Here is an update on recent en banc activity in patent cases at the Federal Circuit. Highlights include two new amicus briefs supporting a petition raising questions regarding the written description requirement and obvious-type double patenting. The court also denied a petition for en banc rehearing raising questions about inducement of infringement and skinny-labeling. Here are the details.
New Amicus Briefs
Since our last update, the court received two new amicus briefs in Allergan USA, Inc. v. MSN Laboratories Private Ltd. The petition filed by MSN Laboratories raises questions regarding the written description requirement and obvious-type double patenting. Both amicus briefs support rehearing.
In the first amicus brief, the Association for Accessible Medicines argues the “panel decision turns” the obvious-type double patenting “doctrine on its head.” First, AAM asserts, the “panel’s decision creates an apparently inadvertent but enormous loophole through which multiple, separate entities will be able to own—and enforce—admittedly obvious variations of the same patent claim.” As a result, AAM claims, patentholders “can now separate ownership and licensing of patent claims that are indisputably obvious variants of one another.” Second, AAM argues, “the panel’s decision improperly elevates filing and issuance dates.” Finally, AAM reasons, the panel erred in holding that the asserted claims met the written description requirement. In this regard, AAM argues, “the panel relegated an optional limitation as entirely superfluous for purposes of evaluating the written-description requirement.”
In the second amicus brief, Alvogen PB Research & Development LLC argues the panel’s holding is at odds with 35 U.S.C. §§ 101, 121, 154, 156, and 253. According to Alvogen, these provisions do not allow for the panel’s holding granting “common ownership of two patents with different expiration dates that claim obvious variants of the same invention.” Additionally, Alvogen argues, the panel’s opinion is not supported by the statute’s legislative history. Alvogen argues this history instructs the Patent Office to reject claims on the basis of obvious-type double patenting. Finally, Alvogen continues, the panel’s opinion “is not compatible with the basic tenets of [obvious-type double patenting] because it (1) extends the term of the earlier-expiring patent beyond its statutory grant, (2) allows for the common ownership of duplicative patents that are not united by a terminal disclaimer, and (3) denies the public its expectation that when the earlier patent expires, the invention claimed in that patent becomes part of the public domain.”
Denial
Since our last update, the Federal Circuit denied the petition in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. Hikma Pharmaceuticals had raised the following questions:
- “Where it is undisputed that a generic drugmaker has ‘carved out’ a patented method of use from its labeling under 21 U.S.C. § 355(j)(2)(A)(viii), does the generic drugmaker induce infringement of the patented method by (a) referring to its product as a ‘generic version’ of a branded drug approved for the patented method; and (b) quoting sales figures for the branded product—without mentioning the patented method?”
- “Can a patentee state a claim that a defendant ‘actively induces infringement’ of a patented method under 35 U.S.C. § 271(b) without identifying any alleged statement by the defendant that even mentions, let alone encourages, practicing the claimed method?”