Working the Busy Intersection of Law, Science and Business

Burns & Levinson partner John Serio deploys his expertise in patent law and regulatory matters to assist clients in the pharma, medical device and food sectors.

CCBJ: You have considerable experience applying patent and regulatory law to scientific matters, including cases for clients in the food and drug industry that need to navigate complex regulatory terrain. What are some of the most interesting projects you’ve been involved with recently?

John Serio:My practice involves domestic and international clients ranging from startups to world-class academic institutions, to multinational corporations with worldwide patent portfolios where I direct the patent strategy. In my U.S. Food and Drug Administration (FDA) practice, I assist both small and large companies with FDA petitions, advertising and promotion, as well as with clinical trials on both a federal and state level.

I also help multinational food companies that are seeking to enter the U.S. market or want to promote the benefits of modified food products that have potential health benefits. I recently filed a qualified health claim petition with the FDA for a “functional foods” client seeking to promote the potential health benefits of a food product that has been processed using patented methods to increase nutrient content that’s thought to have beneficial medical properties.

You work extensively with companies that are regulated by the FDA. What issues are your clients dealing with right now in that space?

The Food Safety Modernization Act (FSMA), which regulates the way foods are grown, harvested and manufactured, has required greater regulatory oversight for domestic and foreign food companies, and it has also required foreign companies to comply with FDA requirements for food products produced oversees but sold in the U.S. For example, FSMA has caused regulatory hurdles for many foreign food producers dealing with pesticide residues in raw foodstuffs that may be acceptable in Europe and elsewhere but are unacceptable in the U.S. I recently had a large European food company that was seeking to enter the U.S. market, but the European wheat in its product contained a pesticide that the Environmental Protection Agency found unacceptable. We were able to identify this issue at an early stage, allowing the company to secure an alternative source of acceptable wheat. For another multinational food company, we brought both their raw and finished products into compliance with established U.S. Statements of Identify for food.

On the FDA drug side, I recently helped a client with construction plans for a manufacturing facility that would ensure compliance with Good Manufacturing Practices. The construction of pharmaceutical plants is an expensive undertaking, and therefore their design and systems need to be well thought-out, so that they will pass muster with regulatory inspectors. Contamination of pharmaceuticals and/or foods by impurities in the manufacturing facility is something that proper facility design and adequate quality control methods and systems can prevent.

You have experience helping pharmaceutical and medical device companies negotiate and prepare for clinical trials. What does this work entail and why is it so important?

Clinical trials are designed and conducted to generate data on safety and efficacy for an experimental drug or device. In addition to ensuring the safety of the participants, these trials need to comply with the federal regulatory framework, state regulations and foreign regulations, so that the data they produce can be used to support a regulatory application. I help clients ensure that the various kinds of documentation needed for these studies are compliant with the regulations, and I negotiate agreements with clinical sites that govern strict adherence to the study protocol and to Good Clinical Practices. If the therapeutic is manufactured by a contract manufacturer, I draft and negotiate the necessary supply agreements. If issues arise with a clinical site or the FDA, I help clients with those negotiations and discussions.

Pharmaceutical companies are increasingly using social media as part of their direct-to-consumer advertising campaigns. What legal and regulatory minefields do they have to navigate to be successful?

While companies are increasingly using social media as part of their promotional activities, it must comport with well-established guidelines for promoting pharmaceuticals and devices. The challenge with social media is that it is dynamic and can produce a narrative that is apt to change and is not as well controlled as traditional media forms. Pharmaceutical companies need to prevent the off-label promotion of their approved therapeutics. The problem with social media is that it can allow promotional activities to morph from a controlled message into one that has been changed by people who are not associated with the company – potentially resulting in off-label promotions that can be extremely damaging to a company.

How do you help clients prepare for and respond to an FDA recall?

It is imperative that a root cause analysis begins as early in the recall process as possible to ensure that an impurity or defect is truly present and to contain any recall to only those lots affected. As the company starts an analysis of a potential recall, my role is to begin a dialogue with the FDA, in order to understand their concerns and ensure that we are reacting in an appropriate manner. Timing is crucial in these matters, and an analysis of potential harm to the public dictates the measures needed to remove any product that poses a risk.

When it comes to recalls, the best offense is a good defense. I work with clients to make sure that they have a strong quality control function before a recall situation develops. Proper testing and validation of the products, and proper documentation of this important function, is not only required by regulations but also serves to prevent the occurrence of substandard products being released to the public.

Are there any FDA regulatory issues on the horizon?

Our firm has a cannabis practice group with a national reputation for handling legal issues in this emerging industry. I advise companies in this space on regulatory issues that are rapidly changing as the industry matures and gains acceptance. For example, the FDA recently approved a cannabis derivative (cannabidiol, or CBD) that has uses for epilepsy. One issue that this brings up is that it can be difficult to educate clients on the regulatory requirements for making health claims about products when many of their competitors seem to be unaware of or ignore the need to have FDA approval before they market cannabis products for medicinal use.

Last year, Sens. Orrin Hatch and Thom Tillis introduced the Hatch-Waxman Integrity Act of 2018. What do you think of this proposed amendment?

The Hatch-Waxman Integrity Act would prevent Abbreviated New Drug Application (ANDA) and biosimilar applicants from challenging patents in an inter partes review (IPR) or post-grant review (PGR) at the patent office, and it would bar those who already have challenged relevant patents from seeking FDA approval via an ANDA or biosimilar pathway. The intended effect of this amendment is that companies would have to choose between relying on the safety and efficacy of the approved product, in which case they could not challenge the patents by IPR/PGR, or challenging patents in a patent office trial proceeding, in which case they would have to develop their own safety and efficacy data.

I believe that the amendment is an important policy that preserves the benefits of the original Hatch-Waxman Act while allowing patent owners to prevent abusive efforts to invalidate protections for their medical therapies.

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