Visual Memory v. NVIDIA: The Importance of a Robust Written Description

Introduction

In Visual Memory v. NVIDIA (Fed. Cir. 2017), the Federal Circuit reversed the district court’s holding that Visual Memory’s U.S. Patent No. 5,953,740 is drawn to patent-ineligible subject matter. Instead, the court ruled that the ’740 patent claims an improvement to computer memory systems and is not directed to an abstract idea.

The ’740 Patent

At a high level, the ’740 patent describes a computer memory system that can be connected to different kinds of processors. The memory system has “programmable operational characteristics” based on characteristics of the processor; it includes several caches and a main memory (DRAM) connected to a bus. One cache can be programmed to store only code data, and another cache can be programmed to buffer data writes to the main memory only from the processor. The main memory can be programmed to selectively reopen either code or non-code data pages. (See ’740 patent abstract.) Figure 1 of the patent is copied below.

As shown in Figure 1, the memory system 10 includes a system memory (DRAM) 12, an internal cache 16, a pre-fetch cache 18 and a write buffer cache 20, each connected to bus 14. Access to DRAM 12 is controlled by DRAM controller 22. The data stored in system memory 12 can be divided into code data (instructions) and non-code data. The memory system 10 is designed for use with a host processor in combination with other bus masters or devices that compete with the host processor for access to the memory system 10. (See ’740 patent col. 3 lines 34-50.) Continue Reading

Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) must do when the applicant refuses discovery that the patent owner needs to determine whether it has a good faith basis for suit. Neither the collateral order doctrine nor mandamus provides the solution.

Under the BPCIA, an applicant for a biosimilar product can piggyback on a reference biological product that FDA has approved by showing that “there are no clinically meaningful differences between the biological product and the reference product in terms of … safety, purity, and potency.” Slip op. at 3 n.1 (citing 42 U.S.C. § 262(l)(2)(A)-(B)). Under the head-spinning statutory patent dance addressed by the Supreme Court in Sandoz, Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017), the applicant must, inter alia, provide the patent owner (the sponsor of the reference product) a copy of the application “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” Slip op. at 3 (citing 42 U.S.C. § 262(l)(2)(A)). Based on that information, the parties identify patents to be immediately litigated in a first phase of the litigation under paragraph (l)(3). Id.

Continue Reading

Regeneron Pharmaceuticals, Inc. v. Merus N.V.: The Federal Circuit Revisits the Defense of Inequitable Conduct

In Regeneron Pharmaceuticals, Inc. v. Merus N.V., No. 2016-1346, slip op. (Fed. Cir. July 27, 2017) (hereafter, “Slip Op.”), the Federal Circuit seems to have loosened the standards for finding a patentee culpable of inequitable conduct during patent prosecution. By affirming the district court’s finding of inequitable conduct, the court in Regeneron condones the use of circumstantial evidence arising during litigation to infer that the patentee had specific intent to deceive the Patent and Trademark Office (PTO) during prosecution. The opinion was authored by Chief Judge Prost and joined by Judge Wallach. Judge Newman dissented.

Inequitable Conduct

“Inequitable conduct is an equitable defense to patent infringement that, if proved, bars enforcement of a patent.” Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1285 (Fed. Cir. 2011). To show that an applicant engaged in inequitable conduct before the PTO, a party must show by clear and convincing evidence that “the applicant misrepresented or omitted material information with the specific intent to deceive the PTO.” Id. at 1287. This analysis requires a showing of both materiality of the misrepresentation and intent to deceive. Id. The defense is most often wielded as an assertion by the accused infringer that the patent applicant knowingly withheld a material prior art reference from the PTO during prosecution. Continue Reading

USPTO Report on Patent Eligible Subject Matter

 

On July 25, the USPTO published a new report titled “Patent Eligible Subject Matter: Report on Views and Recommendations From the Public.” The report attempts to synthesize public comments on the appropriate boundaries of patent eligible subject matter.

The report includes a section reviewing the historical development of patent subject matter eligibility in the U.S. This section includes a discussion of the Supreme Court’s Bilski, Mayo, Myriad and Alice decisions, as well as the Federal Circuit’s application of the Supreme Court’s framework. Continue Reading

The Federal Circuit Reverses a Hindsight Reconstruction of An Important Pharmaceutical Invention

In Millennium Pharmaceuticals v. Sandoz,[1] the Federal Circuit reversed the district court’s holding of obviousness of certain claims of Millennium-owned U.S. Patent No. 6,713,446 (the ‘446 patent), finding that the district court improperly applied the lead compound analysis and the inherency doctrine and clearly erred by rejecting objective indicia of non-obviousness.

The disputed claims of the ‘446 patent[2] are directed to Velcade®, a freeze-dried (lyophilized) formulation of D-mannitol N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronate (I) and methods of its preparation and reconstitution. Velcade is Millennium’s oncology product prescribed for multiple myeloma and mantle cell lymphoma. Compound (I) is a mannitol ester of bortezomib. The portion of the molecule depicted in red below identifies the ester linkage between bortezomib and the mannitol sugar. Continue Reading

“All Expenses Paid” Is No Trip to the E.D. Va. for Patent and Trademark Applicants

Authored by: Kristie Butler, Summer Associate

On June 23, 2017, the Federal Circuit confirmed in Nantkwest, Inc. v. Matal (No. 2016-1794) that patent applicants facing rejection from the Patent Trial and Appeal Board (PTAB) may seek relief in the Eastern District of Virginia under 35 U.S.C. §145, but ruled that these litigants must pay the USPTO’s attorneys’ fees, regardless of their cases’ outcomes. Section 145 provides that “[a]n applicant dissatisfied with the decision of the [PTAB]…may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the Eastern District of Virginia.… All the expenses of the proceedings shall be paid by the applicant.”

In Nantkwest, the applicant argued that the presumption against an award of attorneys’ fees under the “American Rule” (i.e., each party pays its own costs) could only be overcome if an express provision in either a statute or contract were present, and the “all expenses” provision in § 145 did not include attorneys’ fees. The appellant further argued that Congress would have specified attorneys’ fees in the statute if they were meant to be included. The Federal Circuit was not persuaded that the American Rule applied and disagreed with the applicant’s interpretation after analyzing prior cases, definitions from legal dictionaries and treatises, and Supreme Court precedent, and interpreted the “all expenses” provision of the statute broadly to include attorneys’ fees. And because “all expenses” had already been interpreted by the Federal Circuit to apply to all cases, regardless of their outcomes, the USPTO’s attorneys’ fees must be borne by the applicant, regardless of whether the applicant prevails in the civil action. Continue Reading

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants).[1] In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing information as contemplated by the BPCIA, and (2) biosimilar applicants may provide statutory 180-day notice of commercial marketing after or before receiving FDA approval.

The BPCIA “patent dance”

The BPCIA was approved by Congress in 2010 for the purpose of creating an abbreviated approval pathway for biosimilars, or follow-on biologics. In contrast to conventional chemically synthesized drugs, biologics are isolated from natural sources such as animals or microorganisms and may include such diverse products as vaccines, recombinant proteins or somatic cells.[2] Biosimilar manufacturers may take advantage of the BPCIA’s abbreviated approval pathway to piggyback on the safety, purity and potency showings of a previously licensed reference product. In exchange, the BPCIA allows for up to 12 years of regulatory exclusivity for the reference product after the date the product was first licensed, regardless of whether there is patent protection.  Continue Reading

Supreme Court Finds Lanham Act Disparagement Clause Unconstitutional Under First Amendment

In a victory for the Asian-American rock band The Slants, the Supreme Court ruled on June 19 that the ban on the registration of disparaging trademarks under Section 2(a) of the Lanham Act violates the First Amendment.

The ruling follows a lengthy battle by The Slants as to whether it could obtain a federal trademark registration for its name, which the U.S. Patent and Trademark Office (“USPTO”) found “disparaging” under U.S.C. §1052(a) (“Section 2(a)”). As we discussed previously in a post about The Slants’ Federal Circuit case, Section 2(a) permits refusal of registration of a trademark that “[c]onsists of or comprises immoral, deceptive, or scandalous matter; or matter which may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute.” In determining whether a mark is disparaging under this section, the USPTO considers the meaning of the mark in common parlance and whether that meaning may be disparaging to a substantial composite of the group referenced by the mark. Continue Reading

PTAB Grants Discovery to Underlying Test Data

Discovery in inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) is typically quite limited, and the PTAB normally is reluctant to grant motions for additional discovery. It is instructive, therefore, when the PTAB does so. In a recent order in Mylan Pharmaceuticals Inc. v. Allegan, Inc., IPR2016-01127, Paper 28 (PTAB May 31, 2017) (Order), the PTAB granted a motion in part for additional discovery for pharmacokinetic (PK) data underlying figures in certain exhibits that had been submitted in Rule 132 declarations during the prosecution of one of the patents-at-issue, U.S. Patent No. 8,685,930. In particular, declarations of Drs. Schiffman and Attar were said to include figures used to allege the criticality of, and unexpected results from, a claimed formulation to treat dry eye, also known as keratoconjunctivitis sicca (Paper 27 at 2). After going through the Garmin factors, the PTAB ultimately allowed the additional discovery in part (Order at 3-5).[1] Continue Reading

Equivalence in Chemical Cases

In Mylan Institutional LLC et al. v. Aurobindo Pharma Ltd. et al., 2017-1645 (May 19, 2017), the Federal Circuit attempted to clarify the application of the doctrine of equivalents in chemical cases. Although affirming a district court grant of a preliminary injunction on a patent directed to isosulfan blue (ISB), a dye used for lymph node mapping, the court reversed the grant of the injunction to the extent it was based on two process patents. According to the Federal Circuit, the district court erred in determining that Mylan had demonstrated a likelihood of success in showing that Aurobindo infringes U.S. Patent 7,622,992 (the ’992 patent) and U.S. Patent 8,969,616 (the ’616 patent) because “the district court’s analysis of equivalence in this case was flawed.” Slip opinion at 12.

The ’992 and ’616 patents claim a process for preparing ISB comprising reacting isoleuco acid with silver oxide, recovering the ISB acid and treating the ISB acid with a sodium solution. Aurobindo’s process (the accused process) for preparing ISB differs from the patented process in that manganese dioxide is used in place of silver oxide as an oxidizing agent. The district court found that the accused process likely infringed the patented process under the doctrine of equivalents. Aurobindo argued on appeal that the district court erred, because manganese dioxide is a strong oxidizing agent that requires use of an acid, whereas silver oxide is a weak oxidizing agent that does not require an acid. Thus, according to Aurobindo, manganese dioxide and silver oxide oxidize isoleuco acid in different ways. Mylan countered, arguing that in the context of the process patents, silver oxide and manganese dioxide are equivalent. Mylan supported its assertion with expert testimony that the crude ISB yield from both the silver oxide and manganese dioxide processes is similar, a result that Mylan contended would not be expected if silver oxide and manganese dioxide were substantially different. Continue Reading

LexBlog