What led you to found your own law firm and what advice do you have for anyone considering doing the same?
In-house patent departments have faced increasing challenges in the past decade. The evolution of the America Invents Act, including post-grant proceedings, along with other developments in subject-matter eligibility, have exacerbated uncertainty and require ever-more sophisticated counsel. Meanwhile, legal and IP department budgets continue to shrink. I founded this firm as a special operations team to address clients’ needs with a high degree of expertise, while also maintaining a lean profile and efficient operations.
This decision proved to be a good one, and I encourage others to follow suit if they see a client need for a different kind of patent practice. Anyone looking to make such a move should be prepared to consider and reconsider every aspect of operations, to minimise internal inefficiencies and to keep client concerns paramount.
What are the most important USPTO-related considerations for pharma companies engaged in patent infringement proceedings?
While the USPTO does not handle patent infringement proceedings, pharma companies may engage in post-grant proceedings and/or prosecution of continuation or divisional applications at the office in parallel with infringement litigation in the courts or at the International Trade Commission. Although numerous factors play into both types of proceeding, considerations of portfolio management may be of heightened importance. Different types of claims of varying scope, and different patents or applications with different implications for patent term, may strengthen the rights holder’s position and place substantial hurdles in the path of its competitors. For important portfolios, maintaining a pending application can act as a moving target and shield the patent owners against competitor designarounds and validity challenges.
Which of your cases is the most memorable and why?
Our firm does not comment publicly on specific client matters. However, generally, we have handled memorable questions of enablement and written description under Section 112(b), especially with respect to claim scope for pharmaceutically or biologically active ingredients such as proteins and nucleic acids. (for deeper explanation of these issues, see Amgen v Sanofi, 987 F 3d 1080 (Fed Cir 2017); PacBio v Oxford Nanopore, 996 F 3d 1342 (Fed Cir 2021)). These questions arise, on one hand, in the context of patent prosecution, and on the other in the context of freedom to operate over potentially invalid competitor patents. Popular attention in the IP world may focus more on other issues that we encounter for clients, for example subject-matter eligibility under Section 101. Still, enablement and written description questions have an economic impact on the scope of protection available to pharmaceutical and life sciences companies.
Can you share some of your top tips for building trust and understanding with clients?
In my experience, trust and understanding spring from high-quality analysis and good communication. Particularly in chemistry and life sciences, clients expect counsel to dive deeply into the technical aspects. They want thoroughly considered recommendations and advocacy that relies on high proficiency in both the subject matter and the law. Such service has to come hand-in-hand with effective communication. Succinct plain-language explanations, timely but unobtrusive reminders and convenient updates can greatly enhance the client experience, enabled by strong cooperation between attorneys and staff.
Ultimately, all patent firms are trying to earn clients’ trust. Those that work the hardest and maintain the best focus on high-quality work and good communications will come out on top.
What trends do you see emerging in the life sciences and biotech space – and how can companies best position themselves to take advantage of these?
Calls for lower drug prices and different ideas about the US healthcare system may further complicate the already intricate balances that Congress has struck with the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act. In particular, the importance of biologics and the passage of the Defend Trade Secrets Act may make trade secret protection an attractive alternative to patent applications. Companies that file patent applications should manage portfolios strategically. Pending applications can serve as a tool for adapting to new developments in biotech intellectual property.
The accelerating pace of discovery in biotechnology has the potential to transform medicine and other scientific pursuits. Personalised medicine, computer-aided diagnostics and other digital technologies may require cross-disciplinary expertise in legal counsel. At the same time, advances in genetics and other microbiological fields require greater and greater depth of knowledge from patent attorneys. These concerns drive our firm’s special operations approach.
Kirsten Grüneberg is managing partner and co-founder of Grüneberg and Myers. Now in business for more than four years, the firm has experienced tremendous growth with Dr Grüneberg at the helm. Companies across the spectrum of technologies, including some of the largest chemical, pharmaceutical, and life sciences corporations in Europe, Asia, and North America, trust high-value IP projects to Dr Grüneberg and to the impressive team that she has attracted.