Posts Tagged: "Guest Contributor"

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”).

Noncompete agreements have always been controversial to some extent. Employers like them because they avoid messy litigation over whether the employee has breached confidentiality; a noncompete eliminates the risk as a practical matter. But it is a blunt instrument, preventing fair as well as unfair competition…. In contrast, employee confidentiality agreements have almost universally been embraced by courts, even though they usually operate in perpetuity to restrain use or disclosure of information. This is mainly because even without a contract, the common law recognized a duty of confidentiality by all employees to respect the trust implied by having access to secrets.

Autonomous vehicles were designed with the purpose of minimizing accidents on urban roads and providing more safety and comfort, assisting or performing independently some tasks that are the driver’s responsibility. The Society of Automotive Engineers (SAE) has developed a classification of autonomous vehicles, creating six categories for autonomous driving. Level zero refers to conventional cars without any technology of this type, while at the other extreme, at level five, the driver becomes a passenger, needing only to activate the vehicle and indicate the destination. In such case, it is up to the vehicle control system to carry out in a fully autonomous way the driving of the vehicle throughout the route and to carry out any emergency decision-making. The intermediate levels of autonomous driving include systems already found on the market, such as parking assistance, emergency braking and lane change assistance, among others.

On June 12 and 13, 2023, the German giant textile company, Oerlikon Textile G.M.B.H. & CO. K.G. (Oerlikon), filed two applications with the Unified Patent Court’s (UPC’s) Milan Local Division to preserve evidence against two Indian companies accused of infringing the (Italian portion) of the European patent EP214848B1, which covers a “False twist texturing machine”. The defendants, Himson Engineering Private Limited (“Himson”), and Bhagat Group, were exhibiting two machines at a trade fair, bearing the trade names Machine 2 and Machine 2-TS, along with a machine bearing the trade name, Bhagat Textile Engineers.

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.

In addition to unrecoverable issues like divided infringement, it’s no secret that patents have come under increased scrutiny over the last decade. The Patent Trial and Appeal Board (PTAB) continues to invalidate patent claims at an alarming rate, defendants have ever-increasing invalidity and non-infringement arguments to make in district court, and the Supreme Court’s Alice decision on patent eligibility continues to baffle the entire patent community…. While the patent community debates the need for reform, an easy and attainable solution, and one that is within your control, is simply to strengthen the patents before they issue.