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USPTO Proposes Rule and Director Implements Policy Likely to Limit Multiple Patent Validity Challenges Ted M. Cannon On Friday, October 17, the USPTO published a proposed rule that, if implemented, would likely...

On October 31, 2025, Director Squires spoke to the American Intellectual Property Law Association and provided a forceful statement on his view for the direction of patent law. Of particular...

The United States Patent and Trademark Office recently announced two new pilot programs available at the early stages of patent prosecution in original applications. The Automated Search Pilot Program allows...

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical device manufacturer....

Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete...

In the article “Capitalizing on Medical Device IP Opportunities in a Changing Environment,” published in Intellectual Asset Management’s latest special report on life sciences IP, partners Philip Nelson, Sabing Lee,...

In the article “Legislative Developments in Patents: Prospects for the PREVAIL and RESTORE Acts and PERA in 2025,” published by IP Watchdog, partner Philip Nelson discusses three significant bills that...

In the Law360 article “How 2 Proposed Bills Could Transform Patent Law,” partner Philip Nelson writes about the potential impact of two pieces of legislation that could affect patent law:...

Today Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) introduced the Patent Eligibility Restoration Act (PERA), bipartisan legislation mirroring a proposed law introduced last year by Senators Thom Tillis (R-NC) and Chris Coons (D-DE). The proposed law seeks to restore patent eligibility to inventions across many fields and affirms the basic principle that the patent system is central to promoting technology-based innovation.

In recent years, Congress has considered potential new laws for patent reform, typically changes to the system supported by patent owners. Two main areas of focus are “Section 101” and the “PTAB.” Below is a summary of two such efforts currently being considered by Congress.

On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks to address limitations in one of orthopedic care’s fundamental treatment methods: the cast. A soggy cast can lead to infections, reduced support, skin infections, and more. But as discussed in Cast21’s white paper, Cast321’s FDA-approved product touts a waterproof and breathable design, allowing patients to shower, swim, or wash their limbs.

Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent protection so that they can profit from their inventions underlying those same products. In both cases, the companies seek to persuade federal government agencies to approve their requests.

Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the end of 2022, addressing concerns over the cybersecurity of medical devices. Risks from cybersecurity incidents involving medical devices may include “Health Insurance Portability and Accountability Act (HIPAA) violations, improper patient health assessments, miscalculated medication dosages, and other potentially fatal outcomes,” according to Lifesciences Intelligence.

Introduction The Mayo/Alice subject-matter eligibility test has been a controversial topic since its creation. Many have argued that it leaves innovators, particularly in the software field, with uncertainty as to whether their advances are patentable. In American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, the Federal Circuit extended this uncertainty into the mechanical field.

The European Commission ("EC") has long sought to improve data privacy for Europeans, even when they interact with global or non-European companies. Laws like the General Data Protection Regulation (or “GDPR”) seek to control how even U.S. companies, for example, use data from European citizens. To comply with the GDPR, U.S. companies doing business in Europe are required to use standard contract clauses, or “SCCs” in their agreements governing use of EU citizens’ data.

While the "right to be forgotten" is part of European law, it is at odds with U.S. precedent. See, e.g., Garcia v. Google, Inc., 786 F.3d 733, 745-46 (9th Cir. 2015). A Georgia law allowing the father of a deceased rape victim to sue a television station for publicizing the victim’s name unconstitutionally violated the First Amendment. Cox Broadcasting Corp. v. Cohn, 420 U.S. 469 (1975). And in 2004, the California Supreme Court cleared corporations of any wrongdoing when publishing any information from official public records. Gates v. Discovery Communications, Inc., 34 Cal. 4th 679, 685 (2004). In the United States, the First Amendment wins.

On April 27, 2021, a class action lawsuit was filed against Google, Inc. ("Google") alleging that the Google-Apple Exposure Notification System, ("Gaen") - the company’s COVID-19 contact tracking app – contained a flaw that may allow third parties to access user medical information. Google had promised users of GAEN that their medical information would be held in the utmost privacy. The company explained that “the list of people you’ve been in contact with doesn’t leave your phone unless you choose to share it,” implying the data was safe from unauthorized third-party access. Further, Google promised that data collected was all anonymized such that even if third parties could access the data, the information could not be linked to a particular individual.

On February 26, 2021, Judge James Donato of the U.S. District Court for the Northern District of California granted final approval of a proposed $650 million settlement in a biometric privacy class action lawsuit brought against Facebook. In re Facebook Biometric Information Privacy Litigation, Case No. 3:15-cv-03747-JD, Dkt. No. 537 (N.D. Cal. Feb. 26, 2021). The long-running litigation began in 2015, when class members alleged that Facebook collected and stored digital scans of their faces without prior notice or consent in violation of Sections 15(a) and 15(b) of the Illinois Biometric Information Privacy Act (“BIPA” or “the Act”), 740 Ill. Comp. Stat. 14/1 et seq. (2008).

Virginia just became the second state to pass a comprehensive privacy law, the Consumer Data Protection Act ("CDPA"). Business and privacy professionals should evaluate the ramifications: what does it require, who does it apply to, and what are the penalties?

Partner Philip Nelson was quoted in “How counsel balance USPTO and court edicts on Section 101,” an article published by Managing IP. Excerpt: “Philip Nelson, partner at Knobbe Martens in California, says...

It's generally recognized that the General Data Protection Regulation (GDPR) can apply to entities outside the European Union. However, scant court rulings guide non-European controllers and processors on this question. The English High Court’s recent decision in Soriano v. Forensic News LLC and others (2021) helps fill the gap.