- Supreme Court Denies Patent Petitions on Arthrex, Eligibility – The U.S. Supreme Court denied petitions for certiorari in two cases coming out of the Federal Circuit: IYM Technologies LLC v. RPX Corporation and Advanced Micro Devices, Inc. and WhitServe LLC v. Donuts Inc.
- Amgen, GSK Urge Justices To Allow Patents On Genus Claims – A trio of amicus briefs filed on Monday urge the Supreme Court to grant Merck’s petition for certiorari and ensure that companies are able to patent genus claims.
- COVID-19 Vaccine Leader Moderna “Not Aware of Any Significant Intellectual Property Impediments” in Development of its Vaccine Despite Mixed Results at PTAB – As global leaders in COVID-19 vaccine development receive promising results from their clinical trials, the focus turns to whether legal intellectual property obstacles may impede vaccine distribution.
Here’s the latest.
Supreme Court Denies Patent Petitions on Arthrex, Eligibility
On Monday, the Supreme Court denied reviewing two cases from the U.S. Court of Appeals for the Federal Circuit. The first case is IYM Technologies LLC v. RPX Corporation and Advanced Micro Devices, Inc., in which the Federal Circuit issued an order affirming the Patent Trial and Appeals Board’s decision that the patent claims were unpatentable as obvious. IYM requested a panel rehearing and a rehearing en banc, relying on the Federal Circuit’s decision in Arthrex, Inc. v. Smith & Nephew. IYM states that its patent rights were abrogated by an unconstitutionally appointed panel of APJ’s. Following the Federal Circuit’s denial of IYM’s petition, IYM sought review from the High Court. Rebecca Tapscott summarizes the petition for certiorari.
In particular, IYM asked the Supreme Court to grant review “to determine whether the Arthrex decision applies to all appeals that were pending when [the Arthrex decision] issued.” Comparing the case to Arthrex, IYM stated that “unconstitutionally appointed APJs adjudicated IYM’s patent rights, and the remedy should be the same as in Arthrex—the Board’s final written decision should be vacated, and the case remanded for a constitutionally valid proceeding.” The Supreme Court denied IYM’s request.
The second case is WhitServe LLC v. Donuts Inc. There, the Federal Circuit affirmed a lower court ruling that WhitServe’s patent claims were directed at an abstract idea and were therefore invalid under § 101. WhitServe argued that the district court should not have made its final decision at the pleading stage. The Federal Circuit rejected this argument and WhitServe sought review from the Supreme Court. Tapscott provides insight into WhitServe’s position.
In particular, WhitServe asserted its position that a determination of patent ineligibility over a patentee’s contrary factual assertions is inconsistent with the requirements of Rule 12 because “such a determination necessitates impermissible fact-weighing at the pleading stage and eviscerates the statutory presumption of validity” under 35 U.S.C. § 282(a).
WhitServe also asserted that due to the factual considerations underlying Section 101, “alone or in combination with the statutory presumption of 35 U.S.C. § 282(a), a patentee alleging patent infringement cannot be deemed to have asserted an invalid or ineligible patent at the pleading stage.”
Amgen, GSK Urge Justices To Allow Patents On Genus Claims
Three amicus briefs from Amgen, GlaxoSmithKline, and a group of intellectual property professors raised concerns about the Federal Circuit’s approach to handling genus claims. The briefs ultimately warned the U.S. Supreme Court justices that the future of innovation is on the line if they do not grant certiorari in a petition filed by Merck unit Idenix Pharmaceuticals LLC back in September. The case is Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. A 2-1 Federal Circuit panel upheld a judge’s finding that Idenix’s patent is invalid because it is not enabled under Section 112 of the Patent Act and further concluded that the patent lacked sufficient written description. Idenix now seeks review from the Supreme Court to decide “whether genus claims can ever be enabled under Section 112, and whether that same section of the law requires an inventor to possess the claimed invention to meet written description requirements.” Dani Kass articulates some of the concerns the amicus briefs raise.
GSK said years of research and billions of dollars go into finding those “critical” genus claims. Without being able to patent those findings, companies may not be able to recoup that investment, discouraging them from engaging in such research.
In the same vein, Amgen said, “With the barriers to broad protection extending ever higher, companies will leave the high-risk business of true innovation in favor of far less economically risky ‘fast follower’ drugs that target known biological pathways.”
COVID-19 Vaccine Leader Moderna “Not Aware of Any Significant Intellectual Property Impediments” in Development of its Vaccine Despite Mixed Results at PTAB
Moderna is among the top COVID-19 vaccine developers and recent news reports indicate that its clinical trials are showing promising results. Moderna’s vaccine is based on mRNA technology. As Dylan Haversack and Daniel Shores explain, once the mRNA enters the recipient’s cells, the mRNA molecules hijack the cell’s “computer system,” telling the cells to make the infamous spike proteins. The immune system then recognizes these spike proteins as antigens and begins building its defenses against the antigen. Thus, the immune system readies itself for an actual COVID-19 infection. However, in order for the mRNA to function properly, it needs a delivery system.
Arbutus Biopharma owns certain patents relating to lipid-nanoparticle “delivery systems” for mRNA molecules. These delivery systems essentially wrap the molecules in balls of fat to both disguise them, thereby preventing attack by the immune system, and to allow the target cells to readily ingest the mRNA molecules. Moderna lost its sublicense to those disputed patents in 2016 and then (before the pandemic) sought to invalidate the patents through three USPTO inter partes review (IPR) proceedings that were decided earlier this year.
In the article, Haversack and Shores examine the status of these proceedings. According to Haversack and Shores, the first IPR ended in success for Moderna, the second IPR produced mixed results, and the third and final written decision regarding “the ’069 patent” was unsuccessful for Moderna.
Importantly, Arbutus’s ’127, ’435, and ’069 patents are similar to the extent they claim stable nucleic acid-lipid particles (SNALP) and methods of delivery. These patents appear to cover liquid nanoparticle (LNP) technology, which can be used to deliver messenger ribonucleic acid (mRNA) to cells. In the past, Moderna has indirectly licensed such LNP technology from Arbutus, but it has recently begun to develop its own proprietary LNP technology.
Despite the ‘069 patent being upheld, Moderna stated it “is not aware of any significant intellectual property impediments” toward products it intends to commercialize. Additionally, while Moderna promised to not enforce its COVID-19 related patents against others making vaccines to combat the pandemic, it is uncertain whether companies may enforce its patents against Moderna.