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19 August 2021GenericsAlex Baldwin

Fed Circ upholds three Teva patents, axes others

The  US Court of Appeals for the Federal Circuit has affirmed US  Patent Trial and Appeal Board’s (PTAB) decisions upholding three patents related to Teva Pharmaceutical’s migraine drug Ajovy, but has invalidated six others.

In a  precedential opinion handed down on Monday, 16 August, the court ruled that US pharmaceutical company  Eli Lilly failed to prove why Teva’s method of treatment patents were obvious over prior art.

But in  two other opinions published on the same day, judges Alan Lourie, William Bryson and Kathleen O’Malley affirmed that the other six patents related to the drug were invalid over the prior art.

Steven Rizzi, principal with  McKool Smith, said: “These decisions validate a common practice among innovators in the life sciences sector: the pursuit of multiple patents directed to different aspects of their innovations.

He added: “Here, even though Teva may no longer be able to enforce the antibody patents, the method of treatment patents alone may be sufficient for it to maintain exclusivity and bar competitors from the market.”

Precedential opinions

The panel designated two of the three opinions (those related to the method patents and one set of the antibody patents) as precedential.

According to Rizzi, the opinions offer a new perspective relating to the analysis of patents on the grounds of obviousness.

“The [precedential] opinion concerning the antibody patents includes some interesting discussion regarding two factors in the obviousness analysis—motivation to combine and the nexus requirement of commercial success. For the opinion on the method of treatment patents, the discussion of whether the preamble of the claims is limiting stands out.”

Infringement claims

Teva had originally sued Eli Lilly in 2018 claiming that its competing migraine treatment Emgality infringed the Ajovy patents.

In response, Eli Lilly challenged the validity of all claims of the nine Ajovy patents in inter partes review proceedings before the PTAB. The board issued three final decisions, each dealing with the validity of three patents.

The board invalidated six of the patents directed to the drug, which were related to “antibodies that target calcitonin gene-related peptides”, while upholding the patents related to methods of using the antibodies as treatment.

Infringement proceedings will continue at the US District Court for the District of Massachusetts, “barring any further decisions in these cases on appeal,” Rizzi said.

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1 March 2017   Speciality pharmaceutical company Orexo has filed a complaint against Actavis and its parent company Teva for infringing patents protecting Orexo’s Suboxone and Subutex.
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25 February 2021   A panel of the US Court of Appeals for the Federal Circuit has considered for a second time the $235 million award to GlaxoSmithKline after Teva Pharmaceuticals was found to have infringed its Coreg heart drug.