MARCH 2023 - IP UPDATES

The U.S. Patent and Trademark Office (USPTO)’s transition to electronic issuance of U.S. patents and U.S. trademark registration certificates, the USPTO has now issued a Final Rule in the Federal Register to implement electronic patent issuance effective April 18, 2023.

According to the USPTO, all U.S. utility, design, plant, and reissue patents will be issued electronically beginning on April 18, 2023. The so-called “eGrant” will be the official copy of the granted patent.  Prior to April 18^th, the USPTO will still mail an official paper ribbon copy of each issued U.S. patent. The USPTO will also provide a “ceremonial paper copy” of issued patents during the transition period at no additional cost to the patentee. This ceremonial paper copy will be reminiscent of the previous paper ribbon copy, bound with a coversheet, official seal, and signature of the USPTO Director, but it will indicate that it is merely a ceremonial copy of the a patent that is instead officially issued electronically. Read more here.

Director Vidal Issues a Precedential Director Review Decision Regarding the Treatment of Multiple Dependent Claims

On February 24, 2023, in the case Nested Bean v. Big Beings, USPTO Director Vidal issued a precedential decision of first impression regarding the treatment of multiple dependent claims in an Inter Partes Review proceeding before the Patent Trial and Appeal Board. In this decision, Director Vidal interprets the language of the fifth paragraph of 35 U.S.C. § 112 (pre-AIA) based on its plain language, the language from 35 U.S.C. § 282 and 37 C.F.R. § 1.75(c), long standing MPEP guidance, and on an extensive review of prior court decisions.  Director Vidal concludes that the statute requires separate consideration of the patentability of alternative dependencies of a multiple dependent claim. In other words, when considering the patentability of a multiple dependent claim, the PTAB must consider separately the limitations of each claim incorporated by reference into the multiple dependent claim. Of note, paragraph (e) of 35 U.S.C. § 112 (AIA) recites the same language of interest such that the same conclusion would be expected for patents issued under the AIA. The decision can be read here. 
 

AI UPDATES

UK Supreme Court Hears Arguments on AI as an Inventor

BY SAMEER GOKHALE

On March 2, 2023, the UK Supreme Court heard arguments from representatives of Dr. Stephen Thaler (the owner of the AI machine known as "DABUS"). Questions before the Court include whether a patent can be granted without a named human inventor; and whether, in the case of an invention made by an AI machine, the owner, creator and user of that AI machine is entitled to the grant of a patent for that invention. This issue regarding DABUS has been reviewed in patent jurisdictions such as the US, the European Patent Office (EPO), and Australia. While these jurisdictions have so far rejected Dr. Thaler’s efforts, Thaler has secured patents in South Africa and Saudi Arabia. 

The UK Comptroller-General of Patents signaled that it is acceptable for Dr. Thaler to be listed as the inventor in this case. However, Dr. Thaler’s representatives are explicitly arguing that Dr. Thaler is not the inventor and “DABUS” should be listed as the inventor.

The UK Supreme Court is the first supreme-level court in the world to hear Dr. Thaler’s arguments and consider the issue on whether AI can be listed as an inventor.”
 

FEDERAL CIRCUIT UPDATES

In re Google LLC, No. 2023-101 (February 1, 2023) (Lourie, Taranto, Stark*)

BY DON MCPHAIL

In another case from the United States District Court for the Western District of Texas, the panel found that the district court had erred in its evaluation of the Volkswagen factors and so abused its discretion when it denied Google’s motion to transfer the case to the United States District Court for the Northern District of California. In granting Google’s petition, the panel re-evaluated the Volkswagen factors and found that, of the eight, two of the factors were neutral rather than weighing against transfer, one weighed heavily in favor of transfer rather than only slightly, and two favored transfer instead of being neutral.

First, in an opinion written by Judge Stark, the panel held that the district court erroneously concluded that the factor considering “all other practical problems that make trial of a case easy, expeditious, and inexpensive” weighed against transfer. The district court had relied on a co-pending case against Apple in the Western District in evaluating this factor, but the panel noted that not only had Apple moved to transfer that case to the Northern District of California, but there was also a case involving the same patents (Jawbone v. Amazon) that had been transferred from the Eastern District of Texas to the Northern District of California. The panel concluded that any efficiencies that might arise from combining cases asserting the same patents against different defendants with different accused products were as likely to appear in the Northern District of California as the Western District of Texas, and this factor therefore did not weigh against transfer but, rather, was neutral. The panel also held that the district court abused its discretion in holding that the factor considering “administrative difficulties flowing from court congestion” weighed slightly against transfer, and this factor should be accorded no weight in cases like this where the patent owner is not engaged in product competition in the marketplace, and so is not threatened in the market in a way that would add any urgency to resolution of the dispute.  

Turning to the other factors, the panel held that the district court erred in holding the “willing witness” factor weighed only slightly in favor of transfer. The panel observed that the Northern District of California was more convenient for most, if not all, of Google’s potential witnesses as well as several third-party witnesses. The panel found that, based on these facts, the district court should have held that this factor weight firmly in favor of transfer, not just slightly. Read a more detailed discussion here.
 

LIFE SCIENCES NEWS

Dietary Supplements and Patent Eligibility

BY RICHARD D. KELLY

Dartmouth University is the owner of U.S.P. 8,197,807 (‘807) directed to dietary supplements containing isolated nicotinamide riboside (NR). In litigation against Elysium Health, both the district court and the Federal Circuit on February 13, 2023, found the ‘807 to be directed to patent ineligible subject matter even though the NR compositions with isolated NR were far more effective than the NR found in milk, a natural source of NR. The problem was that the claims did not set forth any minimum amount of NR in the supplement and other than the recitation of “isolated NR” read on the composition of milk. The objective of the dietary supplement was to increase the production of coenzyme nicotinamide adenine dinucleotide, or NAD+. Such deficiencies can cause diseases in both animals and humans. Milk contains NR in a concentration of parts per million well below the amount taught in the ’807 patent needed to achieve the desired result.

Dartmouth argued that the characteristics of isolated NR differed from that found in milk. However, the ‘807 claims did not specify to what extent the NR was isolated, i.e., its content in the composition needed to achieve the desired results nor did the claims contain functional language which distinguished the claimed composition over that found in milk. The result a was an affirmance of the district court’s holding of patent ineligibility. For a more in-depth discussion see our blog post here.

Federal Circuit Affirms Patent Delisting from Orange Book

BY RICHARD D. KELLY

The Orange Book (OB) patent listings play an important role in the interaction between brand products and generic equivalents. The OB lists all approved small molecule, non-biologic, drugs along with a list of patents claiming either the drug, including formulations, and methods of using the drug, NDA approved drugs. Other patents related to a drug are not to be listed in the OB. Jazz had listed U.S.P. 8,731,963 (‘963) which claimed a method of Risk Evaluation and Mitigation Strategies (“REMS”) for its drug Xyrem which was subject to abuse to facilitate date rape. The objective of a REMS was to provide a method for a drug company to police the abuse of its products. Jazz implemented the ‘963 system to assist it trying to reduce the abuse. The issue was whether the ‘963 system patent met the definition of a method of using the Xyrem. The district court and the Federal Circuit found that a system claim was not a method and affirmed the district’s order that the ‘963 patent be delisted.

Had Jazz instead or additionally included method of patient selection using the method practiced by the system, then the claim would have been properly listed. When drafting claims for pharmaceutical products its necessary to consider the FDA statutes if one is to obtain a claim protecting the product or its use. A detailed discussion of this is here.

In an IPR and PGR Try and Try Again to Succeed

BY RICHARD D. KELLY

In PGR2021-00030 Daiichi Sankyo, Inc. and AstraZeneca Pharmaceuticals, LP (Petitioner) filed a Petition requesting a post-grant review of claims 1–5, 9, and 10 of U.S. Patent No. 10,808,039 (‘039) where petitioner was involved in parallel litigation in the Eastern District of Texas with Seagen, the patent owner. The basis for the petition was lack of enablement and written description. The PTAB in June 2021 refused to institute the PGR relying on Fintiv since its decision would be 4 months after the Texas trial. Petitioner sought a rehearing which was granted and resulted in the PTAB in April 2022 where, following Director Vidal’s Fintiv guidance, instituted the PGR citing “strong merits” for the petition’s invalidity arguments. On the next day in the parallel Texas action Seagen defeated the petitioner’s invalidity defenses also asserted in the PGR. Seagen sought and received a rehearing granted in July 2022 and ended the review. In its decision the PTAB relying on Vidal’s Fintiv memo noting that review should not be denied where there was compelling invalidity evidence, the PTAB regarding the evidence said "we cannot conclude that petitioner's enablement case is compelling." The PTAB ignored the different standard of proof required in the two proceedings.

Petitioner again requested rehearing and a Precedential Panel Opinion (POP) review. The POP was denied with instructions that the PTAB should determine if petitioner had presented “compelling merits of unpatentability.” The POP denial also instructed the PTAB the determination was to be made on the information presented at the institution stage. One week later the PTAB granted the rehearing and instituted the PGR because it found the evidence compelling.

Here the petitioner’s “ant-like persistence” yielded the result it should have received originally.