Tagged: Patent Litigation

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...

USPTO Waives Certain Deadlines in Light of the Coronavirus Outbreak

On March 31, 2020, the United States Patent and Trademark Office (“USPTO”) issued a notice permitting 30-day extensions to the time allowed to file certain patent-related documents and to pay certain required fees. Gibbons previously analyzed the first USPTO coronavirus guidance. For this second guidance, the USPTO determined, under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), that the COVID-19 “emergency has prejudiced the rights of applicants, patent owners, or others appearing before the USPTO in patent matters, and has prevented applicants, patent owners, or others appearing before the USPTO in patent matters from filing a document or fee with the Office.” The USPTO thus provided parties with the ability to extend certain patent deadlines if the party is personally affected by the COVID-19 outbreak. The USPTO notice expressly provides that three Patent Trial and Appeal Board (PTAB) deadlines may be extended for 30 days upon request: a request for rehearing of a PTAB decision; a petition to the Chief Judge under 37 C.F.R. § 41.3; and a patent owner preliminary response in a trial proceeding. “For all other situations, a request for an extension of time where the COVID-19 outbreak has prevented or interfered with a filing before the Board can be made by contacting the PTAB.” Relief under the notice is...

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...

District Court Must Consider Whether the Patentee Must be Joined Before Dismissing the Case for Lack of Statutory Standing

The question of who must join a patent infringement suit often raises interesting questions of rights, obligations, and control of the litigation. In the global marketplace with increased licensing arrangements, the extent of retaining rights can have a direct impact on the viability of a lawsuit and protecting intellectual property. Recently, the Federal Circuit in Lone Star Silicon Innovations v. Nanya Technology provided further clarification on what meets the standing requirement to bring a patent infringement case, and for dismissing a case for lack of standing. In this patent litigation, the asserted patents (twelve in all) were originally assigned to Advanced Micro Devices (AMD). AMD later executed an agreement purporting to transfer “all right, title and interest” in the patents to Lone Star. The transfer agreement, however, imposes several limitations on Lone Star. For example, Lone Star may only assert the patents against “Unlicensed Third Party Entit[ies]” specifically listed in the agreement. To add new entities, Lone Star and AMD both must agree. If Lone Star sues an unlisted entity, AMD has the right, without Lone Star’s approval, to sublicense the patents to the unlisted entity. Further, AMD can prevent Lone Star from assigning the patents, and AMD and its customers can continue to practice the patents. Finally, AMD shares in any revenue Lone Star...

CAFC Decision Issues Interpreting the Original Patent Requirement

As reported in a prior post, the Court of Appeals for the Federal Circuit (CAFC) recently had the opportunity to revisit the legal standard for invalidating reissue patent claims under the original patent requirement. In Forum US, Inc. v. Flow Valve, LLC, the CAFC affirmed a district court grant of partial summary judgment that certain reissue claims were invalid under the original patent requirement of 35 U.S.C. § 251. In the process, the Federal Circuit reaffirmed the legal standard set forth in a 2014 CAFC decision, Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir. 2014). In Antares Pharma, the Federal Circuit held that to comply with the original patent requirement, an invention claimed in a reissue patent must either be for: (i) the same invention disclosed in the original patent or (ii) a newly claimed invention “clearly and unequivocally” disclosed as a separate invention in the original patent. See id. at 1362-1363. In Forum US, the plaintiff sought a declaratory judgment that claims 14-20 of U.S. Reissue Patent 45,878 were invalid. The original patent related to the machining of pipe joints used in the oil and gas industry. Each of the thirteen original patent claims required “a plurality of arbors.” The summary of the invention likewise referred to a plurality of...

Legislators Propose Framework To Reform Patent Eligibility Under Section 101

On April 17, 2019, Senators Chris Coons and Thom Tillis, and Representatives Doug Collins, Hank Johnson, and Steve Stivers unveiled a framework to reform 35 U.S.C. §101. Section 101 of the Patent Act currently makes patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Although the statute is relatively permissive, courts have limited patentable subject matter beyond the statutory mandate by creating judicial exceptions. Under these exceptions as articulated in Alice Corp. v. CLS Bank International, “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” The proposed framework seeks to address these exceptions to patent eligible subject matter through statute versus an ever-growing list of case law. Under the lawmakers’ proposed framework, reformed Section 101 would: Keep existing statutory categories of process, machine, manufacture, or composition of matter, or any useful improvement thereof. Eliminate, within the eligibility requirement, that any invention or discovery be both “new and useful.” Instead, simply require that the invention meet existing statutory utility requirements. Define, in a closed list, exclusive categories of statutory subject matter which alone should not be eligible for patent protection. The sole list of exclusions might include the following categories, for example: Fundamental scientific principles Products that exist solely and exclusively in nature Pure...

Recent Decision Highlights Importance of Pleading Compliance with the Federal Patent Marking Statute

A Delaware district court recently held that a patentee failed to state a claim for past patent infringement damages where the patentee failed to plead compliance with the patent marking statute in its complaint. See Express Mobile, Inc. v. Liquid Web, LLC, C.A. Nos. 18-01177-RGA, 18-01181-RGA, 2019 U.S. Dist. LEXIS 64362, at *5 (D. Del. Apr. 15, 2019). The decision highlights the importance of pleading compliance with the marking statute even where a product covered by the patent is not being offered for sale or sold in the United States. The federal patent marking statute (“Marking Statute”) provides a limitation on recoverable damages in patent litigation. See 35 U.S.C. § 287(a). It provides that “Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented, either by fixing thereon the word ‘patent’ or the abbreviation ‘pat.,’ together with the number of the patent.” The Marking Statute further provides that “[i]n the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except on proof that the infringer was notified of the infringement and continued to infringe thereafter,...