Tagged: Patent Infringement

Increasing Patent Damage Awards with Pre-Judgment Interest

In VLSI Technology LLC v. Intel Corporation, the United States District Court for the Western District of Texas recently awarded pre-judgment and post-judgment interest on a jury’s damage award in a patent infringement case. An issue examined by the court was whether the patentee was entitled to pre-judgment interest during periods in which the patentee did not own the patent. The defendant argued that since the patentee only acquired the patent rights in December 2018 and was not formed as an entity until 2016, pre-judgment interest from 2013 would be a windfall. The court dismissed this argument and indicated that the patentee “acquired the Asserted Patents and is therefore entitled to all the rights associated with patent ownership, including the rights to collect damages and interest from infringers.” The court then awarded pre-judgment interest beginning on the date of infringement (i.e., 2013) to the date of judgment. In support of this holding, the court cited the Federal Circuit’s decision in Energy Transp. Grp., Inc. v. William Demant Holding A/S, 697 F.3d 1342, 1358 (Fed. Cir. 2012) stating that “award of pre-judgment interest is the rule, not the exception.” The court also noted that there was no exceptional circumstances such as an undue delay in filing the lawsuit that would warrant denying pre-judgment interest in this...

District of New Jersey Denies Motion to Amend Invalidity Contentions, Citing Defendant’s Lack of Diligence and Timeliness in Filing Motion

In Razor USA LLC v. DGL Group, Ltd., the United States District Court for the District of New Jersey recently denied a defendant’s motion to amend its invalidity contentions to include an additional written description argument. The case involves utility and design patents pertaining to a hoverboard. After learning that the design patent issued with drawings had previously been rejected by the Patent and Trademark Office (PTO) (as opposed to those that the PTO later approved), the defendant sought to add an argument that the design patent was invalid pursuant to 35 U.S.C. § 112(a) for the same reasons that the PTO had previously rejected the published drawings. The defendant asserted that it learned about this “new” defense after the plaintiff’s expert stated in a declaration that he had reviewed the prosecution history of the design patent, which prompted the defendant’s own investigation of the prosecution history. In evaluating whether the defendant’s application met the requirements of Local Patent Rule 3.7, the court looked to the defendant’s diligence and the timeliness of the motion. The court concluded that both were lacking. With respect to diligence, the “dominant consideration” in the motion to amend, the court concluded that the defendant had failed to act with the requisite diligence in discovering the information it sought to add...

The Russo-Ukrainian War’s Implication on Intellectual Property Rights

Following the 2014 so-called “Ukrainian Revolution of Dignity” and the Russian Federation’s annexation of Crimea, a major escalation of the ongoing Russo-Ukrainian War occurred in 2022, culminating in the Russian invasion of Ukraine on February 24. The invasion triggered Europe’s largest refugee and humanitarian crisis since World War II, causing an unprecedented amount of human suffering and countless civilian casualties.

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

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...

28 Days to Amend Contentions Following Disclosure of Preliminary Claim Constructions

In an interesting decision applying California’s Local Patent Rules, Northern District of California District Court Judge William Alsup held that “after receiving the other side’s preliminary claim construction disclosure under Rule 4-2, a party in a patent litigation must move promptly to disclose any back-up contentions it may wish (or eventually wish) to make for its infringement or invalidity case, in the event the other side’s claim construction is thereafter adopted or else any such back-up contentions will be deemed waived. Promptly means within 28 days at the latest.” Fluidigm Corp., et al. v. IONpath, Inc. at 4. Judge Alsup’s decision was his answer to “the question of the extent to which our patent local rules require infringement and invalidity contentions to set forth not only a party’s primary theory but also its backup theory in case its opponent’s claim construction prevails.” Id. at 1. In answering that question, Judge Alsup provided a brief exposition on California’s Local Patent Rules. “Before our local patent rules, parties struggled to determine the opposing party’s theory of liability via discovery requests, such as contentions interrogatories.” Id. at 6. The adoption of local patent rules “replaced the bone-crushing burden of scrutinizing and investigating discovery responses with the parties’ infringement and invalidity contentions.” In alleviating that burden, local patent rules...

Paragraph IV to Paragraph III Conversion Does Not Deprive a District Court of Subject Matter Jurisdiction in Hatch-Waxman Cases

In a significant Hatch-Waxman decision, a Delaware District Court recently denied the defendants’ motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), rejecting the argument that the conversion of the defendants’ Paragraph IV certifications to Paragraph III certifications deprived the court of subject matter jurisdiction, but granted the defendants’ motion for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c). In H. Lundbeck A/S v. Apotex Inc., the defendants converted their Paragraph IV certifications for certain patents at issue to Paragraph III certifications. Under 21 U.S.C. § 355(j)(2)(A)(viii), an ANDA filer must make any one of four (I-IV) certifications for each Orange Book listed patent. A Paragraph IV certification is an ANDA filer’s statement that it intends to market its bioequivalent pharmaceutical product before the expiration of a patent listed as covering that product because the ANDA filer believes such patent is either not infringed or invalid. A Paragraph III certification is an ANDA filer’s statement that it will not market its bioequivalent product until after the expiration of a patent listed as covering that product. The Court reasoned that in a Hatch-Waxman action, subject matter jurisdiction exists when a patent owner alleges that the filing of an ANDA infringes its patent under 35 U.S.C. § 271(e)(2) and conversion from a...

“Good Cause” Not Required for Contention Amendments in the District of Delaware

In Bio Delivery Sciences International Incorporated v. Alvogen PB Research & Development LLC, a Delaware District Court recently denied the plaintiffs’ motion to strike two prior art references from the defendants’ supplemental invalidity contentions, reasoning that the defendants were not obligated, as the plaintiffs argued, to demonstrate good cause for the amendment. The court noted that the case’s scheduling order did not contain a “good cause” requirement for amending contentions or a requirement that contentions be amended before the date on which the defendants served their amended contentions. The court reasoned that, while the amended contentions did need to comport with the requirements of Fed. R. Civ. P. 26, an analysis under the Pennypack factors did not require striking the references. In particular, the “possibility of curing the prejudice” and “likelihood of disruption of trial” factors militated strongly in the defendants’ favor because the plaintiffs did not need further discovery on the references and could address them easily in their expert reports, which would not have any impact on the trial date. Interestingly, had these defendants been litigating in the District of New Jersey they would have been obligated to demonstrate “good cause,” where Local Patent Rule 3.7 requires a showing of “good cause” for any party to amend “contentions, disclosures, or other documents required...

Plaintiffs’ Local Patent Rule 3.2(b) Document Production Sufficient to Support an “Invention Date” Predating a Disclosed “Priority Date”

Applying the plain language of the District of New Jersey’s Local Patent Rules, Chief Judge Wolfson recently ruled in Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., that the plaintiffs were not precluded from asserting an “invention date” derived from their Local Patent Rule 3.2(b) disclosures that differed from the “priority date” expressly disclosed in their Local Patent Rule 3.1(f) contention disclosures. Local Patent Rule 3.1(f) requires that infringement contentions disclose, “[f]or any patent that claims priority to an earlier application, the priority date to which asserted claim is allegedly entitled.” Local Patent Rule 3.2 governs the document production that must accompany Local Patent Rule 3.1 disclosures and Local Patent Rule 3.2(b) requires the production of “[a]ll documents evidencing the conception, reduction to practice, design, and development of each claimed invention, which were created on or before the date of application for the patent in suit or the priority date identified pursuant to L. Pat. R. 3.1(f), whichever is earlier.” An “invention date” and a “priority date” have distinct meanings in patent law. An “invention date” is the date when the inventor conceived the invention and reduced it to practice and the “priority date” is the filing date of the earliest patent application to which the patents-in-suit are entitled. The plaintiffs’ Local Patent Rule 3.1(f) infringement...

FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data, the Orange Book will now include (1) the number of potential first applicants; (2) the 180-day decision date; (3) the date of the “first applicant” approval; (4) the date of first commercial marketing by any first applicant; and (5) the expiration date of the last qualifying patent. According to the FDA, the updated data listing comports with the Agency’s commitment under the Drug Competition Action Plan where the FDA “committed to enhancing efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals.” Historically, the Orange Book Paragraph IV Certifications list has contained relevant information related to 180-day eligibility for generic drug products. Until recently, the listings included the name of the drug product, dosage form, dosage strength(s), the reference listed drug, the New Drug Application Number and the date upon which the first substantially complete application containing a Paragraph IV certification was submitted to the Agency. The new data will provide greater clarity to Hatch-Waxman litigants in a variety of ways. More specifically, with respect to the number of first applicants, the data will provide the number of...