Posts Tagged: "written description"

Thought Experiment: Is Our Patent System Ready for a Potential Future of Brain Interfacing?

Currently, brain recording and/or brain stimulation is used almost entirely for medical or research purposes. Invasive surgery is generally required to read neural signals with high temporal and spatial resolution. High resolution of neural signals enables researchers to decode a brain’s underlying intentions, sensations, reactions, etc. rather reliably, if only in constrained environments. With regard to stimulation, researchers have demonstrated the ability to trigger different types of effects. For example, stimulating the reticular formation can cause a subject to become awake; stimulating the amygdala can evoke fear; stimulating the motor cortex can trigger movement; stimulating the visual cortex can cause a subject to see light flashes. However, the state of the art is neither able to decode complex and unrestrained thoughts nor cause a subject to have a particular “target” complex thought. At least not yet.

Implications of Filing Subsequent Patent Applications in the United States (Part III)

In Part I, the authors reviewed the law behind subsequent patent applications. In Part II, we reviewed the different types of subsequent applications. Part III will discuss some of the implications of these. When an applicant seeks to add new claims pursuant to a continuation or divisional application, U.S. Patent Law explicitly requires that the original specification provide adequate support for the new claims by the original specification satisfying the Section 112(a) written description and enablement requirements for the new claims. 35 U.S.C. § 120. The same is also true for continuation-in-part (CIP) applications claiming overlapping subject matter but not for claims comprising “new matter” because the new matter claimed must find support in additional disclosure, i.e., in material added to the CIP application itself.

Federal Circuit Remands District Court Decision for Erroneous Claim Construction

On August 27, the United States Court of Appeals for the Federal Circuit (CAFC) reversed and remanded a decision of the U.S. District Court for the District of Delaware in Baxalta Inc. v. Genentech, Inc. The CAFC reversed the district court’s claim construction of the terms “antibody” and “antibody fragment” in Baxalta’s patent claims and remanded for proceedings consistent with the correct constructions.

Federal Circuit Affirms Decision Finding Zohydro ER Patents Obvious

On December 27, U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Jimmie Reyna authored an opinion affirming the U.S. District Court for the District of Delaware’s finding that the asserted claims of U.S. Patent Nos. 9,265,760 (‘760) and 9,339,499 (‘499), both titled “Treating Pain in Patients with Hepatic Impairment,” held by Persion Pharmaceuticals LLC,  were invalid due to obviousness. The CAFC found no reversible error in the district court’s decision and therefore affirmed.

Federal Circuit Invalidity Determination for Idenix Underscores Continuing Intra-Circuit Split

One day before the now-famous Arthrex decision was issued, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided an appeal by Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively “Idenix”) against Gilead Sciences, Inc. (Gilead) that reiterates the extent to which the Court is split in its approach to so many issues. The precedential opinion was authored by Chief Judge Prost, with Judge Newman dissenting. In 2013, Idenix sued Gilead for infringement of U.S. Pat. No. 7,608,597 (the ‘597 patent), which claims a drug directed to the treatment of the hepatitis C virus (HCV). In response, Gilead argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements. At trial, the jury found for Idenix and upheld the validity of the patent. Gilead filed a renewed motion for Judgment as a Matter of Law (JMOL) on the written description and enablement requirements, and the court granted the motion only on enablement grounds, thus holding the patent invalid. The decision overturned the jury’s award to Idenix of $2.5 billion.

‘Substantially Equivalent’ Disclosure May Satisfy Written Description Requirement Under Certain Circumstances

The Federal Circuit recently affirmed in part and reversed in part a district court decision holding that Actavis Laboratories FL, Inc.’s (“Actavis’s”) generic Abbreviated New Drug Application (“ANDA”) product infringed claims of patents owned by Nalpropion Pharmaceuticals (“Nalpropion”) and that the asserted claims were not invalid. The Court found that the district court did not err in finding that Nalpropion’s U.S. Patent No. 8,916,195 (“the ’195 patent”) was not invalid for lack of written description, but that the district court did err in finding that the asserted claims of U.S. Patent Nos. 7,375,111 (“the ’111 patent”) and 7,462,626 (“the ’626 patent”) were not obvious in view of the prior art.

Claimed Method As a Whole Must Be Described to Satisfy Written Description Requirement

The Federal Circuit recently affirmed a Patent Trial and Appeal Board (Board) decision finding that Dr. Stephen Quake and Dr. Christina Fan’s (collectively, “Quake”) asserted claims were unpatentable for lack of written description under 35 U.S.C. § 112. See Quake v. Lo, Nos. 2018-1779, 2018-1780, 2018-1782, 2019 U.S. App. LEXIS 20407 (Fed. Cir. July 10, 2019) (Before Reyna, Chen, and Hughes, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge). The claims were directed to a method for determining the presence of a chromosomal abnormality, called aneuploidy, in fetuses. Aneuploidy occurs when a fetus is born with either an abnormally high or low number of chromosomes. The claimed detection was accomplished using a method called massively parallel sequencing (MPS). Specifically, the claims recited a “random” MPS method, which amplified and sequenced all DNA in a sample rather than specific, targeted sequences of DNA. Quake, based out of Stanford University, and Dr. Dennis Lo (“Lo”) based out of Chinese University of Hong Kong began developing the claimed methods around the same time and requested interferences with respect to a number of applications to determine who invented the method first.

PTAB Overturned on Criticality of Broadened Claim Term in Reissue

Global IP Holdings, LLC, the owner of U.S. Patent No. 8,690,233, achieved a victory with the Federal Circuit vacating a decision of the Board and remanding for the Board to address predictability and criticality of the claim term to determine whether the written description requirement has been satisfied. Although victorious, Global did not achieve everything it wanted. Global had requested the Federal Circuit to simply overrule the Board. Judge Stoll, however, explained that there was not support in the record sufficient to determine whether the “plastic” claim limitation was critical or important. Therefore, the Federal Circuit vacated the Board’s decision and ordered the Board, on remand, to address predictability and criticality of the claim term in question in order to determine whether the written description requirement has been satisfied.

Mission Impossible? How U.S. Drafters Can Minimize Support/Clarity Issues Under Article 84 EPC

When drafting Patent Cooperation Treaty (PCT) applications, or applications intended to be prosecuted abroad, a U.S. drafter inevitably faces the challenge of providing a description in line with the requirements of different jurisdictions. By the time feedback is received from the foreign patent offices, it will be too late to make any adjustments, and important aspects of the invention may inadvertently be lost. The challenge might feel impossible when dealing with the requirements of the European Patent Office (EPO), as the European Patent Convention (EPC) regulations on written description are framed in a way that is fundamentally different from U.S. regulations. For example, the requisites of providing an adequate description and notice of the metes and bounds of the claimed invention are framed in the United States as separate requirements (written description and definiteness respectively) with different legal bases (35 USC 112(a) for written description and 35 USC 112(b) for definiteness respectively).

Federal Circuit Deems Written Description Requirement Satisfied if Specification Identifies the Claimed Invention in a Definite Way

The United States Court of Appeals for the Federal Circuit recently issued a ruling reversing a district court’s grant of summary judgment of non-infringement and invalidity for failure to satisfy the written description requirement. See CenTrak, Inc. v. Sonitor Techs., Inc., 2019 U.S. App. LEXIS 4442 (Fed. Cir. Feb. 14, 2019) (Before Reyna, Taranto, and Chen, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge). The Court said the written description requirement does not require that the specification provide either examples or an actual reduction to practice. Instead, a constructive reduction to practice may be sufficient if the specification identifies the claimed invention in a definite way.

Federal Circuit Corrects District Court’s Claim Construction

The United Stated Court of Appeals for the Federal Circuit recently held that a district court erred in its claim construction and vacated the district court’s judgment of noninfringement, which the parties stipulated to based on the erroneous construction. See Continental Circuits LLC v. Intel Corp., No. 2018-1076, 2019 U.S. App. LEXIS 3920, 2019 WL 489069 (Fed. Cir. Feb. 8, 2019) (Before Lourie, Linn, and Taranto, J.) (Opinion for the court, Lourie, J.). The Court highlighted that the first step in claim construction should always be to determine the plain and ordinary meaning of the claims. Further, the specification should serve to limit the plain and ordinary meaning only when it includes a definition for a claim term or a clear disclaimer or disavowal of claim scope.

District of Delaware Makes it Harder to Corner the Market on Antibody Patents in MorphoSys v. Janssen

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

Even If New Matter, Entire Application Relevant to Assessing Compliance with Written Description Requirement

Several weeks ago, in a non-precedential opinion, the Court of Appeals for the Federal Circuit issued a decision in In re: David Tropp, which vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB). The PTAB decision had affirmed an examiner’s rejection of a patent application covering a luggage inspection technology. The Federal Circuit panel of Chief Judge Sharon Prost and Circuit Judges Raymond Clevenger and Kimberly Moore determined the PTAB erred in its written description analysis by failing to consider all of the language of the specification as filed when determining whether there was sufficient support for the claimed invention. “Even if it is new matter, the language in the ’233 application as filed is relevant to assessing compliance with the written description requirement,” Judge Moore wrote. “The Board’s failure to consider this language was erroneous.”

Supreme Court Denies Cert in Two-Way Media v. Comcast, Refuses Another 101 Case

The U.S. Supreme Court denied a petition for writ of certiorari in Two-Way Media Ltd. v. Comcast Cable Communications, refusing to hear yet another appeal in a case involving a question of patent eligibility… Simply put, the answer to the first question asked by Two-Way Media in its Petition for Certiorari is absolutely not. There never has been a requirement that a patent claim must be — or even should be or can appropriately be — read in isolation. In fact, decisions that purport to ascertain the meaning of claim languagewithout the pomp and circumstance of Markman are openly violating the clear dictates of the Supreme Court. 

Time Warner Asks CAFC to Vacate $139.8M Reasonable Royalty Awarded to Sprint

John O’Quinn, partner at Kirkland & Ellis and counsel representing Time Warner at the Federal Circuit, argued that the entire verdict should be vacated, not just the damages portion, because the court allowed the jury to use a 2007 verdict granted to Sprint against Vonage on the same asserted patents as evidence to determine the damages award. That verdict involved the use of a 25 percent rule of thumb for determining a royalty rate, a rule that the Federal Circuit has subsequently held to be inappropriate in a landmark ruling in 2011.