Imagine a patent lawyer deciding that the best strategy for his company would be to not seek a patent for a new product. Tim Witkowski, executive counsel for intellectual property at Boehringer Ingelheim, the world’s largest privately-held biopharmaceutical company, says that sometimes, that is the best course of action.
“Just because you can file for a patent doesn’t mean you should,” Witkowski explains. “Being a good in-house attorney means understanding and recommending actions that will further your company’s business goals. This means you need to know a lot more than just the legal issues and strategies that are possible.”
Witkowski’s perspective is informed by his undergraduate and graduate degrees in chemistry. “Having a scientific background influences the way I approach problems and gives me confidence to take on whatever comes my way,” he says. “Science teaches you to look for patterns and to try to extract rules to predict what will happen in future cases, which is very useful in the legal context.”
Along the way, Witkowski also learned different ways to practice patent law. “Some patent attorneys are happy doing just patent prosecution. They spend most of their time writing patent applications and getting them granted. Others focus on patent transactions and contracts. Others specialize in litigation—enforcing or attacking existing patents. All are important, but I thought I could be more effective if I understood and worked in all three areas.”
Witkowski discovered that to do all those things well, he needed to know the company’s overall business objectives and what it hoped to achieve with a certain product. Only then was he able to determine the right approach. “More patents are not always better,” he says. “If you automatically try to obtain patents on everything that is new, you may waste resources on unproductive activities and could actually reduce the exclusivity of your product.”
“Science teaches you to look for patterns and to try to extract rules to predict what will happen in future cases, which is very useful in the legal context.”
“For example, if a company gets a patent on a doorknob made of brass, their product, and then gets a second patent on a doorknob made of wood—essentially a variant of the brass doorknob—they might be required by the courts or the patent office to give up the time remaining on the first patent if it extends beyond the second patent. If the wood doorknob is not commercially important, the company may have lost years of protection for the brass doorknob for no good reason.”
In order to avoid problems and recognize opportunities, understanding patent law is not enough. Other legal exclusivities unique to biopharmaceutical products and FDA laws and regulations that apply to small-molecule drugs, biotech products, brand products, and generics must be mastered.
Consider a brand drug that has only one FDA-approved and patent-protected indication on the label (eg, reducing inflammation). Imagine, however, that the company receives FDA approval for that same drug’s ability to reduce pain, but does not obtain a patent for that indication. A generic company will then, in most circumstances, be able to issue the drug with just the second, pain-reducing indication on the label, essentially nullifying the drug’s patent protection for inflammation.
“The removal of patent-protected indications from generic products is known as ‘carving out’ or ‘skinny labeling’ and occurs when a brand product has more than one FDA-approved indication,” Witkowski explains. “You can see why pursuing approval for a second indication for a brand product might not be the right decision and has to be very carefully analyzed.”
To make the right decisions, Witkowski collaborates with Boehringer Ingelheim’s executive team, scientists, developers, regulatory affairs professionals, competitive intelligence analysts, marketers, and other members of the legal department and patent team (Boehringer Ingelheim has approximately sixty patent professionals worldwide—about a dozen based in the United States).
“It’s definitely not just me sitting in my office deciding what to do,” Witkowski says. “We all contribute useful perspectives to help make decisions that will contribute to the company’s overall strategy and goals, especially our ultimate objective of providing innovative products to patients to improve their health.”
In fact, collaboration helped Witkowski win Boehringer Ingelheim’s President’s Award for work related to Spiriva (in 2013) and Pradaxa (in 2015), two of the company’s top-selling drugs. “A lot of that work did not involve just patents,” he says. “I served as a counselor and strategist on those projects, challenging myself and others to think as creatively and broadly as possible and perhaps surprising some people who had a more limited view of what a legal counsel’s typical role is.
“If you define the ways you serve your company too narrowly, you’re unnecessarily limiting the impact you can have.”
Witkowski likes to think of patent attorneys that keep the “big picture” in mind as “product exclusivity strategists,” a title he proudly bestows on himself. Are young lawyers being taught this approach? “It’s hard to teach all this outside of practice. It would be more effective as an apprenticeship,” he says. “But students and young attorneys need to know that being an effective attorney requires a much broader approach than most people realize. You have to be ready to ask lots of questions, learn new things all the time, and analyze problems from a nonlegal perspective whenever necessary.” AHL