Roman Fayerberg and David J. Dykeman, Greenberg Traurig
A strategic patent portfolio is key to a medtech company’s growth and success, but building a robust patent portfolio takes strategy, time and money.
While there are no shortcuts to building a strategic patent portfolio, there are several ways medtech companies can get a head start on the competition.
1. Establish processes to identify and protect inventions
Early-stage medtech companies should implement in-house processes and procedures to capture and protect innovations in a strategic manner.
Many large medtech companies employ experienced in-house patent attorneys whose primary responsibility is building and managing their company’s patent portfolio. Without in-house patent attorneys, these decisions become yet another responsibility of the busy chief technology officer or lead engineer. Even when they understand the importance and are familiar with the patent process, patenting can take a backseat to other priorities and responsibilities. As a result, patent decisions are reactive to the circumstances, with filings non-strategic and driven by last-minute choices amid failure to capture all inventive concepts.
Best practices include a patent process that is proactive with clear strategic goals. To help develop and manage a strategic patent portfolio, a medtech company should have formal processes and procedures designed to efficiently gather information from inventors, identify potential patent filings, respond to patent application office actions and monitor competition.
A company should have an easy-to-use invention disclosure form to help capture and keep track of the inventive developments. It should have regularly scheduled discussions (monthly or quarterly) with its patent attorney to review and address potential application filings and USPTO office actions in a strategic manner, rather than chaotically at the last moment. Smart medtech companies should monitor and review the patent landscape for competitors in their technology space. The knowledge of the relevant patent landscape helps medtech companies focus their product development and patent application filing strategy on the technology spaces with less patent coverage, while avoiding the technology spaces with a crowded patent landscape.
While establishing patent processes and procedures requires planning and time to set up, medtech companies will benefit from having them in place in the long run. Companies can protect their innovations in a timely and strategic manner, while minimizing the risk of potential patent infringement.
2. Utilize USPTO’s fast track programs
While the USPTO has made progress in reducing the patent application examination backlog, a typical non-provisional utility application still takes an average of about 15.4 months to receive the first action from the USPTO and about 22.9 months from application filing to patent issuance (28.3 months for applications with request for continued examination).
To beat the USPTO’s wait time, a medtech company should consider utilizing the USPTO’s Track One program. While the USPTO charges an additional fee for this program, the Track One program reduces the time to the first action to an average of 1.8 months. It can result in an issued patent in about half the time of the regular examination, about 10 months from patent application filing to a patent. To fully take advantage of the program, the Track One application should be focused on the commercial embodiment of the product to get the application to allowance and issuance faster. Prior to the first application issuing as a patent, the applicant can file a continuation application with claims of different scope to form a “picket fence” of patent protection around the technology’s core aspects.
Another popular method to accelerate USPTO examination is the Patent Prosecution Highway (PPH). Under the PPH program, the applicant can request an accelerated examination in the USPTO of claims deemed allowable in a corresponding international application, including a PCT application. The applicant may need to narrow the pending claims before the USPTO examination to correspond to the allowable claims outside the United States, but, similar to the Track One program, the applicant will be able to pursue claims with a broader scope of protection in a continuation application.
It’s also possible to accelerate a USPTO examination based on the age or health of an inventor. For example, the applicant can request accelerated examination and review if an inventor is at least 65 years old.
The USPTO fast track programs are more expensive than regular examinations, but medtech companies can still utilize these programs for their key patent applications to build a patent portfolio faster
3. License proven technology and patents
A medtech company should consider supplementing its patent portfolio by licensing in third-party patents.
Another benefit of monitoring the patent landscape in the relevant area is to identify potential licensing opportunities. The licensed patents can supplement the company’s patent portfolio to provide broader protection around the company’s technology and offer additional options for patented commercial products.
One potential source for licensing opportunities are academic institutions and research hospitals. Because the academic institutions and research hospitals are typically at the forefront of innovation, patents licensed from them can provide an earlier priority date than the patent applications developed in-house. Even if the as-filed claims of the licensed patents do not directly cover the commercial technology, medtech companies can utilize the continuation application strategy to obtain more relevant claims with a priority date that predates the competition.
If such an opportunity arises, medtech companies should consider licensing an already-tested, patent-protected technology to quickly establish their presence in the technological space.
While there are no short cuts to building a patent portfolio, medtech companies can successfully develop a strategic patent portfolio by working with business-minded patent attorneys to implement formal processes and procedures, utilize fast-track USPTO prosecution programs and identify patent licensing opportunities.
This article reflects the opinions of the authors, and not of Greenberg Traurig or Medical Design & Outsourcing. The article is presented for informational purposes only and it is not intended to be construed or used as general legal advice nor as a solicitation of any type.
Roman Fayerberg is a registered patent attorney with more than 15 years of experience in patent and intellectual property law at Greenberg Traurig in Boston. He advises clients on procurement and enforcement of IP rights, including domestic and international patents, with the focus on medtech and life science technologies. His patent practice builds on seven years of experience he gained as a research and development engineer at C.R. Bard (now Beckton Dickinson) and Boston Scientific. He can be reached at firstname.lastname@example.org or (617) 310-5206.
David J. Dykeman, is a registered patent attorney with nearly 25 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. Dykeman’s practice focuses on securing worldwide intellectual property protection and related business strategy for high-tech clients, with particular experience in medical devices, wearables, robotics, life sciences and information technology. He can be reached at email@example.com or at (617) 310-6009.