Novartis counsel: ‘Enablement is a consequential hurdle to patentability’
Senior pharma attorney and LSPN Boston speaker delves into emerging tech and patent law, the importance of communication and awareness, and the challenge of enablement | Advice on effective management of IP portfolios in the life sciences sector.
Joshua Buchman, senior patent attorney at Novartis, will be a speaker on the panel ‘Best Practice—Traversing the New Patent Eligibility Framework’ at LSPN Boston in May. Ahead of his appearance, he speaks to LSIPR about navigating tech and patent law, the challenge of ‘enablement’, and the need for communication and awareness to balance innovation and collaboration.
LSIPR: What are the most important emerging technologies on the horizon? And how are they affecting patent law and strategy in the life sciences sector?
Joshua Buchman: Artificial intelligence (AI) and advanced complex biologics,eg, CAR-T technologies. AI may be the tool that ushers in a new era in biotechnology, but also it raises a host of issues concerning inventorship and the sufficiency of human contribution.
Patent applications directed to complex biologics require drafting attorneys to carefully consider telling their invention story in a way that establishes non-obviousness, while describing inventions that often bring together components of multiple technologies.
How can companies balance the need for patent protection with the need for open innovation and collaboration?
The keys to success are communication and awareness.
Pharmaceutical companies and those in the academic and healthcare sectors all thrive and depend on collaboration with one another to develop new ideas, bring new treatments to patients, and determine whether those treatments are safe and provide real benefit.
However, it is important to understand each party’s incentives and interests in a given collaborative endeavour to strike the right balance between promoting innovation and to ensure the protection of hard-earned rights.
This balance is only achieved by parties engaging their legal counsel (and other internal stakeholders) to establish the priorities, goals, and potential pitfalls of a collaboration, followed by conversations between the parties to achieve a mutual understanding and an agreement that meets the needs of all participants.
What do you perceive as the biggest challenges/risks when it comes to patent protection in your field?
Enablement has come back as a highly consequential hurdle to patentability in the last year with the Supreme Court’s ruling in Amgen v Sanofi.
The Amgen decision upended many practitioners’ understanding of what quantity of examples in a patent application is necessary to meet the enablement threshold and what claim scope those examples can support.
The tension between filing early to establish priority and waiting to collect enough data to satisfy the requirements of 35 U.S.C. § 112 has always existed, but Amgen suggests that practitioners need to think about these issues even more carefully than in the past.
Why did you pick the topic/session that you did on the agenda? Why is this important to you?
Practitioners, the US Patent and Trademark Office (USPTO), and to some extent the judiciary itself have been clamouring for years to receive better guidance on implementing the Section 101 jurisprudence.
The courts have tried to issue rulings consistent with those of the Supreme Court of the US, the USPTO has issued new tests and examiner guidance, and practitioners have done their best to make it through the necessary drafting and prosecution hoops to establish eligibility of claimed subject matter.
Nevertheless, confusion remains as far as what subject matter meets the 101 requirements.
Congress may finally be able to establish some clarity in this arena, and this is an effort worth pursuing.
What advice do you have for effective management of IP portfolios in the life sciences sector?
A lot of important IP management is not done in the act of drafting or prosecuting patents but in ensuring that a company’s confidential information remains just that.
To that end, knowing your stakeholders are aware of basic strategies for protecting IP and confidential information—and are comfortable discussing questions around IP with you—goes a long way toward ensuring your IP portfolio is not hampered by unwanted or unauthorised disclosures.
Additionally, understanding project priorities and how to leverage your team’s expertise can help you to allocate your effort to where it is needed most, and avoid wasting time on lesser priorities.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox
