Intellectual Property in Life Sciences: Strategies for U.S. Market Entry




Unlock the full potential of your life sciences innovations in the U.S. market with essential intellectual property strategies— read this guide to safeguard your competitive edge and navigate the complex legal landscape.

Intellectual property (IP) concerns are a critical aspect for any company, but they take on heightened importance for pharmaceutical and medical device companies where investments in research and development are substantial, and the products are highly technical and innovative. When entering the U.S. market, companies from the UK, Europe, and other regions must understand and navigate the U.S. IP legal framework to protect their innovations and maintain competitive advantage.

“The U.S. is known for its litigious approach to intellectual property protection, which can be daunting for foreign entities. Navigating this aggressive landscape requires a proactive stance on IP issues. It’s not just about having rights; it’s about being fully prepared to defend them in court if necessary. At Thorelli & Associates, we advise our clients to develop a comprehensive enforcement strategy that anticipates litigation, so they’re not caught off guard by the challenges of the U.S. legal system.”

Thomas Wells

Thomas Thorelli

Partner, Thorelli & Associates

Key Intellectual Property Rights in the U.S.


In the U.S., the United States Patent and Trademark Office (USPTO) grants patents to inventors who have created a new, useful, and non-obvious invention. Patents give inventors the exclusive right to use, sell, or license their invention for a certain period, usually 20 years from the filing date of the patent application. Pharmaceutical and medical device patents can include product patents (for the product itself), process patents (for the manufacturing process), and use patents (for specific uses of the product).


Trademarks protect symbols, names, and slogans used to identify goods or services. The USPTO registers trademarks, providing companies with the right to prevent others from using a confusingly similar mark in a way that could deceive consumers. For healthcare companies, trademarks are crucial for brand recognition and to differentiate their products from those of competitors.

Trade Secrets

Trade secrets encompass formulas, practices, processes, designs, instruments, patterns, or compilations of information that are not generally known or readily ascertainable. Protection of trade secrets in the U.S. falls under both state and federal law, including the Uniform Trade Secrets Act (adopted by most states) and the federal Defend Trade Secrets Act.


Although not as commonly associated with pharmaceuticals and medical devices, copyrights protect original works of authorship, such as software, literature, and marketing materials. In the healthcare sector, this might apply to software that runs medical devices or proprietary research reports.

If your company is planning to enter the US market or just get maximum IP protection globally, connect with GTM’s IP experts at Thorelli & Associates. Book a free consultation here.

Challenges in Protecting IP in the U.S.

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The U.S. IP protection system may differ significantly from those in other countries. For example, the U.S. operates on a “first to file” patent system, not a “first to invent” system, which was the case until the America Invents Act (AIA) came into effect in 2013. Companies must be prepared to file for patents quickly to secure their inventions.

Complexity of Patent Law

Pharmaceutical and medical device patents can be highly complex, and the process of obtaining and enforcing patents can be fraught with challenges, including prior art searches, patentability analysis, drafting detailed patent applications, and potentially defending the patent against infringement or challenges to its validity.

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The process of obtaining and maintaining IP protection in the U.S. can be expensive. This includes application fees, attorney fees, and the costs associated with potentially defending IP rights in litigation.


Even after securing IP rights, enforcement can be challenging and costly. If a company’s IP rights are infringed upon, they may need to engage in litigation to enforce their rights, which can be a long and costly process.

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GTM Events - F2F Networking

Regulatory Exclusivity

In addition to patents, regulatory exclusivity periods can provide protection from competition for certain new drugs (e.g., new chemical entities) or for certain modifications to existing drugs (e.g., new formulations). Understanding and navigating these exclusivity periods can be as important as obtaining patent protection.

Strategies for IP Protection in the U.S.

Early and Comprehensive Filing

Companies should file patent applications early and ensure they are comprehensive, covering all aspects of their inventions and any future developments they might anticipate.

Conducting Thorough Due Diligence

Before entering the U.S. market, companies should perform due diligence to ensure they are not infringing on existing U.S. patents and that their own IP can be protected.

Maintaining Secrecy When Necessary

For trade secrets, companies should establish strict confidentiality protocols and ensure that employees, contractors, and business partners understand and adhere to these protocols.

Monitoring and Enforcement

Companies should actively monitor the market for potential infringement and be prepared to enforce their IP rights through litigation if necessary.

Working with IP Professionals

Engaging with attorneys and consultants who specialize in U.S. IP law is crucial for navigating the complexities of the IP landscape and developing a robust IP strategy.

By effectively managing their intellectual property rights within the U.S. legal framework, UK and European companies can protect their investments, maintain a competitive edge, and maximize the commercial potential of their products in the U.S. healthcare market.

If your company is planning to enter the US market or just get maximum IP protection globally, connect with GTM’s IP experts at Thorelli & Associates. Book a free consultation here.

Here’s a Quick Reference FAQ Reminder

What are the key intellectual property considerations for life science companies entering the U.S. market?

Life science companies should consider patent protection, trademark registration, trade secret management, and regulatory compliance as key intellectual property considerations when entering the U.S. market. Ensuring robust IP protection can help maintain a competitive advantage and prevent infringement.

How can life science companies protect their innovations with patents in the U.S.?

Companies can protect their innovations by filing for patents with the United States Patent and Trademark Office (USPTO). It’s critical to file patents before publicly disclosing any innovation, as the U.S. operates on a “first to file” system, and prior disclosure can jeopardize patentability.

Why is trademark registration important for life science companies in the U.S.?

Trademark registration is important to establish brand identity and protect against unauthorized use of company names, logos, and product names. Registered trademarks help prevent confusion in the marketplace and offer legal remedies against infringement.

What role do trade secrets play for life science companies, and how can they be protected?

Trade secrets are a form of intellectual property that includes formulas, practices, processes, designs, instruments, or compilations of information not generally known or reasonably ascertainable. Life science companies can protect trade secrets through non-disclosure agreements (NDAs), employee training, and robust internal security measures.

How does regulatory compliance intersect with IP strategy for life science companies in the U.S.?

Regulatory compliance, particularly with the Food and Drug Administration (FDA) for life science companies, is essential for market entry. Compliance intersects with IP strategy as it may affect the patentability of products, the timing of market entry, and the overall protection of IP assets.

What is the significance of conducting a Freedom to Operate (FTO) analysis for U.S. market entry?

An FTO analysis is crucial for identifying potential patent infringement risks before launching a new product or service in the U.S. It helps companies navigate existing patents and determine the freedom to operate without infringing on the IP rights of others.

Can life science companies rely on international IP treaties when entering the U.S. market?

International IP treaties, such as the Patent Cooperation Treaty (PCT) and the Madrid Protocol for trademarks, can simplify the process of securing IP rights across multiple countries, including the U.S. However, companies must still meet U.S.-specific legal requirements for IP protection.

Other Useful Resources

Disclaimer: The information provided in this article is for general informational purposes only and should not be construed as professional advice. Readers should not rely on any information contained herein as a substitute for professional guidance and should seek independent expert assistance when making decisions related to transfer pricing or US expansion.


Ian Collins
Ian Collins
Ian Collins, with an extensive background spanning over 30 years in business development and general management, co-founded GTM Global in 2015. His experience encompasses hi-tech industries such as security, artificial intelligence, business intelligence, and enterprise software solutions. In his career, Ian has started several tech companies, overseen two corporate ventures, executed a management buy-in, and led two business turnarounds. He has also been involved in buying, selling, and merging various of his companies, and has achieved two successful business exits. Ian's expertise is particularly focused on business growth strategies and leading-edge proposition development.