In the first of an occasional series of features spotlighting individual practitioners, Senior Legal Editor Dana Elfin of Bloomberg BNA interviewed Terry G. Mahn, a partner in Fish & Richardson’s Washington office, about practicing Food and Drug Administration law, in early June.
Mahn is managing principal of Fish & Richardson’s Washington office, and also leads the firm’s Regulatory and Government Affairs Practice Group. His practice is primarily before the FCC and FDA with emphasis on complex product authorizations. His FDA practice involves pharmaceutical and medical device approvals with special emphasis on drug exclusivities and patent protections under Hatch-Waxman and the Biologics Price Competition and Innovation Act for biosimilars. Mahn’s Federal Communications Commission practice includes all facets of spectrum allocation, wireless technology and licensing, and equipment approvals. He also is a member of the advisory board for the Bloomberg BNA Pharmaceutical Law & Industry Report.
The information contained in this article is not intended to constitute legal advice.
Counsel’s Corner: Integrating FDA Law With Intellectual Property Law Interview with Terry G. Mahn
Mahn started his involvement in FDA law in the mid-1970s, when the Medical Device Amendments were first adopted. Before that, devices weren’t really subject to government oversight, he said. ‘‘There were no 510(k)s, no PMAs or anything, so we began to take a look at the medical devices practice, and eventually got pulled into the drug [regulatory] practice, too.’’
In describing the unique aspects of his firm’s FDA practice, Mahn said, ‘‘Traditionally, the firms that specialize in FDA regulatory work don’t have a comfort with the patent work.’’ In big law firms, there’s often a disconnect between the firm’s patent work and its FDA regulatory work. Fish & Richardson, Mahn said, decided that the firm was going to ‘‘work that interface smoothly without any bumps’’ and bring both areas of expertise together.
He said he’s particularly proud that he has helped move the thinking of industry, drug regulators and other lawyers about the importance of recognizing method-of-use patents and how to protect them.
Incentivizing, developing and protecting method patents is going to be a critical issue for the industry if the field of personalized medicine is going to move forward, Mahn said. ‘‘Without it, we’re not going to move as quickly as we need to in that direction,’’ he said.
In the Hatch-Waxman arena, the pendulum swings very much in favor of generic drugmakers, Mahn said. But, he said, this swing has undermined the value of patents. A sizeable chunk of drug industry strength is founded on the strength of the U.S. patent system, he said.
‘‘There’s been a chipping away of patent protection,’’ he said. ‘‘You have a Food and Drug Administration regulatory policy that finds ways—intended or not—to avoid patent protections.’’ Other issues such as patent trolling also have contributed to this ‘‘chipping away,’’ he said.
‘‘This leads to a weakening of the patent foundation on which the drug business is built.’’
A big change in the Hatch-Waxman landscape, he said, came in 2003 when Congress made changes to the statute that affected what patents drug-company pioneers could submit for listing in the FDA’s Orange Book.
‘‘It fundamentally changed the way that brand companies were using the Orange Book,’’ he said. ‘‘It stopped some of the abuse that was occurring in terms of brand name companies getting multiple 30-month stays on [generic drug] approval.’’
Currently, he said, the drug industry is facing a substantial challenge in the area of off-label uses of its products.
The off-label issue affects a plethora of legal areas, Mahn observed, including First Amendment issues, Fifth Amendment issues, product liability, the False Claims Act, patent infringement and unfair trade.
And while the FDA recently announced it was planning to issue guidance clarifying some off-label-related topics (12 PLIR 838, 6/13/14), Mahn said, ‘‘They’re just nibbling at the edges. The FDA’s got a really tough job in this area.’’
When asked if he has advice for new lawyers interested in going into the FDA practice area, Mahn said lawyers starting out in this area should seek out a specialty that ‘‘can’t be done in-house.’’
‘‘Stand out from the crowd,’’ he said. ‘‘Ask what you can do that clients aren’t going to pull in-house: litigation is a good example but there are other areas as well,’’ he said.
Also, he said, lawyers new to FDA practice should be aware that, compared to some other agencies, ‘‘the FDA is a very opaque organization to deal with.’’
‘‘Too much decision making is hidden and undisclosed and it’s quite a bit based on discretion rather than concrete rules,’’ he said.
Lawyers going into the FDA practice ‘‘don’t necessarily need a technical background,’’ Mahn said, ‘‘but they need to be very comfortable with wanting to learn new science.’’