• By Donald Zuhn —

    Colombia FlagLast month, we reported on a letter sent by three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), in which the organizations informed the CEWG of resistance to efforts to secure a compulsory license in Colombia for Imatinib, marketed by Novartis as Gleevec® or Glivec.  According to the Colombian organizations, "enormous pressure" was being applied by developed countries and pharmaceutical companies to block Colombia from issuing a compulsory license for Imatinib, and that resistance to such a compulsory license had combined "inaccuracies, distortions of international trade rules and even threats of trade claims under the dispute settlement mechanism."

    U.S. Trade RepresentativeWhen word of the resistance to Colombia's issuance of a compulsory license for Imatinib reached Capitol Hill, two Senators and fifteen Representatives sent separate letters in May to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on compulsory licenses.  Representatives Sander Levin (D-MI), James McGovern (D-MA), Jim McDermott (D-WA), Jan Schakowsky (D-IL), Eddie Bernice Johnson (D-TX), Peter Welch (D-VT), Rosa L. DeLauro (C-CT), John Lewis (D-GA), Barbara Lee (D-CA), Chris Van Hollen (D-MD), Peter DeFazio (D-OR), Lloyd Doggett (D-TX), David Price (D-NC), Carolyn Maloney (D-NY), and Sam Farr (D-CA) signed the first letter, and Senators Sherrod Brown (D-OH) and Bernard Sanders (I-VT) signed the second letter.

    In the letter from Senators Brown and Sanders, the legislators began by expressing their concern that "representatives of the U.S. government may have pressured the Colombian government not to issue compulsory licenses for pharmaceutical products," and urging the USTR "to publicly clarify that issuing a compulsory license for a pharmaceutical product and promoting access to medicines are consistent with Colombia's international trade obligations."  The Senators referred to reports of "leaked diplomatic letters" indicating that congressional staffers conveyed opposition to the issuance of a compulsory license to Colombian Embassy officials, and that embassy officials were under the impression that issuance of the compulsory license for Imatinib could threaten U.S. funding to Columbia as well as Colombia's future membership in the Trans-Pacific Partnership.  The leaked letters also refer to the USTR's concerns regarding the compulsory license, and the USTR's attempts to meet with the Colombian Ambassador to discuss the compulsory license.

    The Senators state that they "object to any efforts to intimidate and discourage Colombia's government from taking measures to protect the public health of Colombians in a way that is appropriate, effective, and consistent with the country's trade and public health obligations," and "find it unconscionable that any representatives of the U.S. government would threaten to rescind funding for Colombia's peace initiative if a compulsory license for Glivec were issued."  They note that compulsory licenses have been permitted under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement since 1995, that the ability to issue compulsory licenses was confirmed in 2001 with the Doha Declaration on the TRIPS agreement, and that this authority was reiterated in the U.S.-Colombia Free Trade Agreement in 2012.  Senators Brown and Sanders contend that:

    Attempts to dissuade Colombia from using these authorities — especially by threatening unrelated streams of financial support — would be inconsistent with the goals of these agreements and would signal that the United States is not committed to living up to the standards of our free trade agreements when it does not suit corporate interests.  Moreover, they would give the appearance that the United States is elevating corporate profits over public health priorities.

    They conclude their letter by urging the USTR "to immediately and publicly clarify that compulsory licenses are not only permitted under international trade agreements, including the Colombia FTA and the TRIPS Agreement, but also a legitimate means of promoting access to medicines."

    The Representatives similarly express their "serious concern" that recent press reports indicated that U.S. officials may have discouraged Colombian government officials from issuing a compulsory license for Imatinib, and that a "Senate Finance Committee spokeswoman also recently suggested that the issuance of a compulsory license 'may be inconsistent with international trade obligations.'"  According to the Representatives, the Colombian officials were "left with the deeply troubling impression that $450 million in U.S. funding to aid peace efforts could be in jeopardy if Colombia failed to change course."

    After discussing the trade agreements that conferred the authority to issue compulsory licenses, the Representatives stated that they "find it deeply troubling that U.S. officials may not be respecting the Doha Declaration."  They added that they were unaware of "any actions that Colombia has taken or is considering taking that are inconsistent with [requirements under the trade agreements]."  Noting that "the annual price of [Imatinib] in Colombia is almost twice as much as the average annual income per person in Colombia," the Representatives argue that the U.S. "should not seek to limit the existing, agreed upon flexibilities public health authorities have to address these concerns."

    Like the Senators, the Representatives conclude by asking the USTR to "clarify the position the Administration has taken in meetings with Colombian officials on this important issue as soon as possible."

  • By Donald Zuhn –-

    USPTO SealAs we reported earlier this week, the U.S. Patent and Trademark Office originally set a June 30, 2016 deadline for customers to migrate their deposit accounts and electronic funds transfer accounts (EFTs) to Financial Manager, the Office's new online fee payment management tool.  Financial Manager allows customers to store and manage different payment methods (e.g., credit or debit cards, deposit accounts, or EFTs) and generate transaction history and monthly statements.

    In an e-mail alert distributed today, however, the Office indicated that the migration deadline has been extended through July, and that a new deadline will be announced at a later date.  After the to-be-announced new deadline passes, the Office will no longer accept legacy deposit account or EFT credentials for payments, and customers who have not migrated their deposit accounts and EFTs to Financial Manager will only be able to make payments as a guest using a credit or debit card.

    Additional information regarding Financial Manager can be found here.  In order to migrate deposit accounts and EFTs, customers will first need to create a uspto.gov account.  In addition to the Financial Manager webpage, the Office has provided several additional resources regarding Financial Manager.  To migrate accounts to Financial Manager, the Office has provided a Financial Manager Quick Start Guide and Introduction to Payment Method Migration.

  • Mathematical Algorithm Found to be Unpatentable

    By Joseph Herndon —

    District Court for the Central District of CaliforniaOn June 21, 2016, the U.S. District Court for the Central District of California issued an order granting a motion to dismiss pursuant to Rule 12(b)(6) for lack of patentable subject matter under 35 U.S.C. § 101.  Defendants NVIDIA Corp., Autodesk, Inc., and Pixar filed the motion to dismiss over Plaintiff Louis A. Coffelt, Jr.'s (proceeding pro se) U.S. Patent No. 8,614,710.  The outcome here is not surprising given the state of the law with respect to unpatentable subject matter as applied to software patents.

    The '710 Patent is directed to a method of selecting a color for a portion of a digital image by calculating and comparing various vectors within a specific region of space, known as a "steradian".  The '710 Patent contains one independent claim, and it is reproduced below.

    1.  A method for deriving a pixel color comprising the steps of:
        a computer calculating a first position vector for a geometric graphic object;
        a computer calculating a particular steradian region of space;
        a computer calculating a particular steradian radius of said steradian region of space;
        a computer calculating that first second position vector is located in said particular steradian region of space;
        a computer calculating a second position vector for a geometric graphic object;
        a computer calculating that said second position vector is located in said particular steradian region of space;
        a computer calculating a length of said first position vector
        a computer calculating a length of said second position vector;
        a computer comparing said first length to said second length;
        for a first pixel, a computer deriving a pixel color for said first position vector from a result of said length comparison;
        for a second pixel, a computer deriving a pixel color for said second position vector forma result of said length comparison.

    During prosecution of the '710 Patent, the Examiner rejected the then-pending claims as being directed to non-statutory subject matter under § 101.  In response, on March 7, 2013, Plaintiff amended his claims to include a limitation that the methods outlined in the claims would be performed by a machine, specifically, "a computer".

    In the motion to dismiss, Defendants argue that the claims of the '710 Patent are not patent-eligible under § 101 because such claims are directed to an abstract idea — a mathematical algorithm — without adding any inventive concept.

    The District Court followed the two-step approach set for by the Supreme Court in Alice, in which first it is determined whether the claims at issue are directed a patent-ineligible concept, and if so, then the court determines whether any additional elements transform the nature of the claim into a patent-eligible application.  The Supreme Court made clear that the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.

    Whether the Claims are Directed to a Patent-Ineligible Abstract Idea

    Defendants argue that the steps recited in method claim 1 merely express a mathematical algorithm and only explain how to calculate two vectors, calculate a steradian region, determine whether those vectors are located in that steradian region, compare the length of the vectors and then use that information to derive color information for the two vectors.

    Defendants further point out that the calculations claimed can be done by a human mentally or with a pen and paper, and although the '710 Patent issued after Plaintiff placed the word "computer" to accomplish the steps in claim 1, the Examiner's implied reason for allowance directly contravenes the Supreme Court's ruling in Alice.

    The Court found that Plaintiff did not rebut these contentions, and instead, went to great lengths to argue that space is not abstract, but is instead a region, and real object, we all exist in.  Plaintiff relied on the contentions that space "exists literally" and that the computer calculations in claim 1 bring a particular steradian into existence to support his assertion that claim 1 is directed to Real Objects rather than to an abstract idea.

    The Court noted the critical flaw with this argument, however, is that the '710 Patent does not claim "space", but rather claims methods of calculating a region of space and comparing various calculations to choose a pixel color.

    The Court concluded that the steps recited in claim 1 are directed to an abstract, mathematical algorithm.  The Court found that a pixel color is derived mathematically using vectors in a particular steradian region, and the calculations claimed can be done by a human mentally or with a pen and paper.  There is no specific machine claimed for performing the calculations, nor do the claims inherently require one.

    Whether the Claims Include an "Inventive Concept"

    Defendants contended that the claims do nothing more than state the abstract idea to be applied using a generic computer.

    Plaintiff responded by noting that the '710 Patent includes a full, concise, and exact description of the inventive step.  Plaintiff argued that the '710 Patent's "inventive concept" is evidenced by the fact that the software built around the '710 Patent accomplishes things that the industry has struggled to do for many years.  However, the Court noted that while an invention may be new, useful, or lucrative that does not demonstrate that the invention is thus eligible for patent protection under § 101.

    The Court found that because the claims themselves do not contain any limitations regarding specific hardware or software that must be used to perform the claimed methods, and the specification provides that "[o]bviously, the mathematical calculations set forth herein may be executed by various computer programming languages," then the claims lack any inventive concept.

    Thus, the methods claimed in the '710 Patent were found to be unpatentable under 35 U.S.C. § 101 because they recite merely a series of mathematical calculations that can be used to create a steradian region.

    Looking at claim 1, clearly, the claim is written broadly to cover how to determine a color of a pixel.  Perhaps adding further context to the claim to define where the pixel came from, what the geometric graphic object refers to, or even just tying the steradian region of space to the geometric graphic object in some way could be helpful.  This claim appears to have issues, even prior to the Supreme Court in Alice, and after Alice, it stood no chance.

    In addition, while it may have been possible to convince an examiner to allow claims through the addition of a "computer" performing the steps in 2013, that no longer will suffice today.  Rather, the claims must recite non-routine or non-conventional use of the recited "machine".

    Coffelt v. NVIDIA Corp. (C.D. Cal. 2016)
    Order by District Judge S. James Otero

  • By Kevin E. Noonan —

    Washington - Capitol #5Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal to reduce the exclusivity term for biologic drugs from 12 years to 7 years (see "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements").  Last Thursday, Representative Jan Schakowsky (D-IL 9th) introduced a bill (H.R. 5573, the "Price Relief, Innovation, and Competition for Essential Drugs Act"; the "PRICED Act") to do just that, joined by Reps. Elijah Cummings (D-MD 7th), Rosa DeLauro (D-CT 3rd), Lloyd Doggett (D-TX 35th), Marcy Kaptur (D-OH 9th), Jim McDermott (D-WA-7th), and Peter Welch (D-VT); Senator Sherrod Brown (D-OH) and John McCain (R-AZ) are co-sponsors of an identical companion bill in the Senate (S. 3094).  Their motivation is simple:  the Government Accounting Office released a report last October finding that the Federal government had spent more than $4.4 billion on newly approved biologic drugs through its Medicare Part B program in 2013.  The text of the bill reads in its entirety as follows:

    To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

    Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

    SECTION 1. SHORT TITLE.

    This Act may be cited as the "Price Relief, Innovation, and Competition for Essential Drugs Act" or the "PRICED Act".

    SEC. 2. EXCLUSIVITY PERIOD FOR BRAND NAME BIOLOGICAL PRODUCTS.

    (a) In General.—Section 351(k)(7)(A) of the Public Health Service Act (42 U.S.C. 262(k)(7)(A)) is amended by striking "12 years" and inserting "7 years".

    (b) Conforming Changes.—Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended by striking "12 years" each place it appears and inserting "7 years".

    (c) Applicability.—This Act and the amendments made by this Act apply only with respect to a biological product for which the reference product (as such term is used in section 351 of the Public Health Service Act (42 U.S.C. 262)) is licensed under subsection (a) of such section on or after the date of enactment of this Act.

    Subpart (c) is important, of course, to forestall claims that enactment of the bill would constitute a taking requiring recompense, which of course could wipe out (at least in the short term) any savings the government might garner by imposing this change.

    The bill was referred to the Committee on Energy and Commerce in the House and Sen. Brown's companion bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

    Despite the logic of the members' motivations, it is curious that the issue has arisen now (or perhaps lobbyist for the biosimilar industry are just being forward thinking), because most if not all of the biologic drugs that are current targets for biosimilar competition have long since lost their regulatory exclusivity.  This change in the law will do little to nothing to affect biosimilar availability for many years.  And yet the drumbeat has been pounding from before the BPCIA was passed (see "Snatching Defeat from the Jaws of Victory?").

    The Biotechnology Innovation Organization (BIO) not unexpectedly is opposed to the bill, saying in a statement by federal government relations Senior Vice President Jeanne Haggerty that the change in the law "would disrupt the careful balance, created by Congress with broad, bipartisan support [in the BPCIA] between the need to encourage investment in innovative, groundbreaking biological therapies and the desire to ensure that patients have increased choices offered by biosimilar products after a reasonable period of exclusivity for the innovator product."  And Ms. Haggerty noted that the bill would trade short-term price reductions for the risk of inhibiting investment in these drugs, which typically have high development and regulatory compliance costs.

    In our economic system there is always a balance between the amount of risk an investment carries and the size and likelihood of the return on investment.  The only peer-reviewed study of this question for biologic drugs recommended (at the time the exclusivity provisions were being debated) that about 17 years was the necessary exclusivity term (see "Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs").  The 12-year term represents a compromise between a variety of proposals, including the 7 year term the Obama administration is so enamored with and the Federal Trade Commission's proposal that there be no exclusivity term (reminding us that things could be much worse) (see "No One Seems Happy with Follow-on Biologics According to the FTC").

    It is unlikely that this bill will move to passage in the 114th Congress, in view of the limited time left in the session, the impending Congressional and Presidential elections, and the general failure of Congress to pass legislation over the past few years.  But it is likely in equal measure that this bill will be back in the 115th Congress and whether it passes or not will depend on the outcome of these elections.  Vote accordingly.

  • By Donald Zuhn –-

    USPTO SealLast week, the U.S. Patent and Trademark Office sent an e-mail alert reminding practitioners and applicants that the deadline for migrating their deposit accounts and electronic funds transfer accounts (EFTs) is June 30, 2016.  Financial Manager is the Office's new online fee payment management tool, which will allow practitioners and applicants to store and manage different payment methods (e.g., credit or debit cards, deposit accounts, or EFTs) and generate transaction history and monthly statements.  Additional information regarding Financial Manager can be found here.  In order to migrate deposit accounts and EFTs, customers will first need to create a uspto.gov account.

    The Office's e-mail alert noted that after June 30, the Office will no longer accept legacy deposit account or EFT credentials for payments, and that customers will instead be required to store deposit accounts and EFTs in Financial Manager.  After the June 30 deadline, customers who have not migrated their deposit accounts and EFTs to Financial Manager will only be able to make payments as a guest using a credit or debit card.

    In addition to the Financial Manager webpage, the Office has provided several additional resources regarding Financial Manager.  To migrate accounts to Financial Manager, the Office has provided a Financial Manager Quick Start Guide and Introduction to Payment Method Migration.

    In a separate e-mail alert distributed earlier this month, the Office noted that the existing EFS-Web payment process will continue to be available in the short-term to allow customers to transition to the new payment system, but will eventually be phased out.  For information regarding how to pay fees from EFS-Web using a stored payment method through Financial Manager, the Office has provided the EFS-Web Fee Payment Quick Start Guide.  Additional information can also be found here.

  •         By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.
    1:16-cv-11117; filed June 14, 2016 in the District Court of Massachusetts

    • Plaintiff:  Janssen Biotech, Inc.
    • Defendants:  Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Hospira, Inc.

    Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on defendants' alleged control of the development of cell culture media, used to manufacture of defendants' infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).  View the complaint here.


    Janssen Biotech v. Hyclone Laboratories
    1:16-cv-00071; filed June 14, 2016 in the District Court of Utah

    Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on HyClone's development of cell culture media, supplied to Celltrion and Hospira to manufacture an infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).  View the complaint here.


    Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical Inc.
    1:16-cv-00431; filed June 13, 2016 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Breckenridge Pharmaceutical Inc.

    Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 8,410,131 ("Cancer Treatment," issued April 2, 2013), and 8,778,962 ("Treatment of Solid Tumors with Rapamycin Derivatives," issued July 15, 2014) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected).  View the complaint here.


    LEO Pharma A/S et al. v. Perrigo UK FINCO Limited Partnership et al.
    1:16-cv-00430; filed June 10, 2016 in the District Court of Delaware

    • Plaintiffs:  LEO Pharma A/S; LEO Laboratories Ltd.; LEO Pharma, Inc.
    • Defendants:  Perrigo UK FINCO Limited Partnership; Perrigo Co.

    Infringement of U.S. Patent Nos. 6,432,452 ("Anti-Cancer Compounds," issued August 13, 2002), 6,787,161 (same title, issued September 7, 2004), 6,844,013 ("Methods of Stimulating the Immune System," issued January 18, 2005), 7,410,656 ("Anti-Cancer Compounds," issued August 12, 2008), 8,278,292 ("Therapeutic Compositions," issued October 2, 2012), 8,372,827 (same title, issued February 12, 2013), 8,372,828 (same title, issued February 12, 2013), 8,377,919 (same title, issued February 19, 2013), 8,536,163 (same title, issued September 17, 2013), 8,716,271 (same title, issued May 6, 2014), and 8,735,375 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of LEO Pharma's Picato® ( ingenol mebutate gel, used  for the topical treatment of actinic keratosis).  View the complaint here.


    Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc.
    1:16-cv-11091; filed June 10, 2016 in the District Court of Massachusetts

    • Plaintiff:  Purdue Pharma, L.P.
    • Defendant:  Collegium Pharmaceutical, Inc.; Collegium Pharmaceutical, Inc.

    Infringement of U.S. Patent No. 9,155,717 ("Pharmaceutical Formulation Containing Irritant," issued October 13, 2015) based on Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.


    Aurobindo Pharma USA Inc. et al. v. Apicore US LLC et al.
    1:16-cv-03358; filed June 9, 2016 in the District Court of New Jersey

    • Plaintiffs:  Aurobindo Pharma Usa Inc.; Aurobindo Pharma Ltd.; Auromedics Pharma LLC
    • Defendants:  Apicore US LLC; Mylan Institutional LLC

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010), 8,969,616 (same title, issued March 3, 2015), and 9,353,050 (same title, issued May 31, 2016) based on Aurobindo's filing of an ANDA to manufacture a 1% strength isosulfan blue for injection.  View the complaint here.

  • Federal Circuit Concurrence — Decide Patentability with Patent-Eligibility

    By Joseph Herndon —

    Federal Circuit SealThe Federal Circuit earlier today vacated a District Court's order dismissing BASCOM's complaint and remanded for further proceedings.  BASCOM sued AT&T Inc. for patent infringement of U.S. Patent No. 5,987,606, and the U.S. District Court for the Northern District of Texas held that BASCOM failed to state a claim upon which relief can be granted because the claims of the '606 patent are invalid as a matter of law under 35 U.S.C. § 101.  The District Court followed the two-step approach for analyzing patent-eligibility including an abstract idea analysis followed by a search for an inventive concept.

    However, the Federal Circuit vacated that decision, and instead found that the claims are patent-eligible.  Judge Newman's concurring opinion also proposes a possible improvement to the way in which patent-eligibility challenges should be handled that looks to handle "inventive concepts" as a patentability analysis instead of a patent eligibility analysis.

    Looking at the patent-in-suit, the '606 patent (filed in 1997) describes that some websites contain information deemed unsuitable for some users, and corporations had the need to prevent their employees from accessing websites with certain types of information, such as "entertainment oriented sites," while allowing them to continue to access "technical or business sites," and parents had the need to prevent their families from accessing websites containing "sexually explicit or other objectionable information."  The computer industry responded to this need by developing a software tool that allowed control over the type of information received over the Internet.  The software tool inspected a user's request to access a website and applied one or more filtering mechanisms:  exclusive filtering ("black-listing") which prevents access to all sites on a predetermined list of Internet sites; inclusive filtering ("white-listing") which allows access only to a predetermined list of Internet sites; and word-screening or phrase-screening which prevents access to web site pages which contain any word or phrase on a predetermined list.

    According to the '606 patent, filtering software was first placed on local computers, such that each local computer had its own tool for filtering websites (or other Internet content) requested by the operator of the computer.  But to overcome some of the disadvantages of installing filtering software on each local computer, the '606 patent describes a filtering system that avoids being modified or thwarted by an end-user, and avoids being installed on and dependent on individual end-user hardware and operating systems or tied to a single local area network or a local server platform by installing the filter at the ISP server.  The claimed filtering tool retains the advantage of a filtering tool that is located on each local computer, and individuals are able to customize how requests for Internet content from their own computers are filtered instead of having a universal set of filtering rules applied to everyone's requests.

    To summarize, the claimed invention of the '606 patent includes an ISP server that receives a request to access a website, associates the request with a particular user, and identifies the requested website.  The filtering tool then applies the filtering mechanism associated with the particular user to the requested website to determine whether the user associated with that request is allowed access to the website.  The '606 patent describes its filtering system as a novel advance over prior art computer filters, in that no one (in the 1997 timeframe) had previously provided customized filters at a remote server.

    The '606 patent contains two groups of claims:  a first group that is limited to individual-customizable filtering on a remote ISP server, and a second group that is further limited to a hybrid filtering scheme implemented on the ISP server comprised of a master-inclusive list, an individual-customizable set of exclusive lists, and an individual-customizable set of inclusive lists.  For the individually customizable filtering claims, BASCOM points to claim 1 as instructive:

    1.  A content filtering system for filtering content retrieved from an Internet computer network by individual controlled access network accounts, said filtering system comprising:
        a local client computer generating network access requests for said individual controlled access network accounts;
        at least one filtering scheme;
        a plurality of sets of logical filtering elements; and
        a remote ISP server coupled to said client computer and said Internet computer network, said ISP server associating each said network account to at least one filtering scheme and at least one set of filtering elements, said ISP server further receiving said network access requests from said client computer and executing said associated filtering scheme utilizing said associated set of logical filtering elements.

    For the hybrid filtering scheme claims, BASCOM points to claim 23, which depends on claim 22, as instructive:

    22.  An ISP server for filtering content forwarded to controlled access network account generating network access requests at a remote client computer, each network access request including a destination address field, said ISP server comprising:
        a master inclusive-list of allowed sites;
        a plurality of sets of exclusive-lists of excluded sites, each controlled access network account associated with at least one set of said plurality of exclusive-lists of excluded sites; and
        a filtering scheme, said filtering scheme allowing said network access request if said destination address exists on said master inclusive-list but not on said at least one associated exclusive-list, whereby said controlled access accounts may be uniquely associated with one or more sets of excluded sites.

    23.  The ISP server of claim 22 further comprising:
        a plurality of inclusive-lists of allowed sites, each controlled access user associated with at least one of said plurality of inclusive-lists of allowed sites, said filtering program further allowing said network access request if said requested destination address exists on said at least one associated inclusive-list.

    Step One — Abstract Idea

    At the District Court, AT&T argued that the claims were directed to the abstract idea of "filtering content," "filtering Internet content," or "determining who gets to see what," each of which is a well-known "method of organizing human activity" like the intermediated settlement concept that was held to be an abstract idea in Alice.  AT&T analogized the idea of filtering content to a parent or librarian forbidding children from reading certain books, and argued that performing the filtering on the Internet does not make the idea non-abstract.

    BASCOM responded by arguing that the claims of the '606 patent are not directed to an abstract idea because they address a problem arising in the realm of computer networks, and provide a solution entirely rooted in computer technology, similar to the claims at issue in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014).  But the District Court agreed with AT&T, as did the Federal Circuit.  Specifically, the Federal Circuit found that claim 1 is directed to filtering content, which is an abstract idea because it is a longstanding, well-known method of organizing human behavior, similar to concepts previously found to be abstract.

    Step Two — Inventive Concept

    In its search for an "inventive concept," the District Court first determined that no individual limitation was inventive because each limitation, in isolation, was a well-known, generic computer component or a standard filtering mechanism.  The District Court then determined that the limitations in combination were not inventive either because filtering software, apparently composed of filtering schemes and filtering elements, was well-known in the prior art and using ISP servers to filter content was well-known to practitioners.  The District Court also noted that the absence of specific structure for the generic computer components raises the likelihood that such claims could preempt every filtering scheme under the sun.

    The Federal Circuit agreed with the District Court that the limitations of the claims, taken individually, recite generic computer, network, and Internet components, none of which is inventive by itself.  However, the Federal Circuit disagreed with the District Court's analysis of the ordered combination of limitations.

    The Federal Circuit stated that the District Court's analysis in this case looks similar to an obviousness analysis under 35 U.S.C. § 103, except lacking an explanation of a reason to combine the limitations as claimed.  But the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art.  As is the case here, an inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.

    The Federal Circuit found that the inventive concept described and claimed in the '606 patent is the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user.  This design gives the filtering tool both the benefits of a filter on a local computer and the benefits of a filter on the ISP server.  BASCOM explained that the inventive concept rests on taking advantage of the ability of at least some ISPs to identify individual accounts that communicate with the ISP server, and to associate a request for Internet content with a specific individual account.  According to BASCOM, the inventive concept harnesses this technical feature of network technology in a filtering system by associating individual accounts with their own filtering scheme and elements while locating the filtering system on an ISP server.

    The Federal Circuit provided a caveat that, "[o]n this limited record, this specific method of filtering Internet content cannot be said, as a matter of law, to have been conventional or generic."

    The Federal Circuit noted that (i) the claims do not merely recite the abstract idea of filtering content along with the requirement to perform it on the Internet, or to perform it on a set of generic computer components, and (ii) the claims do not preempt all ways of filtering content on the Internet.

    The Federal Circuit seemed to focus on the "technical aspects" of the claimed invention and stated that while filtering content on the Internet was already a known concept, the patent describes how its particular arrangement of elements is a technical improvement over prior art ways of filtering such content (e.g., prior art filters were either susceptible to hacking and dependent on local hardware and software, or confined to an inflexible one size-fits-all scheme).

    The Federal Circuit analogized DDR to the present case in which the '606 patent is claiming a technology-based solution (not an abstract-idea-based solution implemented with generic technical components in a conventional way) to filter content on the Internet that overcomes existing problems with other Internet filtering systems.  The Federal Circuit stated that by taking a prior art filter solution (one-size fits-all filter at the ISP server) and making it more dynamic and efficient (providing individualized filtering at the ISP server), the claimed invention represents a "software-based invention[ ] that improve[s] the performance of the computer system itself."

    Thus, while the claims of the '606 patent are directed to the abstract idea of filtering content, BASCOM adequately alleged that the claims pass step two of Alice's two-part framework.

    In a concurring opinion, Judge Newman stated that she agreed with the Court that the claims of the BASCOM patent are patent-eligible, but wrote separately to urge a more flexible approach to the determination of patent eligibility, "for the two-step protocol for ascertaining whether a patent is for an 'abstract idea' is not always necessary to resolve patent disputes."  Judge Newman stated that there is no good reason why the District Court should be constrained from determining patentability, instead of eligibility based on "abstract idea," when the patentability/validity determination would be dispositive of the dispute.  Judge Newman noted inefficiencies with an initial evidentiary procedure for determination of eligibility at trial and appeal, followed by another cycle of patentability litigation when eligibility is found, when an initial decision directed to patentability may resolve or moot any issue of eligibility.  Initial determination of eligibility often does not resolve patentability, whereas initial determination of patentability issues always resolves or moots eligibility.

    Judge Newman specifically proposed returning to the letter of Section 101, where eligibility is recognized for "any new and useful process, machine, manufacture, or composition of matter," and if any of these classes is claimed so broadly or vaguely or improperly as to be deemed an "abstract idea," this could be resolved on application of the requirements and conditions of patentability.  This determination would avoid resolving an undefined "inventive concept" applied to eligibility.

    Judge Newman's opinion would be welcomed because determining what satisfies § 101 is unpredictable today, whereas, guidelines for determining what satisfies § 102, § 103, and § 112 are well-established.  Judge Newman wrote that a new and useful process or machine or manufacture or composition of matter is not an abstract idea, and if the claims are deemed to be so broad as to be abstract, application of the requirements of patentability is a direct path to resolution of validity disputes.  More specifically, Judge Newman stated:

    Claims that are imprecise or that read on prior art or that are unsupported by description or that are not enabled raise questions of patentability, not eligibility.  35 U.S.C. § 112(a) requires a written description in "full, clear, concise, and exact terms," and § 112(b) requires "claims particularly pointing out and distinctly claiming the subject matter" of the invention.  The process, machine, manufacture, or composition of Section 101 must comply with Section 112.  Subject matter that complies with Section 112 averts the generality or vagueness or imprecision or over-breadth that characterize abstract ideas.  These are conditions of patentability, not of eligibility.  The "conditions and requirements of this title" weed out the abstract idea.

    As support for this proposition, Judge Newman noted that in arguing "inventive concept" for the § 101 challenge here, both sides presented arguments that would also be relevant to patentability.  But in the District Court, the only issue that was finally decided was that of eligibility.  Thus, remand is the appropriate next step.  However, direct resolution of patentability would lead to increased efficiency, and savings in cost and time.

    Judge Newman concluded by stating that "when evidence of patentability is needed or presented to resolve a challenge to eligibility of claims to a new method or machine or manufacture or composition, the District Court and the parties should have the flexibility to resolve patentability at this threshold," and "[i]f the claims are unpatentable, any issue of abstractness, however defined, is mooted.  And if the subject matter is patentable, it is not an abstract idea."  Judge Newman thus urged that expediency should be an available response to challenges on the ground of "abstract idea."

    BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC (Fed. Cir. 2016)
    Panel: Circuit Judges Newman, O'Malley, and Chen
    Opinion by Circuit Judge Chen; opinion concurring in the result by Circuit Judge Newman

  • Supreme Court Building #3The Supreme Court issued an order this morning denying certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc.  Patent Docs will provide more analysis of the Court's denial of certiorari in a subsequent post.

  • Continuation Application Filed on Same Day Parent Issues Satisfies § 120 Requirement That Continuation Be Filed Before the Patenting of Parent

    By Donald Zuhn —

    Federal Circuit SealLast week, in Immersion Corp. v. HTC Corp., the Federal Circuit reversed the decision of the District Court for the District of Delaware that U.S. Patent No. 7,148,875 ("the '875 patent"), assigned to Immersion Corp. ("Immersion"), was not "filed before the patenting" of Immersion's U.S. Patent No. 6,429,846 ("the '846 patent") within the meaning of 35 U.S.C. § 120, because the '875 patent application was filed on the same day that the '846 patent issued.

    Because Immersion asserted neither the '875 patent nor the '846 patent against HTC Corp. and HTC America, Inc. ("HTC"), a brief review of the relationship of the '875 and '846 patents to the asserted patents would be helpful.  On January 19, 2000, Immersion filed U.S. Application No. 09/487,737 ("the '737 application"), which issued as the '846 patent on August 6, 2002.  On the same day that the '846 patent issued, Immersion filed U.S. Application No. 10/213,940 ("the '940 application"), which claims the benefit of the '737 application and five earlier-filed applications, and which eventually issued as the '875 patent.  Immersion subsequently filed three continuation applications that issued as U.S. Patent Nos. 8,031,181 ("the '181 patent"); 7,982,720 ("the '720 patent"); and 8,059,105 ("the '105 patent").  The '720, '181, and '105 patents claim the benefit of the '940 application through one of two later-filed continuation applications.

    In 2012, Immersion filed suit against HTC for infringement of the '720, '181, and '105 patents.  HTC moved for summary judgment of invalidity under 35 U.S.C. § 102(b) in view of Immersion's International Publication No. WO 2001/54109, which published on July 26, 2001, and which corresponds to International Application No. PCT/US01/01486, which claims the benefit of and has a written description that is materially identical to the '737 application.  In moving for summary judgment, HTC alleged that the '720, '181, and '105 patents were not entitled to the benefit of the '737 application's filing date because the '940 application was not "filed before the patenting" of the '846 patent within the meaning of 35 U.S.C. § 120, and therefore, that WO 2001/54109 disclosed the subject matter of the asserted claims more than a year before the effective filing date of the asserted patents.

    The relevant portion of § 120 states that:

    An application for patent for an invention [adequately] disclosed . . . in an application previously filed in the United States . . . shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application . . . [emphasis added].

    In an opinion by Judge Taranto, joined by Chief Judge Prost and Judge Linn, the Federal Circuit notes that the question is "whether . . . the continuing application has to be filed at least one day before the earlier application is patented, or whether an application may be 'filed before the patenting' of the earlier application when both legal acts, filing and patenting, occur on the same day" (emphasis in original).  Reversing the District Court's determination of invalidity, the panel adopts the latter position, pointing out that while "[t]he statutory language [of § 120] does not compel, though it certainly could support, adoption of a day as the unit of time for deciding if filing is 'before' patenting[,] . . . history is decisive in permitting the same-day-continuation result, under which, using units of time of less than a day, a 'filing' is deemed to occur before 'patenting.'"  In support of its decision, the panel notes that the Supreme Court approved same-day continuations in 1863 and that the 1952 Patent Act, which first introduced § 120, codified existing continuation practices.  The panel also notes that:

    [S]ame-day continuations have been approved by a consistent, clearly articulated agency practice going back at least half a century, which has plausibly engendered large-scale reliance and which reflects the agency's procedural authority to define when the legal acts of "filing" and "patenting" will be deemed to occur, relative to each other, during a day.

    The panel explains that the language of § 120 "does not by its terms answer the question whether a later-filed application can claim the same filing date as an earlier-filed application when the later one is filed on the day of the earlier one's patenting" because "that language does not say that the unit of time is a day, as opposed to some smaller unit."  HTC's argument was based on a construction of § 120 that depends on "date-level granularity" – i.e., that in determining whether a continuation application has been filed before the patenting of a parent, the "before" measurement must be made in units no smaller than a day.  However, as the panel points out, HTC's construction — asserting that "'[b]efore' a statutory deadline means before that date, not on or before that date" (emphasis in original) — is "at best question-begging, where the statutory language, as with the phrase at issue here, does not actually speak in terms of days or dates."

    Looking beyond the relevant language of § 120, the panel notes that the day-as-unit meaning put forth by HTC "might . . . be the most natural one to adopt—the one that would fit best with the statute as a whole—if the statute were new and without history."  And that history, the panel states "is so weighty as to be determinative."  That history begins with the Supreme Court's decision in Godfrey v. Eames, 68 U.S. (1 Wall.) 317 (1864), which the panel indicates established the basis for same-day continuations for priority-date purposes long before Congress enacted § 120.  In Godfrey, the Court held that an application filed on the same day as an earlier-filed application was withdrawn and the earlier-filed application were "to be considered as parts of the same transaction, and both as constituting one continuous application, within the meaning of the law," and therefore, that the later-filed application was entitled to the priority date of the earlier-filed application.

    The opinion notes that other federal courts and the Patent Office followed Godfrey's rule in the decades following the Supreme Court's decision.  The opinion also notes that "[n]one of the legislative history or contemporaneous commentary [for § 120] indicates an intent to alter Godfrey's long-established result approving same-day continuations for priority-date purposes," and further, that every edition of the MPEP since 1961 has "specifically notified the public of the agency practice concerning same-day filing and patenting: 'If the first application issues as a patent, it is sufficient for the second application to be copending with it if the second application is filed on the same day or before the patenting of the first application" (emphasis in opinion).  In further support of its construction, the panel points out that "[t]he Supreme Court has long recognized that a 'longstanding administrative construction,' at least one on which reliance has been placed, provides a powerful reason for interpreting a statute to support the construction," citing Zenith Radio Corp. v. United States, 437 U.S. 443, 457–58 (1978).

    The opinion concludes that:

    [T]he repeated, consistent pre-1952 and post-1952 judicial and agency interpretations, in this area of evident public reliance, provide a powerful reason to read section 120 to preserve, not upset, the established position.  And the conclusion is reinforced by the fact that Congress has done nothing to disapprove of this clearly articulated position despite having amended section 120 several times since its first enactment in 1952.

    With respect to the Patent Office's same-day-continuation policy, the Office's position is "essentially [a] procedural one establishing when the agency will consider an input into its process (the legal act of 'filing') and an output of its process (the legal act of 'patenting') to occur relative to each other—neither one being a precisely identifiable self-defining physical act, but a legally defined event."  As a result, the Federal Circuit reversed the decision of the District Court, and remanded the case.

    Immersion Corp. v. HTC Corp. (Fed. Cir. 2016)
    Panel: Chief Judge Prost and Circuit Judges Linn and Taranto
    Opinion by Circuit Judge Taranto

  • CalendarJune 29, 2016 – "Arrival of a New Privilege and a Review of Potential Waivers of Privilege in Business Contexts" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    June 30, 2016 – "Goodbye to Seagate: Willfulness and Enhanced Damages After Halo" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    June 30, 2016 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership (U.S. Patent and Trademark Office) – Alexandria, VA

    June 30, 2016 – "Ethics in Intellectual Property" (Intellectual Property Law Association of Chicago New Programming Committee) – Chicago, IL

    July 6-8, 2016 - Fundamentals of Patent Prosecution 2016: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    July 7, 2016 – "Cuozzo v. Lee: Implications for Post-Grant Review Following New Supreme Court Ruling" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 7, 2016 – "Unitary Patent & Unified Patent Court 2016" (Premier Cercle) – Munich, Germany

    July 12, 2016 – "Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls — Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 13, 2016 – "Understanding and Applying the Defend Trade Secrets Act of 2016" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    July 26, 2016 – "Pharma and Chemical Patent Applications: Meeting Written Description Requirement — Demonstrating Evidence of Possession of the Invention, Navigating the Guidelines, Maintaining Chain of Priority" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 4-5, 2016 - Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 8-9, 2016 - Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    ***Patent Docs is a media partner of this conference or CLE