Knowles Intellectual Property Strategies, LLC
What has been your career highlight to date?
During my early law firm associate days, I played a lead role in the prosecution of the patent portfolio covering emtricitabine (FTC), currently one of the most widely prescribed medicines for HIV and a cornerstone of Gilead’s HIV franchise. I created the strategy for interferences and global oppositions in addition to complex US and global prosecution, and I like to think that I helped clear the way to commercialise a drug that has saved many lives. This experience allowed me to travel the world as a patent attorney, making life-long connections with colleagues who I still call on as matters arise in their countries. As chief patent counsel at GSK, I played a key role in its challenge to the USPTO’s final rules to limit the number of continuations and place draconian restrictions on the number of claims presented. We had great industry and trade organisation support for that litigation, which was favourably settled and the rules withdrawn. In addition, I have been very active in challenging the inappropriate judicially created law on patent eligibility in the United States, including via testimony before the US Senate Judiciary Committee and an article on the “Unconstitutional Application of 35 USC 101 by the US Supreme Court”. Of course, at the core, I mostly cherish the many clients that I have embedded with to progress life-saving drugs.
What emerging trends and technologies are having the biggest effect on the US biopharma patent landscape?
The creativity of current innovation in the life sciences area amazes me. Scientists are finding new ways to modulate prior ‘undruggable’ disease-associated proteins by degrading them in vivo using disease-transformative complex pharmaceutical molecules in small catalytic amounts, notably for cancer. One of our clients has developed a first-in-class pharmaceutical that will put healthy cells to sleep during chemotherapy, to increase quality of life during cancer treatment and decrease dangerous side effects. Another has created a pharmaceutical drug to treat covid-19 (or HCV) that can be taken at home as a simple pill. Yet another is developing a first-in-class topical cream to treat women with positive Pap smears and precancerous lesions. Other developmental products include transformative methods to treat ocular diseases to preserve eyesight. Cell therapies are also emerging that can train off-the-shelf human cells from donor sources to be injected into a patient to treat serious diseases. We all owe a debt of gratitude to the great scientists dedicated to improving our lives and the lives of our family members and friends, and to the biopharmaceutical companies that invest years and hundreds of millions of dollars to get these medicines to our cabinets.
What three factors would you say make a world-class IP strategy?
Can I suggest four? First, think outside of the box and dream the dream. Second, there is no substitute for hard work. Third, represent your clients with zeal and commitment. And fourth, try to leave the practice of patent law better than how you found it by contributing your time to patent law and policy improvements.
You established the Malmar Knowles Foundation and, through it, the Kectil Program. Can you tell us more about these and why they are so important?
It occurred to me that youth in developing countries have great talent but are missing exposure to an innovation ecosystem, mentors who have succeeded and advice on how to expand their vision to accomplish their goals. I decided to create a global mentoring organisation to help young people with a curriculum, networking opportunities and ways to meet each other to form a ‘Kectil Generation’ ready to advance themselves and their communities. We currently have more than 600 young people in our programme and a database of almost 3,000 globally. They are very inspiring and we are proud of all of them. The momentum is growing yearly.
How do you expect the biopharma licensing landscape to evolve in the next five years?
I expect the biopharma licensing landscape to become more global, which will require those of us in the field to know more about the business, legal and economic frameworks in other countries. I have worked on three large licences between US and Chinese companies in the past four months alone. Previously, deals were limited to United States/United States, United States/Europe or Europe/Europe. Chinese and other Asian companies are agreeing to Western-level deal terms, which they resisted in the past. This is opening doors to new collaborations.
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, Ms Knowles 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 Patent 1000 2020 profile.