Posts Tagged: "patentability requirements"

The Canadian Federal Court of Appeal (FCA), in Attorney General of Canada v. Benjamin Moore & Co. [2023 FCA 168], a 3-0 decision, recently set aside the test on subject matter eligibility of computer-implemented inventions laid down by the Federal Court [2022 FC 923] last year. Acclaimed by patent professionals as a “favorable decision for Canadian applicants who have computer-implemented inventions,” the test had, for the first time, presented a declaratory relief and guidance for examining subject-matter eligibility, particularly for computer-implemented inventions. While the setting aside of the test relays subject matter assessments back to the procedure set by the Commissioner of Patents (Canada), the FCA clarified some key areas associated with the claim construction and patentability analysis.

The Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), found that antibody claims defined by their binding and blocking function lacked enablement…. The Supreme Court’s decision relied highly on the unpredictability of the art—scientists cannot always predict how substitutions of even single amino acids will affect the binding and/or blocking function of an antibody. The disclosed methods of identifying species within the scope of the claim were little more than “trial and error.”… The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. The remaining questions are: Are patent applicants limited to claiming species (e., sequence listings)? What steps may a patent applicant take to obtain broader coverage?

In an IPWatchDog post of September 6, 2022, Anthony Prosser and I traced the history of the doctrine of “Non-Statutory Judicially Created Obviousness-Type Double Patenting” (ODP). We confirmed (as its name indicates) that no Congressional statute has ever codified this doctrine. It is ultra vires because Congress has the sole right to create patent law…. In the Cellect decision issued yesterday, the Federal Circuit stretches the word “disclaimer” in Section154(b)(2)(B) beyond credibility as justification for the ODP doctrine itself and assumes that is what Congress was talking about without actually saying it (stating with agreement that “The Board also reasoned that terminal disclaimers arise almost exclusively in situations to overcome ODP rejections, and so Congress, by addressing terminal disclaimers in §154, effectively addresses ODP”).

Pfizer, Inc. and BioNTech SE on Monday hit back at competitor COVID-19 vaccine maker Moderna with inter partes review (IPR) petitions against two Moderna patents on mRNA vaccine technology at the Patent Trial and Appeal Board (PTAB). Pfizer/ BioNTech told the PTAB that Moderna’s patents include “unimaginably broad claims directed to a basic idea” and asked the Board to cancel all of the challenged claims of both patents.  

U.S. patent practitioners have had a rocky relationship with the once-straightforward patent eligibility requirement under 35 U.S.C. 101 in recent years. Decisions such as Mayo and Alice upended the status quo, muddying the threshold test for patent subject matter eligibility. When dealing with difficult 101 rejections under this new status quo, it can sometimes help to think outside of the box about how to overcome a given rejection. This article presents a potential unlabeled “Step Zero” of the Subject Matter Eligibility Analysis which could help you overcome or avoid 101 rejections.

On July 14, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in SNIPR Technologies Limited v. Rockefeller University reversing a decision by the Patent Trial and Appeal Board (PTAB) that invalidated all claims from five SNIPR patents. In reversing, the Federal Circuit found that the PTAB erroneously subjected SNIPR’s patents to interference proceedings that Congress meant to eliminate when it enacted the America Invents Act (AIA) of 2011.

Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. Patent No. 8,101,659 (“the ‘659 patent”). On July 7, 2023, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. The district court’s decision highlights a clear tension between claim construction and enablement that, if left to stand, could permit pharmaceutical companies to block lower-cost generic medications with patents they did not actually invent.

The Supreme Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s longstanding requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions with such clarity and specificity as to enable one skilled in the art to make and use the claimed invention. Moreover, the Court has consistently held that a patent fails to satisfy the enablement requirement if a person having ordinary skill must engage in undue experimentation to practice the claimed invention. The Federal Circuit has gone a step further, requiring that patents enable the full scope of a claimed invention. Amgen is a ratification of this aspect of the Federal Circuit’s enablement jurisprudence.

Recovering money from users of technology requires movement on the part of inventors of technology. For example, receiving compensation from those who use patented designs without permission often requires patent owners (e.g., inventors) to send cease and desist letters, file complaints in federal district court, and at times endure patent litigation to its completion. All of these movements require the inventor to possess a patent. In this manner, one way to view the patent is as a vehicle in commerce.

Last week, retired U.S. Court of Appeals for the Federal Circuit (CAFC) Chief Judge Paul Michel and law professor John F. Duffy filed an amicus brief with the U.S. Supreme Court in support of CareDx, Inc. and the Board of Trustees of the Leland Stanford Junior University. The company and university are asking the Supreme Court to review a 2022 decision invalidating claims of its patents directed to detection levels of donor cell-free DNA (cfDNA) in the blood of an organ transplant patient. In the amicus brief, Michel and Duffy wrote, “this case concerns [us] because it represents a continuing trend of uncertainty and inconsistency in patent-eligibility jurisprudence…The outcome undermines the innovation promoting goals of U.S. patent law.”

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled in a precedential decision today that Medtronic, Inc. failed to show the challenged claims of five patents covering catheter technology unpatentable. The CAFC specifically upheld the Patent Trial and Appeal Board’s (PTAB’s) finding that the primary prior art reference cited by Medtronic did not qualify as prior art under pre-America Invents Act (AIA) first-to-invent provisions. Judge Dyk dissented, arguing that the prior art reference had been shown to qualify as prior art, and thus could support a determination of anticipation or obviousness.

As most in the IP world know by now, the U.S. Supreme Court issued its ruling in Amgen v. Sanofi on Thursday, holding that the U.S. Court of Appeals for the Federal Circuit (CAFC) was correct in finding that Amgen’s patents for its popular cholesterol drug failed to meet the enablement requirement…. IP practitioners diverge on the degree to which the decision will change patent practice in the biotech industry going forward, with some claiming the Court merely reiterated the existing law on enablement, and others saying it represents a major shift.

Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.

On day one of IPWatchdog’s Patent Litigation Masters program yesterday, the U.S. Supreme Court denied two patent eligibility cases that the U.S. Solicitor General had recommended granting. The denials make it fairly clear that the High Court is not interested in helping to resolve the current problems with U.S. patent eligibility law, which generally have to do with a lack of clarity, arguably fostered by many of the Court’s own precedents. Following the last panel of the day on Monday, in which speakers discussed ways to improve and streamline patent enforcement in America, retired U.S. Court of Appeals for the Federal Circuit Chief Judge Paul Michel told IPWatchdog he thinks the Supreme Court’s refusal to take up patent eligibility is self-serving. “I think the Court doesn’t want to admit they messed up the law in the four decisions – Bilski, Myriad, Mayo and Alice. They don’t even admit that it’s a big problem, but it is a huge problem, and everybody in the patent world knows it’s a huge problem,” Michel said.

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.