs then won at trial. Following trial, the plaintiffs argued that the claims dismissed pursuant to the court’s case narrowing order should be without prejudice based on “fundamental fairness.” The court disagreed, finding that fundamental fairness was best supported by the certainty that came with a dismissal with prejudice. This ruling appears to have created a split within the District of Delaware. In Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, 645 F. Supp. 3d 335 (D. Del. 2022), another Delaware Court held that claims withdrawn pursuant to the court’s case narrowing order were dismissed without prejudice. In light of the court’s ruling in Exeltis, plaintiffs in Hatch-Waxman cases in the District of Delaware should be aware of the risk that the court...

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

by

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...

The Regulatory Accountability Act of 2017 May Require a Revisit of Recent Precedent

by

Posted in Patent / USPTO

On March 22, 2017

The Regulatory Accountability Act of 2017 is currently pending before the Senate Committee on Homeland Security and Governmental Affairs, which was recently passed by the House of Representatives with a 238-183 vote. If enacted, this bill would repeal the Chevron deference standard (“Chevron standard”), among other reforms, which potentially will require the courts to reconsider and overturn past precedent regarding the patent statute. The Chevron standard frequently appears in litigations involving federal agencies. This standard is rooted in the U.S. Supreme Court case, Chevron U.S.A. Inc. v. Nat. Res. Def. Council, 467 U.S. 837, 104 S. Ct. 2778 (1984), where the Court held that it should defer to agency interpretations of a statute that is “silent or ambiguous with respect to the specific issue.” Under this bill, courts instead would have to review relevant questions of law in these cases de novo. This bill would affect agency guidance from all federal agencies including the U.S. Food and Drug Administration, Environmental Protection Agency, and the agency most relevant to patent practitioners, the United States Patent and Trademark Office (“USPTO”). Although it is difficult to determine the reach of the implications from this bill, if enacted, it is possible that patent practitioners could see the effects. For instance, the 2011 America Invents Act gave the USPTO the...

The Supreme Court Weighs in on PTAB’s Claim Construction Standard for IPR Proceedings

by

Posted in Patent

On August 12, 2016

In a recent decision, the Supreme Court affirmed the Federal Circuit’s ruling that the Patent Trial and Appeal Board (PTAB) was within its authority to give a patent claim “its broadest reasonable construction” during an inter partes review (IPR) proceeding. The Court found that the PTAB was authorized to apply this standard because 35 U. S. C. §316(a)(4) granted the Patent Office authority to issue “regulations . . . establishing and governing inter partes review under this chapter.”

Long Lost Wright Brothers’ Patent File Found

by

Posted in Patent

On April 4, 2016

On Sunday, The Washington Post published an interesting article explaining how the long lost Wright brothers’ patent file for the “Flying Machine” was finally found in March. The government had been searching for this file for the last 16 years. The file, which was last seen in 1980, was thought to be stored in a vault at the National Archives. But, in 2000, when an official commemoration was being planned, they realized it was missing. Ultimately, they were able to locate it in a limestone storage cave in Lenexa, Kansas. Although there was concern that the important record was stolen, the conclusion now is that it was probably just misfiled. The article indicates that the National Archives was able to identify this file as a part of a larger effort to locate missing documents.

Federal Circuit Reaffirms its Patent Exhaustion Doctrine Decisions

by

Posted in Licensing / Patent

On February 25, 2016

On February 12, 2016, the en banc Federal Circuit, in a 10-2 decision in Lexmark Int’l, Inc. v. Impression Prods., Inc., reaffirmed its long-standing rules that: (1) the exhaustion doctrine does not apply to patented articles sold subject to single-use/no-resale restrictions that were communicated to the buyer at the time of sale; and (2) the exhaustion doctrine does not apply to the sale of patented goods outside of the U.S.

Heightened Pleading Requirement for Direct Patent Infringement Action Effective December 1, 2015

by

Posted in Patent

On December 2, 2015

On December 1, 2015, revised Federal Rule Civil Procedures went into effect and changed pleading requirements for patent cases. The new rules were adopted by the Supreme Court on April 29, 2015, based on recommendations of the Judicial Conference of the United States and will eliminate Form 18. Form 18 set for a bare bones requirement for patent infringement complaint and merely required the plaintiff to provide notice of its claims. Form 18 simply required: (1) an allegation of jurisdiction; (2) a statement that plaintiff owns the patents; (3) a statement that defendant has been infringing the patent by making, selling and using the device embodying the patent; (4) a statement that plaintiff has given the defendant notice of its infringement; and (5) a demand for injunction and/or damages.

Federal Circuit En Banc Reaffirms Laches as a Defense to Patent Suits

by

Posted in Patent

On October 19, 2015

Recently, the Federal Circuit, sitting en banc, ruled in SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC that laches remains a viable defense in patent infringement actions. In doing so, the Federal Circuit rejected the extension of the Supreme Court’s 2014 decision in Petrella v. Metro-Goldwyn-Mayer, Inc., which held that the laches defense does not apply in copyright cases because the copyright statute provides a three year statute of limitations for bringing an infringement suit.

District Court’s Preliminary Injunction Opinion Offers Cautionary Tale Over Engaging in Settlement Negotiations with a Rival

by

Posted in Patent

On September 3, 2015

A recent decision from the Western District of Washington denying a motion for a preliminary injunction offers a cautionary tale to keep in mind when considering whether to engage in settlement negotiations with a competitor. BitTitan brought suit against SkyKick for infringement of U.S. Patent No. 8,938,510, a patent directed to the migration of email data from one email system to another. According to BitTitan, the ‘510 patent covered the essential elements of BitTitan’s email migration product and SkyKick was its main competitor in this industry.

Federal Circuit Expands Liability for Direct Infringement Under § 271(a)

by

Posted in Patent

On August 21, 2015

Last week, en banc, the United States Court of Appeals for the Federal Circuit in Akamai Technologies Inc. v. Limelight Networks, Inc. “unanimously set forth the law of divided infringement under 35 U.S.C. § 271(a),” and expanded direct infringement liability to include instances where, “an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”

Connect:

About Gibbons

With 200 attorneys, Gibbons is a leading law firm in New Jersey, New York, Pennsylvania, Delaware, Washington, DC, and Florida, ranked among the nation’s top 200 by The American Lawyer. More…

Subscribe

Archived Blog Posts

Categories