Profiles

Brian Malkin: Standing Out at the Intersection of Patent Law and FDA Regulatory Practice

August 23, 2022

By June Johnson

Attorney Brian Malkin, a partner at McDermott Will & Emery, counsels pharmaceutical and biotechnology clients on U.S. Food and Drug Administration (FDA) matters and intellectual property (IP) law. Working at the intersection of FDA regulation and patent law, Malkin is able to assist clients throughout the entire product life cycle, from financing, development, and approval to IP protection and transactional issues. He began his career as regulatory counsel at the FDA before working at several law firms in the District.

Where are you from originally, and why did you decide to practice law in the District of Columbia?

I am from Bethesda, Maryland, so it was natural for me to practice in D.C. I originally [took] the Maryland Bar and then waived into D.C. to simplify the admissions process. I moved to New York for a number of years, when my wife was involved in investment banking, and then we moved back [here] to raise our two boys.

How did you get into health care law?

Before deciding to attend law school, I had been interested in medicine. As I looked further into the medical profession, however, I realized that was more interested in … making my contribution regarding health care policy and public health by helping companies bring new and innovative products to market and address regulatory and other legal issues that may be preventing them from obtaining or continuing their market approval. Health care law is a very broad area that includes not only the FDA but [also] aspects of intellectual property; corporate law and contracts; privacy; finances, including funding research and development; [and] planning for payment and reimbursement for medical products and services and more.

You have a biochemistry degree. Is a science background required for this area of law?

A science background is not required for health care law, but [it] certainly helps with aspects such as intellectual property and understanding the clinical trial data presented to the FDA and other regulatory bodies for new product approvals. I did not study biochemistry initially in my undergraduate studies, which were primarily economics. I returned to university to obtain a biochemistry degree so I could also practice patent law in addition to my prior FDA regulatory legal practice.

How do you handle negotiations with the FDA to bring a product to market that is truly innovative or controversial?

Because I worked at the FDA before, I have a good understanding of what types of issues may provide the FDA with pause to approve a new or controversial product. Working as outside counsel for our pharmaceutical and other medical product companies, I can help [clients] provide the FDA with the required confidence to approve those new products and develop appropriate labeling and mechanisms, when required, to address any relevant safety or other concerns and educate health care providers appropriately to enable the products to provide maximum value to patients. In this capacity, I am acting as … a lawyer interpreting laws but [also], as you noted, a negotiator to help resolve issues and provide a path to market entry for new, sometimes controversial products. I believe that understanding where the FDA is coming from is critical to helping your client/company satisfy the regulatory requirements for marketing FDA-regulated products.

How much does patent law play a part of your daily practice?

While I am primarily a regulatory attorney, my “value add” is the ability to combine regulatory and patent law considerations for clients, so they can maximize their return for investing in various health care-related ventures, primarily related to pharmaceutical products. Patent law is a driver for companies to be able to obtain financing for their medical products, whether seeking external funds or internal support, if in a larger company already.

Obtaining both regulatory approvals and patents requires, in many instances, good clinical data and technical support, but the standards for FDA approval versus allowing a patent are different. It becomes critical to understand both areas to maximize returns for investment in clinical studies, which are very expensive and can be time-consuming, depending on the product and indications for use. So I would say patent law figures in daily but often in different ways depending on the project at hand.

What are the keys to successfully navigating patent law?

Understanding all of the elements of patent law, even if your practice, as in most cases, is limited to patent prosecution, litigation, or related issues such as settlements or negotiations or capital investments. In addition, I think it is important to identify your strengths to determine what areas are best suited to your skill set or inclinations for your primary practice area within patent law.

Has the cannabis industry impacted your practice? If so, how?

I think the cannabis industry is fascinating because while cannabis has been around for centuries or more, the legal issues are still developing and involve many legal disciplines, including intricacies involving federal and state law.

When I helped form the Cannabis Committee on Cannabis Law (and now Cannabis Law Section) for the New York State Bar Association, I thought it was critical to bring together all of those legal disciplines, from regulatory to corporate, intellectual property, real estate, criminal, environmental, banking, labor law, and more, including members from academia who were tracking how the area of cannabis law was developing nationally and internationally beyond being a merely medical or recreational product, which has many nuances. For instance, there is still a lot unsettled [around] cannabis “intoxication” when it comes to driving or operating dangerous machinery. I think there is a lot of research that still needs to be done to better understand the benefits and risks associated with cannabis use, whether for medicinal or recreational/adult uses, to properly regulate this space.

What professional obstacles have you encountered, and how have you overcome them?

It makes a lot of sense to combine patent law with my current and prior FDA regulatory practice, but it has not been always easy to find a way to combine both practice areas in a larger law firm. I have learned that not all law firms are alike in terms of culture and corporate structure, so for me it was critical to identify a law firm that has a team culture for projects rather than some firms with more siloed practice groups. For instance, the high volume of transactional and litigation work at McDermott helps to bring different legal disciplines within health care and life sciences and other areas together naturally.

What advice would you give a 3L student thinking of practicing in this area?

I think it is important for 3L students to truly understand all the facets of health care law to identify the areas that interest them the most. While many firms have health care practices, depending on the firm and its client base, those services may be limited, for example, to transactional or regulatory matters, without addressing all areas of health care holistically. As a result, it is important to identify specific interest areas, and then the appropriate law firms, companies, associations, etc. that have needs in those areas so a 3L can develop a background that would facilitate entry into those legal practice areas. For instance, I think for regulatory law, a good understanding of administrative law and legislative practice is key to build on as a foundation. In law school, I believe it is critical to take these foundational courses to enable lawyers to grow in their practices and also to think out of the box, when appropriate.

How has the D.C. Bar assisted in your career?

The D.C. Bar offers CLEs that have exposed me to advanced training in my field as well as provides opportunities for me to give back by taking on leadership positions in its Communities programs and providing mentorship to new attorneys. I also see the D.C. Bar as a way to connect with lawyers in other firms and corporate or regulatory environments to improve my practice and understanding of legal issues affecting various members in the same legal field.

What activities help you after a rough day at the office?

I try to get outside for physical exercise, whether it be for a simple walk around the block after a long meeting/call, a swim or workout in the gym, or something else to provide some release.