IP Law Alert Blog

Proposed “Safeguarding American Innovation Act” Would Target Foreign Influence in Research

Proposed “Safeguarding American Innovation Act” Would Target Foreign Influence in Research

A bipartisan group of U.S. Senators is sponsoring proposed legislation to stop China and other countries from allegedly stealing federally funded research and using the information to damage U.S. economic and national security. The bill was introduced on June 18, 2020 and is entitled the “Safeguarding American Innovation Act.” The proposed legislation was drafted and co-sponsored by Senator Rob Portman (R-OH) and Senator Tom Camper (D-DE). It is currently supported by eight Republican Senators and five Democratic Senators.  There is no counter legislation pending in the House of Representatives. According to Senator Portman, “We cannot continue to allow our global competitors to steal taxpayer-funded research and innovation in order to benefit their military and economy.”  The legislation contains several key provisions of interest to U.S. Research Institutes and Organizations regarding: Disclosing Foreign Funding and Relationships: Key purposes of the legislation are to disclose foreign sources of support to academic institutions and to provide information about foreign relationships when applying for federal research grants. The proposed legislation not only provides a fine for not reporting foreign sources of funding, but for the first time, it also criminalizes not reporting the relationships when applying for federal research money grants.  The criminal penalty...

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

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...

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

“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...

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

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...

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

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...

Gibbons Again Ranked Among World’s Leading Patent Professionals by Intellectual Asset Management

Gibbons Again Ranked Among World’s Leading Patent Professionals by Intellectual Asset Management

Intellectual Asset Management (IAM) has again ranked the Intellectual Property Department of Gibbons P.C. among “The World’s Leading Patent Professionals,” granting the firm its “Gold Band” rating for practices that earned the highest number of positive reviews from sources. Gibbons is one of only three Gold Band firms in New Jersey. In addition, eight Gibbons attorneys—David E. De Lorenzi, Chair of the Intellectual Property Department, and Thomas J. Bean, Charles H. Chevalier, George M. Gould, George W. Johnston, Samuel H. Megerditchian, Robert E. Rudnick, and Christopher H. Strate—were ranked individually among IAM’s leading patent practitioners, spanning the litigation, prosecution, and transactions categories. Gibbons has the highest number of ranked attorneys on the New Jersey list this year. This is the tenth straight year that David De Lorenzi and the firm have been recognized by IAM. “Remarkably, nearly half of the Gibbons patent team have top-flight in-house experience,” notes IAM. The publication later reports, “This is a group, then, that intimately understands what clients need, and how and when they need it – and it delivers on all fronts.” To compile the IAM Patent 1000, the IAM team conducts extensive research over the course of five months with thousands of private practice attorneys based in dozens of countries, as well as the users of their services,...

USPTO Takes Measures to Help Small Businesses Patent and License COVID-19 Inventions

USPTO Takes Measures to Help Small Businesses Patent and License COVID-19 Inventions

On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new COVID-19 Prioritized Examination Pilot Program. Under this Pilot Program, the USPTO will grant qualified requests for prioritized examination of COVID-19-related patent applications without requiring payment of fees associated with other prioritized examination programs. Why is the COVID-19 Prioritized Examination Pilot Program important? This Pilot Program is the latest measure by the USPTO to spur innovation related to fighting the coronavirus. “Independent inventors and small businesses are often the difference makers when it comes to cutting-edge innovation and the growth of our economy,” said USPTO Director Andrei Iancu. “They are also in most need of assistance as we fight this pandemic.” Iancu continued, “Accelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly.” Who may participate in the Pilot Program? Applicants of COVID-19-related patent filings who qualify for either small entity (37 C.F.R. §1.27) or micro entity status (37 C.F.R. §1.29) may participate. When can I apply? On May 14, 2020, the USPTO started accepting requests for prioritized examination under the COVID-19 Prioritized Examination Pilot Program. How long will the Pilot Program...

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

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,...

Senator Sasse Proposes Legislation Extending the Patent Term for Inventions Intended to Treat COVID-19

Senator Sasse Proposes Legislation Extending the Patent Term for Inventions Intended to Treat COVID-19

On March 30, 2020, Senator Ben Sasse, R-Neb., introduced a bill that would create the Facilitating Innovation to Fight Coronavirus Act. The first part of the legislation would shield healthcare providers from federal, state, and local civil liability if they are testing or treating coronavirus patients in certain circumstances. The second part of the bill would extend patent protection for new and existing medical devices and drugs intended to treat COVID-19. The added patent protection under the bill would only apply to eligible patents. An eligible patent is “a patent issued for a new or existing pharmaceutical, medical device, or other process, machine, manufacture, or composition of matter, or any new and useful improvement thereof used or intended for use in the treatment of the Coronavirus Disease.” The bill proposes that the term for new eligible patents “not begin until the date on which the national emergency declared by the President …terminates.” Moreover, the bill provides that the term for an eligible patent “shall extend for 10 years longer than it otherwise would under [the Patent Act].” Thus the bill would enhance patent protection for inventions covering technologies created to treat the coronavirus and inventions covering existing technologies adapted to...

USPTO Waives Certain Deadlines in Light of the Coronavirus Outbreak

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...