Posts Tagged: "Guest Contributor"

Famously, section 337 investigations before the U.S. International Trade Commission (ITC) are fast. By statute, the ITC must conclude section 337 investigations “at the earliest practicable time . . .” 19 U.S.C. § 1337(b)(1). Investigations institute within 30 days after the Commission receives a complaint, evidentiary hearings (akin to trial) regularly occur within 8–9 months, and the ITC’s target dates for completing investigations routinely land at 14–16 months.

If a sanctions order is the stuff of a Patent Trial and Appeal Board (PTAB) practitioner’s bad dreams, then the issuance of sanctions outright cancelling a client’s patent(s) qualifies as their worst nightmare. That nightmare happened to Longhorn Vaccine (“Longhorn”) in April of this year, when the PTAB canceled five  of its patents as sanctions for Longhorn’s violation of the duty of candor relating to withholding test data that the PTAB deemed relevant to the patentability of the challenged claims. A month later, U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal sua sponte ordered Director Review of PTAB’s sanctions order. We now await her decision. This article examines the PTAB’s unprecedented sanctions order in the context of Director Vidal’s recent crackdown on inter partes review (IPR) abuses and provides guidance as to what practitioners can do now to avoid accusations of misconduct before the PTAB.

Breakthrough discoveries often receive the spotlight and intellectual property (IP) protection. Unfortunately, lesser, yet nonetheless valuable, contributions often go unrecognized and unprotected. Determining when to contact your institution’s Technology Transfer Office in order for them to assess research projects for IP protection is vital. Reaching out to Tech Transfer early and often will help researchers protect their accomplishments and receive the recognition they deserve.

The period following the filing of a section 337 complaint with the U.S. International Trade Commission (ITC) can be chaotic. During this period, the Commission “examine[s] the complaint for sufficiency and compliance with” its rules, 19 C.F.R. § 210.9(a), routinely asks the complainant to provide additional information, and typically decides whether to institute an investigation within 30 days after the complaint is filed, see 19 C.F.R. § 210.10(a)(1). The complainant must address the Commission’s requests for additional information while preparing for the coming investigation. The named respondents must scramble to find counsel, assess the allegations, and ready for battle. And all section 337 litigants confront a series of strategic decisions that can send them on the path to success or failure in the investigation.

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 Hatch-Waxman Act (“the Act”) was designed to strike a delicate balance between pharmaceutical innovation and faster access to affordable drugs. However, one aspect of the Act, the patent listing process, when used improperly, can knock this balance out of whack. Unfortunately, in the present environment, the potential for improper patent listing is high, and current remedies are insufficient.

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?

Regulatory Law in the Life Sciences and Agribusiness sector plays an essential role in balancing scientific innovation and the protection of public interests. In Brazil, a country recognized for its vast biodiversity and potential for scientific research, regulation in this field is crucial to ensuring responsible access to genetic resources and to address emerging issues, such as cannabis regulation. Before commercializing products in the Brazilian market, a company must be able to navigate a vast array of laws and regulations, especially in cases involving pharmaceuticals, seeds, pesticides, food or feed, cosmetics and medical devices. On top of that, when it comes to biotechnology related products involving genetically modified organisms (GMOs), or products derived from access to genetic resources or where traditional knowledge is associated, another layer of rules is applicable.

The regulatory framework for the inter partes review (IPR) process has long been the subject of criticism from both patent owners and petitioners. There is a growing consensus that the existing rules need to be revised to address loopholes and unintended consequences that have developed over the 10 years the America Invents Act (AIA) has been in effect. To that end, both the U.S. Patent and Trademark Office (USPTO) and Congress have proposed changes in the regulatory framework. While the two disparate approaches seek to change the IPR playing field, their purpose and approach are significantly different. This article discusses those similarities and differences.

For corporate intellectual property practitioners, the quest to excel can be daunting and all-consuming. Indeed, IP teams and their clients face a multitude of complex internal and external challenges amidst an ever-evolving business, legal, and technology landscape. Cognizant of the considerable trust and influence bestowed upon them by the C-suite, IP teams naturally desire to perform at the highest possible level. As chief IP counsel at a global company, I constantly put myself and my team under the proverbial microscope. I reflect upon our people, strategy, and operations; assess our individual and collective performance; and seek new ways to maximize the value we deliver to our company and internal clients. In some instances, such new ways entail minor course corrections. In other instances, they encompass the pursuit of novel pathways that upend the status quo.

Confusion and misunderstanding among some independent inventors might slow or stall progress of the excellent eligibility reform bill recently introduced by Senators Chris Coons (D-DE) and Thom Tillis (R-NC). Titled the Patent Eligibility Restoration Act (PERA), the legislation would overturn Supreme Court and Federal Circuit decisions that scrambled settled law, excluding many worthy classes of inventions, such as medical diagnostic methods and advanced computer applications.

Intellectual property (IP) theft has severe consequences for U.S. business, and many companies—particularly small businesses—can feel overwhelmed at the seemingly insurmountable task of stopping IP theft that occurs overseas. Introduced by Senators Tammy Baldwin (D-WI) and John Cornyn (R-TX) earlier this summer, the American IP Defense and Enforcement Advancement Act, or the “American IDEA Act,” promises to protect U.S. businesses against international IP theft. It is not to be confused with the Inventor Diversity for Economic Advancement (IDEA) Act, which aims to improve demographic data-gathering efforts at the U.S. Patent and Trademark Office (USPTO).

The contentious issues surrounding Right to Repair are getting super-heated as the U.S. Copyright Office concludes its triennial rulemaking review of exemptions to section 1201 of the Digital Millennium Copyright Act (DMCA). Exemptions granted would be in force for three years beginning October 2024.  When is an exemption not an exemption? When it’s an exemption from common sense.

Given current and ongoing economic realities, patent practitioners—both in-house and outside counsel—are constantly being asked to do more within existing budgets. Meanwhile, more robust patent applications thick with technical detail are necessary to satisfy courts and patent offices around the world. Working within budgetary constraints without sacrificing quality requires outside the box thinking and use of available tools to streamline as much of the process as possible. Enter Artificial Intelligence (AI), which is taking the world by storm, and recently garnered the attention of the American Bar Association, which has just announced the creation of a task force that will examine the impact of AI on law practice and the ethical implications of its use for lawyers.

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”).