US Legal and Regulatory Update

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References

Braier

. A brief summary of the America Invents Act. J Gen Med 2012; 9: 29–32.

PGR2014-00010, over U.S. Patent 8,598,219, listed in the Orange Book for Aloxi® brand of palonosetron.

http://www.uspto.gov/sites/default/files/documents/AIA_stats_thru_20150327.pdf (accessed 21 July 2015).

http://www.uspto.gov/sites/default/files/documents/071615_aia_stat_graph.pdf (accessed 21 July 2015).

These include non-patentable subject matter, indefiniteness or ambiguity in the claims, and failure of the specification to support the claims.

http://www.uspto.gov/patents-application-process/appealing-patent-decisions/statistics/aia-trial-statistics. Version consulted is updated through 30 April 2015.

Once instituted, the USPTO must issue its final written decision in 12 months. The USPTO has the option of extending this to 18 months, but has not, to the author’s knowledge, ever done so.

Fuller

. The PTAB may be taking a more balanced approach in biotech and pharmaceutical IPRs. Pharm Law & Ind Rep 2015; 13: 378–378.

The term “ex parte” means the procedure is between the patent owner and the decision-maker (the USPTO). Third parties are not permitted to participate in such procedures. This is contrasted with “inter partes” procedures like the IPR and PGR, in which an adverse party (the patent challenger) takes an active role.

10.

http://www.uspto.gov/sites/default/files/documents/AIA_stats_thru_20150327.pdf (accessed 21 July 2015).

11.

Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011).