“Great technology wins markets. Great IP keeps you there.” That was the core message of a recent Fogarty-sponsored Lunch & Learn, led by Kregg Koch, patent attorney and partner at Knobbe Martens, who brought IP strategy to life for entrepreneurs in attendance.
“As the innovators and CEOs of a company, you must have a finger on the pulse of the IP,” he said. “It’s what prevents other people from copying the product that you spent millions of dollars and years of research and development on.” And yet, many founders don’t fully recognize how patents can function as a strategic asset—or that they require a deliberate approach and ongoing attention.
Here are some key takeaways from the recent event, shaped by Koch’s extensive industry expertise.
Start early, and be thoughtful about the strategy
One of the most important early steps is filing a provisional patent application, what Koch calls your “stake in the ground,” which establishes an early filing date and can help prevent others from beating you to the Patent Office.
Because a provisional application is only as good as the disclosure it contains, it should include as much detail as a non-provisional application. “If the provisional application can’t support the limitations in the ultimate claims you want in order to protect your core technology, that provisional application may not only be worthless, but can give the inventor overconfidence that can result in other costly mistakes which can have a huge impact on the company’s IP,” he cautioned.
As an example, not having a well-detailed and comprehensive patent application in place before publicly discussing your innovations can prevent you from ever getting a patent on your innovations, or at least on what was publicly disclosed. Even just a casual conversation with colleagues or clinicians can create a risk of losing patent rights if there was no agreement to keep the information you shared confidential. While U.S. law provides a limited grace period, many other jurisdictions don’t. The safest approach is to file before you publicly disclose any inventive details and to use written confidentiality agreements in advance of any disclosures of confidential information whenever possible.
Agreements related to ownership of IP is another area that too often results in time-and-money-draining difficulties for companies, Koch explained. Agreements with collaborators should clearly define who owns any resulting IP. “Ideally, it would be your company and such an agreement would be executed before development begins,” he said.
Given that patents are a valuable commodity that can be bought, sold, and licensed, even partial ownership in a patent confers these and other rights. A case in point would be a joint inventor of a patent (such as a consultant who contributes to the invention of a single claim in a patent) who has not assigned their rights to your company. In the United States, co-inventors have the right to generally exploit the patent any way they want without the consent of the other co-inventors, unless their ownership rights have been assigned to another (e.g., your company).
In university settings, for example, institutions often retain ownership and license the technology to startups. In those situations, it is very important that the terms of the license agreement are carefully considered and drafted to ensure the best value and rights for the startup.
“Get agreements in place early that are really clear in terms of defining who’s going to ultimately get the IP ownership because these disputes are really difficult to untangle the further you get down the road,” Koch said. “This ounce of prevention is worth 50 pounds of cure.”
Strong patents start with strong disclosure
Koch recommends a comprehensive and detailed disclosure that goes well beyond describing just the core details of the invention. A thorough description of any features or characteristics of the preferred embodiment of an invention which are novel or innovative can provide valuable protection. But that is just the starting point. Including more details about other alternative solutions, such as different components, features, materials, operating parameters, procedural steps, and the like, adds even more value to a patent application and is recommended by Koch, even for a provisional application.
“Applications rich in different embodiments and alternatives can result in much better claim protection, which make it much harder for competitors to design around your patent,” Koch noted. One approach to shaping your patent strategy is to align it with the competitive advantages you highlight in your marketing materials. Koch recommends considering how you would pitch the product to doctors and hospitals and using those same features as at least a checklist to guide what should be protected. “Those big improvements over the prior art can provide a good framework for your claim strategy,” he said. Describing advantages of the device or procedure can also have many benefits. “An examiner is going to be more persuaded that your invention is novel and non-obvious over the prior art if you can explain why a particular feature or component is so important,” Koch said.
Koch also recommends considering other feasible alternatives that were conceived during the development phase. “Consider including a detailed description of those alternatives in the application,” he suggested, noting that he has seen those alternatives supporting very valuable claims later in the life of a patent portfolio. Another useful exercise for identifying important alternatives involves closely reviewing the embodiments that are disclosed in an application and imagining how a competitor could change the design and still provide a useful product or process.
Inventors must take ownership
While patent attorneys play a valuable role, Koch stressed that founders shouldn’t abdicate the work: “I’ve seen too many cases where a really remarkable point in the technology wasn’t communicated as well as it could have been to the attorneys and therefore didn’t end up in the patent application.” Except in limited circumstances, discrepancies cannot be corrected after an application is filed. So, the more involved the company is at an early stage of preparing a patent application, the better the results tend to be.
It’s also worth considering a design patent, which protects the ornamental appearance of a product rather than its function. For medtech companies, this can be especially relevant for elements like device handles or other distinctive features that may influence adoption.
Claims and prior art
While much of a patent application focuses on description, the claims ultimately determine what is protected. Accordingly, company and innovator involvement in the claim strategy, or at least ensuring that the attorney handling the claim strategy understands the most important objectives for protection, often yields much better results.
Sometimes, “the best claim is the narrowest claim that is infringed,” Koch said. “If you’ve got a claim that is so broad that it is vulnerable to invalidity attacks, that claim is not going to be as powerful as a claim that is narrow but still covers the competitor’s product.” This is why claim diversity – having multiple and diverse layers protecting different aspects of the invention – is so important.
Moreover, during the patent examination process, there is often substantial back-and-forth with the Patent Office, and claims are frequently narrowed in response to prior art. Prior art can be any publicly accessible published document or product existing before the filing or priority date of an application, including patents and patent application publications, products, product brochures, photographs, or even public demonstrations or videos that predate the filing or priority date of a patent application. Even though the United States offers a one-year grace period for certain disclosures of the inventors such as in some of the examples listed above, most countries do not.
Align patent strategy with business strategy and budget appropriately
Patent protection is a long-term investment, and companies need to plan for it accordingly. As the product evolves and you make improvements, prioritize filing new applications. Kregg suggests a staged approach, such as the following, which are meant for general guidance only:
- Early stage: Company should focus on:
- Protecting core technology with a comprehensive initial application rich in details and alternatives
- Initiating international filings on core technology company should
- Keeping at least US applications in core patent families pending
- Mid-stage: Company should
- Have granted US patents with a diverse claim set covering the core technology
- Expand claim coverage to additional components, methods of use, and related systems like the software interface
- Make progress on international filings in important countries
- Have pending patent applications (if not granted patents) that cover future iterations of its products or processes
- Commercial stage: Company should have:
- A strategic portfolio of granted patents with diverse claim protection covering all aspects of system and relevant processes in the US and in the more important international markets
- Have issued patents covering multiple generations of products or processes
- Patents that cover close competitor products
While U.S. patent protection is often the priority, medtech companies eventually need to consider international markets. The Patent Cooperation Treaty (PCT) can help manage both cost and timing for utility applications by allowing companies to initiate international protection with a single application that can be later used for national stage applications in any of the 158 “Contracting States” that are part of the PCT system.
Use AI carefully
No modern conversation is complete without touching on AI. Koch compared it to “a very sharp knife – an effective tool if used carefully, but with dire consequences if not.”
One of the biggest potential risks is breaching confidentiality, which can prevent a company from getting a patent and can give an unwanted advantage to a company’s competitors. Many public AI platforms provide no guardrails to protect against public disclosure. This means that information or data that you input into an unprotected AI platform, such as technical details or early concepts, can be shared with other users outside of your organization, used to train AI models, or otherwise be discoverable by other third parties. These risks can be reduced or eliminated by using enterprise and other non-public facing AI platforms, opting out of data sharing, and reviewing AI platform terms of use policies carefully and avoiding AI platforms that don’t have such safeguards in place.
Related to this, many AI platforms store user data which can be discoverable in litigation. If, for example, you did a patentability analysis using AI and disclosed confidential information about your invention to the AI platform, this can be tantamount to a public disclosure.
AI can also introduce limitations around the very concept of inventorship. Because the US and other patent systems require that inventors be human, using AI as a source of new ideas or technical solutions can create a cloud on inventorship. For example, if an AI system generates alternative approaches or expanded parameters that are inventive and that are incorporated into the disclosure and claims of a patent application, there is a substantial risk that such inventions would not qualify for patent protection.
If using AI to help prepare invention disclosure or descriptions for a patent application, Koch suggested keeping iron-clad records that prove you and/or the other joint inventors were the ones who conceived of the inventions. “Describe different alternatives and commit as many details as you can to writing, such as in a laboratory notebook – something where you can’t remove or insert pages – before generating any content using AI as solid evidentiary proof that you or the joint inventors were the real inventors.” Filing a provisional patent application, or emailing the write-up to yourself to have proof of what was conceived before any AI output was generated, can also provide a safeguard.
While AI can play a supporting role for research tasks, Koch cautioned the audience to always verify the information. “Beware of AI hallucinations and verify the accuracy of anything you get.”
Building IP that lasts
As attendees learned, patents are an ongoing part of building and scaling a medtech company, rather than a one-time milestone. Effective teams will stay closely involved and align their IP strategy with the larger plan to compete and grow.
Koch appreciated the back-and-forth interaction experienced during the session. “I always value the thoughtful, engaging discussions with the innovator community.” he said. “I left feeling inspired and optimistic about the future of medtech after spending time with such an exceptional group.”