Patent Docs
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Patent Docs is a weblog authored by patent practitioners, which focuses on biotech/pharma patent law, including reports on changes in USPTO rules and procedures, recent court decisions, newly filed patent litigation, and recently issued patents.
Patent Docs
2h ago
By Joshua Rich -- In a Federal Register notice dated March 29, 2024, the U.S. Patent and Trademark Office is updating the required method for serving it with a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, a notice of election to proceed by civil action in district court, or a request for extension of time to file a notice of appeal or commence a civil action. Previously, all such notices or requests had to be served by mail. Under the new rule, the notices and requests are to be served by email (with Priority...
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Patent Docs
2h ago
By Kevin E. Noonan -- Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Cardiovalve Ltd. v. Edwards Lifesciences Corp., which has as its most significant aspect an unnecessary untethering of obviousness with evidence regarding the skill and inventiveness of the person of ordinary skill in the art under KSR International Co. v. Teleflex Inc. The case arose with Edwards's challenge of claims 1-3, 5, 6, and 8-11 of Cardiovalve's U.S. Patent ..read more
Patent Docs
2d ago
By Kevin E. Noonan -- Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc. v. Teleflex Life Sciences Ltd. The case arose in two IPR proceedings involving U.S. Patent No. 8,142,413, owned by Teleflex and related to methods for using a coaxial guide catheter in interventional cardiology procedures. Claims 1, 2, 4, 5, and 7-14 were challenged by Medtronic for being unpatentable for anticipation* or obviousness; claim 1 was consid ..read more
Patent Docs
6d ago
By Joshua Rich -- As discussed in our earlier post, Microsoft opened its motion to dismiss portions of the New York Times's OpenAI case pled against it with an extended analogy to the Betamax case. It argued that the Times was acting like the Motion Picture Association of America in crying wolf over the death of its industry in light of the development of a new technology.[1] But no analogy is perfect, and the Times opened its opposition to the motion to dismiss by noting the distinctions between an LLM and a VCR. The Times's opposition starts with an unambiguous...
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Patent Docs
1w ago
By Joshua Rich and Michael Borella -- Responding to the OpenAI brief that read more like a press release than a traditional motion to dismiss, the New York Times attacked OpenAI's approach from the very first sentence, calling the factual background of OpenAI's brief "grandstanding about issues on which it hasn't moved." The Times echoed the concern we raised in our post on OpenAI's motion to dismiss, that the motion "introduces no fewer than 19 extrinsic documents, none of which can be properly considered on a motion to dismiss, in a submission that for nearly 10 pages reads more like...
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Patent Docs
2w ago
By Kevin E. Noonan -- Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in five inter partes review (IPR) proceedings were obvious. In light of the Office's promulgation of Guidance to the examining corps as well as PTAB judges of the "increased flexibility" in obviousness determinations mandated by the Supreme Court's decision in KSR v. Teleflex and the Federal Circuit's application of that mandate since the Court's decision, th ..read more
Patent Docs
2w ago
By Kevin E. Noonan -- After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this year. The first of these is simlandi (adalimumab-ryvk), approved on February 24th, made by Alvotech and Teva Pharmaceuticals, and interchangeable with Humira). The biosimilar, a TNF alpha inhibitor, was approved to be provided as a single-dose autoinjector delivering 40 mg/0.4 mL, for treating plaque psoriasis, Crohn's disease, ulcerative colitis, rhe ..read more
Patent Docs
2w ago
By Joshua Rich and Michael Borella -- Like OpenAI before it, Microsoft has sought to dismiss portions of the lawsuit the New York Times has brought against it over ChatGPT. While raising some of the same arguments, Microsoft takes a more traditional path with its motion relying on the facts pled in the Times's complaint. However, it also relies on an extended analogy to the VCR (and the Supreme Court's "Betamax" decision) to suggest a framework for the court's analysis. Microsoft's brief opens with a "Preliminary Statement" about the Motion Picture Association of America's resistance to the VC ..read more
Patent Docs
3w ago
By Joshua Rich and Michael Borella -- In response to the lawsuit the New York Times has filed against it, OpenAI has sought to dismiss portions of the complaint.[1] But instead of filing a traditional motion to dismiss that argues that the allegations of the complaint are insufficient to support legal liability, OpenAI went on the offensive. It sought to recast the case by including an extensive factual background that went far beyond -- and sometimes is incompatible with -- the allegations of the complaint. In short, the motion to dismiss seems more like an attempt to influence the public ..read more
Patent Docs
3w ago
By Michael Borella -- On February 27, 2024, the U.S. Patent and Trademark Office published its Updated Guidance for Making a Proper Determination of Obviousness ("Guidance") in the Federal Register. The stated goal of the Guidance is: To provide a review of the flexible approach to determining obviousness that is required by KSR Int'l Co. v. Teleflex Inc. (KSR). The focus of this document is on post-KSR precedential cases of the United States Court of Appeals for the Federal Circuit (Federal Circuit), to provide further clarification for decision-makers on how the Supreme Court's directives sh ..read more