Posts Tagged: "Patentability"

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.

USIJ and Medical Device Group Urge Movement on PERA and PREVAIL

The Medical Device Manufacturers Association (MDMA) and the Alliance of U.S. Startups and Inventors for Jobs (USIJ) sent a letter today to the leadership of the Senate Judiciary Committee and the Judiciary Committee’s Subcommittee on Intellectual Property to express their support for both the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) and the Patent Eligibility Restoration Act (PERA). Both PREVAIL and PERA were introduced on June 22, 2023. The PREVAIL Act aims to reform Patent Trial and Appeal Board (PTAB) practices while PERA would eliminate all judicially-created exceptions to U.S. patent eligibility law.

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).

Rader’s Ruminations – Patent Eligibility II: How the Supreme Court Ignored Statute and Revived Its Innovation-Killing Two-Step

The Supreme Court has never quite grasped the distinction between patent eligibility and patentability. Eligibility involves entire subject matter categories or fields of inventive enterprise, like the categories “process, machine, [article of] manufacture, or composition of matter.” 35 U.S.C. 101. Ascertaining eligibility should therefore require little more than checking the patent title and ensuring that, in the words of the venerable Judge Giles Rich, “[the invention] produces a useful, concrete and tangible result.”  State Street Bank v. Signature Fin. Group, 149 F. 3d 1368 (Fed. Cir. 1998). In simple terms, Section 101 requires little more for eligibility than a showing that an invention has applied natural principles to achieve a concrete purpose within the expansive categories articulated by Thomas Jefferson in 1793. Patentability, on the other hand, proceeds as a detailed claim-by-claim, feature-by-feature examination of “the conditions and requirements of this title.” 35 U.S.C. 101. Ironically this fundamental distinction that eludes the Supreme Court is explicit in the statutory language of 35 U.S.C. 101 itself.

USPTO AI Guidance Reiterates DABUS Decision

The U.S. Patent and Trademark Office (USPTO) today released guidance for determining inventorship of artificial intelligence (AI)-assisted inventions. As the Office has previously stated, the guidance clarifies that “while AI-assisted inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions, as patents function to incentivize and reward human ingenuity.” The USPTO issued a call for comments on AI inventorship in February 2023. That Federal Register Notice (FRN) asked the public to respond to 11 questions, including “how does the use of an AI system [in the invention process]…differ from the use of other technical tools”; whether AI inventions may be patentable under current patent laws on joint inventorship by, for example, simply listing the natural person involved in inventions created by AI machines; and whether statutory or regulatory changes should be made to better address AI contributions to inventions.

Top 10 Software Patent Myths and How to Free Yourself from Them

The first software patent was granted in 1968. It’s now been three decades since the “Year of the Algorithm” in 1994, when cases such as In re Allapat, In re Lowry, and In re Beauregard initiated a wave of software patents. Well over half of U.S. patents granted annually are at least “software-related,” and even a cursory search of U.S. patents reveals software patents in fields ranging from encryption to speech recognition to network security. Why, then, do so many people continue to think that software cannot be patented at all? What explains the stark contrast between the long-standing legal reality and the beliefs of otherwise well-informed engineers, high-tech business people, and even some lawyers?

Witnesses Clash Over Potential Pros and Cons of PERA in Senate IP Subcommittee Hearing

The Senate Judiciary Committee’s Subcommittee on Intellectual Property today held a hearing featuring eight witnesses who testified about the need to restore certainty to U.S. patent eligibility law. Most, but not all, agreed such a need exists and urged quick passage of the Patent Eligibility Restoration Act of 2023 (PERA). Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced PERA in June of last year. The bill would eliminate all judicially-created exceptions to U.S. patent eligibility law.

Can AI Prompts Be Patented? Don’t Be Too Quick to Dismiss this Question

Recent debates about AI patentability have focused on whether the outputs of an AI system, such as a neural network, can be patented. Such debates have been spurred not only by recent general advances in the power of AI but also by Dr. Stephen Thaler’s “Artificial Inventor” project’s attempts to obtain patents on devices generated using his neural network-based DABUS software. If you thought that whether an AI-generated output can be patented is a cutting-edge question, then consider whether an input to an AI system, such as a prompt to a large language model (LLM), can be patented.

EPO Enlarged Board of Appeal Introduces Strong Presumption of Priority Entitlement

The Enlarged Board of Appeal of the European Patent Office (EPO) on October 10 issued its (consolidated) decision G1/22 & G2/22, which promises to significantly reduce priority issues for applicants—U.S.applicants in particular. When the applicants for a European patent application differ from the applicants on the priority application, the EPO employs the well-established “joint applicants approach” to evaluate the priority claim’s validity. For the priority claim to be valid, and assuming there’s been no transfer of the priority right, all applicants of the priority application must also be among the applicants of the subsequent European patent application. The table below outlines various scenarios and indicates whether the priority claim is valid according to the joint applicants approach.

Amici for IP and Auto Industries Tell Full CAFC to Stick with What Works on Design Patents

Late last week, more than half a dozen amicus briefs were filed in support of GM Global Technology Operations in a case that is set to potentially shake up design patent law. The latest briefs generally urged the en banc U.S. Court of Appeals for the Federal Circuit (CAFC) to keep the law as is in order to avoid major disruptions. In June of this year, the CAFC 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.

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…”

Meeting Marvels: The Value and Necessity of Invention Disclosure Meetings

The single best tool available to increase patent value and decrease patent costs is not directed to application drafting or patent prosecution or law firm selection. Instead, it occurs much earlier in the process. The best tool is meeting with inventors. When I was outside counsel and I received a new application to draft, the very first thing I did was set up a meeting with the inventors. As in-house counsel, when I receive a new invention submission, I do the same. It does not matter if the invention is simple, non-enabling, or incomplete. It does not matter if the inventor is familiar, experienced, or knowledgeable. It does not matter if we meet in person, by phone, or by video. For every invention, we meet.

Artificial Intelligence in Drug Development: Patent Considerations

Artificial intelligence (AI) is a field of computer science that creates software or models that mimic human reasoning or inference. Machine learning is a subset of AI which uses algorithms trained on massive amounts of data to allow the computer to learn with gradually improving accuracy without explicitly being programmed. The biopharmaceutical and healthcare fields produce massive amounts of data, including properties and characteristics of drug compounds, biological, genomic, and clinical data, efficacy of treatments, adverse events and risks, and electronic health records. The data may come from many sources, both public and proprietary. AI systems trained on such data can streamline and optimize the drug development process, including drug discovery, diagnosing diseases, identifying treatments and risks, designing clinical trials, and predicting safety and efficacy profiles, leading to increasing efficiency and reducing costs. 

Atlas Global v. TP-Link: A Missed Opportunity to Clarify the Scope of Standards Related Licensing Obligations

A recent decision out of the Eastern District of Texas granted the plaintiff patent owner summary judgment with respect to the defendants’ counterclaim that the plaintiff breached licensing related obligations owed to the Institute of Electrical and Electronics Engineers (IEEE) by not communicating with the defendants prior to suing for infringement…. While the result is reasonable, the explanations provided by the court raise several questions.