Category: Patent

USPTO Final Rule Limits a Reduction of Patent Term Adjustment to the Period the Applicant Failed to Undertake Reasonable Prosecution Efforts

On June 16, 2020, the United States Patent and Trademark Office (USPTO) published a final rule revising patent term adjustment under 35 U.S.C. 154(b) in view of Supernus Pharm., Inc. v. Iancu. In Supernus, the Federal Circuit held that a reduction of patent term adjustment must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. The USPTO thus cannot deduct an amount of time beyond the period during which the applicant failed to undertake reasonable efforts to conclude prosecution. The USPTO revised relevant provisions pertaining to reduction of patent term adjustment, aligning the provisions with Federal Circuit law. Section 154(b)(2)(C) of the Patent Act authorizes the USPTO to reduce the total amount of patent term adjustment for certain delays by deducting the number of days equal to the period of time that “the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” The USPTO implemented this section with 37 CFR § 1.704. In 2006, Supernus Pharmaceuticals filed patent applications in both the United States and Europe covering an osmotic drug delivery system. In February 2011, Supernus filed a Request for Continued Examination (RCE) in the U.S. application after a final rejection. Supernus’s European application was granted later...

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...

Organizations Commit to Share Their Intellectual Property to Support the Fight Against the Coronavirus

The Open COVID Pledge calls on organizations around the world to make their patents and copyrights freely available to combat the coronavirus. The Pledge was developed by the Open COVID Coalition (“Coalition”), an international group of scientists and lawyers, seeking to accelerate the rapid development and deployment of diagnostics, therapeutics, medical equipment, and software solutions to this urgent public health crisis. Many major technology companies and academic organizations have “signed onto” the Pledge. The Pledge, however, does not appear to be as popular with biopharmaceutical companies. Am I eligible? How do I make the Pledge? Anyone who holds intellectual property rights is eligible by either issuing a public statement making the Pledge or issuing a press release and notifying the Coalition. What IP is covered? Pledging parties may share any of their intellectual property rights, including patents and copyrights relating to the coronavirus pandemic. The Pledge does not cover trademarks or trade secrets. How do I implement the Pledge? The Coalition has published three standard licenses. A pledging party may adopt one of these standard licenses, adopt its own compatible license, or adopt an alternative license. What are some of the key terms of the standard licenses? Grant: Simply stated, the standard licenses grant a non-exclusive, royalty-free, worldwide license to use and commercialize the intellectual...

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...

US Patent and Trademark Office Measures Taken in View of COVID-19 Outbreak: What Applicants and You Should Know

The US Patent and Trademark Office (USPTO) has implemented several measures over the past week to assist patent and trademark applicants in view of the COVID-19 outbreak and its disruption to businesses. The USPTO stresses that, until further notice, USPTO operations will continue without interruption. Below are the key USPTO measures and what you should know if you have a pending patent or trademark application, are planning to file such an application, or are involved actively in a PTAB proceeding. Unlike the European Patent Office and Canadian Intellectual Property Office, which have eased the burden on their patent applicants by extending all deadlines until at least the earliest April 17 and April 1, 2020, respectively, the USPTO has offered more limited relief. On March 16, 2020, the USPTO announced that it will not extend any deadlines, including new and existing patent and trademark application, prosecution, and PTAB deadlines. Instead, the USPTO will waive revival petition fees for those whose patent applications were deemed abandoned or had reexamination proceedings terminated when the effects of the COVID-19 outbreak led to a missed deadline. This waiver will also apply to trademark applications labeled abandoned or whose registrations were canceled or expired based on missed deadlines. The USPTO has stated that it “considers the effects of the Coronavirus outbreak”...

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,...