Brent R Bellows
Trade secrets can be a key part of clients’ innovations but incorporating them into an IP strategy presents various obstacles. What can IP professionals do to overcome these?
Trade secrets can drive significant economic advantages under the right conditions, but many clients tend to focus primarily on patents as a basis for protecting intellectual property. Our role is to assist clients in balancing patent protection with trade secret protection. This is especially important for technologies that are particularly difficult to protect with patents due to infringement detection, or where disclosure through a patent publication may provide key technological advancement insight for a competitor, allowing them to develop potential workarounds. In the life sciences, I tend to raise trade secret protection in biologics manufacturing, where an efficient manufacturing process can be difficult to develop, reverse engineering is not probable and the client does not need to disclose the process in scientific presentations.
What are the main challenges facing your clients at present, and how are you helping them to mitigate these?
The pharma and biotech industry in the United States is facing significant challenges: a dearth of readily available financing due to marketplace and economic uncertainty, unsettling and drastic changes in patent laws that have significantly weakened patent protection, and the government’s foray into drug price controls through the ill-conceived Inflation Reduction Act, which has disincentivised companies from targeting our biggest disease indications. In navigating these issues, we work closely with our clients to ensure that they fully understand the likelihood of challenges to their patented assets, the expected timelines for such challenges and the runway of expected exclusivities affecting market share. This allows them to structure and manage their businesses accordingly.
If you could change three things about the life science patent prosecution landscape in the United States, what would they be, and do you think they are likely to happen?
I would revise what seems to be a heightened written description requirement for pharma/biologic inventions, especially for foundational, early discoveries as they relate to method of use claims. Second, I would impart a presumption of validity in line with Title 35 of the US Code, Section 282, for patents being challenged in inter partes reviews and post-grant reviews at the PTAB. Last, I would provide an off-ramp mechanism that would allow a granted patent challenged in an inter partes review or post-grant review at the PTAB to go back into prosecution before an examiner at the USPTO. The current claim amendment procedures at the PTAB are unfairly restrictive and unworkable, especially given the import of estoppel effects that come with a final written decision rejecting a claim amendment. Unfortunately, each of these measures would likely require congressional intervention, which I think is unlikely.
What are your top tips for SMEs trying to build a robust IP portfolio, especially in the biotech sector?
All too often, SMEs fail to anticipate how costly robust IP protection can be, so they inaccurately budget for patent filings and prosecution. Given today’s difficult patenting environment, protecting a pharma/biological asset requires a comprehensive filing strategy from day one, an understanding of the prior art, suitable data to establish written description and enablement, and a well-written patent application that – if the asset makes it to market – will surely be challenged. Initial patent filings cannot be an afterthought in forming the business, but must be treated with just as much importance as the science that supports the asset. Without strong patents, the SME will continuously face challenges in securing funding, which can sink development of the asset and ultimately the company.
What has been the biggest challenge that you have faced in your professional career, and how did you overcome it?
When I was a very young attorney, a partner that I did much of my work for, whom I viewed as my advocate and mentor, left the firm I was working for. It was an incredibly challenging and uncertain time for me. Following this departure, I made a conscious effort to readjust my expectations of what my ideal practice would look like, which allowed me to reach out to other partners for work in areas outside of my comfort zone. I was incredibly lucky to be staffed on projects that I would never have been staffed on had it not been for the departure, which drastically expanded my experiences and understanding of patent law.
Brent R Bellows
Brent R Bellows is a partner with Knowles Intellectual Property Strategies in Atlanta, Georgia. He focuses on pharmaceutical and biotechnology patent strategy, including domestic and international patent preparation and prosecution, portfolio creation and management, and due diligence. Dr Bellows is particularly attuned to the strategic positioning and strengthening of patent portfolios encompassing clinically valuable assets. He represents a diverse range of clients, from entry-level and emerging start-ups to global corporations.