Sherry M Knowles

What is your proudest achievement over the past 12 months?

I am proudest of the work we do to support innovators in pharmaceutical life sciences. There is currently a big debate about how to reduce drug prices, and very little discussion about how to create new drugs and then finance the expenditure to get them adequately tested and to market. There are many diseases for which there is no or an insufficient treatment, so this goal touches each of us. We help our clients with IP strategy to protect their inventions of new drugs so they can attract the funds needed to support development. We also address strategy issues when they arise to keep the advances on course and to patients.

I am also proud to contribute to the conversation on patent policy. There is currently an anti-patent sentiment that can demotivate innovation. We all need to speak up and support strong patent rights, which allows the patent holder to have a well-settled expectation of market exclusivity and confidence to fund the commercialisation of inventions, which give all of us a better quality of life.

The landscape for patent eligibility in the United States continues to lack certainty – what predictions would you make for this area in the next 12 months?

There is currently an effort in Congress by some senators to pass a bill to override the US Supreme Court’s unconstitutional case law that changes, instead of interprets, 35 USC 101. I applaud these Congressional efforts, because the US Constitution grants Congress the sole power to create patent law. It is extremely problematic that the Supreme Court has ignored the Constitution and created judicial exceptions to the statute. That said, we are approaching 2022 midterm elections and then a presidential election in 2024. This may slow progress on a Congressional fix to the problem.

Kathi Vidal was appointed head of USPTO earlier this year – what difference, if any, have you observed so far under her leaderships?

Director Vidal is currently ‘drinking from the firehose’. There are so many issues to address, and conflicting views on how to go forward, that it will certainly be hard to stay focused and make progress. It is my hope that she does not take the draconian steps suggested by a few senators to increase the burden on patent applicants to search and analyse their own claims. This would be a nightmare in later litigation as it pertains to the duty of disclosure. I would also like to see Director Vidal acknowledge that the judicially created non-statutory doctrine of obviousness-type double patenting was not codified by Congress nor was its antidote, terminal disclaimers, as currently required by the Patent Office.

Now that the dust is beginning to settle after the pandemic, do you think that covid has permanently altered the direction of the biopharma industry, or is it a return to business as usual?

The accelerated research on mRNA covid vaccines and new pharmaceutical drugs for the treatment of coronaviruses will have a positive effect on future therapeutic treatments. Again, the pharmaceutical industry has quickly come to the rescue to fight a global health challenge. We will no doubt see an acceleration of additional vaccines against a range of viruses and new drugs in the pipeline that we will benefit from for years to come.

How do you manage expectations and maintain close working relationships with clients when the stakes are so high?

I work very closely with my clients and personally care about their needs. It is important to feel the same urgency that your client feels to deliver whatever tasks arise. It also takes hard work to truly understand the issues and add value to the solutions.