Tagged: Patent Prosecution

New Jersey’s Patent Filings Place It Fifth in the Nation for Innovation

NJBIZ recently reported on a study from CommericalCafe that named New Jersey the fifth most innovative state based on the number of patents filed and granted in New Jersey from 1975 through 2019. Of those patents, New Jersey’s top sections were: (1) Chemistry and Metallurgy, (2) Electricity, (3) Human Necessities, (4) Physics, and (5) Emerging Cross-Sectional Technologies. New Jersey’s standing is not limited to the acquisition of patent rights, but includes the enforcement and protection of those rights as well. This year, the Administrative Office of the U.S. Courts reported that the United States District Court for the District of New Jersey ranks seventh in the nation for the number of intellectual property cases filed in the 12-month period ending on March 31, 2020. Given the importance of development and enforcement of intellectual property rights in New Jersey, Gibbons P.C.’s Intellectual Property Department, headquartered in Newark, New Jersey, is routinely called on to represent its New Jersey clients in handling both patent prosecution and litigation across a vast number of industries.

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...

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...

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 treat the coronavirus. The CARES Act, enacted on March 27, 2020, provides $140.4 billion in...

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...

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...

PTAB Tackles Patentability Issues After New Guidelines

Recently, the United States Patent and Trade Office (USPTO) enacted new guidelines to “clarify” the patentability standard and analyses. The USPTO stated that it had undertaken this clarification because many court decisions on the issue of patentability of method type patents in the computer arena had become very difficult for examiners to understand and apply in a predictive manner. As such, there were concerns that the examining corp was not reaching consistent examination and prosecution results. Following the enactment of the new guidelines, a Patent Trial and Appeal Board (PTAB) panel reviewed four patents relating to methods of electronically storing financial documents. The patents involved were US Patents 6,963,866, 7,552,118, 7,836,067 and 9,141,612 belonging to Mirror Imaging LLC (Mirror). Those patents were challenged by Fidelity Information Services LLC (Fidelity) because Fidelity asserted that only abstract ideas were involved, thereby being unpatentable subject matter under section 101. In fact, in a previous PTAB challenge on the same four patents, the PTAB actually opined that the Mirror patents were likely invalid. At the hearing, the questioning by the administrative patent judges centered around whether the abstract ideas are “integrated into a practical application.” Answers to the question of the practical application revolved around the elimination of manually arranging and documenting financial information, as well as the improvement...

Recently Created USPTO Precedential Opinion Panel to Decide Joinder Issues in First Review

In September, the United States Patent and Trademark Office (USPTO) revised its Standard Operating Procedures 2, addressing among other things, the new Precedential Opinion Panel and the processes the panel will follow during any review. The newly created panel recently accepted its first case where it will consider issues of party and subject matter joinder as part of a larger review of patentability of patents directed to fracking technology. Proppant Express Investments v. Oren Technologies, IPR2018-00914, Paper 24 (PTAB Dec. 3, 2018). This blog post will provide an overview of the Precedential Opinion Panel and the issues it will address in its first review. USPTO Standard Operating Procedures 2, “sets forth the composition of the Precedential Opinion Panel, describes the mechanisms for invoking Precedential Opinion Panel review of a Board decision recently issued in a pending case, and explains the Precedential Opinion Panel review process.” The panel will typically consist of the USPTO Director, the USPTO Commissioner for Patents, and the Chief Judge of the Patent Trial and Appeal Board (PTAB). The resulting decisions will be precedential and have binding authority. Under USPTO procedures, there are three ways to obtain a rehearing from the Precedential Opinion Panel: “The Director may convene a Precedential Opinion Panel to review a decision in a case and determine whether...

USPTO Proposes a New Rule to Use Narrower Phillips Standard During Claim Construction in AIA Trial Proceedings

On May 9, 2018, the United States Patent and Trademark Office (USPTO) proposed to amend the current rules to change the claim construction standard used in America Invents Act (AIA) reviews and bring it in line with the standard used in district court and ITC proceedings. Under the amended rules, the Patent Trial and Appeal Board (PTAB) would no longer use the broadest reasonable interpretation (BRI) standard for claim construction, and instead would use the narrower Phillips standard. The proposed rules would apply to claim interpretations occurring in inter partes review (IPR), post-grant review (PGR), and covered business method (CBM) patents proceedings. The Board currently construes unexpired patent claims and proposed claims in AIA trial proceedings using the BRI standard, as directed by 37 CFR 42.100(b), 42.200(b), and 42.300(b). Each of these sections currently provides that “[a] claim in an unexpired patent that will not expire before a final written decision is issued shall be given its broadest reasonable construction in light of the specification of the patent in which it appears.” This standard differs from the Phillips standard used by district courts. Under the proposed changes to these sections, the PTAB will adopt the Phillips standard and construe claims “given their ordinary and customary meaning,” which is “the meaning that the term would have to a...

Rule Change Alert! The Bayh-Dole Act Has New Time and Reporting Requirements

On April 30, 2018, The National Institute of Standards and Technology (NIST) issued rule changes regarding the Bayh-Dole Act. The Bayh-Dole Act was enacted in 1980 as the Patent and Trademark Law Amendments Act (Pub. L. No. 96-517), amended in 1984 by the Trademark Clarification Act of 1984 (Title V of Pub. L. No. 98-620), and again in 2000 by the Technology Transfer Commercialization Act of 1999 (Pub. L. No. 106-404). The Bayh-Dole Act created a uniform policy that allows small businesses and nonprofit organizations the option to retain title to inventions made under government contracts, grants, or cooperative agreements that are for the performance of experimental, developmental, or research work. The implementing regulations are found at 37 C.F.R. Part 401 and Federal Acquisition Regulation (FAR) Subpart 27.3. The April 30, 2018 revisions to the Bayh-Dole Act are categorized as follows: No time limit for government to request title. Since implementation, the government had 60 days within which it could request title to any inventions. The new rule removes the 60 day notice period. Quicker timeframe to prosecute patent applications. Previously, contractors and grant recipients had to notify the agency who granted them money of their intent to prosecute a patent application and maintain it and enter into reexamination or opposition proceedings not less than...