“It is only when the number of combinations that do not work becomes a significant number that a really skilled craftsman is forced to ‘experiment too much’ to find one that actually exists or works, that ‘claims May actually be invalid.” – Amgen Answer Summary
On March 6, biotechnology developer Amgen filed a petition with the U.S. Supreme Court to invalidate claims directed to antibodies effective in blocking low-density lipoprotein (LDL) cholesterol receptors. The complaint addresses allegations brought by both competing pharmaceutical company Sanofi and the U.S. federal government in Amgen’s appeal of the invalidity of its patent claims as a matter of law under 35 USC § 112. and the District Court ruled as a matter of law. (JMOL) after a jury verdict upheld the validity of Amgen’s patent claims.
amgen vs sanofi Since the Supreme Court granted Amgen’s waiver petition last November, dozens of court hearings have been filed and a very active docket has been submitted to the Supreme Court. Many of the more than 10 Amicus filings filed with the court on January 3, 2018 challenged § 112 invalidity under enhanced legal standards requiring patent owners to disclose their full text. Upheld the US Court of Appeals’ reverse of the affirmative Federal Circuit decision. The scope of the claimed invention, a very unfavorable criterion for the generic claim. On February 10, another Amicus brief was filed, many of which supported Sanofi’s decision that claiming a genus like Amgen was too broad a legal issue.
Sanofi called for a ‘standard of cumulative effort’ but now denounces it as ‘the Strowman argument’
Amgen’s most recent gist begins by refuting Sanofi’s contention that the Federal Circuit has not adopted a higher standard for Section 112 validation. In Sanofi’s February 3 response brief, Sanofi said Amgen was raising a “Strauman argument” over the “cumulative effort standard” allegedly applied by the Federal Circuit. Nonetheless, several U.S. federal court cases and a 2021 U.S. Patent and Trademark Office administrative decision against Sanofi have interpreted the decision as raising the enablement standard under section 112. As Amgen points out, Sanofi has repeatedly told the Federal Circuit that Amgen’s patent claims should be invalid due to the cumulative effort required to find all the antibodies of interest. also claimed. Therefore, it should now be denied that Sanofi does not demand standards that many reviewers have determined to be a significant change from the status quo.
In lieu of the Federal Circuit’s new “full coverage” test, Amgen is asking the Supreme Court to revert to the statutory language of Section 112. It requires the patent owner to allow others skilled in the art to “make and use” the claimed invention. Regarding disclosure of patent specifications. “A claim is valid if the patent’s instructions are ‘clear enough’ to guide a skilled craftsman to a ‘successful application’ beyond the scope of ‘invention,'” states the Supreme Court in his 1916 under judgment Minerals Separation, Ltd. v. Hyde“But cataloging all the embodiments is the job of the machinist, not the inventor,” asserts Amgen.
The “specific undisclosed embodiment” standard is not supported by case law
Amgen notes that some of the cases cited in Sanofi’s briefing have shown that even if the patent disclosed a roadmap for making inventions that span a particular genus, the federal courts would not be able to validate the challenged patent claims. He said that it shows that he has come to support sex. The genus could not be properly described in the specification. Amgen, meanwhile, said it had not seen any precedent requiring patents to teach skilled craftsmen to “predictably create specific, undisclosed embodiments of the claimed invention” for Sanofi’s proposed standard. claim.
Citing the Federal Circuit’s 1984 decision, Atlas Powder Company v. EI du Pont De Nemours & Co., Amgen argues that the appropriate legal standard recognizes that invalid embodiments within a genus do not invalidate a claim. Above ‘it suggests that ‘a claim may actually be invalid’ only if a skilled craftsman is forced to ‘experiment unduely’ to find out what exists or works.” claims Amgen’s response summary. Amgen argues that this case is Sanofi’s proposed It highlights the issue of standards.
“The allusion is not supported by any evidenceA Sanofi-Regeneron expert said: opposetestify that there is no correlation Between number of bound amino acids [antibody’s] Blocking the interaction of PCSK9 with the LDL receptor”… The incontrovertible testimony is that “if an antibody has a structure that allows it to bind to one or more residues in the sweet spot,” which residue or how many Even though it was “blocking”. Interaction of PCSK9 with LDL receptors. – Amgen Summary of Response
Amgen argues that it is ironic that Sanofi invoked the “specific undisclosed embodiment” standard. This is because Sanofi, the District Court, and the Federal Circuit have never identified an antibody within the genus that cannot be made according to Amgen’s roadmap, including Sanofi’s creation of the cholesterol drug Praluent. Contains his four antibodies. Although only 26 antibodies are disclosed by amino acid sequence, Amgen’s patent disclosed that Amgen had actually made 384 antibodies within the genus according to the claimed roadmap. It includes 20 antibodies within the “intermediate binder” class, refuting Sanofi’s previous assertion that no such “intermediate binder” antibodies have been disclosed by Amgen.
Section 112 validation does not require structurally representative disclosures
A similar argument by the U.S. government about lack of enablement due to Amgen’s meager patent disclosure should also fail, Amgen counters. In addition to the fact that Amgen actually discloses the production of hundreds of antibodies within the claimed genus, Amgen has argued that the government has told the court that the amino acid sequences Amgen disclosed are structurally representative of the entire genus. , which is not required for traditional tests for enablement.
The U.S. government argued that federal courts required patents claiming a genus to disclose in the specification “‘some general property that spans the entire genus,'” but Amgen argued that this standard , points out that it is not the only way patent claims describe a genus. Invention from a functional rather than a structural point of view to overcome enablement challenges. Indeed, the influential Supreme Court decision diamond vs chakrabarty (1980) paved the way for the modern U.S. biotechnology industry by upholding the validity of patents claiming inventions performed by functional biological production rather than by structural assembly. , claims Amgen.
In addition, Sanofi and the U.S. government have referred to Amgen’s disclosed roadmap as ” [Amgen’s] Amgen says the roadmap will allow skilled artisans to start where Amgen’s research left off. The roadmap disclosed by Amgen includes assays to identify antibodies that bind to the antigenic “sweet spot” of PCSK9, the precise three-dimensional structure and biochemical characterization of the sweet spot region that binds to the LDL receptor. It contains several techniques and teachings previously unknown.
Enhanced Enablement Standards Facilitate Infringement of Biological Inventions
Finally, Amgen responded to claims raised by multiple Amicus filings in February, many of which were filed by other pharmaceutical companies, that genus claims do not contribute to innovation. As reported here on IPWatchdog and cited in Amgen’s summary of responses, Sanofi and several pharmaceutical companies making such claims have patents that rely on genus claims. Disclosure of amino acid sequences is one of his ways of claiming biological discoveries, but it is not the only way courts have allowed over the years. Current legal doctrine also makes it difficult to deal with infringement when disclosure of such sequences is required by rising patentability standards. .
“The Doctrine of Equivalence seldom ‘addresses’[es] th[e] The risk that mimics avoid infringement by making minor changes to the amino acid sequence. This doctrine “does not apply where any limitation of the claim does not exist for the defendant.” [product]’ The court therefore refused to apply the ‘argument of equivalence’. Because it “reads the amino acid sequence limitation from the claim” and “effectively expands” the scope of the claim, [claimed] effect. ‘No company would invest billions of dollars in research and development of new antibodies in the hope that the doctrine of equivalents would prevent competitors from avoiding amino acid sequence claims. – Amgen Summary of Response
