Antibody Patents: Details Under the Microscope

Antibody Patents: Details Under the Microscope

Antibodies are the microscopic superheroes of our immune system. Think of them as targeted missiles designed to annihilate specific threats like viruses, bacteria, or malignant cancer cells. Over the past couple of decades, scientists have figured out how to create custom antibodies to fight disease—a breakthrough that has helped lead to revolutionary treatments in cancer, autoimmune diseases, and inflammatory diseases.

But here’s the twist: while the number of antibodies successfully used in disease treatment is steadily growing, the laws around patenting them are complicated at best. And it’s making life quite difficult for biotech companies, researchers, and yes, intellectual property lawyers.

The basic idea of patenting an antibody is pretty straightforward: simply speaking, if you invent a new, nonobvious, and useful antibody, you can get exclusive rights to it for a limited time. Antibody patents help inventors protect their hard work and help companies get a return on the millions they invest in research. But when the invention is a protein with many possible configurations and a complex function, things get murky fast.

In the past, applicants have found it possible to get relatively broad patents covering antibodies. If they found one antibody that bound to a certain target, say, a cancer cell, they could often claim a whole family of similar antibodies, including some that hadn’t been made yet. The thinking was: “we’ve shown this works, and our reward for disclosing it to the public is that anything similar should belong to us.”

Enter the 2023 Amgen v. Sanofi case, where the U.S. Supreme Court let a lower court’s decision stand. The ruling tightened the screws on how specifically antibody patents must be written. Basically, the court indicated that broad “functional” antibody claims based on only a few specific examples may not be patentable because it would require undue experimentation to identify and characterize which of the broad class of claimed antibodies have the desired function.

This case highlighted the rule that to obtain a patent inventors are required to “enable” others to make and use their inventions without undue guesswork. For antibodies, when strictly applied, that means individually testing and describing thousands of molecular variants, each with its own slight differences, a potentially enormous undertaking.

Critics may argue that although strict interpretation of the enablement requirement guards against overreach it can also have a chilling effect. Strict interpretation of the enablement requirement can make patenting antibodies more expensive, time-consuming, and less predictable. This may discourage patent filing, delaying benefit to the public. On the other hand, stricter rules may prevent companies from hoarding intellectual property they haven’t fully developed.

So, where does that leave us?  Scientists continue to push the boundaries of what antibodies can do therapeutically, while patent attorneys are hard at work securing the legal armor for these advances, helping shepherd promising antibodies toward the clinic.

Julie K. Staple is a partner at Fishman Stewart with over 20 years of experience working with scientists and biotech executives and entrepreneurs. She has written and prosecuted patent applications in diverse areas relating to biotechnology including molecular and cellular biology, biochemistry, pharmaceuticals, chemistry, cancer biology and bio-electrochemical systems. Prior to turning to the practice of intellectual property law, she received a Ph.D. in neuroscience from the University of Michigan in Ann Arbor. Her research interests included the mechanisms which regulate the molecular components of the neuromuscular junction and regulation of synaptic protein heterogeneity in CNS synapses.