Court of Appeals for the Federal Circuit

In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for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

In an interesting development in the post-TC Heartland world, it appears that the Federal Circuit will soon answer the question whether the Supreme Court’s venue decision was a change in the law, or merely a course-correction to honor preexisting law. Here, in a case arising out of the Eastern District of New York, the Federal Circuit ordered AlmondNet, Inc., Datonics, LLC, and Intent IQ, LLC to respond to a petition for a writ of mandamus submitted by Yahoo Holdings, Inc.  In its petition, Yahoo argued that the District Court erred in denying its motion to transfer, and specifically that it waived the right to challenge venue on the basis that TC Heartland did not change the law of venue.

Continue Reading Yahoo Asks Federal Circuit to Determine Whether TC Heartland Changed, or Merely Clarified, Venue Rules

In a precedential opinion issued on October 11, 2017, the United States Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeals Board’s (“PTAB”) finding of non-obviousness where the prior art taught away from some, but not all, of the embodiments covered by the challenged claims.  In Owens Corning v. Fast Felt Corp., No. 2016-2613 (Fed. Cir. Oct. 11, 2017), the panel held that the PTAB had applied an unreasonably narrow construction to the exclusion of embodiments that were not taught away from by prior combinations disclosing all of the claim elements.

PTAB’s Improper Claim Construction

Fast Felt owns U.S. Patent No. 8,137,757 (“the ‘757 patent”), which it asserted against Owens Corning in the U.S. District Court for the Northern District of Ohio.  In turn, Owens Corning petitioned for inter partes review of the claims of ‘757 patent, and the PTAB instituted trial.  Owens Corning contended that the challenged claims were rendered obvious by prior art combinations disclosing all elements of the independent claims.  However, in its final written decision, the Board determined that Owens Corning failed to provide a motivation to combine and upheld the patentability of the challenged claims. Owens Corning timely appealed.

Continue Reading Federal Circuit Clarifies the Requirements for a Teaching Away by the Prior Art

The United States Court of Appeals for the Federal Circuit’s recent decision in Aqua Products Inc., v. Matal materially changes the burden of proof associated with the patentability of amended claims during an inter partes review (“IPR”), shifting the burden from the Patent Owner seeking the amendment to the IPR Petitioner opposing it.

Prior to the Aqua decision, if a Patent Owner sought to amend claims during an IPR, the Patent Trial and Appeals Board (the “Board”) placed the burden on the Patent Owner to prove that the proposed amended claims were patentable.  When Patent Owner Aqua attempted to amend its claims during an IPR challenge to its U.S. Patent No. 8,273,183, the Board found that Aqua had not met its burden and denied Aqua’s motion to amend.

Continue Reading AQUA PRODUCTS: The Federal Circuit Shifts The Burden of Proof On Amending Claims During An IPR From The Patent Owner To The Petitioner

The Federal Circuit yesterday issued an opinion in In re: Smith Int’l, Inc., No. 2016-2303 (Fed. Cir. Sept. 26, 2017) reversing an affirmance by the Patent Trial and Appeal Board of the rejection of several claims of U.S. Patent No. 6,732,817 being challenged in ex parte reexamination.  In so doing, the Court held the Board’s construction of “body” in the ’817 Patent claims to be unreasonable as inconsistent with the specification.

The ’817 Patent concerns a downhole drilling tool for oil and gas operations.  In affirming the examiner, the Board found it “perfectly reasonable” to interpret the “body” of the tool as encompassing other components because neither the claims nor the specification explicitly limit the scope of the term.  Even though the specification describes the body as separate from other elements, the Board reasoned that it doesn’t expressly define “body” or otherwise preclude the examiner’s interpretation.  But according to Smith, the ’817 Patent consistently refers to and depicts the body as a component distinct from other components of the drilling tool – like the “mandrel” or “piston” located inside the drilling tool – and should be interpreted simply as an “outer housing.”

Continue Reading “In Light of the Specification”: Federal Circuit Weighs in on the Broadest Reasonable Interpretation

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

After an eight-year battle through the Federal Courts, the fight over attorneys’ fees in Octane Fitness v. ICON Health & Fitness has likely reached its end with the Federal Circuit upholding the hotly disputed $1.6 million award to Defendant Octane Fitness. This case previously made it up to the Supreme Court, which overturned the Federal Circuit’s prior standard for determining exceptional cases under 35 U.S.C. § 285. Following a remand to the District Court applying the new totality-of-the-circumstances test established by the Supreme Court, the parties again appealed to the Federal Circuit.

Continue Reading Octane Fitness Hits the Showers: Federal Circuit Affirms Attorneys’ Fees Award in Landmark Case

Last week, the Federal Circuit held computer memory system patent claims not abstract and thus patent-eligible under Section 101, reversing a lower court dismissal of the case under Rule 12(b)(6).  Visual Memory LLC v. NVIDIA Corp., No. 2016-2254, 2017 U.S. App. LEXIS 15187 (Fed. Cir. Aug. 15, 2017).

U.S. Patent No. 5,953,740 (“the ‘740 patent”) describes a memory system that can be tailored for use with multiple different processors without reducing performance.  Id. at 3.  The ‘740 patent explains that when “the [memory] system is turned on, information about the type of processor is used to self-configure the programmable operational characteristics.”  Visual Memory, No. 2016-2254, slip op. at 4.  “For example, depending on the type of processor, internal cache 16 can store both code and noncode data, or it can store only code data.”  Id. at 4.  Claim 1 recites the following:

Continue Reading In a Reversal, Federal Circuit Finds Data Processing Claims Patent-Eligible Under Section 101 in Visual Memory v. NVIDIA