The Court of Appeal’s decision has far-reaching implications for drug patents.
A US appeals court recently restricted patent claims on the treatment of antibodies, and legal experts suggest the decision could force biologics manufacturers in the pharmaceutical industry to review the protection of their products. The decision was made due to a feud between Amgen and Sanofi, who were competing for market share of PCSK9 inhibitors, cholesterol-lowering injectables. After years of conflict, the appeals court ruled that two of Amgen’s patents for its Repatha cholesterol drugs were invalid.
The methods Amgen used to assert claims in its patents have been questioned. For this reason, pharmaceutical manufacturers will have to be more careful when issuing patents in the future. This leads to questions about the types of claims companies may have about monoclonal antibodies.
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In essence, the court argued that an application was only complete if it contained enough information about its invention “so that someone else could make the same invention without undue experimentation”. What the court questioned in Amgen’s case was that there was an exaggerated “functional claim” or information about what his product did, “rather than describing the invention itself in more detail”. The court therefore came to the conclusion that “an excessively expansive functional claim that does not reveal sufficient details can be regarded as invalid”.
In his claims for Repatha, a monoclonal antibody, Amgen referred to any monoclonal antibody that binds to a particular protein. However, this could have referred to hundreds or more antibodies, although the patent only fully described a small number. As a result, someone would have to examine all of these antibodies to see if they fulfill the function Amgen claims, ”the decision said. This would have required “inadequate experimentation”.
“I think that’s a big deal,” said Jacob Sherkow, a law professor at the University of Illinois at Urbana-Champaign who specializes in patents and life sciences. “A huge swath of antibody patents is just like Amgen’s patents. So if these are not valid according to this new standard [issued by the appeals court]Then you can think that the other patents are probably not valid either. This affects the market power for these drugs. You add up and do some analysis and I think you are in the billion dollar range. So much [revenue] would be wiped out if we got rid of anywhere between 10% and 50% of the antibody patent property. From an economic point of view, this is a significant case. “
Robin Feldman, a professor at UC Hastings College of Law, added. “At the end of the covenant [appeals court] said the parameters were insufficient. The [court] did not close the door completely when it came to functional requirements. However, the space provided is so cramped that it’s hard to imagine anyone could fit through it, ”explained Robin Feldman, professor at UC Hastings College of Law. “This will put pressure on the pharmaceutical industry as drug manufacturers headlong into the high-priced biologics market. Patent attorneys in the industry now have to think long and hard about whether or not they can rely on many of the patents in their portfolios, especially with organic companies. “
Biologicals manufacturers have to balance functional claims against those clearly outlining the invention of a product, or they may have a day in court.
A US court ruling can force biologics manufacturers to review patent protection
According to Amgen’s decision, biologics is subject to stricter patent examination