in the ” ninth and Federal Circuit, already-Entered decisions can be overturned without a full tribunal reviewed and without any change by the Commission Judge by adding a new judge for the “panel” hearing. – Novartis petition
Last week, Novartis Pharmaceuticals filed a June 2022 decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) in September 2022 to invalidate the company’s patent for a dosing regimen for its multiple sclerosis treatment Gilenya. We have fulfilled our commitment to appeal the decision to the United States Supreme Court. After the CAFC denies a request for a rehearing of the case.
The two questions posed in the petition are:
- 28 USC § 46 and the principles of sound administration of justice require that the Court of Appeals add new judges to form a new panel, after the original three-judge panel has already decided the case and delivered its verdict. Whether redetermination of the case is prevented.
2. Whether 35 USC § 112 should be construed consistent with plain text requiring the patent specification to include a “written description of the invention” in a form understandable to “a person skilled in the art,” or the Court of Appeals Appropriate reading of the heightened requirements that allow de novo examination to consider the specification unsuitable, and to replace the point of view of those skilled in the art.
judicial authority
In June 2022, the CAFC reversed another three-judge panel’s January 2022 opinion in favor of Novartis’ U.S. Patent No. 9,187,405. In the original decision, Chief Justice Moore dissented from the majority. At the hearing, Moore crafted an opinion overriding his January decision, which Judge Lynn dissented.
The District of Delaware originally held final judgment that Novartis’ patent claims directed to the treatment of multiple sclerosis were not invalid because they did not meet the written description requirements under 35 USC § 112. If a negative claim limitation exists, “the specification explains why it excludes the pertinent” [element]Citing a 2012 Federal Circuit decision, by court dominate Santarus, Inc. v. Par Pharmaceuticals, Inc. “Silence is generally not disclosure,” wrote Chief Justice Moore, reiterating a point she raised in her January dissent.
Following the January precedent judgment, HEC requested a rehearing of the panel and Novartis subsequently submitted a response. A week after Novartis submitted its response, Judge O’Malley resigned. Judge Hughes was assigned with Judge Lynn and Chief Justice Moore to consider the request for rehearing of the panel, and despite not being a member of the original panel, Judge Hughes decided to reconsider the panel. I agreed with Chief Justice Moore that it should. At the panel hearing, Chief Justice Moore’s dissenting opinion was the majority, and this time Judge Lynn dissented.
Novartis claimed in its Jan. 18 petition that it is currently “only in the Ninth and Federal Circuits.” [that] Decisions already made can be overturned by adding new judges for a ‘panel’ review without review by the full court or change of mind by a panel judge. All other circuit courts, according to Novartis’ petition, said that all cases should be heard and decided by his three-judge panel, and that “a majority of the judges on that panel should decide.” is final.” Court of Appeals. ” The only exception to this rule is to the bank review.
substantive review
The petition also states that the Court of Appeals for the Federal Circuit “again…imposes…[d] A limitation of patent law that contradicts the letter of the law,” writes Novartis. Bilski V. Kappo.
The June CAFC decision adopted Judge Moore’s dissenting opinion. in these wordsor by verbatim incorporation from the claims into the specification to convey that the inventor intended to exclude that particular element, the written description does not include any disadvantages, alternatives, etc. A discussion of negative limitations must be included.
Novartis’ petition said the opinion “replaces the view of those skilled in the art and adds new and enhanced requirements that allow courts of appeal to substitute that view.” Also’” The petition continued:
“Instead of the law’s flexible case-by-case approach, the Federal Circuit’s new ruling requires patents to explicitly or implicitly describe the elements of a patent’s claims. A fact-finder cannot rely on a statement implied by a skilled artisan in the relevant field on the basis of common knowledge, nor would a skilled artisan understand the description of the invention without such disclosure. Even a court can invalidate a patent.”
Novartis is asking the court to “immediately withdraw the first question, allow any question now,” or suspend the petition pending further action. amgen vs sanofithe ruling was handed down in November.
Commenting on the CAFC’s June 2022 decision, IPWatchdog founder and CEO Gene Quinn said last August:[w]Without hyperbole, this procedural madness is literally unprecedented. “
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Author:72soul
