You searched for Patent | 天美传媒; Lardner LLP / Legal services in Boston, Massachusetts Tue, 26 Aug 2025 14:48:23 +0000 en-US hourly 1 /wp-content/uploads/2024/11/cropped-Foley-Favicon-1-32x32.png You searched for Patent | 天美传媒; Lardner LLP / 32 32 Securing Value: Patent Strategies for AI-Accelerated Drug Repurposing /p/102l0hd/securing-value-patent-strategies-for-ai-accelerated-drug-repurposing/ Thu, 21 Aug 2025 15:35:45 +0000 Drug development can be slow, costly, and risky, often taking more than a decade and billions of dollars to bring a single therapy to the...

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Drug development can be slow, costly, and risky, often taking more than a decade and billions of dollars to bring a single therapy to the market. Drug repurposing offers a faster, lower-risk path to new therapies by leveraging the established safety and efficacy profiles of existing drugs. Nevertheless, many repurposing programs fail due to low clinical efficacy or unexpected toxicities, and the process often remains labor-intensive and time-consuming. A recent review by explains different approaches for using artificial intelligence (AI) to accelerate drug repurposing and overcome some of the main challenges of this process. While this scientific progress is crucial, repurposed drug candidates must also overcome significant regulatory and patent challenges for successful commercialization.

Wan et al. emphasize that AI can leverage large-scale biological and clinical datasets to identify new therapeutic uses for existing drugs. By integrating various data types, like transcriptomic and proteomic profiles, drug-target interaction databases, and real-world evidence from electronic health records, AI models can evaluate drug candidates across a wide range of metrics. Drug repurposing pipelines based on such AI models can reveal hidden on- or off-target effects and predict novel drug鈥揹isease associations to dramatically accelerate the search for viable candidates. Key obstacles to the commercial success of AI-enabled repurposing of drugs include data reliability, clinical validation, and regulatory hurdles. However, recent developments suggest that AI is rapidly transforming drug repurposing from being dependent on serendipity into a systematic and data-driven discipline.

Repurposed drugs also face significant patent protection obstacles because their core molecules are already public. As I explored in a previous article on patent strategies for repurposed drugs, successful protection requires a multi-layered approach, including:

  • Methods-of-use patents (covering new indications, dosing regimens and routes, and/or patient subpopulations)
  • Formulation patents (extended-release, injectable depot, or novel delivery mechanisms)
  • Combination patents (synergistic pairing with another therapeutic agent)

Strategic patent protection can transform repurposed drugs and associated innovations into valuable assets. Aligning AI innovation with a thoughtful IP strategy will not only safeguard value but also ensure that scientific breakthroughs in drug repurposing translate into market success.

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USPTO Addresses Reports of New Patent Fee Structure /p/102kzay/uspto-addresses-reports-of-new-patent-fee-structure/ Thu, 07 Aug 2025 13:52:24 +0000 In a recent webinar hosted by the Licensing Executives Society, U.S. Patent and Trademark Office acting Director Coke Morgan Stewart...

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In a recent webinar hosted by the Licensing Executives Society, U.S. Patent and Trademark Office acting Director Coke Morgan Stewart addressed speculation that the Trump administration may introduce a value-based fee on patents. The proposal, reportedly under consideration by Commerce Secretary Howard Lutnick, could involve charging patent holders 1% to 5% of their patent鈥檚 value, potentially generating tens of billions in revenue.

While Stewart did not confirm the plan, she acknowledged Lutnick鈥檚 public concerns about the disparity between the low cost of obtaining a patent鈥攖ypically around $2,000鈥攁nd the potentially immense value it can represent for companies. Lutnick believes this disconnect warrants reevaluation of the current fee structure.

Despite the speculation, Stewart urged stakeholders not to focus too heavily on recent reports about specific fee models. She emphasized Lutnick鈥檚 interest in engaging with the intellectual property community to explore ways to modernize and strengthen the U.S. patent system. His goal, according to Stewart, is to ensure a reliable and forward-looking IP framework that reflects the true value of innovation.

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Paul Hunter Authors Assessment of Potential Value-Driven Patent Fee Structure /news/2025/08/hunter-authors-assessment-of-potential-value-driven-patent-fee-structure/ Tue, 12 Aug 2025 18:13:46 +0000 The post Paul Hunter Authors Assessment of Potential Value-Driven Patent Fee Structure appeared first on 天美传媒; Lardner LLP.

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US Considers Charging Fees Based on Patent Value /p/102kyke/us-considers-charging-fees-based-on-patent-value/ Wed, 30 Jul 2025 15:31:04 +0000 The Trump administration is reportedly considering a proposal to charge patent holders a fee based on the value of their patents,...

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The Trump administration is reportedly considering a proposal to charge patent holders a fee based on the value of their patents, potentially ranging from 1% to 5%. Experts have raised serious concerns, arguing that determining patent value is highly complex and subjective, and such a fee could discourage innovation, especially among small companies. 

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The Patent Eligibility Restoration Act and Life Sciences Innovation /p/102ksqq/the-patent-eligibility-restoration-act-and-life-sciences-innovation/ Mon, 14 Jul 2025 13:59:39 +0000 The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by...

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based products. Innovations like gene therapies, therapeutic proteins, and precision diagnostics enhance disease detection and treatment, drive personalized medicine, and bolster global food security through advanced crop protection and yield optimization.[1]

The life sciences sector has witnessed significant advancements, despite facing tighter research funding. In 2024, for instance, the U.S. Food and Drug Administration (FDA) approved 32 new chemical entities and 18 new biological entities. These first-in-class therapies addressed various areas such as oncology, rare genetic disorders, metabolic diseases, and autoimmune conditions, highlighting the industry’s resilience and inventive capacity.[2] With respect to diagnostics, FDA approved several new in vitro diagnostic (IVD) tests and imaging agents such as: expanded oncology panels for liquid biopsies and tumor profiling, next generation sequencing, novel contrast agents, and point of care tests for rapid pathogen detection.[3] These diagnostics strengthen early detection, enable real-time treatment decisions, and support outbreak preparedness.

However, there is concern that the reduction in federally-supported biomedical research will impact America鈥檚 health care infrastructure and innovation, which in turn could impact the pace of biomedical treatments for long-felt needs like cancer and autoimmune disorders.[4] With diminished federal grants, support from venture capital and private investment can help fill that gap. A strong patent system can help encourage and protect these investments. 

The Patent Eligibility Restoration Act of 2025[5] or 鈥淧ERA鈥 can further strengthen our patent system and provide needed additional support for life science and biotech investments.

Retired federal appeals judges Paul Michel and Kathleen O鈥橫alley recently argued that Congress should pass PERA to reverse the harm done to U.S. innovation by misguided U.S. Supreme Court rulings. PERA seeks to overturn U.S. Supreme Court rulings (Mayo v. Prometheus, Alice v. CLS Bank) that have significantly narrowed patent eligibility in diagnostics, biotech, and software. Post-Mayo, investment in diagnostics plunged by an estimated US$9 billion over four years, with many startups exiting the field.[6] Innovation would be supported by explicitly restoring patentability for certain diagnostic methods and biotech inventions previously deemed ineligible. However, isolated human genes and mere computer implementation of processes remain ineligible for patenting.[7]

The urgency of passing PERA is underscored by the current global landscape, where China is leading the U.S. in 57 out of 64 critical technology sectors.[8] By restoring patent eligibility for categories of inventions that courts have wrongly declared ineligible鈥攁nd establishing clear guidelines to prevent future uncertainty 鈥 PERA could give U.S. inventors and companies confidence to invest in technologies that will define our future. 

Indeed, when my colleague Courtenay Brinckerhoff testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee considering an earlier version of PERA, about potential erosion of the U.S. position in the global marketplace, including due to competition with China and uncertainty surrounding patent eligibility of important technologies in diagnostic, biotechnology, and quantum computing fields. 

[1] See https://www.techtarget.com/pharmalifesciences/feature/The-Impact-of-Biotechnology-Breakthroughs-in-Healthcare.

[2] See https://pubmed.ncbi.nlm.nih.gov/39788065/.

[3] See https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

[4] See https://www.latimes.com/science/story/2025-07-06/nih-budget-cuts-threaten-the-future-of-medical-research-and-young-scientists; https://yaledailynews.com/blog/2025/02/12/analysis-nih-funding-cuts-threaten-biotech-innovation-and-economy/; https://www.pharmasalmanac.com/articles/nih-funding-cuts-put-innovation-health-equity-and-lives-at-risk.

[5] See https://www.congress.gov/bill/119th-congress/senate-bill/1546.

[6] See https://www.pharmasalmanac.com/articles/nih-funding-cuts-put-innovation-health-equity-and-lives-at-risk.

[7] Id.

[8] Id.

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Patent Fees Reimagined: Evaluating the Trump Administration’s Value-Driven Fee Structure and Its Impact on Innovators /insights/publications/2025/07/patent-fees-value-driven-fee-structure-impact-innovators/ Thu, 31 Jul 2025 17:53:10 +0000 The post Patent Fees Reimagined: Evaluating the Trump Administration’s Value-Driven Fee Structure and Its Impact on Innovators appeared first on 天美传媒; Lardner LLP.

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IAM Recognizes Foley Attorneys and Jurisdictions in 2025 Edition of IAM Patent 1000: The World鈥檚 Leading Patent Practitioners /news/2025/06/iam-recognizes-foley-attorneys-jurisdictions-2025-edition/ Thu, 05 Jun 2025 18:15:18 +0000 The post IAM Recognizes Foley Attorneys and Jurisdictions in 2025 Edition of IAM Patent 1000: The World鈥檚 Leading Patent Practitioners appeared first on 天美传媒; Lardner LLP.

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Foley Attorneys Analyze Patent Takeaways in Recent Machine Learning Ruling /news/2025/05/foley-attorneys-explore-patent-takeaways-in-recent-machine-learning-ruling/ Tue, 13 May 2025 22:05:00 +0000 The post Foley Attorneys Analyze Patent Takeaways in Recent Machine Learning Ruling appeared first on 天美传媒; Lardner LLP.

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GLP-1 Drugs in Focus: Trends, Needs, and What’s Next /insights/events/2025/09/glp-1-drugs-focus-trends-needs-whats-next/ Tue, 19 Aug 2025 16:09:32 +0000 The post GLP-1 Drugs in Focus: Trends, Needs, and What’s Next appeared first on 天美传媒; Lardner LLP.

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Protecting Trade Secrets and Confidential Information in Global Supply Chains: Legal Strategies for Manufacturers /insights/publications/2025/08/protecting-trade-secrets-confidential-information-global-supply-chains-legal-strategies-manufacturers/ Tue, 26 Aug 2025 14:47:32 +0000 The post Protecting Trade Secrets and Confidential Information in Global Supply Chains: Legal Strategies for Manufacturers appeared first on 天美传媒; Lardner LLP.

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In the era of globalization, companies are increasingly reliant on complex international supply chains to design, manufacture, and distribute their products. These extended partnerships鈥攚ith contract manufacturers, component suppliers, joint venture partners, and logistics providers鈥攁llow businesses to reduce costs and increase agility. However, they also introduce significant legal risks, particularly in the protection of confidential information and intellectual property.

A single misstep鈥攕uch as a confidentiality breach or trade secret misappropriation鈥攃an lead to multi-million-dollar losses, regulatory scrutiny, and irreparable harm to a company鈥檚 competitive edge. As the legal landscape continues to evolve, businesses must adopt a holistic, forward-looking strategy to protect their proprietary data across jurisdictions.

This article examines the core legal and strategic considerations for protecting confidentiality and intellectual property in global supply chains, focusing on five key areas:

  • confidentiality and trade secrets in supply chains,
  • global variations in confidentiality agreements,
  • legal ramifications of confidentiality breaches abroad,
  • mechanisms for protecting trade secrets and intellectual property in foreign partnerships, and
  • allocating patent litigation risk across the supply chain.

Why Trade Secrets and Confidential Information Matter in Global Supply Chains

Trade secrets and confidential information are often at the heart of a company鈥檚 competitive advantage. These intangible assets include manufacturing methods, product designs, formulations, algorithms, pricing models, customer data, and business strategies. In supply chains, this sensitive information is frequently shared with multiple third parties, each of which presents a potential point of vulnerability.

A company that fails to adequately protect such information may face not only competitive losses but also difficulties in enforcing trade secret rights if it cannot demonstrate that it took 鈥渞easonable steps鈥 to preserve secrecy鈥攁n essential requirement under laws like the U.S. Defend Trade Secrets Act (DTSA) and the EU Trade Secrets Directive.

Effective protection begins with information governance: classifying information appropriately, limiting access, using secure communication protocols, and requiring third parties to sign robust confidentiality agreements before disclosure. But in global settings, contractual protections alone may not be enough.

Navigating Global NDA Variations and Confidentiality Laws in Supply Chains

Confidentiality agreements, including non-disclosure agreements (NDAs), are the most common legal tool used to protect sensitive information. However, drafting and enforcing these agreements across borders requires careful consideration of jurisdictional differences in language, legal culture, and enforceability.

Jurisdictional Differences in NDA Enforcement and Trade Secret Protection

In jurisdictions like the United States, United Kingdom, Germany, and Japan, well-developed legal frameworks recognize and enforce NDAs. But in other regions鈥攑articularly in developing economies or jurisdictions with weak rule of law鈥攃ontract enforcement may be inconsistent, and remedies for trade secret violations limited or uncertain.

In China, for example, significant progress has been made through recent updates to the Anti-Unfair Competition Law (an updated version takes effect October 15, 2025) and court reforms, but enforcement remains variable. In some Middle Eastern and Southeast Asian jurisdictions, confidentiality protections may rely more on equitable principles or specific business customs than codified laws.

Governing Law, Venue, and Arbitration for Cross-Border NDAs

Cross-border NDAs should explicitly designate a governing law and dispute resolution forum. U.S.-based companies often prefer to use their home jurisdiction鈥檚 laws and courts, but foreign partners may reject such provisions. Arbitration, particularly under institutions like the International Chamber of Commerce (ICC) or Singapore International Arbitration Centre (SIAC), are often used as neutral alternatives, especially where enforceability under the New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards is advantageous.

Careful attention must also be paid to venue selection (physical location for disputes), language of the contract, and choice-of-law clauses, to avoid uncertainty in enforcement.

Language Barriers and Red Flags in International NDAs

Agreements should be executed in the native language of all parties鈥攐r at minimum, be accompanied by professionally certified translations. Ambiguities due to translation can render key provisions unenforceable.

Other red flags in foreign NDAs include:

  • Overbroad or undefined exclusions from confidentiality,
  • Lack of injunctive relief provisions,
  • Weak or missing enforcement mechanisms,
  • Vague definitions of confidential information, and
  • Short or ambiguous confidentiality terms.

Companies must avoid using a 鈥渙ne-size-fits-all鈥 template for NDAs in cross-border contexts and instead tailor protections based on the jurisdiction, industry, and nature of the information at stake.

Legal Ramifications of Breached Confidentiality in Foreign Countries

When a breach of confidentiality or theft of trade secrets occurs in a foreign jurisdiction, the aggrieved company must navigate a web of legal, procedural, and practical hurdles. These may include forum non conveniens defenses, unfamiliar procedural rules, and uncertain enforcement environments.

Challenges of Litigating Abroad

Key challenges include:

  • Local Legal Systems: In jurisdictions without strong IP enforcement mechanisms, local courts may delay proceedings or favor domestic parties.
  • Evidentiary and Procedural Hurdles: Common law systems typically allow broad discovery, while civil law systems (e.g., France, Germany, China) provide for relatively more limited access to evidence.
  • Costs and Timeframes: Litigation in foreign jurisdictions often requires local counsel, translators, experts, and travel鈥攓uickly escalating costs and prolonging timelines.
  • Reputational and Political Dynamics: In some countries, bringing claims against local entities can result in public backlash, regulatory scrutiny, or interference from state actors.

Available Remedies

Where trade secret protections exist, available remedies typically include:

  • Injunctive Relief: Courts may issue cease-and-desist orders to prevent ongoing misappropriation.
  • Monetary Damages: This may include actual losses, unjust enrichment, or statutory damages.
  • Criminal Penalties: Some jurisdictions impose criminal liability for misappropriation (e.g., China, South Korea, UAE).
  • Contractual Penalties: Where permitted, liquidated damages clauses in NDAs can provide a deterrent and a clearer remedy.

However, the effectiveness of these remedies is only as strong as the jurisdiction鈥檚 enforcement infrastructure.

Case Studies: Major Global Trade Secret Disputes and Lessons Learned

Several international IP cases illustrate the high stakes and complex legal paths in play:

  • Motorola v. Lemko (U.S./China): Motorola accused Lemko, a U.S.-based startup with Chinese ties, of conspiring with former Motorola employees to steal proprietary source code and trade secrets related to cellular network technology. The litigation spanned both civil and criminal cases. Ultimately, several defendants pled guilty, and Motorola was awarded substantial damages, though enforcement abroad remained problematic.
  • DuPont v. Kolon Industries (U.S./Korea): DuPont brought a trade secrets case against South Korean competitor Kolon for allegedly stealing information related to Kevlar fiber technology via former DuPont employees. A U.S. jury awarded DuPont nearly $920 million in damages in 2011. Although the award was later overturned on appeal and settled for a lesser amount ($275 million), Kolon also faced a criminal plea and agreed to pay $85 million in criminal fines.
  • Tata Consultancy Services (TCS) v. Epic Systems (U.S./India): Epic Systems sued TCS, alleging improper access and copying of its confidential software testing system. In 2016, a U.S. jury awarded Epic $940 million (later reduced to $420 million) for misappropriation of trade secrets. TCS appealed, and the matter eventually settled for $440 million, marking one of the largest U.S. trade secret awards involving an Indian company.

These cases highlight the cross-border challenges of litigation, but also show that substantial remedies may be available in U.S. courts鈥攅ven when the defendant is based abroad.

Protecting Trade Secrets and IP in Foreign Partnerships

To reduce exposure to misappropriation in global supply chains, businesses should adopt a layered and proactive approach to intellectual property (IP) protection.

Robust Confidentiality Agreements

All partners, vendors, and subcontractors should be required to sign NDAs before receiving access to sensitive information. Key clauses should include:

  • Clear definitions of 鈥渃onfidential information,鈥
  • Duration of confidentiality obligations (often 3鈥5 years post-termination),
  • Obligations to safeguard data and limit disclosure,
  • Return or destruction of materials upon request, and
  • Rights to injunctive relief and venue selection.

NDAs should be reviewed periodically and updated to reflect changes in the law or business operations.

Tiered Ownership of IP

Many supply chain relationships involve co-development of technology, components, or software. In these cases, ownership of the resulting IP should be addressed upfront. Contractual provisions should clarify:

  • Who owns pre-existing IP,
  • Who owns improvements or derivatives,
  • Assignment obligations for newly developed inventions, and
  • Licensing rights (exclusive, non-exclusive, territorial, etc.).

Avoid vague or open-ended 鈥渏oint ownership鈥 clauses, which can lead to disputes over future use and monetization.

Patent Cooperation Treaty (PCT)

The Patent Cooperation Treaty allows companies to file a single international patent application and later pursue protection in multiple countries while preserving their original filing date. This can be an efficient strategy for companies seeking global protection for inventions shared with foreign partners.

Additionally, companies should consider registering trademarks, designs, and domain names in each jurisdiction where they do business or maintain supply relationships.

Allocating Patent Litigation Risk Across the Supply Chain

Even when IP rights are protected, supply chain participants may still face legal exposure for infringing products鈥攅specially if they import, assemble, or resell goods containing third-party IP. To mitigate this risk, companies should use contractual tools to shift or share liability.

Indemnification Clauses

Well-drafted indemnity provisions can require suppliers to:

  • Defend the buyer against IP infringement claims,
  • Reimburse litigation and settlement costs, and
  • Replace infringing goods or cease sales.

Key considerations include:

  • Scope (types of IP covered),
  • Triggering events (claims vs. final judgments), and
  • Control over defense and settlement.

Buyers should ensure that indemnities are backed by financially capable counterparties or secured through insurance or escrows.

IP Insurance

Intellectual property liability insurance is increasingly used to manage risk in technology-driven supply chains. Policies may cover:

  • Defense costs for infringement suits,
  • Damages or settlements, and
  • Loss of revenue due to injunctions.

Policies vary widely, so companies should review exclusions, coverage limits, and whether subcontractors or downstream customers are covered.

Limitation of Liability

To manage the risk of excessive damages, supply contracts often include:

  • Caps on total liability (e.g., contract value or multiple thereof),
  • Carve-outs for willful misconduct or IP infringement, and
  • Exclusions for indirect or consequential damages.

Companies should carefully reconcile these limitations with indemnity and insurance provisions to avoid conflicts or gaps in protection.

Conclusion

In a globalized economy, managing the risks of confidentiality breaches and intellectual property misappropriation is essential to protecting a company鈥檚 innovation, market position, and bottom line. As supply chains stretch across borders, so too must the legal strategies that safeguard trade secrets, enforce confidentiality, and allocate liability.

By investing in well-structured contracts, choosing appropriate jurisdictions for enforcement, and using international tools like the Patent Cooperation Treaty and arbitration mechanisms, companies can significantly reduce their exposure. Likewise, the strategic use of indemnity, insurance, and limitation of liability clauses allows businesses to share or shift risk and ensure resilience in the face of disputes.

Ultimately, protecting intellectual assets in the global supply chain is not just a legal function鈥攊t is a strategic imperative for sustainable growth and competitiveness in the modern economy.

We will be posting a weekly article exploring different facets of聽Navigating Legal Challenges in Global Supply Chain Management.

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