Patent Docs

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)

By Donald Zuhn –-

Last month, in FWP IP ApS v. Biogen MA, Inc., the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board granting Biogen's motion that FWP's U.S. Application No. 11/576,871 did not provide an adequate written description under 35 U.S.C. § 112 for claims directed to a method for treating multiple sclerosis.  The MS treatment at dispute involves administering a specific daily dosage (480 mg) of fumarates, specifically dimethyl fumarate (DMF) and/or monomethyl fumarate (MMF), to a subject.

The appeal arose from an interference proceeding involving the above method for treating multiple sclerosis.  U.S. Patent No. 8,399,514, owned by Biogen, describes and claims such a method.  The '871 application, which was assigned to FWP by original Appellant Forward Pharma A/S after the appeal was docketed, discloses controlled release compositions of fumarates.  In the interference proceeding, Forward argued that the '871 application describes the treatment method in dispute.  Although the Board determined that the '871 application had an earlier priority date than the '514 patent, it granted Biogen's motion that the MS treatment method Forward sought to claim was not supported by an adequate written description.

The '871 application is a U.S. national phase filing of a PCT application that was filed on October 7, 2005, and which claims priority to a Danish patent application filed on October 8, 2004.  The '514 patent claims priority to a U.S. provisional patent application filed on February 8, 2007.  During prosecution of the '871 application, Forward cancelled all pending claims and added claims that closely tracked the claims that issued in the '514 patent.  The Board declared an interference between the '871 application and '514 patent, designating Forward as the senior party with a constructive reduction to practice date of October 8, 2004.

Finding that the focus of the '871 application was on "controlled release fumarate compositions" and that "general teaching of applicability of the fumarates to [the] treatment of a variety of possible disease or conditions and the teaching of a broad range of possible dosages would not have conveyed possession or description of the specific treatment of MS that [Forward] now claims," the Board granted Biogen's motion that the claims of the '871 application were not supported by an adequate written description.  The Board pointed to claim 69 of the '871 application as representative:

69.  A method of treating a subject in need of treatment for multiple sclerosis comprising
    (a) a therapeutically effective amount of dimethyl fumarate and
    (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate is about 480 mg per day.

Looking to claim 69, the Board distilled the claimed treatment method at issue into three limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of DMF and/or MMF, at (3) a dosage of 480 mg per day.  With respect to the first limitation, the Board determined that the '871 application lists over twenty diseases and conditions, that MS is not identified as a disease or condition of particular interest, and that the application instead focuses on psoriasis and conditions associated with psoriasis.  Regarding the third limitation, the Board determined that while the 480 mg/day dosage is expressly mentioned in the specification, there "is no discussion that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day, or any other therapeutically effective dose within the ranges disclosed."

The Board also rejected Forward's arguments based on Snitzer v. Etzel, 465 F.2d 899 (CCPA 1972); Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006); and Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269 (Fed. Cir. 2012).  The Board determined that unlike the invention in Snitzer, Forward's case required the selection and combination of claim elements from more than a single limited list, and that unlike Falkner and Streck, the '871 application did not provide the blaze marks necessary to guide a skilled artisan to the claimed invention.  The Board concluded that even though each required claim element is mentioned separately in the '871 application, the specification did not disclose the claimed invention in a manner that adequately describes the claimed MS treatment to a skilled artisan, and therefore, that the claims of the '871 application failed to meet the written description requirement.

On appeal, Forward argued that the interference count was disclosed in an up-scale table in the '871 application, which Forward argued (1) discloses a 480 mg/day dosage, (2) is reasonably directed at using DMF to treat the listed conditions, and (3) is linked to the treatment of MS.  The up-scale table describes scaling up the daily dosage level of fumerates over a nine-week period, with the 480 mg/day dosage occurring during week seven, and is designed to minimize the side-effects of ingesting fumarates by increasing the dose gradually over time to allow the patient to acclimate.  The Federal Circuit, however, stated that it was not persuaded by Forward's argument, and agreed with the Board that "the '871 application does not disclose the now-claimed MS treatment as a unified whole."

With respect to the 480 mg/day dosage, the Federal Circuit noted that this dosage is an interim dosage, and that Forward failed to present persuasive evidence as to why a skilled artisan would have understood the week seven interim dosage to be therapeutically effective.  The Court also noted that Biogen's expert testified that because MS is a chronic disease, a skilled artisan would not have viewed a one week, interim dosage in the middle of a nine week up-scale schedule as an adequate treatment dosage, let alone one for a particular disease such as MS.

In affirming the Board's decision, the Federal Circuit stated that "[g]iven the brief references to MS and the lack of recognition of 480 mg/day as a therapeutically effective daily dosage, we agree with the Board’s finding that there 'is no discussion [in the '871 application] that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day. . . .'"  The Court was also unpersuaded by Forward's attempt to use the prior art to supply the link between the therapeutically effective dose of 480 mg/day and MS, noting that "even if we allow Forward to rely on the prior art for establishing a prior, known link between MS and fumarates, the prior art does not teach the key limitation of the count: the 480 mg daily dosage."

The Federal Circuit also rejected Forward's argument that the original claims of the '871 application adequately describe the MS treatment that it was seeking to claim.  According to the Court, "Forward's argument is premised on piecing together elements of several of the claims."  In rejecting this argument, the Court explained that:

Th[e original] claims are mainly directed to controlled release compositions of numerous fumarates and pharmaceutically acceptable salts.  Some claims recited numerous possible dosing schedules (claims 30–32) and dosages (claims 33–38).  And others replicate the laundry list of diseases and conditions enumerated in the specification (claims 44 and 45).  This large number of disease conditions, dosages, dosing schedules, active ingredients, pharmaceutical formulations for controlled release, and combinations thereof covered by the original claims detracts from Forward's argument that it possessed and invented the now-claimed, specific MS treatment.  . . .  Rather, what the scale of the claims demonstrate is that Forward possessed, as of the 2004 critical date, a mere wish for obtaining some type of fumarate formulation to treat any one of a number of diseases and conditions, one of which was MS, using almost any possible daily dosage.

Finding that "the '871 application does not disclose 480 mg of fumarates per day as a therapeutically effective dose for treating MS," the Federal Circuit determined that substantial evidence supported the Board's finding that the MS treatment Forward sought to claim was not supported by an adequate written description under 35 U.S.C. § 112.  The Federal Circuit therefore affirmed the Board's decision.

FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Wallach and Chen
Opinion by Circuit Judge Chen

Ancora Technologies, Inc. v. HTC America, Inc. (Fed. Cir. 2018)

By Michael Borella --

Ancora sued HTC in the Western District of Washington alleging infringement of U.S. Patent No. 6,411,941.  HTC moved to dismiss the case, contending that the claims of the patent were ineligible under 35 U.S.C. § 101.  The District Court granted HTC's motion.  Ancora appealed to the Federal Circuit.

The '941 patent is directed to mechanisms for preventing a computer from running unlicensed software.  While using license keys to control software was well-known at the time of the patent's earliest priority date (1998), the patent purports to do so in a rather unusual fashion (for that time).

Particularly, a key that uniquely identifies the computer that the software is installed upon is stored in read-only memory (ROM) of the computer's basic input / output system (BIOS).  Thus, the key cannot be modified, removed, or hacked by users or applications without significant effort.  Further, a record that is associated with the licensed software contains the names of the software, its vendor, and a number of licenses thereof.  The record is stored in volatile BIOS memory, encrypted by the key.  The software contains an unencrypted copy of the license record.

When the software is run, it is loaded into main memory, obtains a copy of the key, and performs encryption of its copy of the license record.  If this matches the encrypted license record stored in the BIOS, the program is permitted to continue executing.  Otherwise, the program is considered "unlicensed" and is either halted or run with reduced functionality.

This technique is different from how software licensing was previously enforced.  Software-based licensing required storing licensing information on the computer's main non-volatile storage device (e.g., a hard drive).  But this device was easily accessed and susceptible to hacking.  Hardware-based licensing required use of a pluggable dongle, which was poorly suited to software that was downloaded rather than sold in stores.

Further, BIOS memory was typically used to store low-level bootstrapping code that assisted startup of the hardware and initiation of the operating system, not license verification data.  Thus, the use of BIOS is unusual.

Claim 1 of the '941 patent was considered representative.  It recites:

1.  A method of restricting software operation within a license for use with a computer including an erasable, non-volatile memory area of a BIOS of the computer, and a volatile memory area; the method comprising the steps of:
    selecting a program residing in the volatile memory,
    using an agent to set up a verification structure in the erasable, non-volatile memory of the BIOS, the verification structure accommodating data that includes at least one license record,
    verifying the program using at least the verification structure from the erasable non-volatile memory of the BIOS, and
    acting on the program according to the verification.

In Alice Corp. v. CLS Bank Int'l, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101.  One must first decide whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But generic computer implementation of an otherwise abstract process does not qualify as "significantly more," nor will elements that are well-understood, routine, and conventional lift the claim over the § 101 hurdle.

The District Court viewed the claim as focused on "the abstract concept of selecting a program, verifying whether the program is licensed, and acting on the program according to the verification."  The District Court was led to this conclusion because of the claim's breadth and that it did not recite "how usage of the BIOS to store the verification structure leads to an improvement in computer security."  With part one of Alice complete, the District Court found the claim lacking under part two as well, writing: "specifying that the BIOS be used to house the verification structure [calls for nothing more than] storing data in the memory of a computer component that generally stores data."  Since the District Court found the claim abstract and without an inventive concept, it entered judgment in favor of HTC.

On appeal, the Federal Circuit rapidly answered the patent-eligibility question in the positive.  Relying on recent precedent, such as Finjan, Inc. v. Blue Coat System, Inc., the Court stated that "[i]mproving security—here, against a computer's unauthorized use of a program—can be a non-abstract computer-functionality improvement if done by a specific technique that departs from earlier approaches to solve a specific computer problem."

The Court went on to disagree with the District Court, noting that the claim does recite storing the verification structure in a section of BIOS with certain beneficial characteristics, which was asserted to be an unexpected technique at the time of invention.  Thus, in the view of the Federal Circuit, the claim does not recite a mere desired outcome, but how to achieve this outcome.  Further, the claim addressed a technological problem associated with computers -- software license verification -- rather than a business, mathematical, or financial problem.

Oddly, while still considering the claim under the first part of Alice, the Court made an analogy to BASCOM Global Internet Services v. AT&T Mobility.  The latter case stands for the principle that an unconventional combination of well-known additional elements can make a claim patent-eligible under part two of the test.  The Court seemed to do so in order to support its conclusion that the claim was directed to a technical improvement in computer functionality.

With claim 1 found to be non-abstract, the Court did not need to explicitly move on to part two.  Thus, the Federal Circuit reversed the District Court, and found that the '941 patent met the requirements of § 101.

Ancora Technologies, Inc. v. HTC America, Inc. (Fed. Cir. 2018)
Panel:  Circuit Judges Dyk, Wallach, and Taranto
Opinion by Ciurcuit Judge Taranto

Conference & CLE Calendar

November 20, 2018 - "Lessons From PTAB Full or Partial Denials to Avoid Institution of an IPR or Avoid a Denial" (Strafford) - 1:00 to 2:30 pm (EST)

November 27, 2018 - "Patent Claim and Specification Drafting and Prosecution -- Avoiding Traps That Lead to Royalty Free Licensing of Patented Technology" (Strafford) - 1:00 to 2:30 pm (EST)

November 28, 2018 - "Ch-Ch-Changes: Updates to the PTAB's Patent Trial Practice Guide for AIA Proceedings" (Federal Circuit Bar Association PTAB/TTAB Committee) - 3:00 pm to 4:00 pm (EST)

December 3, 2018 - "Phillips Construction in PTAB Trials: Strategies for Petitioners and Patent Owners" (Federal Circuit Bar Association PTAB/TTAB Committee) - 3:00 pm to 4:00 pm (EST)

FCBA Webast on Phillips Construction in PTAB Trials

The Federal Circuit Bar Association (FCBA) PTAB/TTAB Committee will be offering a webcast entitled "Phillips Construction in PTAB Trials: Strategies for Petitioners and Patent Owners" on December 3, 2018 from 3:00 pm to 4:00 pm (EST).  John D. Vandenberg of Klarquist Sparkman, LLP will moderate a panel consisting of Eldora Ellison of Sterne, Kessler, Goldstein & Fox P.L.L.C.; Justin Kriege of Kilpatrick Townsend & Stockton LLP; and Rubén H. Muñoz, of kin Gump Strauss Hauer & Feld LLP.  The panel will discuss new strategies for petitioners and patent owners facing the same claim construction standard in the PTAB and district court, including new timing considerations, issue preclusion and judicial estoppel risks, dealing with "indefiniteness," stays of district court actions, and mandatory disclosures of earlier constructions.

The webinar is complimentary for FCBA members, $100 for government, academic, or retired practitioners, or $175 for private practitioners.  Those interested in registering for the webcast, can do so here.

Webinar on Patent Claim and Specification Drafting

Strafford will be offering a webinar entitled "Patent Claim and Specification Drafting and Prosecution -- Avoiding Traps That Lead to Royalty Free Licensing of Patented Technology" on November 27, 2018 from 1:00 to 2:30 pm (EST).  Thomas L. Irving, Mark J. Feldstein, and Anthony M. Gutowski of Finnegan Henderson Farabow Garrett & Dunner will guide patent counsel on the impact of case law on daily U.S. patent practice, offer best practices of sound principles to prepare and prosecute patent applications to avoid traps for the unwary or careless claim terminology and untoward language in the specification, and also give real-world examples of "worst" practices that have led to the destruction of U.S. patent rights.  The webinar will review the following issues:

• How can a single word in claim language lead to the demise of U.S. patent rights?
• How do Federal Circuit and PTAB decisions impact drafting claims and specifications?
• What steps can counsel take to avoid careless claim terminology?

The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

FCBA Webast on Updates to the PTAB's Patent Trial Practice Guide

The Federal Circuit Bar Association (FCBA) PTAB/TTAB Committee will be offering a webcast entitled "Ch-Ch-Changes: Updates to the PTAB's Patent Trial Practice Guide for AIA Proceedings" on November 28, 2018 from 3:00 pm to 4:00 pm (EST).  Russell E. Cass of Clark Hill PLC will moderate a panel consisting of David Cavanaugh of WilmerHale LLP, Eugene Goryunov of Kirkland & Ellis LLP, and Eldora Ellison of Sterne, Kessler, Goldstein & Fox P.L.L.C.  The panel will discuss the changes made in the Trial Practice Guide, the implications of those changes, how those changes affect strategies for Petitioners and patent owners, and what further changes might be expected in the future.

The webinar is complimentary for FCBA members, $100 for government, academic, or retired practitioners, or $175 for private practitioners.  Those interested in registering for the webcast, can do so here.

Webinar on Lessons From PTAB Full or Partial Denials

Strafford will be offering a webinar entitled "Lessons From PTAB Full or Partial Denials to Avoid Institution of an IPR or Avoid a Denial" on November 20, 2018 from 1:00 to 2:30 pm (EST).  Thomas L. Irving, Joshua L. Goldberg, and Cory C. Bell of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with an analysis of the ever-increasing number of Patent Trial and Appeal Board (PTAB) denials and partial denials and offer take-home lessons applicable in practitioners' daily practice.  The webinar will review the following issues:

• How can practitioners use the lessons of the PTAB denials to learn what patent owners are doing to achieve their ultimate success: An IPR petition denial?
• What can petitioners learn from the partially denied IPR institution decisions?
• How can practitioners prosecute applications and claims to enhance the likelihood of denial of IPRs and PGR petitions?

The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.