In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did not infringe an Amgen protein folding patent. The Federal Circuit affirmed the non-infringement finding despite statements made in Apotex’s pre-litigation letters sent during the parties’ information exchange (i.e., the “patent dance”), which the district court found were controverted by evidence presented by Apotex at trial.

Background

Amgen makes the biologic drugs Neulasta® (pegfilgrastim) and Neupogen® (filgrastim). Apotex submitted aBLAs (“abbreviated Biologics License Applications”) to the FDA seeking approval of biosimilar versions of both drugs under the BPCIA (“Biologics Price Competition and Innovation Act”) framework. The parties engaged in the BPCIA’s “patent dance” information exchange process, whereby Apotex provided Amgen with copies of Apotex’s aBLAs. Amgen ultimately brought suit under 35 U.S.C. § 271(e)(2)(C), (a) and (g), asserting that Apotex’s proposed manufacturing processes would infringe, among others, Amgen’s U.S. Patent. No. 8,952,138 (the ‘138 patent).

The ‘138 patent covers a method of refolding misfolded proteins. This process purportedly allows for large-scale protein refolding using lower reagent volumes than was previously possible. The district court construed (and the Federal Circuit did not reverse) asserted claim 1 of the ‘138 patent to require “refold mixture” protein concentrations above 1.0 g/L. Continue Reading Federal Circuit Evaluates Import of Factual Statements Made During BPCIA Pre-litigation Patent Dance

On November 15, 2017, the United States Court of Appeals for the Federal Circuit resolved a split among district courts on the question whether the United States Supreme Court’s TC Heartland decision constituted a change in the law, or merely a course-correction to honor preexisting law. The Federal Circuit held that the Supreme Court’s decision changed the controlling law. In re: Micron, No. 17-00138 at 13 (Fed. Cir. Nov. 15, 2017).

Micron Technology, Inc. asked the Federal Circuit to set aside the district court’s denial of its motion to dismiss or transfer the case for improper venue. The district court held that Micron waived its objection to venue because it failed to raise an available venue defense in its initial Rule 12 motion to dismiss, and concluded that TC Heartland was not a change in the law.

The Federal Circuit disagreed. It reasoned that the Supreme Court clearly rejected V.E. Holding and concluded that the definition of “resides” in § 1391(c) does not apply to § 1400(b). The Federal Circuit further reasoned that the Supreme Court changed the law by severing § 1400(b) from § 1391(c). As a result, the objection was not “available” under Rule 12(g)(2) when Defendant filed its motion to dismiss in 2016, before TC Heartland came down. On this basis, the Federal Circuit reversed and remanded the case. This decision resolves a previously open question in the wake of TC Heartland that we wrote about here.

In issuing its precedential decision earlier this month in Two-Way Media v. Comcast, the Federal Circuit affirmed a Delaware district court determination that four data streaming patents were directed to ineligible subject matter pursuant to § 101 and the Alice framework. The four related patents (U.S. Patent Nos. 5,778,187, 5,983,005, 6,434,622, and 7,266,686) describe methods and systems for streaming audio/visual data over a communications system (e.g., the Internet) and, in particular, a scalable architecture for delivering real-time information to a number of users, including a control mechanism allowing for management and administration of users intended to receive the real-time information.

Under Alice step one, the Court found that the patents claimed the abstract idea of sending and monitoring the delivery of audio/visual information. The Federal Circuit agreed with this characterization of the claims, finding that the claims used results-based functional language with no articulation of how the particular results are achieved. Two-Way Media also proposed claim constructions that it argued tied the claims to a scalable network architecture. Even after adopting Two-Way Media’s propose constructions, both the District Court and the Federal Circuit found that the constructions, at best, encompassed using generic computer components to carry out the abstract idea and still failed to indicate how the claims themselves “are directed to a scalable network architecture that itself leads to an improvement in the functioning of the system.” (emphasis added) Continue Reading Federal Circuit Affirms Delaware Alice Decision

Late last week, the Federal Circuit granted a writ of mandamus in In re Cray, 2017-129 (Fed. Cir. Sept. 21, 2017), overturning Judge Gilstrap’s four-factor test for determining whether a defendant possesses “a regular and established place of business” in a district such that the defendant could be sued for patent infringement in that district.  In re Cray provides useful guidance because it is the first time since the Supreme Court’s TC Heartland decision that the Federal Circuit has weighed in on what constitutes a “regular and established place of business.”  The patent venue statute, 28 U.S.C. § 1400(b), provides that venue is proper in a patent infringement lawsuit only where the defendant (1) resides or (2) has “committed acts of infringement and has a regular and established place of business.”  TC Heartland clarified that a defendant “resides” only in the state in which it is incorporated.  It did not address the second prong, however, which is an alternative way of establishing venue.  More frequently patent owners are looking to the second prong to determine the locus of an appropriate venue now that the first prong of the statute has been interpreted narrowly.

Continue Reading Federal Circuit Clarifies Venue Requirement Post-TC Heartland by Granting Mandamus Relief in In re Cray

On March 3, 2017, the United States Court of Appeals for the Federal Circuit reaffirmed, in a precedential opinion, that prosecution disclaimers may only limit the scope of a claim where the disclaimer is “both clear and unmistakable to one of ordinary skill in the art.” In Technology Properties Ltd. v. Huawei Technologies Co., Ltd., the Federal Circuit made clear that statements made during patent prosecution will not constitute a disclaimer of claim scope where the statements are “ambiguous or amenable to multiple reasonable interpretations,” but that a disclaimer based on unambiguous statements during prosecution may serve to surrender more claim scope than was necessary to overcome a rejection. Continue Reading Federal Circuit Reiterates That Patent Prosecution Disclaimers Must Be “Clear and Unmistakable”

723px-US-CourtOfAppeals-FederalCircuit-Seal_svgThe Federal Circuit has further clarified the scope of the covered business method (CBM) review program under the America Invents Act (AIA), explaining in Secure Axcess, LLC. v. PNC Bank National Association that in order for patent to be a CBM patent, it is not enough that the claimed subject matter may be used in a financial activity.  Rather, to qualify as a CBM patent, a patent must have at least one claim that contains a financial activity element.

The AIA contains a temporary program by which a CBM patent may be challenged on any ground of patentability.  A threshold requirement to CBM review is that the challenged patent is in fact a covered business method patent.  The AIA defines a CBM patent as “a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions.”  AIA §18(d)(1). Continue Reading Federal Circuit Clarifies Scope of Covered Business Method Review

Patent Agent PrivilegeSeveral recent court decisions have shed light on the patent agent privilege, and now the U.S. Patent and Trademark Office (USPTO) is seeking to weigh-in on the issue.

As previously reported at Global IP Matters, the Federal Circuit held in March in In re Queen’s University at Kingston that communications between patent agents and their clients regarding patent prosecution matters are privileged and should be shielded from discovery in subsequent litigation regarding the patents.

Continue Reading Patent-Agent Privilege and the USPTO’s Proposed New Rule

723px-US-CourtOfAppeals-FederalCircuit-Seal_svgThe Federal Circuit reaffirmed last week that the Patent Trial and Appeal Board’s (PTAB’s) decision to discontinue inter partes review (IPR) proceedings is not reviewable on appeal.   In Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc., the Federal Circuit held that just as the PTAB’s initial decision whether to institute inter partes proceedings is not appealable in light of 35 U.S.C. §314(d) and the Supreme Court’s recent Cuozzo decision, neither is a subsequent decision to vacate that institution decision.

Bosch sued Cardiocom (a subsidiary of Medtronic) in 2013 for infringing two Bosch patents.  Cardiocom then filed petitions for inter partes reviews of the Bosch patents, which the PTAB denied in January 2014.  Medtronic then filed three more petitions seeking inter partes reviews of the same Bosch patents, listing Medtronic as the sole real party in interest.  The PTAB instituted the proceedings but allowed Bosch discovery regarding Cardiocom’s status as a real party in interest.  Based on the discovery, the PTAB granted Bosch’s motion to terminate the proceedings because Medtronic failed to name Cardiocom as a real party in interest as required by 35 U.S.C. §312(a)(2).

Continue Reading PTAB Vacating Its Initial Institution Decision is Not Appealable, Federal Circuit Says

The deadline has come and gone for the ITC and patentee Align to file petitions for certiorari seeking review by the Supreme Court of the Federal Circuit’s decision in ClearCorrect. On November 10, 2015, a panel of the Federal Circuit found that the ITC does not have jurisdiction to bar digital downloads or imports where there was no physical article to bar from importation.  After the panel decision, the ITC and the patentee Align submitted a petition for rehearing en banc, which was denied on March 31, 2016.  The deadline for further appeal was August 26 and neither the ITC nor Align filed for certiorari.

Continue Reading ITC Declines to File Petition for Certiorari – CAFC Holding that ITC Does Not Have Jurisdiction over Digital Imports Stands

On July 5, 2016, in United States v. Nosal, the Ninth Circuit Court of Appeals clarified the definition of “trade secret,” finding that data derived from a compilation of publicly available information can constitute a protectable trade secret in a case involving allegations under the Economic Espionage Act (EEA). The Defend Trade Secrets Act (DTSA) amended the EEA to create a federal private civil cause of action for trade secret misappropriation. Thus, the Ninth Circuit’s opinion in United States v. Nosal provides important guidance regarding the definition of “trade secret” in cases under the DTSA. With this decision, the Ninth Circuit recognizes that a collection of public information can be a protectable trade secret, especially where a proprietary process is used to compile or search that information. Continue Reading Ninth Circuit Provides Clarification Concerning the Definition of Trade Secret