Life Sciences

Protecting innovation in the life sciences requires more than technical insight—it demands legal strategies that are aligned with research, regulatory environments, and market applications. Brooks Kushman helps companies secure and enforce intellectual property across the full spectrum of life sciences.

Connect with us to discuss how we can support your intellectual property portfolio.

Common Intellectual Property Challenges

The life sciences industry sits at the intersection of discovery and regulation. From early-stage biotech startups to global pharmaceutical companies, innovation drives competitive advantage. Yet, bringing a product from concept to market is rarely a straightforward process. Breakthroughs in diagnostics, biologics, or therapeutics often face challenges tied to subject-matter eligibility, data protection, and evolving standards for patentability.

Growing concerns about data privacy, AI-assisted research, and cybersecurity complement these challenges. Institutions must also navigate ownership disputes involving collaborative research or academic partnerships. Without careful intellectual property planning, valuable assets—from genetic sequences to bioinformatics tools—may be left unprotected or become difficult to defend.

How We Can Help

Brooks Kushman supports clients in securing, managing, and enforcing intellectual property in accordance with the sector’s scientific and regulatory requirements. Our attorneys work closely with in-house teams, research organizations, and technical stakeholders to capture inventions, assess patentability, and coordinate filings across multiple jurisdictions.

We assist clients with utility patents, design patents, trade secrets, and licensing agreements, often involving inventions with overlapping legal and technical considerations. Whether you’re developing a novel assay, a therapeutic compound, or an AI-driven diagnostic platform, we craft legal strategies that align with your business model and development pipeline.

Why Partner With Us?

With more than 11,000 patent applications filed in the past five years, Brooks Kushman brings a depth of experience that’s especially valuable in life sciences. We’ve supported companies developing pharmaceuticals, diagnostics, laboratory systems, and health-related algorithms, offering legal strategies that address innovation and commercialization.

Working with a life sciences intellectual property Attorney from our team means engaging professionals who understand the nuances of patent eligibility under evolving USPTO and international guidelines. We align patent prosecution with your product development strategy, helping to mitigate risks that often arise in later phases, including competitive challenges or post-grant proceedings.

Key IP Considerations for Life Sciences

Complex, Multi-Disciplinary Innovation

Life sciences innovations often combine biology, chemistry, engineering, and data analytics. Protecting these inventions requires attorneys who understand molecular structures, biological pathways, diagnostic technologies, and device engineering. Our team works across these disciplines to build comprehensive IP strategies that capture value in both the core invention and its integrated applications.

Patent Eligibility and Regulatory Alignment

Patent protection in life sciences can be complex due to evolving standards for patent eligibility, especially for naturally occurring substances, diagnostic methods, and software-enabled medical tools. We help clients craft claims that emphasize novel compositions, engineered processes, and measurable technical benefits. Our approach also accounts for regulatory timelines with agencies such as the FDA and EMA, ensuring that IP protection supports product approval and commercialization strategies.

Data and Clinical Trial Results as Competitive Assets

Clinical data, trial results, and patient outcome records often form a critical competitive advantage. While not always patentable, these assets can be protected through trade secrets, data-use agreements, and careful control over disclosure. We help clients secure rights in their proprietary data and navigate privacy compliance under HIPAA, GDPR, and other applicable regulations.

Trade Secrets for Manufacturing and Formulations

Many life sciences companies protect proprietary manufacturing methods, synthesis techniques, or formulation details as trade secrets. We assist in determining when to seek patent protection and when to maintain confidentiality, and we implement protocols, agreements, and vendor controls to safeguard sensitive information over the long term.

Freedom to Operate and Competitive Intelligence

The life sciences patent landscape is crowded, with overlapping rights across product classes, formulations, and delivery systems. We conduct freedom-to-operate (FTO) analyses to identify potential barriers early, assess licensing options, and reduce infringement risks. Our monitoring programs help clients anticipate competitor filings and adjust strategies as markets evolve.

Global Patent Strategy and Market Exclusivity

Life sciences innovations are typically commercialized worldwide, and IP strategies must align with global regulatory, market, and manufacturing considerations. We develop coordinated filing strategies to secure patent rights and regulatory exclusivities, such as data protection and market exclusivity periods, in target jurisdictions. Our team works closely with foreign counsel to ensure compliance with jurisdiction-specific standards for biotechnology and pharmaceutical inventions.

IP Strategy for Collaborations and Licensing

Partnerships between pharmaceutical companies, biotech firms, universities, and research institutions are common in the life sciences sector. These collaborations require clear agreements on IP ownership, licensing terms, and rights to improvements. We help clients structure agreements that protect proprietary technology while supporting shared innovation and product development goals.

Patent Term Extensions and Lifecycle Management

Maximizing the value of a life sciences patent often requires strategic management of exclusivity periods, including patent term extensions, supplementary protection certificates, and secondary patents for improved formulations or delivery systems. We assist clients in developing lifecycle strategies that protect revenue streams well beyond the initial product launch.

Specialty Practice Areas

• Assays
• Bioinformatics
• Biotechnology
• Diagnostic Techniques
• Food & Dietary Inventions
• Small Molecule Pharmaceuticals

Brooks Kushman provides legal strategies to protect the technologies advancing modern life sciences, from biotechnology to diagnostics and pharmaceuticals. Reach out to discuss how our intellectual property Lawyers can assist.