Fogarty Innovation’s most recent half-day workshop took a deep dive into intellectual property (IP). Titled “Inventing During Pre-Clinical and Clinical Stages,” the event was organized by Denise Zarins, FI’s COO, and Peggy McLaughlin, FI’s strategic clinical and regulatory advisor, as part of the organization’s ongoing educational programming. The workshop explored the importance of IP throughout the device development process, utilizing real-world case studies to offer valuable insight into how companies can protect themselves with best practices related to data ownership, publications rights and contracts.
The event featured prominent experts from a number of different companies, including Eb Bright of ExploraMed; Peter Socarras of Nevro; Bill Revelos, of Insight Legal Services, representing CorVista Health; Anne Rubin of Perceive Biotherapeutics; Michi Garrison of Michi Garrison Consulting; Aris Gregorian of SLW; and Alex Key and Shefali Tandon of WSGR.
Zarins kicked off the event with an overview highlighting the importance of IP and areas where startups commonly face challenges in filing patents during the preclinical and clinical stages. As companies gain new insights into how they can improve their technology, it necessitates changing designs and filing more patents along the way. “Advancing through the different stages is an opportunity to keep expanding your IP and building value for the organization,” she said.
Case studies offer real-life lessons
The speakers generously shared their experiences, recounting stories of navigating challenges posed by established competitors or innovating new treatment options by uncovering novel solutions to pressing health issues. These included Nevro’s improved technique to treat pain with spinal cord stimulation; Acclarent’s pioneering work in balloon sinuplasty as a treatment for chronic sinusitis; ForSight Vision5’s creation of sustained release product for patients with glaucoma; Silk Road Medical’s optimization of the Transcarotid Artery Revascularization method for stroke prevention; Neotract’s improved treatment for men with an enlarged prostate; and CorVista Health’s creation of a digital platform that leverages AI technology for non-invasive cardiac diagnoses.
While recounting their diverse journeys and processes, the speakers shared a number of different lessons. These included the importance of analyzing every detail and step of a method to clearly identify the difference from what’s been done before; creating a specification that’s as broad as possible at every stage; utilizing a defensive IP strategy; including all disease states a company may be addressing and patenting every variation of a procedure; and making the most of a platform concept by considering licensing and spinoff opportunities, which further add to the value of the enterprise. By constantly staying on top of opportunities to file new IP—and ensuring that each one offers novelty, utility and non-obviousness—companies can create what one presenter described as “a nice thicket and hornet’s nest for the competition.”
Additional advice included taking the time to thoughtfully plan the strategy when a company receives promising clinical results. While the temptation is to publish the study right away, it’s best to engage the entire team, including the patent attorney, marketing specialist and clinical and regulatory specialists, to coalesce around a go-to-market strategy and common language that will be used in all published materials including the FDA submission, manuals and more, in order to guard against a competitor leveraging part of the approach and technology..
In addition, Gregorian discussed navigating product changes post-patent filing, noting that software, particularly, is a category where it’s easy to iterate the product and roll out changes. In example, he shared the story of a client who developed an app that allowed real-time 3D modeling for improved fit and reduced cost for prosthetics. The client later realized his company could expand to produce precise 3D models for different industries for anything that requires a custom fit, such as helmets, mouth guards and insoles. Because product evolution is inevitable, Gregorian reminded companies to be prepared to take full advantage of opportunities to expand into new markets with new product features.
Finally, the speakers underscored the significance of regularly conducting IP audits. This practice helps identify potential vulnerabilities, ensures alignment with business goals, prepares for market shifts, and maintains awareness of patents and any gaps that may need addressing as products evolve and technologychanges.
Additional insights on protecting vital interests
Alex Key and Shefali Tandon of WSG wrapped up with a primer on how companies, investors and acquirers may be thinking about transactions. They walked the audience through four pillars:
1. Does the company have a clearly articulated partnering transations?
The speakers recommended building in flexibility by avoiding too narrow of a product definition and ideally making sure the transactional strategy is synergistic with product and patent strategy. There are many different types of contracts that can be put together when first getting started to protect the company, from employment agreements to clinical trial agreements, customer contracts and eventually M&A or IPO documentation.
2. Does the company own applicable IP or have sufficient license rights?
While a clear title and/or license to rights to IP seems easy in principle, several companies fail here so the speakers emphasized why unambiguous ownership of IP is paramount. Additionally, it is critical that anyone who’s contributing to IP didn’t bring any trade secrets over from previous roles; doesn’t have conflicting agreements that could lay claim to IP rights for licenses; and that they agree to assign all their inventions to the company.
3. Does the company otherwise have freedom-to-operate contractually?
It’s important to be sure there is no third-party IP that could block the company, given that many strategic partners / acquirers are looking for exclusivity. It’s crucial to ensure there are no conflicting rights or obligations and that the company isn’t subject to non-competes, exclusivity provisions or other material contractual restrictions.
4. Does the company control the message (i.e., publications and other disclosures) regarding its products/technology?
To the extent practical, the company needs to have the ability to control its messaging regarding its product and technologies, including advocating for publication rights and obligations that are reasonably protective of the company. For example, if a university is publishing, will it provide the company with the report before it’s released so that the company can review it and remove confidential information, and/or potentially delay the publication to allow for patent protection? In addition, it’s important to align on press release strategy with other partners.
Overall, the workshop offered numerous practical insights into what companies need to consider as they aim to safeguard their innovations through effective IP strategy. A strong IP framework serves as the foundation for a strategy that will attract investors and help a company refine its medtech innovations to improve patient care.