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Written Description Requirement for Antibody Claims

The Federal Circuit reversed and remanded a decision by the Delaware district court that found claims directed to a genus of antibodies satisfied the written description and enablement requirements. The Federal Circuit held that the district court erred by (1) excluding post-priority-date evidence to demonstrate that the patents did not provide adequate written description and (2) improperly instructing the jury on written description.

Prosecution
Author: Melissa J. Pytel

 

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A Non-limiting Preamble Strikes Again

The PTAB found that methods for treating patients using the chemotherapy drug Jevtana were unpatentable in light of references that taught administering the drug, but were silent on the drug's clinical efficacy. The Board disagreed with Aventis that the preamble of the claim required clinical efficacy, and indeed found the preambles to be non-limiting.

Prosecution, Post-Grant Proceedings
Author: Cynthia M. Bouchez, Ph.D.

 

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"Routine Optimization” Requires Articulated Reasoning

The Federal Circuit in In re Stepan vacated and remanded a PTAB decision that affirmed an examiner’s rejection of Stepan’s claims as obvious, stating that the Board “failed to adequately articulate its reasoning, erroneously rejected relevant evidence of nonobviousness, and improperly shifted to Stepan the burden of proving patentability.”

Prosecution
Authors: Minxi Rao, Ph.D. and Cynthia M. Bouchez, Ph.D.

 

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Velcade Patent Neither Inherently Obvious nor Obvious Under Lead Compound Analysis

In Millenium v. Sandoz, the claim at issue recites a lyophilized compound that is an ester of bortezomib and D-mannitol.  The Federal Circuit formulated the obviousness analysis by asking whether a person of ordinary skill, seeking to remedy the known instability of bortezomib "would obviously produce the D-mannitol ester of bortezomib, a previously unknown compound." Employing a lead compound analysis, the court concluded that the answer was no.  Using bortezomib as the lead compound, the court found that no cited reference provided a reason to produce the claimed mannitol ester.  The court also rejected the district court's inherency analysis as impermissible hinsight.

Prosecution
Author: Cynthia M. Bouchez, Ph.D.
 

 

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Takeaways from the USPTO Report on Subject Matter Eligibility

The PTO recently issued a report on two roundtables held to discuss patent eligible subject matter. Views on recent Supreme Court subject matter eligibility jurisprudence varied depending on the industry affected. The life sciences industry was strongly critical of the Mayo/Alice two-step framework. In particular, representatives from the life sciences industry asserted that “natural products and their derivatives form the basis for many biopharmaceutical innovations” and that “the act of isolating a natural product should be sufficient for patent subject matter eligibility, at least when isolation permits the product to be used or applied in a new or different way.” One commentator cited a National Institutes of Health study which estimated that 75 percent of antibacterial drugs and 80 percent of anti-cancer drugs approved by the FDA between 1981 and 2010 would not be patent eligible.

Prosecution
Authors: Minxi Rao, Ph.D., Cynthia M. Bouchez, Ph.D.

 

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