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The doctrine requires that the patent application show “possession of the invention” as judged from the perspective of a person of skill in the art considering the entire original specification, including “words, structures, figures, diagrams, formulas, etc.” Lockwood v. For this type of analysis, the courts look to the Written Description requirement as one way to ensure that a patent’s exclusive rights are commensurate with what was actually invented. The question in the case is whether the dosage requirement (~480 mg/day) was sufficiently disclosed in the original specification so that it can be specifically claimed. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day. The claimed method has one step: administering about 480 mg of DMF per day along with an excipient. Patent 8,399,514 covers a method of treating multiple sclerosis using the drug dimethyl fumarate (DMF). On appeal, a divided Federal Circuit then affirmed, with Judge Reyna penning the majority opinion joined by Judge Hughes, and Judge O’Malley writing in dissent.īiogen’s U.S.
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In the case, Judge Keeley (N.D.W.Va.) held a bench trial and concluded that the asserted claims Biogen’s MS treatment-method patent invalid for lack of written description. November 30, 2021), the Federal Circuit has extended that metaphor and found Biogen’s patents invalid for lack of written description. We are looking for blaze marks which single out particular trees. It is no help in finding a trail or in finding one’s way through the woods where the trails have disappeared-or have not yet been made, which is more like the case here-to be confronted simply by a large number of unmarked trees. It is an old custom in the woods to mark trails by making blaze marks on the trees. In his 1967 Ruschig decision, Judge Rich applied a colorful woodsman metaphor to the written description requirement: But, as is usual with nomination hearings today no concrete details were provided. Vidal’s testimony offered some clues, suggesting that she may consider rolling back some of the pro-patentee procedural changes to IPRs implemented by Dir. And, importantly, I expect both nominations will be swiftly confirmed by the Senate, although Judge Stark will not be seated until after Judge O’Malley retires in March 2022.
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Stark as a district court judge in the patent-heavy district of Delaware (2000+ patent cases) and Vidal as a patent attorney and patent litigator in Silicon Valley.
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On December 1, 2021, the Senate Judiciary Committee held a hearing on two of President Obama’s patent related nominees: