Key Takeaways

  • Medical patents protect intellectual property related to medical devices, drugs, procedures, and software.
  • There are three main types of patents: utility, design, and plant patents.
  • Patent protection lasts for 20 years, but regulatory exclusivity may extend market exclusivity.
  • Regulatory hurdles such as FDA approvals add complexity and cost to patenting medical inventions.
  • Infringement cases can lead to costly litigation and impact access to medical products.
  • Exclusivity rights granted by the FDA can extend protection beyond patents, affecting generic drug market entry.
  • Strategies for patenting medical innovations include international protection and leveraging trade secrets.
  • Patent trends show growth in biotechnology, AI-driven diagnostics, and digital health technologies.

A medical patent is a type of patent that protects the owners of medical intellectual property from infringement. It prevents other individuals or entities from producing, selling, or using the patented item, idea, or method for a certain duration of time. Medical inventors and entrepreneurs can use patents to protect various inventions, including drugs, medical devices, procedures, and software. By giving medical inventors a competitive edge, medical patents serve the important purpose of promoting medical innovation.

What Is Medical Intellectual Property?

Similar to many other technological fields, the medical industry enables its inventors to use patents and trade secrets to protect their innovations, providing them with the competitive advantage needed to build value and identity for their products or businesses. Usually, the time and cost needed to introduce medical innovations to the market are higher compared to other kinds of innovations.

For some medical inventions, the difficulty may be the result of extended purchasing cycles and purchasing obstacles from hospitals and other medical organizations. Products that need regulatory approval, such as FDA approval, may face even greater obstacles. Since the regulatory pathway may take years and incur a very high cost, it is important to make sure that you will obtain solid intellectual property rights before you head down that path.

The great amount of time and high cost required to bring medical innovations to market makes intellectual property strategy highly critical at the initial stages of product and business development. For instance, it is essential to determine whether or not a certain innovation is patent-worthy or eligible for trade secret protection in the early stages of the process before spending the required time and money. Additionally, it is important to create products that do not infringe the rights of others.

Challenges in Securing Medical Patents

Obtaining a medical patent is complex due to the unique challenges in the healthcare industry. The high costs and long development timelines of medical innovations necessitate securing strong intellectual property (IP) rights early in the process. Some of the key challenges include:

  • Regulatory Approval Requirements – Medical devices and drugs often require FDA approval, adding time and cost before commercialization.
  • Patent Eligibility Issues – Some medical innovations, such as surgical procedures, face restrictions on patentability.
  • Biotechnology and AI Concerns – Emerging fields like biotechnology and AI-driven diagnostics raise ethical and legal questions regarding patent scope.
  • Prior Art and Patentability – A thorough patent search is necessary to ensure that an invention is novel and non-obvious.
  • Global Protection Complexity – Medical patents may need international protection through treaties such as the Patent Cooperation Treaty (PCT).

Given these challenges, inventors often work with patent attorneys to devise an IP strategy that includes patents, trade secrets, and regulatory exclusivity.

What Is a Medical Patent?

A medical patent refers to an exclusive government-granted right that protects an inventor of a unique medical product, process, or technology against market competition. It prevents the patented invention from being produced, sold, or used by competitors for a limited time.

A biotech company uses a patent to protect its intellectual property rights to products such as drugs. A patent gives a drug protection against generic competition for a certain number of years. By doing so, it enables the company that created the drug to earn high profits to compensate for the costly research and development needed to bring it to market. However, this can prevent low-income patients from purchasing the drug. Other examples of medical patents include:

  • Patents for prosthetic limbs
  • Patents for back braces, and other physical therapy devices
  • Patents for software applications for managing patients

A medical patent can be owned by one entity and licensed for use by another, allowing more than one entity to profit from it. There are three types of patents in the U.S.:

  • Utility patent
  • Design patent
  • Plant patent

A utility patent covers machines, processes, manufactured objects, or their improvements, while a design patent protects ornamentation. The U.S. Patent and Trademark Office is the government agency that grants patents in the U.S. A patent is valid for 20 years.

Medical Patent Strategies and Protection

Securing a medical patent is only the first step; protecting and maximizing its value requires a strategic approach. Key strategies include:

  1. Filing for International Protection – Since healthcare markets are global, companies often file patents through:
    • The Patent Cooperation Treaty (PCT) for worldwide applications.
    • Regional filings (e.g., the European Patent Office for EU-wide protection).
  2. Leveraging Trade Secrets – While patents provide public disclosure in exchange for exclusivity, some innovations (such as manufacturing processes) are best kept as trade secrets.
  3. Using Regulatory Exclusivity – In the pharmaceutical industry, exclusivity rights granted by the FDA provide additional market protection beyond patents:
    • Orphan Drug Exclusivity (ODE): 7 years of exclusive rights for rare disease treatments.
    • New Chemical Entity (NCE) Exclusivity: 5 years for new active ingredients.
    • Pediatric Exclusivity: Extends protection by 6 months for conducting pediatric studies.
  4. Monitoring and Enforcing Patents – Companies should actively monitor the market for potential infringement and be prepared to enforce their patents through litigation when necessary.
  5. Patenting AI and Digital Health Technologies – AI-driven medical diagnostics, telemedicine platforms, and health monitoring software have grown in importance. However, the patentability of AI algorithms remains an area of legal debate.

These strategies ensure that medical inventors maximize the protection and commercial viability of their patented technologies.

Infringement of Medical Patents

If a company thinks that another company has violated its intellectual property rights, it can file a lawsuit for patent infringement to prevent that company from making or using its patented invention. Infringement of medical patents can be a significant problem for investors if it has a negative impact on the profitability of the company that is victimized by a patent infringer or if a company that has allegedly infringed another company's patent is being sued or has to stop the sale of an important product.

Patents for biotechnological innovations are a controversial subject. People who are in favor of biotechnology patents argue that they promote scientific progress by promising financial rewards to inventors and companies that successfully develop new products. Those who oppose the granting of biotech patents say that such patents are unethical because they allow the companies that own the rights to the inventions to set high prices and limit poorer individuals' access to health care. This argument is especially relevant in developing countries.

Legal and Ethical Considerations of Medical Patents

The debate over medical patents and accessibility is a critical issue in healthcare. Some of the major concerns include:

  • High Drug Prices Due to Patents – Exclusive rights allow companies to set high prices, potentially limiting access for low-income populations.
  • Compulsory Licensing – Some countries allow governments to override patents in cases of public health emergencies, enabling generic production.
  • Ethical Concerns in Biotech Patents – Patents on genetic materials, CRISPR gene-editing technology, and AI-based diagnostics raise moral and legal issues about ownership of medical innovations.
  • Patent Trolls in Healthcare – Some companies acquire patents solely to sue other businesses rather than to develop new medical technologies.

Efforts to balance innovation incentives with patient accessibility include generic drug competition laws, patent reform proposals, and government subsidies for drug development.

Frequently Asked Questions

  1. How long does a medical patent last?
    A U.S. utility patent lasts 20 years from the filing date, but market exclusivity can be extended through regulatory approvals.
  2. Can medical procedures be patented?
    Surgical methods and diagnostic procedures are often not patentable, but medical devices and software used in procedures can be patented.
  3. What is the difference between a patent and FDA exclusivity?
    A patent protects an invention, while FDA exclusivity provides additional protection for drugs by preventing generic competition for a set period.
  4. How do medical patents impact drug prices?
    Patents allow companies to recoup R&D costs but may also result in higher drug prices by delaying generic competition.
  5. Are AI-based medical technologies patentable?
    AI-based medical diagnostics and health software can be patented, but algorithms alone may not qualify for protection under patent laws.

If you need help applying for a medical patent, you can post your legal need on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Menlo Ventures, and Airbnb.