Deciding whether to invest time and money in pursuing medical device patents requires careful balancing of strategic legal protections against competitive limitations that could inadvertently hamper growth. Robust patents defend innovation but may also narrow implementation, reducing enhancements. Other routes like trademarks or trade secrets offer comparable shelter from copying without restrictive public disclosures. This blog discusses the pros and cons affecting policy to issue patents on medical devices.

Benefits of Patenting Medical Devices

Patents Block Competitors

Patents legally forbid unauthorized parties from making, selling, distributing, or using protected inventions for 20 years from the filing date. Patents prevent competitors from using innovations without independently devising alternative solutions.

Patents Attract Investors

Patents indicate technical competencies to prospective investors, demonstrating novel concepts. Protecting a subject matter area enhances the inventor’s ability to attract capital, partners, and acquisition bids necessary to convert ideas into shipped products.

Patents Safeguard R&D

Patents help justify considerable research and testing expenditures to transform theories into approved medical tools by ensuring that imitators do not copy inventions and undercut product prices by skirting development costs.

Facilitate Licensing

Acquiring patents allows creators of foundational medical technologies to license elements to drug makers, service providers, and/or device manufacturers interested in incorporating these advances into products and services that benefit patients.

Downsides of Patenting Medical Devices

Public Disclosure 

Every patent application requires a detailed disclosure to enable one to make and use the invention. The application must have a full disclosure and a detailed implementation description. The patent application should disclose the inventive aspects of the invention.

Competitors may use this disclosure to design around the claims and create a device that does not infringe on the literal claims. (It is important to have an experienced Patent Attorney write or review claims to make them cover the maximum area possible before they are filed.)

Costs

Pursuing reputable patents averages about 20 billable hours in attorney fees and administrative processes. Costs multiply when prosecuting in multiple countries. There are also maintenance fees after the patent issues.

There may also be enforcement and litigation fees.

Delayed Approvals

Issuance of a patent typically takes three years after filing.

There may also be Examiner Interviews and appeals. Medical inventions are sometimes rejected under public policy principles prohibiting granting an entity a 20-year monopoly on lifesaving procedures, drugs, or equipment.

Invention Constraints

Patented medical device features cannot be adjusted significantly without falling outside the scope of the patent claims. For this reason, there is a limited ability to change the device to address user feedback issues.

Infringement Uncertainty

Good faith efforts in designing around patents may still trigger unexpected infringement accusations. Litigation costs quickly mount, even for baseless claims by overly aggressive Plaintiffs. Many frivolous lawsuits result in settlement payments.

Trade Secret Alternatives

Some medical advances are kept secret and treated as Trade Secrets rather than publishing them in a patent application. Certain types of innovations, such as formulas, compositions of matter, firmware, mechanical tolerances, etc. that cannot be discerned by viewing them, may be kept as Trade Secrets. It is important to consider the use of Trade Secrets to protect innovations, as well as Patents.

Weighing pros and cons allows medical innovators to determine the best intellectual property protections to secure market advantage.

Contact Zale Patent Law, Inc. for advice for protecting your medical innovations.

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