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Protecting Medtech Startup’s Innovations Cheat Sheet (DRAFT) by [deleted]

rotect your medtech startup’s innovations

This is a draft cheat sheet. It is a work in progress and is not finished yet.


When it comes to starting and building a medical device company, a strong patent strategy tied to business goals can be the driving force behind venture capital invest­ment, strategic collab­ora­tions, and mergers and acquis­itions.

In order to safeguard its intell­ectual property (IP), every medtech startup should consider these five tips for protecting and leveraging its innova­tions.

1. File early and file often

Fundam­ental to a strong patent portfolio is establ­ishing solid patent protection for a company’s core techno­logy. First, one or a series of patent applic­ations should be filed providing the broadest possible patent protection covering the core techno­logy. As the core technology evolves, increm­ental improv­ements and varying applic­ations should be patented to form a “picket fence” of protection around the core techno­logy.

Medtech startups should file patent applic­ations as early and as often as their budget permits. This has been partic­ularly true since the passage of the America Invents Act in 2011, which brought the United States into confor­mance with the rest of the world as a first-­to-file country. Thus, a key is to file patent applic­ations before any public disclosure that could limit patent coverage. To ensure both U.S. and intern­ational patent coverage, a patent applic­ation should be filed before the invention is first published, disclosed, used or offered for sale. Savvy companies file patent applic­ations early and often.

2. Proactive patenting

To build a patent portfolio faster, early-­stage medtech companies should consider utilizing the United States Patent and Trademark Office (USPTO) fast track patent examin­ation programs.

Due to the USPTO’s backlog, it can take three years or more for a medtech patent applic­ation to obtain its final decision and issue as a patent. In contrast, the USPTO Track I priori­tized examin­ation program strives to achieve a final go or no-go decision for a patent applic­ation within 12 months of filing. Other ways to accelerate USPTO examin­ation include the Patent Prosec­ution Highway program based on an issued foreign patent or a favorable search report, and the age-based program which speeds up examin­ation for inventors 65 or older.
The USPTO Track I priori­tized examin­ation program is more expensive than regular examin­ation and accele­rates costs that would normally be spread over a few years.


3. Patents attract financing

Medtech startups need a strategic patent position that protects against potential compet­itors and entices investment from venture capita­lists. In today’s innovative economy, a medtech company’s success depends on the strength and value of its patent portfolio. For early-­stage medtech companies, patents are often the only way for investors to place value on the company’s technology and judge the potential success before sales, which often only begin after FDA regulatory approval. Strategic patents can also lead to joint ventures, collab­ora­tions and licenses with strategic partners.

4. Know your compet­itors’ patents

In addition to building their own patent portfolio, early-­stage medtech companies should also become familiar with the prior art patent landscape of compet­itors in their technology space. Knowledge of the patent landscape can help companies further focus their product develo­pment and patent strategy.

Review of the relevant patent landscape can identify technology spaces with fewer barriers for entry due to light patent coverage. By obtaining patent coverage in a technology space with fewer compet­itors, a medtech company can carve out its patent niche and become a dominant player in that space. Also, filing patents covering improv­ements to compet­itor’s products can provide signif­icant control over compet­itor’s product enhanc­ement options. Knowledge of prior art may help companies prepare stronger patent applic­ations that anticipate potential rejections during USPTO examin­ation.

5. Don’t forget about trade secrets

When used in conjun­ction with or as an altern­ative to patents, trade secret protection can provide a viable option to protecting the IP of the medtech company. Trade secret protection involves protecting ideas by taking measures to keep them secret, possibly avoiding the effort and expense associated with filing patent applic­ations. Trade secrets can provide protection for as long as the underlying technology is kept secret, but any public disclosure loses the protec­tion. The algorithms that drive digital health and mobile medical applic­ations are often candidates for trade secret protec­tion.