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Posts Tagged: "Patentability"

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

Hindsight Bias: An Ovine Survey

The arrival of a U.S. Patent and Trademark Office (USPTO) office action citing no less than six earlier patents directed to various sub-combinations in the features of the main independent claim in an application which I was handling prompted the present note. Readers may recall the decision of Judge Rich In re Winslow 365 F.2d 1017 (C.C.P.A. 1966): “We think the proper way to apply the 103-obviousness test to a case like this is to first picture the inventor as working in his shop with the prior art references — which he is presumed to know — hanging on the walls around him.” However, Boltzmann’s entropy formula S = k log W where S represents entropy, a concept associated with a state of disorder, randomness, or uncertainty, and W represents the number of possible states in the relevant system, leaves an unforgettable impression on those who have studied it. Even if the fields from which the earlier patents might be selected are restricted to relevant general classifications, the number of combinations of six references which might have been collected together from the body of prior art in the relevant technical field randomly and without knowledge of the invention is mind-boggling.

Tillis and Leahy Urge USPTO to Address Inconsistent Prior Art Statements by Patent Applicants at the FDA

On Thursday, September 9, Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) sent a letter addressed to Drew Hirshfeld, performing the functions and duties of the Director of the U.S. Patent and Trademark Office (USPTO), discussing the issue of inconsistent statements made by patent applicants pursuant to their disclosure requirements at the USPTO and other federal agencies, especially the U.S. Food and Drug Administration (FDA). The Senators are asking the USPTO to take swift action to ensure that applicants are disclosing all known prior art at both the USPTO and the FDA.

Building High-Quality Patent Portfolios in the United States and Europe: Part I – Intervening Prior Art

One ingredient that distinguishes a good patent portfolio from a great patent portfolio can be the synergistic strength of its U.S. and European patent family members. To develop this strength, it is not enough to have a U.S. attorney and a European attorney simply coordinate the procedural strategy for filing an application; rather, the drafter and manager of the application should analyze important issues upfront and prepare a patent application that accounts for the substantive differences between U.S. examination, U.S. courts, European examination, and national courts in Europe.

CAFC Reverses Massive Jury Verdict for Juno and Sloan Kettering

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed a jury verdict for Juno Therapeutics and Sloan Kettering Institute for Cancer Research (Juno), wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence. The case relates to U.S. Patent No. 7,446,190, owned by Sloan Kettering, which is titled “Nucleic Acids Encoding Chimeric T Cell Receptors.” The patent generally covers cancer immunotherapy technology. Juno sued Kite Pharma, Inc. for infringement of the ‘190 patent through the sale of its YESCARTA product. Kite countersued, seeking declaratory judgments of noninfringement and invalidity. The jury ultimately found in Juno’s favor and, in post-trial briefs, Kite moved for judgment as a matter of law (JMOL) on several grounds, including that the claims were not supported by sufficient written description. The district court denied JMOL and Kite appealed.

Drafting AI Patents: Challenges and Solutions

Artificial Intelligence (AI) is the latest buzzword across all sectors. Every tech and non-tech company is vigorously filing, strategizing or planning to enter the AI patent domain. However, the journey is not as easy as it may seem. While drafting AI-based patent applications, drafters often face challenges in formulating the right strategy for writing claims and identifying the correct scope of the application. Thus, it’s important to know the challenges in detail and to develop practical solutions for drafting a patent-worthy application.

CAFC Reverses PTAB Patentability Finding in Campbell Soup Dispenser Case

The U.S. Court of Appeals for the Federal Circuit yesterday reversed the Patent Trial and Appeal Board’s (PTAB’s) finding that Campbell Soup Company, Campbell Sales Company, and Trinity Manufacturing, LLC did not demonstrate the claimed designs of Gamon, Inc.’s design patents would have been obvious over the prior art. The CAFC held that the designs were obvious because Gamon did not prove a nexus between commercial success and the claims, and because the evidence of Trinity’s copying did not overcome the strong evidence of obviousness provided by the prior art.

In Partial Reversal of Two IPRs, CAFC Says PTAB Erred in Prior Art Determination

On August 17, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed in part, reversed in part, vacated in part, and remanded two final written decisions from the Patent Trial and Appeal Board (PTAB or Board) involving inter partes review (IPR) proceedings that affirmed the patentability of two of Ironburg Inventions Ltd.’s patents.

Teva Wins One, Loses Two at CAFC in Migraine Treatment Patent Cases

The U.S. Court of Appeals for the Federal Circuit today issued two precedential decisions and one nonprecedential decision in cases involving Teva Pharmaceuticals and Eli Lilly, delivering wins and losses for each company. The cases relate to “humanized antagonist antibodies that target calcitonin gene-related peptide (‘CGRP’)” and methods of using such antibodies. All three cases were heard by Judges Lourie, Bryson and O’Malley, with Judge Lourie authoring the decisions.

DABUS Scores Again with Win on AI Inventorship Question in Australia Court

The Federal Court of Australia on Friday ruled in Thaler v Commissioner of Patents [2021] FCA 879 that an artificial intelligence (AI) system can be an inventor under the Australian Patents Act. The Honorable Justice Beach, in a very thorough judgment, set aside the decision of the Deputy Commissioner of Patents that patent application no. 2019363177 did not comply with reg 3.2C(2)(aa) of the Patents Regulations 1991 (Cth), which “requires that the applicant, who in this case is Dr Stephen Thaler, must provide the name of the inventor of the invention to which the application relates.” The Deputy Commissioner of Patents said that Thaler could not name an inventor because an AI simply cannot be an inventor under the Act. But Justice Beach said “that position confuses the question of ownership and control of a patentable invention including who can be a patentee, on the one hand, with the question of who can be an inventor, on the other hand.”

‘AISITAs’ and Written Description Requirements: Considerations and Guidance for AI Patent Applications

Artificial intelligence (AI) is everywhere, touching nearly every aspect of our daily lives, including how we work, communicate, shop, travel and more. The term “AI” is generally understood to encompass computerized systems that perform tasks ordinarily perceived as requiring some form of human intelligence. Many AI-based systems are able to recognize trends, patterns and connections, test hypotheses using available data sets, and continuously improve decision trees based on user input. As such, AI has been shown to have near endless applications, driving a surge of inventions and related patent application filings.

CAFC Reverses PTAB Obviousness Finding, Clarifying Concepts of ‘Teaching Away’ and ‘Commercial Success’

The United States Court of Appeals for the Federal Circuit (CAFC) yesterday concluded that the Patent Trial and Appeal Board’s (PTAB’s) decision finding certain claims of Chemours’ patents obvious was not supported by substantial evidence and that the Board erred in its analysis of objective indicia of nonobviousness. As such, the CAFC reversed the decisions.

A Recent Senate IP Subcommittee Hearing Demonstrates the Danger of Patent Fallacies

During the Senate Judiciary’s Subcommittee on Intellectual Property hearing, titled Protecting Real Innovations by Improving Patent Quality, held on June 22,  Jorge Contreras, Presidential Scholar and Professor of Law at the S.J. Quinney College of Law of the University of Utah, testified under oath that patents are effectively the same thing as products, and seemed to suggest that executive fraud unrelated to patents must make the patents fraudulent too. This, of course, is a fallacy. It shows a fundamental and deep misunderstanding of what patents are and how they work, and completely misrepresents law and logic. If taken seriously, Contreras’ testimony would destroy the value of virtually every patent portfolio and further chill investment in new technologies. It is an alarming position coming from a patent lawyer and credentialed law school professor who claims he is “intimately familiar with the topic of today’s hearings.”

Disclosure Requirements in Software Patents: Avoiding Indefiniteness

How much detail is needed in a patent application for a software-based invention? Software patents present some unique challenges that many other kinds of patent applications do not need to contend with, one of them being the level of disclosure and care in drafting needed to avoid indefiniteness issues. While source code is not required in most cases, a growing body of case law indicates that insufficient detail about the algorithms underpinning the invention could render the patent claims indefinite, meaning that the scope of the claimed invention is too ambiguous. If the patent examiner deems the disclosure to be inadequate during examination, indefiniteness could prevent a patent from issuing. In the case of an already-issued patent, indefiniteness could render the claims unenforceable.

Patent Procurement and Strategy for Business Success Part III: Prosecution – Wielding an Invisible Hand

In the United States Patent and Trademark Office’s (USPTO’s ) patent academy (or today’s version of such), patent examiners are taught that the objective of the patent examiner is to “issue valid patents promptly.” In pursuing this institutional interest, each examiner conducts examinations that they independently manage. Although patent prosecutors cannot control an examiner’s decisions, they can establish a context that encourages a favorable outcome. If first and second application drafters each drafted applications to cover the same invention (that met all of the requirements of 35 USC 112) the presentation of the content in the respective applications could engender drastically different examination processes. This is because there is a relationship between the manner in which the content of a patent application is presented and the character of the examination process that follows.