Navigating the shifting sands of biotechnology patenting

Taken from a webinar between Suzanne Renes, Nicole Mastrangelo and David Diamond on 24 September 2024, chaired by Will Arends (Partner, Marks & Clerk)

The world of biotechnology and therapeutic patents has seen a flurry of activity in recent years, with critical court decisions reshaping the legal landscape. Two landmark cases - the EPO's G2/21 ruling and the U.S. Supreme Court's Amgen v. Sanofi decision - have had a profound impact on how inventors and patent practitioners must approach the ever-important issues of sufficiency of disclosure and enablement.

At the heart of these discussions lies the fundamental question: how much information must be included in a patent specification to justify the scope of the claimed invention? This has become an increasingly complex challenge, particularly in the rapidly evolving fields of biologics, antibodies, and other biotechnological innovations.

The EPO's G2/21 decision marked a significant shift in the legal test in Europe for assessing whether post-published evidence can be used to prove the existence of a technical effect. Previously, patent applicants had to demonstrate that the technical effect was made plausible in the patent application itself. However, the G2/21 ruling replaced this with a more applicant-friendly "encompassed and embodied" standard, apparently lowering the threshold for taking post-published evidence into account.

"The G2/21 decision was a favourable outcome for originators," explains Suzanne Renes, from Sanofi. "It means that as long as the patent application provides a credible disclosure of the technical effect, the burden shifts to opponents to prove that it is not plausible - a higher bar than before."

Crucially, the decision also opened the door for greater use of post-filing evidence to demonstrate the claimed technical effect, provided it was already credibly disclosed in the original application. This gives patentees more flexibility to bolster their case during prosecution, rather than being strictly limited to the information available at the time of filing.

Across the Atlantic, the U.S. Supreme Court's Amgen v. Sanofi ruling has also had a profound impact, underscoring the need for comprehensive disclosure to support broad claims. The court affirmed that the scope of patent claims must be commensurate with the scope of the enablement provided in the specification.

"Amgen made it clear that you can't just have a roadmap or assay for identifying the claimed subject matter - you need to provide representative species and establish a clear structure-function relationship," says David Diamond, Head of Intellectual Property at Capstan Therapeutics.

These decisions have led patent practitioners to re-evaluate their filing strategies, often resulting in longer, more data-heavy applications. "I tell my scientists to give me as much data as possible," says Nicole Mastrangelo, IP Counsel at the Broad Institute of MIT and Harvard. "It's better to have the extra pages and pay the fees than risk having your claims rejected for lack of enablement."

Balancing breadth and sufficiency is a delicate dance. Originators want to secure the broadest possible protection, but they must ensure the specification can withstand scrutiny. One strategy is to include multiple layers of claims - broad independent claims supported by narrower dependent claims with additional functional limitations.

"I like to have at least 10-20 examples of species within the claimed genus to demonstrate how they all work similarly," Mastrangelo explains. "That gives me more hooks to hang my hat on if the broad claims are challenged."

Freedom-to-operate and competitor-monitoring considerations have also taken on greater importance.  Following the recent decisions in this legal area, there is an expectation that more challenges to patent applications will come forward as innovators become aware of their competitor’s portfolios. Patent applicants are also carefully incorporating relevant third-party patents and publications into their own filings, creating a more robust evidentiary record.

"If I see very broad claims without strong support in a competitor's patent, that gives me confidence that those claims won't hold up if challenged," Diamond notes. "Of course, you don't want to have to go down that road, but it's good to know the options."

The shifting landscape has also impacted the handling of medical use claims, particularly in light of increased clinical trial transparency requirements. Practitioners are opting for more narrowly tailored biochemical or molecular mechanism claims in early-stage filings, rather than broad treatment claims.

"You need to be strategic about what you disclose, especially when clinical trial information is becoming public sooner," Renes cautions. "Work closely with your regulatory and medical affairs teams to manage that delicate balance."

As the dust continues to settle on these landmark decisions, one thing is clear: biotechnology patenting has become a more complex landscape. It is ever more important for practitioners to understand the different legal standards and be aware of the challenges they face as well as the opportunities presented by the latest case law. But by staying attuned to the evolving legal landscape, being aware of competitor activity, and collaborating with regulatory colleagues, patent professionals can navigate these shifting sands and secure robust IP protection.