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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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Paying for Unreasonable Conduct – Attorney Fee Awards under § 285

The Federal Circuit recently reversed and remanded a district court's denial of attorney's fees to ADS after Rothschild sued ADS for infringement.1 The Federal Circuit found that the lower court abused its discretion for (a) failing to consider Rothschild’s willful ignorance of the prior art; (b) misjudging Rothschild's conduct in other litigation and (c) improperly conflating Rule 11 with 35 USC § 285.

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

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