Sherry M Knowles

What led you to pursue a career in intellectual property and what advice do you have for anyone considering a similar path?

I sought a career that I would never get bored with, and patent law has not disappointed! Every client we represent provides us with a new technology or legal issue to delve into, allowing me to constantly learn and grow. It is not enough to simply represent a client. I have a passion to ensure that the client is better off than when they knocked on our door by recognising a creative path forward.

How do you build trust and understanding with clients to ensure that they make the most informed IP decisions?

Clients want to know that I have experience and a track record of success. They also want to feel that I personally care about them and their issues, which I always do. The best way to be a good attorney is to imagine ourselves as the client and think about what kind of counsel we would want.

You specialise in pharmaceutical and biotech patent law. These industries have been a focus of attention for patent reform. Why do you think this is and what is the proper approach?

Politicians worry about drug pricing, and we can all sympathise with that. However, patents are not the bad guys. It is basic economics. The higher the risk, the higher the reward must be to motivate the behaviour. In the case of drugs, it takes 10 years or more to advance from idea to approval, and then years on top of that to start making a profit. No rational businessperson would engage in such an industry when there are faster ways to convert capital to profit without a significant return. Further, the percentage of failures along the way is extremely high. We have to decide as a society whether we want cheap drugs or new drugs. It is probably not possible to have both.

If you could change one thing about patent policy in the United States, what would it be, and do you think that it is likely to happen?

I would encourage the government to honour the US Constitution when making patent laws. Only Congress retains the right to create substantive patent law unless a matter is specifically delegated to the USPTO
(eg, the rules for the PTAB) under the US Administrative Practices Act. The US federal courts, even the US Supreme Court, are only empowered to interpret patent laws, not to create them under the Constitution. We have seen repeated instances of the Supreme Court making substantive patent law (eg, with regard to patent eligibility) and the USPTO following the courts’ lead to apply laws not made by Congress. This culture has become embedded in patent law and will need strong action and many voices to correct.

Patent law, and in particular biopharmaceutical law, is becoming more global. How has this changed your practice and what advice do you have for others in the field?

Practitioners in biopharmaceutical patent law must now have a good working knowledge not just of the laws in their countries but the laws of many countries. This includes a working knowledge of what kinds of claim languages are accepted, whether there are any kinds of subject matter not currently patentable in some jurisdictions and how to positively address this, along with whether post-filing data is allowed in a response to office action or what the law is on overlapping claims in continuing applications. We must also gain familiarity with the litigation regime in countries in which our clients have – or want to have – a presence and how the prosecution file-wrapper in that country can affect the chances of successful litigation. In addition, we must be experienced in global opposition and revocation practice because we need to be ready if a client’s patent is challenged or we are asked to challenge a third-party patent. The increasingly global nature of our practice thus greatly expands the fund of knowledge that biopharmaceutical patent attorneys must be ready to use on short notice.