Posts Tagged: "Patentability"

The muddled state of patent eligibility law has direct and significant negative consequences for U.S. R&D investment, and for innovation in key fields of medical, economic, and strategic importance to the United States and its citizens. Uncertainty reduces R&D investment, as has been well-documented, and reliable patent protection mitigates uncertainty and generates increased R&D investment. As we explained in Part I of this series, the experts overwhelmingly agree on these points.

On October 5, American biopharmaceutical firm Amgen filed a supplemental brief at the U.S. Supreme Court, which comes about two weeks after the U.S. Solicitor General’s office filed a brief urging the Court to deny certiorari on Amgen’s petition for writ. Amgen’s petition seeks Supreme Court review of rulings in the lower courts invalidating Amgen’s patent claims for lack of enablement. Amgen’s latest brief argues that Solicitor General’s own arguments further support Supreme Court review to clarify the proper standard for reviewing questions of enablement under 35 U.S.C. § 112.

The United States Patent and Trademark Office (USPTO) announced today that it is seeking comment from the public on “proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while facilitating the broader dissemination of public knowledge to promote innovation and competition.” During IPWatchdog’s LIVE event in Dallas, Texas, in September, USPTO Texas Regional Office Director Hope Shimabuku explained that issuing “robust and reliable patents”—which seems to have replaced the oft-maligned term, “patent quality,”—is a key focus for USPTO Director Kathi Vidal. The request for comment (RFC) tackles this problem from a number of angles, from fee-setting to terminal disclaimer and continuation practices, to improving prior art searches. The RFC stems in part from a July letter sent by the USPTO to the Food and Drug Administration (FDA) outlining the USPTO’s planned initiatives to help combat perceived links between patents and drug pricing problems.

In Part I of this series, we discussed  the importance of identifying and avoiding patentability-blocking ambiguities in a patent application. It is equally important that the patent application drafter bring a sensibility to the drafting of the application that recognizes that conceptually the application must not  simply be seen as a document whose job is to describe an invention but must also be understood to be a document that must have a descriptive capability that enables it to distinguish patent worthy subject matter from prior art. Thus, when the patentability of patent worthy subject matter disclosed by the application is challenged, the application can speak—it is able to defend its patentability. This capability is essential in both pre and post grant forums.

In a June 20, 2022, article on IPWatchdog, I addressed a portion of the June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun  to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal requesting the USPTO to issue a notice of rulemaking or request for comments in the Federal Register by September 1, 2022, on curbing continuation practice as a means to address “patent thickets.”  As of the date of this article, the USPTO has not issued the notice. In this article, I, along with co-author Anthony Prosser, address the other issue raised in the Senators’ June 8 letter—whether elimination of terminal disclaimers that “allow” patents to issue that are “obvious variations of each other” would increase patent quality and whether patents that are tied by a terminal disclaimer should be considered an admission of obviousness and stand or fall together in litigation.

On September 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the Patent Trial and Appeal Board (PTAB) finding that the PTAB did not improperly place the burden of persuasion for proving unpatentability of proposed substitute claims raised sua sponte by the Board on Nike and that substantial evidence supports the PTAB’s obviousness analysis. The decision comes after two prior rulings by the CAFC in related cases between Nike and Adidas. The present appeal concerned the PTAB’s determination that proposed substitute claim 49 of Nike’s U.S. Patent No. 7,347,011 (‘011 patent) was unpatentable as obvious.

June Cohan, Senior Legal Advisor in the Office of Patent Legal Administration at the U.S. Patent and Trademark Office (USPTO) today explained to attendees of an event about the Office’s patent eligibility guidance that there are no plans to revise the guidance in light of the denial of certiorari in American Axle. She also acknowledged several areas of “divergence,” or “outlier cases,” between the USPTO and the U.S. Court of Appeals for Federal Circuit (CAFC) approaches to determining patent eligibility which the Office has no plans for revising, despite the fact that the CAFC is the reviewing court for the USPTO.

The August 2019 announcement that two patent applications had been filed naming an artificial intelligence (AI) algorithm as an inventor in the United States and a dozen other countries was regarded as disruptive and profound at the time. It was one of the hot topics in patent law during those last few months before the pandemic. But since then, given all the other crazy and disorienting stuff that has happened in the world, we have become desensitized to the question, even if it is just as radical and important today. To be sure, the U.S. Court of Appeals for the Federal Circuit’s August 5 ruling that an “inventor” must, under the Patent Act, always be a human being, would seem to definitively resolve the question. As a matter of existing and clearly settled law, Stephen Thaler’s AI machine, DABUS, cannot be a named inventor on his applications for a fractal-shaped beverage container and a neural flame, like we always thought in the Before Times. It’s time to relegate this parlor-game discussion to the same recycle bin as Beeple’s non-fungible token (NFT), The Tiger King, and so many other viral distractions. Or, perhaps, not so fast.

This morning, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022, S.4734, which would amend the U.S. Patent Act to clarify the application of 35 U.S.C. Section 101 to certain technologies. While the bill was welcomed by many in the intellectual property (IP) community, since it would abrogate or weaken many of the seminal decisions that have arguably caused confusion on eligibility over the last decade-plus, some have called the bill out as being far from perfect. Questions remain with respect to the text’s language regarding the definition of “technological” and what it means for software patents, for instance, as some commenters note below.

Last week, the U.S. Supreme Court received several amicus briefs filed in support of the petition for writ of certiorari filed in Biogen International GmbH v. Mylan Pharmaceuticals Inc. If cert is granted, this case will ask the nation’s highest court to clarify the written description requirement under 35 U.S.C. § 112. The appeal follows a contentious decision this March from the U.S. Court of Appeals for the Federal Circuit to deny panel rehearing and rehearing en banc of an earlier ruling affirming the Northern District of West Virginia’s invalidation of Biogen’s patent claims covering a method of treating multiple sclerosis (MS) under Section 112.

A group of patent practitioners told the Supreme Court on Thursday that a case involving a patent for a type of content player would be a better vehicle for unraveling the patent eligibility problem than American Axle & Manufacturing v. Neapco Holdings, which has been awaiting a brief of the U.S. Solicitor General for about one year now. The case is Interactive Wearables, LLC v. Polar Electro Oy and Polar Electro, Inc. Interactive Wearables petitioned the High Court in March 2022.

Last week, U.S. District Judge James Donato of the Northern District of California issued a judgment on the pleadings invalidating claims from one of 12 patents asserted by semiconductor and software developer Broadcom against streaming video provider Netflix. The ruling is the latest setback for Broadcom in its enforcement campaign against Netflix’s use of patented server technologies to support streaming media services that are cutting into Broadcom’s market for semiconductors developed for use in set-top boxes.

On March 24, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a Patent Trial and Appeal Board (PTAB) Precedential Opinion Panel’s (POP’s) decision allowing patent owner DynaEnergetics Europe GmH to amend its claims, and also affirmed the PTAB’s decision that the original claims of the patent were unpatentable. Hunting Titan, Inc. petitioned for inter partes review of claims 1–15 of the U.S. Patent No. 9,581,422, asserting grounds of unpatentability based on anticipation and obviousness, including allegations that the claims were anticipated by U.S. Patent No. 9,689,223 (Schacherer). The Board instituted trial on all grounds and found all of the original claims unpatentable.

Earlier this month, Ameranth Inc. filed a Petition for a Writ of Certiorari to the U.S. Supreme Court requesting review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision affirming a district court ruling that Ameranth’s patent was ineligible under 35 U.S.C. § 101. Ameranth claims that “federal courts have declared thousands of new and useful inventions abstract and patent ineligible” based on SCOTUS’s decision in Alice Corp Pty. v. CLS Bank Int’l (U.S. Supreme Court, 2014). The culmination of the post-Alice upheaval is the CAFC’s paralytic gridlock of denying rehearing en banc in American Axle & Mfg. v. Neapco Holding LLC (CAFC, 2020) according to the petition. Ameranth pled that the court should provide guidance on the standard for patent eligibility, as federal circuits continue to apply the law in a non-uniform and unarticulated manner.

On February 10, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the U.S. District Court for the District of New Jersey, explaining that the district court did not err in finding several Adapt Pharma patents obvious. The asserted claims relate to U.S. Patent Nos. 9,468,747; 9,561,177; 9,629,965; and 9,775,838 (collectively, the “patents-in-suit”). The patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration. Naloxone is the active ingredient in Adapt’s NARCANâ Nasal Spray and is an opioid receptor antagonist, thus helping reverse the effects of opioid overdose. The opinion was authored by Judge Kara Stoll; Judge Pauline Newman dissented.