Knowles Intellectual Property Strategies, LLC
Can you tell us about some of the biggest obstacles you have faced in your professional life – and how you have overcome them?
One of the biggest obstacles I have faced is time management. I have been blessed with a very busy career packed with client needs and, along the way, raised two children and started a global non-profit organisation (Malmar Knowles Family Foundation) to mentor talented youth in developing countries. This has created a wonderful but challenging blend of time commitments. Staying on top of everything takes efficiency, speed and dedication! However, I would not change it one bit. I am particularly honoured to play a role in our clients’ successes and to play my part to help get life-saving drugs to patients.
You have gone from in-house counsel to one of the biggest biopharmas in the world to running your own specialist boutique firm. What changes in your management style has this necessitated?
Actually, I ‘grew up’ in law firm practice, attaining equity partner at a global law firm where I started its pharmaceutical and biotech patent practice. Managing a practice at a global law firm is a complex task because it must be blended into the goals of the firm, which includes conflicts, resources and legal business model. It also involves training associates and ensuring the quality of the work. From there, I moved to GSK, where I was chief patent counsel. In-house practice is not measured in billable hours, but instead in providing solid support to the in-house client – research and transactional teams and senior management. The patent group managed all patent litigation, including abbreviated new drug application (ANDA) generic litigation, which is of critical importance to the company. In stage three of my career, I became entrepreneurial and started my own law firm to use these experiences to assist biopharmaceutical companies of all sizes. This allows me to spend less time on management and more time doing what I love – strategy. Notwithstanding the differences, my drive has always come from the knowledge that the client comes first and my efforts are focused to help the client get to the top of where it can go.
Subject matter eligibility remains a complex topic in the United States. What can be done to provide greater certainty to rights holders, and how likely is that to happen?
What a mess! The US Supreme Court has exercised jurisdiction it does not have under the US Constitution to create patent law by constructing a test for patent eligibility that is inconsistent with US statutory law. This can only be fixed by Congress revising the statute or by a change in judges at the US Supreme Court. Both avenues are difficult and political.
Biopharma companies derive a huge amount of value from their intellectual property. How do you manage expectations with clients when it comes to high-stakes litigation and key deals?
The best way to protect biopharma companies is with high-quality patents that hold up in litigation. It is hard to overestimate the importance of doing a thorough job on the front end. This includes a full understanding of the technology and taking the time to put an IP strategy in place at the beginning, even before patent applications are prepared. The patent application should be reviewed from the standpoint of the potential adversary that wants to invalidate it, so any weaknesses are identified early and overcome. One of the challenges in life sciences is that there is a long timeframe between when the first application is filed and when the drug is commercialised and then litigated. During this time, relevant laws might change, be reinterpreted or overruled, so IP life sciences strategists must view the patent not just with a current view but a potential future view for litigation success.
Looking ahead, what challenges do you see coming up and how can players in the biopharma space best position themselves to meet these?
There is a tremendous pressure on drug pricing, which can erroneously translate to an anti-patent environment. I think that we should attack the drug-pricing problem at its core, which is the cost and lengthy time of regulatory review. We should strive to maintain a strong pro-patent environment and make the regulatory processes more efficient. We must support an environment that motivates new innovation in healthcare to extend and save lives.
Sherry M Knowles
Sherry M Knowles is principal of Knowles Intellectual Property Strategies in Atlanta, Georgia. She provides global guidance on complex IP matters, litigation, licensing and prosecution strategy, policy and investor support. Ms Knowles has more than 30 years’ experience in global corporate and private practice. From 2006 to 2010, she was senior vice president and chief patent counsel at GlaxoSmithKline (GSK) and worldwide head of patents for litigation and transactional matters.
Click here to see her IAM 300 2020 profile.