“Eli Lilly affirmed the Federal Circuit’s decision before the court, stating that ‘a claim like Amgen, which has no structural limitation and is limited only by functional consequences, cannot be used under § 112.’ I asked for explicit clarification that it is void.”
A number of additional Amicus briefs were filed with the U.S. Supreme Court late last week. Amgen vs Sanofi, Featured Case Considering Scope of Validation Searches Under 35 USC § 112. 30 or more Amici In total, we are currently complicit in the case.
The court ruled in November 2022 on the U.S. Attorney General’s recommendation to dismiss the petition. The judge granted certification on one of his two questions presented.
Whether enablement is governed by 35 U.S.C. 112, the statutory requirement that the specification teach one of ordinary skill in the art to “make and use” the claimed invention, or whether the must be able to “reach its full scope”, i.e. cumulatively identify and produce all or nearly all embodiments of the invention without substantial “time and effort”.
Road to SCOTUS Summary
This appeal is based on the Federal Circuit’s February 2021 grant of judgment by the United States Court of Appeals for the Federal Circuit (CAFC) as a matter of law for the District of Delaware (JMOL) that Amgen’s patent claims covering Repatha cholesterol treatment are invalid. This is due to the support of Lack of enablement. The court found that Amgen’s compositional claims were defined by satisfying functional rather than structural limitations, and that the patent specification did not permit the full scope of the claims to be drafted without undue experimentation. .
The Amgen patents at issue are U.S. Patent Nos. 8,829,165 (the “‘165 patent”) and 8,859,741 (the “‘741 patent”). They describe antibodies that work to lower low-density lipoprotein (LDL) cholesterol levels. Specifically, his CAFC at the time explained: Evolocumab, marketed by Amgen as his Repatha®. A claimed antibody is defined by its function. Binds to combinations of sites (residues) on the PCSK9 protein, ranging from one residue to all residues. Blocks PCSK9/LDLR interaction. “
In its appeal to the CAFC, Amgen stated that the district court’s analysis “wand factor” was inappropriate.of with a wand The Federal Circuit said, “Whether undue experimentation is necessary is not a single simple factual judgment, but a conclusion reached after considering many factual considerations.” These factors are used to determine whether “that amount of experimentation is ‘unreasonable’ or routine enough to be reasonably expected to be performed by an ordinary skilled craftsman.” Applies where some experimentation is shown to be necessary to practice a patent claim. put it out
The Federal Circuit ultimately ruled that:[w]Whether the claim meets the enablement requirement [Section 112] The court said it “was not erroneous in concluding that undue experimentation was required to enforce the full range of these claims.” Amgen’s petition argued in part that this test of enablement was inconsistent with Supreme Court precedent. Wood vs Underhill (1846), the Supreme Court opined that “the sufficiency of the specification” to enable one skilled in the art to make and use the invention was “a matter of fact to be determined by a jury.”
Sanofi filed its latest answer to the Supreme Court on February 3, stating that “Amgen misleadingly suggested that the Federal Circuit allowed the adoption of a new test that raised standards and set a high bar. In fact, the Federal Circuit simply pointed out that Amgen itself raised the bar and created its own high hurdles by asserting monopoly over functionally defined claims as a whole.”
Amici Promote status quo
Most Amicus who participated in the survey last month supported Amgen, but nearly all of the 16 Amicus briefs submitted on February 9 and 10 supported Sanofi.
The American Intellectual Property Law Association (AIPLA) has endorsed the Federal Circuit’s decision, stating that the judgment is factual, based on statutory provisions and case law, and that changes in law in this area are made by Congress, not the courts. claims to be entrusted to , make. “Determining that enabling disclosure in this case is inappropriate is a proven analysis that has served patents well by balancing the burden of disclosure on inventors with the public interest in providing access to their inventions.” It was done in a way,” said AIPLA. .
Pfizer’s Amicus brief, which backs Sanofi, said Amgen’s patent was not directed at a “pioneering invention” and that many other companies in the field were simultaneously developing anti-PCSK9 antibodies to treat hypercholesterolemia. “Amgen’s patent is an attempt to monopolize a highly competitive therapeutic market,” Pfizer wrote. The brief added that the Federal Circuit’s decision did not create a new test of enforceability, it simply applied it appropriately. wand “The problem here is not the applied test. Instead, it is the overbroad, functionally defined patent claims that are not commensurate with the inventor’s contribution to the technology.”
Eli Lilly affirmed the Federal Circuit’s decision to the court, stating that “Amgen-like claims (which have no structural limitation and are limited only by functional results) are I asked for clarification that it is invalid. Brief said the claims at issue in the lawsuit are “directed against any antibody that binds to and blocks PCSK9,” and that “the boundaries of Amgen’s claims are endless.”
Genentech, AstraZeneca, Bayer, Gilead, Johnson & Johnson also file briefs in support of Sanofi, saying weakening the Federal Circuit’s currently flexible validation criteria could have a disruptive impact on innovation I warned you. “[O]A detailed patent presents a barrier to the research, development, and delivery of life-saving therapies,” the brief states.
A number of public interest patient advocacy groups, including the Association for Accessible Medicines, Public Interest Patent Law Institute and Arnold Ventures, also joined to support Sanofi, saying that Amgen’s win stifles competition, reduces choice, and creates higher choice. argued that it was possible. patient price.
The lawsuit is scheduled for hearing on March 27, 2023.
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Author: Lena Child
