Posts Tagged: "obviousness"

CAFC Panel Splits on Reasonable Expectation of Success Analysis

In a precedential decision authored by Judge Lourie, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s final judgment that certain claims of several patents owned by Salix Pharmaceuticals for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious. The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. Norwich cross-appealed from that order and also from the denial of its motion to modify the district court’s final judgment.

CAFC Sends Janssen Schizophrenia Treatment Claims Back to District Court for New Obviousness Analysis

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled in a precedential decision authored by Judge Prost on Monday that certain claims of Janssen Pharmaceuticals Inc.’s patent for a schizophrenia drug are not indefinite but vacated and remanded the district court’s finding that Teva Pharmaceuticals had not proven all of the claims obvious.

Victory for Virtek Patent as CAFC Schools PTAB on Proper Motivation to Combine Analysis

In a precedential decision authored by Chief Judge Moore, the U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday partially reversed a Patent Trial and Appeal Board (PTAB) ruling that certain claims of Virtek Vision International’s patent on a method for aligning a laser projector were unpatentable, finding the Board erred as a matter of law in its analysis. The court also affirmed the PTAB’s finding that other claims were not proven unpatentable. Aligned Vision challenged various claims of Virtek’s U.S. Patent No. 10,052,734, which is titled “Laser Projector with Flash Alignment,” arguing claims 1, 2, 5, 7, and 10–13 would have been obvious over prior art references titled Keitler and Briggs (Ground 1), and over Briggs and another reference, Bridges (Ground 3). It also argued claims 3–6 and 8–12 would have been obvious over Keitler, Briggs, and  ‘094 Rueb (Ground 2), and over Briggs, Bridges, and ‘094 Rueb (Ground 4).

SCOTUS Denies Petition to Review CAFC Precedent on Justification for Primary Reference Selection

The U.S. Supreme Court on Monday, March 18, denied a petition filed by patent owner Jodi A. Schwendimann asking the Court to review a decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) that affirmed a Patent Trial and Appeal Board (PTAB) determination that Schwendimann’s patents were obvious. The petition specifically asked the Court to review the CAFC’s holding that Schwendimann’s argument that “justification for selection of a primary reference is a necessary step to guard against hindsight bias for the motivation to combine references” was unsupported by Federal Circuit case law.

Responding to Obviousness Rejections in Light of the USPTO’s New Guidance

The United States Patent and Trademark Office (USPTO) recently released new guidance to patent examiners on making obviousness rejections. The guidance focuses on post-KSR precedential jurisprudence from the U.S. Court of Appeals for the Federal Circuit. Some of the guidance is fairly mundane, some of it is not. The purpose of this article is to propose a few responses one might use to counter rejections that apply certain problematic aspects of the new guidance.

CAFC Affirms PTAB Finding that Reasonable Pertinence Proves Analogous Art

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a brief opinion authored by Judge Chen today that rejected Daedalus Blue LLC’s appeal of a Patent Trial and Appeal Board (PTAB) decision finding certain claims of its patent on a data management system unpatentable. The PTAB held that U.S. Patent No. 8,671,132 was unpatentable as obvious over combinations of three prior art references: “Gelb”, “Tivoli”, and “Callaghan.” Daedalus in part argued on appeal that the Board incorrectly found that Gelb is analogous art because Gelb “is not reasonably pertinent to the problems identified in the ’132 patent.”

USPTO Issues Updated Obviousness Guidance Tracing 15 Years of Case Law Following KSR

On February 27, the U.S. Patent and Trademark Office (USPTO) published a notice in the Federal Register providing updated guidance for agency decision-makers on making proper determinations of obviousness under the U.S. Supreme Court’s 2007 ruling in KSR International Co. V. Teleflex Inc. While the USPTO’s examiner guidance doesn’t constitute substantive rulemaking, it traces 15 years of case law from the U.S. Court of Appeals for the Federal Circuit to clarify several areas of confusion stemming from the Supreme Court’s calls for a flexible approach to the obviousness analysis for patent validity.

The ‘Lead Compound’ Rule: Problems and More Problems

On August 22, 2023, the U.S. Court of Appeals for the Federal Circuit issued yet another decision reinforcing what can only be described as the “lead compound” rule for challenging pharmaceutical and other chemical compound patents on the basis of obviousness…. The Federal Circuit has been utilizing the “lead compound” construct since around 2000. The Sun panel cited an earlier decision which couched the construct as something the court “ordinarily” employs. Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 678 F. 3d 1280, 1289 (Fed. Cir. 2012). That earlier decision cited yet an earlier decision which stated that the “lead compound” methodology is used “in general.” Esai Co. v. Dr. Reddy’s Labs., Ltd., 533 F. 3d 1353, 1359 (Fed. Cir. 2008).

CAFC Affirms Obviousness of Memory Cell Design Patents Over Dyk Dissent

On October 26, a panel majority of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB) invalidating patent claims owned by Monterey Research and covering improved static random access memory (SRAM) cell designs. Dissenting from the majority was Circuit Judge Timothy Dyk, who believed that both the Board and CAFC panel majority erred by concluding that claim amendments made during reexamination did not differentiate the claims from asserted prior art references.

Is the United States’ Nonobviousness Test ‘Plausibly’ Similar to the EPO/UK Inventive Step Standard?

Recent cases in the European Patent Office (EPO), the UK, and United States illustrate substantive differences between these jurisdictions as they continue to develop their inventive step/nonobviousness frameworks. In particular, the EPO and UK have recently provided guidance on a concept known as “plausibility,” i.e., whether the scope of the patent must be justified by the patentee’s technical contribution to the art in solving an identified problem. “If it is not plausible that the invention solves any technical problem then the patentee has made no technical contribution and the invention does not involve an inventive step.” Sandoz Limited v. Bristol-Meyers Squibb Holdings [2023] EWCA Civ 472. That standard, however, is quite dissimilar from the United States’ statutory standard of whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious…”

Amici Speak Up in En Banc Challenge at CAFC to Rosen-Durling Framework for Design Patent Obviousness

This week, 10 amici weighed in at the U.S. Court of Appeals for the Federal Circuit (CAFC) in a rare en banc review of the court’s January, 2023, decision in LKQ Corporation v. GM Global Technology Operations. That decision affirmed a Patent Trial and Appeal Board (PTAB) ruling that LKQ failed to show by a preponderance of the evidence that GM’s design patent was anticipated or would have been obvious.

CAFC Reverses PTAB Finding for Patent Owner Due to Analysis ‘Doubly Infected by Error’

The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision finding the Patent Trial and Appeal Board (PTAB) erred in too narrowly confining its motivation-to-combine inquiry and improperly limiting its definition of the relevant art to hold that Axonics, Inc. had failed to prove Medtronic, Inc.’s patent claims obvious. The patents at issue are Medtronic’s U.S. Patent Nos. 8,626,314 and 8,036,756. They cover “a neurostimulation lead and a method for implanting and anchoring the lead.”

Full Federal Circuit to Review Challenge to Test for Design Patent Obviousness

The U.S. Court of Appeals for the Federal Circuit (CAFC) has granted a rare en banc review of its January, 2023, decision in LKQ Corporation v. GM Global Technology Operations, which affirmed a Patent Trial and Appeal Board (PTAB) ruling that LKQ failed to show by a preponderance of the evidence that GM’s design patent was anticipated or would have been obvious. U.S. Patent D855,508 covers a “vehicle front skid bar.” In its January decision, the Federal Circuit explained that “applying the tests established in Rosen and Durling, the Board found that LKQ failed to identify a sufficient primary reference, and therefore failed to prove obviousness by a preponderance of the evidence.

‘Obvious Over What?’ LKQ’s En Banc Petition Threatens to Turn Test for Design Patent Obviousness on its Head

Just like utility patents, design patents can be found obvious under 35 U.S.C. § 103 by combining prior art references. But the test for obviousness for design patents differs from the more familiar standards for utility patents. The U.S. Court of Appeals for the Federal Circuit recently reaffirmed this distinction, but the issue is far from resolved. A long line of Patent Trial and Appeal Board (PTAB) actions between LKQ and GM Global Technologies escalated to the Federal Circuit, where LKQ submitted an argument seeking to fundamentally change the obviousness analysis for design patents.

CAFC Affirms Ruling that Blocks Generic Version of Amgen’s Psoriasis Drug Until 2028

Yesterday, in a precedential decision, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that upheld the validity of several claims in two Amgen patents and barred Sandoz and Zydus from producing generic versions of Amgen’s psoriasis drug Otezla until 2028. The CAFC ruling also upheld the district court’s ruling that three claims in Amgen’s U.S. Patent 10,092,541 were invalid. However, that did not stop Amgen from declaring victory in the case in a press release.