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Commerce Secretary Howard Lutnick has made the decision to terminate all current appointments to the Patent Public Advisory Committee (PPAC) and the Trademark Public Advisory Committee (TPAC), effective immediately. Secretary Lutnick is expected to appoint new members to both committees and move forward with public meetings for these advisory bodies in May 2025, as originally planned.

Those following the appointments and hirings made by President Donald Trump during his second term may notice that Secretary Lutnick is likely to appoint new members to the PPAC and TPAC who are ideologically aligned with the President’s stance on intellectual property (IP) policy. This shift reflects a contrast with Trump’s first term, where some early nominees had their own political agendas that didn’t always align with the administration’s broader goals. However, during his second term, the focus has shifted to appointing individuals whose views are closely aligned with the President and who are willing to work collaboratively toward a shared vision for the future.

New Membership for Public Committees Advising USPTO Director

Both the PPAC and TPAC were established in 1999 as part of the American Inventors Protection Act, with governing provisions outlined in 35 U.S.C. § 5. Under this statute, each committee consists of nine members who “serve at the pleasure of the Secretary of Commerce.” If vacancies arise, the Secretary is required to fill them within 90 days, and new members will serve the remainder of the predecessor’s term, which could involve one- or two-year appointments to maintain staggered terms.

The primary role of both public advisory committees is to review the policies, goals, performance, budget, and user fees of the U.S. Patent and Trademark Office (USPTO). Specifically, PPAC reviews USPTO’s patent operations, while TPAC reviews its trademark operations. Both committees also provide advice to the USPTO Director and prepare annual reports on their respective areas of focus. These reports are submitted to the Secretary of Commerce, the President, and the Judiciary Committees of both houses of Congress.

Section 5 of the statute also outlines qualifications for prospective members, requiring them to have substantial backgrounds in areas such as finance, management, labor relations, science, technology, and office automation. Additionally, both committees must include members who represent entities applying for patent or trademark rights, including a mix of large and small entities. Notably, PPAC must include at least 25% of its members from small entity patent applicants, with at least one independent inventor included.

Changes at the USPTO Following Executive Turnover

Secretary Lutnick’s move to reshape the PPAC and TPAC comes amid a wave of executive staff turnover and reassignment at the USPTO during the early months of the second Trump Administration. Coke Stewart was appointed Deputy Director and is currently serving as Acting Director while awaiting the confirmation of Director nominee John Squires.

In February, it was reported that Vaishali Udupa, the USPTO’s former Commissioner of Patents, had resigned to take advantage of the deferred resignation program available to federal workers under the Trump Administration. Several other leadership changes followed, with Will Covey stepping in as Acting Deputy Director, Janet Gongola becoming Acting Director of Communications, and Farheena Rasheed assuming the role of Acting PTAB Vice Chief Judge. Valencia Martin Wallace has been named Acting Commissioner for Patents, and Dan Vavonese is now serving as Acting Commissioner for Trademarks. Chris Shipp has returned as Chief of Staff, and Frederick Steckler, the former Chief Administrative Officer, has stepped down from his duties, although the circumstances surrounding his departure remain unclear.

The Association of American Publishers (AAP) recently submitted a response to the White House Office of Science and Technology Policy’s call for public comment on the Artificial Intelligence Action Plan. The AAP’s submission underscores the importance of robust copyright protections for ensuring the United States remains a global leader in both technology and intellectual property (IP), especially in the rapidly evolving AI sector. Here are the key points from their submission:

Key Points from AAP’s Submission:
Strong Copyright Protections: The AAP advocates for strengthening copyright protections to maintain leadership in AI markets. They call on the Administration to reject broader fair use arguments that might undermine creators’ rights.

Partnerships and Licensing: The AAP emphasizes the need for collaborations between American companies and AI developers, promoting licensing arrangements as a way to protect IP while fostering innovation.

Piracy Concerns: A major issue raised is the illegal use of pirate sites to train AI systems. The AAP condemns these practices, arguing that they are harmful to American IP investments and undermine legal and ethical AI development.

International Implications: The AAP warns that weakening copyright protections globally could harm the U.S. IP industry, which generates significant economic value. They also stress that licensing models are essential for both American creators and AI developers, as they incentivize data collection and help smaller companies compete.

Concerns Over Fair Use: The AAP specifically rejects Big Tech’s push for sweeping exceptions to copyright laws, particularly in the form of an expanded fair use defense, which they argue could dismantle long-standing copyright protections and hinder future IP investments.

Economic Impact: The AAP highlights the significant economic contribution of the publishing industry, noting that American publishers contribute nearly $30 billion annually to the economy and are part of a larger industry that adds over $2 trillion to U.S. GDP.

Political Landscape: AAP President Maria Pallante also expressed cautious optimism about the current political landscape, noting that the Trump administration and Congress have historically supported IP protections. However, she acknowledged the influence of the tech sector in Washington, D.C., which adds complexity to these discussions.

AI and Copyright Panel: Pallante also spoke at the London Book Fair in a panel titled “AI and Copyright: Policy Developments in the UK and US,” where she discussed the challenges and opportunities of managing AI development in a way that benefits both creative industries and technology developers.

Broader Implications:
The AAP’s submission comes at a critical time for the publishing industry, which is facing increasing concerns about the unauthorized use of copyrighted materials for AI training purposes. The AAP is actively working to secure legal protections for creators while navigating the growing role of AI in the industry. With multiple lawsuits already in progress over the unauthorized use of copyrighted materials, the AAP aims to establish clear legal precedents that will protect publishers and authors from further exploitation of their work.

Contrast with OpenAI’s Position:
While the AAP is advocating for stronger protections and clear limits on fair use, OpenAI has urged the Trump administration to relax regulations on fair use and eliminate some guardrails, which they believe could hinder AI development. This contrast highlights the ongoing tension between IP rights holders and the tech industry, which often relies on vast amounts of data, including copyrighted materials, to train AI models.

In conclusion, the AAP’s submission is a strong call for copyright integrity and fair business practices in the face of rapid AI advancements. Their efforts reflect the delicate balance between fostering innovation and ensuring that creators and IP owners are properly compensated and protected.

Three years after the University of Pennsylvania accused Roche of infringing its intellectual property related to breast cancer medications, the dispute has been resolved just weeks before a scheduled jury trial.

The lawsuit, filed by Penn in 2022 in the U.S. District Court for Delaware, claimed that Roche and its Genentech unit had infringed on an expired patent for methods of tumor treatment developed at the university’s Abramson Cancer Center.

As part of the settlement, the case has been dismissed with prejudice, meaning neither party can refile their claims. This decision was confirmed in a ruling filed Friday. The case had been set to go before a jury on March 31, according to Bloomberg Law.

The resolution came shortly after Federal Judge Jennifer Hall issued an order to pause the case, pending the fulfillment of certain obligations outlined in the settlement agreement. The parties were required to file a stipulation of dismissal or provide an update by March 24.

Genentech confirmed to Fierce Pharma on Friday that the dispute had been “amicably resolved,” but declined to comment further on the specifics of the settlement.

Penn’s lawsuit involved its ‘558 patent, granted in 2009, which covers a treatment method for ErbB protein-mediated tumors. The university alleged that Roche’s four breast cancer drugs—Herceptin, Herceptin Hylecta, Perjeta, and Phesgo—infringed on this patent by using the same method to treat tumors.

The university’s legal team argued that Roche was “willfully blind” to its patent rights and that the company must have been aware of the patent due to attempts to block similar patents in Europe. Penn was originally seeking damages and ongoing licensing fees from Roche for the alleged infringement.

The rise of generative artificial intelligence (AI) has had a profound impact across industries, from technology to creative fields. AI systems capable of generating computer code, writing news articles, and producing professional-grade graphics have spurred widespread debates about whether they will replace jobs in sectors like technology, journalism, and design, among others.

Alongside these discussions about job displacement, another important question arises: In the age of AI, what does it mean to be an inventor?

For technologists building digital tools or developing software, incorporating AI into the design and development process has become increasingly common. However, as deep learning models continue to evolve and show their capabilities, even highly skilled researchers using AI in their work have started to worry about their own obsolescence.

While debates continue on whether AI can enhance human creativity, emerging data suggests that AI could indeed play a significant role in boosting research and development, especially where creativity is vital. A recent study by Aidan Toner-Rodgers, an economics doctoral student at MIT, found that scientists who utilized AI tools increased their patent filings by 39% and produced 17% more prototypes compared to when they worked without such tools.

Despite these positive findings, the study also revealed a downside: 82% of researchers reported feeling less satisfied with their jobs after integrating AI into their workflows. One researcher expressed disillusionment, saying, “I couldn’t help feeling that much of my education is now worthless.”

This shift in the research environment leads to another critical question: If a scientist uses AI to create something new, does that still count as an invention? From a legal standpoint, this question raises important implications for technology and intellectual property law.

In 2020, the United States Patent and Trademark Office (USPTO) denied the AI system DABUS the status of inventor on patent applications, despite DABUS allegedly designing a food container and a flashing emergency beacon. Subsequent court rulings clarified that under U.S. law, only living person i.e. humans, can be listed as inventors. However, these rulings left open the question of whether inventions developed with the assistance of AI can still qualify for patent protection.

The concept of inventorship and the legal protections granted to inventions are deeply rooted in U.S. law. The U.S. Constitution grants authors and inventors “exclusive rights” to their “respective writings and discoveries,” reflecting the founders’ strong belief that the government should safeguard and promote original ideas.

In a landmark decision, the Court of Justice of the European Union (CJEU) has clarified jurisdictional issues surrounding cross-border patent infringement disputes, opening the door for broader European legal recourse in national courts. The case, BSH Hausgeräte vs Electrolux (C-339/22), addresses critical questions related to the Brussels I bis Regulation, which governs jurisdiction in civil and commercial matters across EU Member States. This ruling is expected to have significant implications for patent litigation across Europe, particularly concerning the jurisdiction of national courts in cases involving patents granted in different EU states.

Key Points of the CJEU Ruling
The CJEU’s ruling provides several important clarifications:

Jurisdiction for Infringement Actions: A court in an EU Member State where the defendant is domiciled has jurisdiction to hear an infringement action related to a patent granted in another EU Member State, regardless of whether the defendant raises an invalidity defense.

Jurisdiction for Invalidity Defenses in Non-EU Patents: Courts in the EU Member State where the defendant is domiciled may also assess the validity of patents granted outside the EU (such as in non-EU countries) in cases involving patent infringement claims that include those patents.

Cross-Border Injunctions: The decision confirms the availability of cross-border injunctions in cases before both national courts and the new Unified Patent Court (UPC), providing broader options for patent holders seeking to enforce their rights across Europe.

Legal Background: The Brussels I bis Regulation
The CJEU’s decision centers on the interpretation of Articles 4(1) and 24(4) of the Brussels I bis Regulation, which governs jurisdiction in civil and commercial matters within the EU.

Article 4(1) establishes general jurisdiction for cases involving defendants domiciled in an EU Member State. In the context of patent infringement, this means that the court in the EU Member State where the defendant is domiciled can hear infringement actions, even if the patent in question was granted in another Member State.

Article 24(4) provides an exception to the general jurisdiction principle, specifying that disputes regarding the registration or validity of patents must be heard by the court of the Member State where the patent was granted. This exclusive jurisdiction applies regardless of whether the validity issue is raised by way of an action or a defense.

In GAT v LuK (C-4/03), the CJEU had previously ruled that when a court in the defendant’s domicile state hears an infringement case and the defendant raises an invalidity defense, that court does not have jurisdiction to rule on the validity of the patent. Instead, the court must refer the validity issue to the jurisdiction of the Member State where the patent was granted. This ruling set the precedent that national courts could not simultaneously handle both infringement and validity claims.

The CJEU’s Latest Decision: Jurisdiction for Infringement and Invalidity
The CJEU’s recent ruling provides clarity on the scope of Article 24(4) in the context of cross-border patent disputes. The court determined that the exclusive jurisdiction under Article 24(4) applies only to the validity of patents. This means that a court in the Member State of the defendant’s domicile can still hear an infringement case, even if the defendant challenges the patent’s validity.

This interpretation narrows the scope of Article 24(4) and helps avoid situations where a defendant’s defense could undermine the court’s jurisdiction over infringement claims. The CJEU’s reasoning is based on the goal of legal certainty, emphasizing that allowing the defendant’s choice of defense (i.e., invalidity) to determine jurisdiction over the entire dispute would lead to uncertainties in jurisdiction and impede the efficient resolution of cases.

Moreover, the CJEU ruled that infringement proceedings can continue in the court of the defendant’s domicile pending the outcome of any validity challenges in another Member State. This allows courts to stay proceedings while awaiting decisions from other jurisdictions where the validity of the patent is being contested.

Implications for Cross-Border Patent Litigation
This ruling has significant practical implications for patent litigation in Europe:

Cross-Border Injunctions and Litigation: The decision affirms that patent holders can seek cross-border injunctions not only through the UPC but also in national courts. This will make it easier for patent holders to enforce their rights across multiple jurisdictions, increasing the effectiveness of enforcement strategies.

Potential for Anti-Suit Injunctions: The ruling may increase the likelihood of parties seeking anti-suit injunctions in non-EU jurisdictions (such as the UK or the US), particularly in cases where the same patent is subject to litigation in both the EU and outside the EU. This is especially relevant in cases where a court in one jurisdiction has already heard a dispute regarding a patent granted in a non-EU state, and a party seeks to prevent further litigation in another jurisdiction.

UPC Alignment: The CJEU’s decision aligns with the UPC’s decision in Fujifilm v Kodak (UPC_CFI_355/2023), where the court ruled it had jurisdiction over infringement cases concerning UK parts of European patents. This reinforces the consistency of the UPC’s jurisdictional principles and its authority over cross-border patent disputes in Europe.

Jurisdiction Over Third-Party Patents: The decision also addresses jurisdictional issues involving patents granted in non-EU states. The CJEU ruled that while Article 24(4) does not apply to third-party patents (e.g., patents granted in the UK or the US), an EU court may still have jurisdiction to rule on the validity of such patents in certain circumstances. However, such decisions would only have inter partes effect, meaning they would not affect the validity of the patent in the non-EU jurisdiction.

Conclusion
The CJEU’s ruling in BSH Hausgeräte v Electrolux (C-339/22) represents a crucial development in European patent law, expanding the jurisdictional reach of EU courts in cross-border patent infringement disputes. It provides clarity on the interplay between national and UPC courts, allowing for more streamlined enforcement of patent rights across multiple jurisdictions. With this decision, patent holders now have enhanced options for securing cross-border injunctions and pursuing infringement actions in EU courts, while also navigating the complexities of invalidity defenses. The ruling paves the way for a more flexible and efficient patent litigation landscape in Europe.

At the end of 2023 and the beginning of 2024, Apple faced a significant setback as a patent dispute with Masimo temporarily blocked the sale of its Apple Watch Series 9 and flagship Apple Watch Ultra 2 in U.S. stores. The dispute centered around the use of Masimo’s blood oxygen sensor technology in the wearables, which led to a ruling that forced Apple to temporarily remove certain functionality from its watches to comply with the court’s decision. However, Apple managed to get its products back on the market after modifying the functionality in question.

As if this legal battle wasn’t enough, Apple faced another looming challenge: a multi-year patent infringement case with AliveCor, a company that accused Apple of violating patents related to heart-rate monitoring technology in its Apple Watch models. This new legal fight had the potential to disrupt Apple’s popular wearable line, especially since the Apple Watch is a key player in the smartwatch and health-monitoring markets.

However, this week, Apple received good news. The U.S. Court of Appeals for the Federal Circuit upheld the previous ruling of the Patent Trial and Appeal Board (PTAB), which had concluded that all three of AliveCor’s patents were unpatentable. The court’s decision to back PTAB’s ruling marks a major victory for Apple, as it effectively puts an end to the legal battle over heart-rate monitoring technology and clears the way for the company to continue selling its wearables without further risk of patent disputes on this front.

The AliveCor Patent Dispute: A Multi-Year Legal Battle

The legal dispute between Apple and AliveCor began several years ago when AliveCor, a startup known for its heart-rate monitoring devices, accused Apple of infringing on its patents related to ECG (electrocardiogram) functionality and heart-rate monitoring on the Apple Watch. AliveCor alleged that Apple used its patented technology to enable heart-rate and ECG monitoring in the Apple Watch Series 4 and later models without permission.

In 2021, AliveCor filed a complaint with the U.S. International Trade Commission (ITC), seeking an import ban on the affected Apple Watch models. However, Apple pushed back, claiming that the patents were either invalid or already expired. As the case progressed, AliveCor also filed lawsuits in various jurisdictions, asserting that Apple’s wearable devices were infringing its intellectual property.

AliveCor’s claims hinged on its patents, which it argued covered the ability to use sensors in a wearable device to monitor heart rate and perform ECG tests. This functionality had become a major selling point for Apple Watches, especially as the company marketed its devices as essential tools for tracking health data.

Court’s Ruling: Patent Invalidity

In a significant turn of events, the Patent Trial and Appeal Board (PTAB) sided with Apple, ruling that AliveCor’s patents were unpatentable. The PTAB determined that the technology described in AliveCor’s patents was either obvious in light of prior innovations or too broad to be enforceable. This ruling effectively nullified AliveCor’s claims, and the decision was subsequently upheld by the U.S. Court of Appeals for the Federal Circuit this week.

When courts conclude that patents are unpatentable, it typically means the patents either lack novelty, are too general, or are not sufficiently distinct from prior art. In the case of AliveCor’s patents, the ruling indicated that the technology they covered was not new or sufficiently groundbreaking to warrant exclusive protection, thereby freeing Apple from any further legal threat on this front.

Implications for Apple and the Wearables Market

With the legal challenge from AliveCor resolved in Apple’s favor, the company can now breathe easier knowing that its heart-rate monitoring functionality is no longer under threat. This is especially crucial for Apple, given the growing importance of health features in its wearables, which have become a major part of its strategy to dominate the smartwatch market.

Apple has been aggressively expanding the health capabilities of its devices, with features like ECG, heart rate monitoring, blood oxygen tracking, and even fall detection. These features are key selling points for the Apple Watch, and resolving this patent dispute clears the way for continued innovation in these areas.

This victory comes at a time when Apple is facing increasing competition in the wearables market, with companies like Samsung, Garmin, and Fitbit offering competing devices. Ensuring that its core health-monitoring features remain unchallenged by patent litigation gives Apple a significant advantage in maintaining its leadership in the sector.

Looking Ahead

While the AliveCor dispute has now been settled, Apple is no stranger to patent challenges. The company has faced, and likely will continue to face, legal battles over its intellectual property as its product lineup expands and new technologies emerge. In fact, the Masimo dispute over blood oxygen monitoring functionality highlighted the ongoing risks Apple faces as it integrates advanced health features into its wearables.

However, the resolution of the AliveCor case signals that Apple remains committed to defending its technologies against patent challenges, whether through legal means or by negotiating licensing agreements with other companies. With the court ruling now firmly in its favor, Apple can move forward with its wearables strategy, undeterred by the threat of legal action from AliveCor or other competitors in the space.

For now, it seems Apple’s wearables are no longer at risk of being pulled from the market, and consumers can continue to rely on the Apple Watch as a leading device for health and fitness tracking, free from the threat of patent litigation — at least for the time being.

Merck’s plans to expand the reach of its blockbuster cancer drug Keytruda with a new subcutaneous (injectable) formulation are encountering a significant obstacle. Halozyme Therapeutics has accused Merck of infringing on its patents related to the hyaluronidase enzyme, which is critical for drug delivery. This dispute could jeopardize Merck’s strategy to maintain Keytruda’s market dominance as the patents for its intravenous (IV) version approach expiration.

Legal Battle Over Hyaluronidase Enzyme Patents

Halozyme claims that Merck’s new injectable version of Keytruda infringes its patented technology for hyaluronidase enzymes, which are used to facilitate the delivery of drugs through subcutaneous injections. This challenge threatens Merck’s efforts to transition Keytruda into an injectable format, potentially extending its market life after the expiration of its IV patents. In response, Merck has vehemently disputed the validity of Halozyme’s patents, signaling an impending and high-stakes legal showdown that could significantly impact the future of its cancer treatment.

Merck stated, “We strongly believe that any Halozyme patents attempting to cover this variant are invalid,” and confirmed it has already filed petitions with the U.S. Patent Office to challenge the patents’ legitimacy. Meanwhile, Merck continues clinical trials for the injectable version of Keytruda and anticipates its launch by early 2026.

The injectable form of Keytruda has shown promising results in clinical trials, with researchers finding it to be as effective as the traditional IV version, which generated $29.5 billion in sales in 2024. To bring the injectable version to market, Merck has partnered with South Korea-based biopharmaceutical company Alteogen, which has developed a variant of the hyaluronidase enzyme that enables large-volume subcutaneous administration.

Halozyme’s Role and Broader Industry Implications

Halozyme, which competes with Alteogen, also develops hyaluronidase enzyme-based drug delivery systems for injectable treatments. The company’s technology is already used in products from major pharmaceutical players like Roche, Johnson & Johnson, and Pfizer. While Halozyme prefers to establish licensing agreements for its intellectual property, it has not publicly commented on the potential for litigation with Merck.

The ongoing legal battle could have broader implications for the pharmaceutical industry’s use of hyaluronidase enzymes in drug delivery. If Merck is forced to halt its use of Halozyme’s technology, it could reshape the landscape of injectable treatments for a variety of drugs, not just Keytruda.

FDA Review for Keytruda’s New Indication

In addition to the ongoing patent dispute, Merck announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for Keytruda, seeking approval for its use as a neoadjuvant treatment for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The application is supported by Phase 3 KEYNOTE-689 trial data, which showed significant improvements in event-free survival (EFS) and major pathological response (mPR) compared to standard adjuvant therapy alone.

The FDA has set a target action date of June 23, 2025, for this application, under the Prescription Drug User Fee Act (PDUFA). The review also falls under the FDA’s Project Orbis, which facilitates simultaneous reviews of oncology drugs across multiple countries, including Israel, Canada, Australia, and others.

Merck’s Expanding Keytruda Portfolio

Merck is also seeking to expand the use of Keytruda under Project Orbis, with a focus on reducing recurrence and disease progression in earlier stages of LA-HNSCC. Dr. Marjorie Green, Merck’s head of oncology clinical development, emphasized the need for new treatment options for LA-HNSCC, given that current standards have not changed for over 20 years. “We look forward to working with the FDA to potentially bring Keytruda to these patients as soon as possible,” said Green.

Keytruda is already approved for use in metastatic and unresectable recurrent HNSCC in combination with other therapies, and Merck hopes the new indication will provide additional treatment options for patients with earlier-stage disease.

The Competitive Landscape

This legal dispute underscores the competitive environment surrounding hyaluronidase enzyme-based drug delivery technologies. While Merck has teamed up with Alteogen for its injectable Keytruda, Halozyme’s technology is used by other major pharmaceutical companies, and the outcome of the dispute could have far-reaching effects on the future of injectable drug delivery systems.

As Merck fights to extend the market life of Keytruda, the legal and regulatory developments will play a crucial role in determining the drug’s trajectory in the years to come.