Next Phase Newsletter

By Michael J. Moedritzer, Associate, Polsinelli (Special Guest Contributor)

For biotech founders, intellectual property (IP) can make or break a company. The life sciences industry is driven by innovation, but it is also crowded with patents. While it’s essential to build your own IP portfolio, it is just as critical to ensure that your product will not infringe on someone else’s. Overlooking this risk can expose your startup to costly lawsuits that could derail your business before it has a chance to grow.

What is an FTO Opinion?
An FTO Opinion is a legal review by an IP attorney that determines whether your startup can develop, manufacture, and sell a product without infringing existing patents. The attorney analyzes relevant patents and applications in your target markets and provides guidance on whether changes to your design or a licensing agreement might be necessary.

Why Founders Need It
For founders, an FTO Opinion provides more than legal coverage. It gives you peace of mind that you are not unknowingly putting your company at risk. It can also provide protection if litigation arises, helping you defend against claims of willful infringement and limiting potential increased damages. Most importantly, it strengthens your credibility with investors and partners by showing that you have done the due diligence to safeguard your innovations.

Where to Start
Securing an FTO Opinion requires working with an experienced IP attorney, who will tailor the analysis to your product and market strategy. While it is an investment, it is one that could save your company millions and ensure that your innovation makes it to market.

Michael Moedritzer is an Associate in Polsinelli’s Intellectual Property department. He focuses his practice on domestic and international patent prosecution and works with clients to revise, analyze and evaluate intellectual property-related issues to provide comprehensive overview of the portfolio.

Tags: AI, artificial-intelligence, business, entrepreneurship, finance, health, investing, startups, technology, venture capital

By Claire Davies, Shareholder, Polsinelli (Special Guest Contributor)

Life sciences companies are constantly innovating with the goal of developing groundbreaking medical products. Unfortunately, the most novel products often face more uncertainty about their regulatory pathway to market—with several factors heightening that uncertainty today. These include the loss of many FDA policy and scientific staff over the past six months and multiple changes in leadership, such as at the head of the agency’s drug and biologics programs. Although significant personnel change may present opportunities for companies that would benefit from a change in the agency’s historic regulatory approach, it also unsettles precedent for the FDA’s expectations. In addition, as numerous companies explore applications of generative AI, the agency itself has indicated that generative AI-enabled products present challenges to existing (often decades old) laws that govern FDA’s regulatory framework.

With these factors in play, companies may be tempted to hold off on spending resources to map out their regulatory strategy and get feedback from the agency. But incorporating regulatory considerations into early business plans remains key for a number of reasons:

• Efficient Product Development: Whether and how FDA will regulate your product determines the level of evidence and type of application needed to enter the market. (Does your AI-enabled product fall within an exception from regulation as a medical device? If not, it may require an FDA application supported by significant data.) An early understanding of the regulatory pathway can help companies budget development costs more accurately. It can also help them anticipate and proactively address regulatory hurdles, ultimately shortening the time it takes to get the product to market.
• Raising capital: Regardless of scientific promise, companies that underestimate the regulatory complexity of getting a medical product to market or that lack an experienced in-house or external advisory team in this area may be viewed as a risky proposition for investors. In contrast, a thorough understanding of the regulatory pathway and plan for navigating the challenges to commercialization can help distinguish a company from the crowd.

Ultimately, an early and proactive approach to your regulatory strategy is a critical investment that can help shorten time to market and increase your company’s attractiveness to investors.

Claire Davies is a Shareholder in Polsinelli’s FDA practice where she provides strategic counsel to help clients navigate FDA regulatory and compliance challenges. Claire has handled a wide range of issues involving medical devices, biological products, drugs and human cells, tissues and cellular and tissue-based products (HCT/Ps). Prior to joining Polsinelli, Claire spent nearly a decade as an attorney in the FDA’s Office of the Chief Counsel. Her work at FDA often involved advising agency leadership on high-profile and significant matters, such as responses to emerging public health threats and user fee negotiations with industry.

About Polsinelli

Polsinelli is an Am Law 100 firm with more than 1,200 attorneys in over 25 offices nationwide. Recognized as one of the top firms for excellent client service and client relationships, Polsinelli is committed to meeting our clients’ expectations of what a law firm should be. Our attorneys provide value through practical legal counsel infused with business insight, offering comprehensive corporate, transactional, litigation and regulatory services with a focus on health care, real estate, finance, technology, private equity and life sciences. Polsinelli PC, Polsinelli LLP in California, Polsinelli PC (Inc) in Florida.

Tags: AI, artificial-intelligence, business, entrepreneurship, finance, health, investing, startups, technology, venture capital