The problems with patenting antibodies
“When it comes to protecting biopharmaceutical inventions, particularly antibody inventions, there is definitely not a one-size-fits-all approach,” remarks Kathy Coulter, senior IP counsel at Bristol-Myers Squibb (BMS) in San Francisco.
“In the case of therapeutic antibodies, patent strategy needs to be specifically tailored for each invention, taking into consideration many factors including the scientific approach used to discover the antibody, the IP landscape for the antibody target, and the jurisdictions in which patent protection will be sought.”
Coulter, whose job it is to develop and implement global patent procurement strategies for BMS, says she was drawn to work for the company due to its track record in discovering transformational cancer therapies and drug discovery research. In her position as senior IP counsel Coulter also conducts diligence and transactional activities in supporting BMS’s oncology research pipeline.
With a PhD in biochemistry and five years of postdoctoral experience, Coulter is well trained to communicate effectively with scientists at BMS. As an IP lawyer, she says it is essential that she works closely with the scientists so that she can fully understand the inventions.
Coulter uses this knowledge and experience to further communicate the results of BMS’s research to patent offices around the world, demonstrating that the company’s inventions should meet requirements for patentability.
She says that working with outside patent counsel in each jurisdiction to understand what to include in each patent application is also important. This process must demonstrate that BMS’s antibody inventions meet the requirements for patentability in each jurisdiction.
Different strokes
Meeting differing protection standards in several regions can present challenges in gaining patent status.
“One example of a challenge that practitioners face in pursuing patent protection for biopharmaceuticals is the different approaches that the US Patent and Trademark Office (USPTO) and the European Patent Office (EPO) adopt in examining antibody inventions to assess non-obviousness/inventiveness,” Coulter explains.
The USPTO’s approach emphasises the structural uniqueness of an antibody, while the EPO approach focuses on the functional uniqueness, she says.
“Savvy patent practitioners need to draft patent applications that take into account both approaches to patentability,” she adds. This is in order to meet the USPTO’s and EPO’s different interpretations of non-obviousness/inventiveness.
“In other words, when a patent practitioner is drafting an application directed to a therapeutic antibody, he or she needs to think strategically and include data in the application showing that the antibody is both structurally and functionally non-obvious when compared with the prior art, thereby satisfying the requirements of both patent offices,” she says.
Staying up to date
With the patent landscape for pharmaceutical and biopharmaceutical inventions evolving, it is important that the law remains up to date with scientific developments.
Coulter also cites the implementation of the inter partes and post-grant review proceedings at the USPTO within the last six years as examples of how the patent landscape is adapting.
In addition, she says, there have been decisions in patent cases that have had a significant impact on the protection of inventions relating to therapeutic antibodies, such as Amgen v Sanofi.
“As a patent practitioner in this space, I find that I must continually adapt to this very dynamic IP landscape,” Coulter says.
While evolving technology has provided opportunities for drug development, it can also present some obstacles that need overcoming.
“Working with outside patent counsel in each jurisdiction to understand what to include in each patent application is also important.”
Coulter highlights that an important challenge is the need to secure patent protection for personalised medicine-related inventions in the US.
“We are currently in a period of rapid innovation in the personalised medicine space,” she comments.
“Personalised medicine has the potential to allow doctors to bring the right drug to the right patient, thereby maximising patient benefit and minimising risk.”
However, according to Coulter, the current state of US law presents barriers to obtaining patent protection for some types of personalised medicine inventions.
“As patent practitioners, we need to do our part to communicate the public policy rationale for ensuring strong patent protection for personalised medicine discoveries in order to ensure continued investment in innovations in this promising area,” she concludes.
