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Most read 2019: Antibody case law clearer in the US than Europe
Pharma innovators say clearer standards on how monoclonal antibody patent applications are reviewed at the USPTO and US national courts have made it easier to file patents there than at the EPO
By Charlotte Kilpatrick
September 05 2019
In-house sources at Sanofi, Bristol-Myers Squibb and a European pharma innovator say the differences in how the US and European patent offices and national courts review monoclonal antibody applications make filing patents clearer and safer in the former.
In Amgen v Sanofi, the Federal Circuit concluded that claiming a broad class of antibodies that could bind to a sequenced target is not enough, and that innovators must provide sufficient examples of new antibodies to support their claims.
This is not the case at the EPO; which, unlike its counterpart across the pond, still considers applications with broad functional class claims. And the added clarity that limits the scope of what can be protected in a claim gives more certainty for drug makers filing at the USPTO.
“The antibody case law is more developed in the US than in the EPO or national European courts,” says Karine Crepin, vice president and head of biologic patents at Sanofi in Paris. “We hope to get more clarity and guidance with time when cases arrive at the Technical Boards of Appeal.”
These therapies are worth a lot of money for pharma innovators. Humira, a monoclonal antibody therapy for rheumatoid arthritis, generated $25.6 billion for AbbVie in 2016. Getting the right patent protection can be worth billions of dollars for drug makers.
“A fundamental difference between the offices is the inventive step approach in Europe for antibodies – compared to the US, where sequence-based claims are generally viewed as non-obvious,” says Paul Golian, vice president and general counsel of IP for Bristol-Myers Squibb in New York.
“The US office has taken the view that an antibody with a novel structure, defined by the amino acid sequences of the variable regions, is not obvious and, therefore, meets the non-obviousness requirement,” he adds.
Golian says the EPO, by contrast, has taken the view that the same antibody would be obvious.
To overcome an antibody inventive step rejection at the EPO, the patent applicant must establish that the claimed antibody has an unexpected technical effect or functional