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  • Court Report

            By Sherri Oslick —

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

    Otsuka Pharmaceutical Co. Ltd. v. Apotex Inc. et al.
    1:15-cv-00109; filed January 29, 2015 in the District Court of Delaware

    • Plaintiff:  Otsuka Pharmaceutical Co. Ltd.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) and 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used to treat hyponatremia).  View the complaint here.


    Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
    1:15-cv-00013; filed January 27, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
    • Defendant:  Mylan Pharmaceuticals Inc.

    Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
    1:15-cv-00079; filed January 23, 2015 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
    • Defendant:  Mylan Pharmaceuticals Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder).  View the Delaware complaint here.

    Senju Pharmaceutical Co. Ltd. et al. v. Paddock Laboratories LLC et al.
    1:15-cv-00087; filed January 26, 2015 in the District Court of Delaware

    • Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Paddock Laboratories LLC; L Perrigo Company; Perrigo Co.

    Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), 8,754,131 (same title, issued June 17, 2014), 8,871,813 (same title, issued October 28, 2014), and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

    AstraZeneca Pharmaceuticals LP et al. v. Glenmark Pharmaceuticals Ltd. et al.
    1:15-cv-00615; filed January 26, 2015 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
    • Defendants:  Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc., USA

    Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  View the complaint here.

    Acorda Therapeutics Inc. et al. v. Actavis Laboratories FL, Inc.
    1:15-cv-00077; filed January 23, 2015 in the District Court of Delaware

    • Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
    • Defendant:  Actavis Laboratories FL, Inc.

    Infringement of U.S. Patent No. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
    1:15-cv-00078; filed January 23, 2015 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Par 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), 7,297,703 ("Macrolides," issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Par'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.

    Astellas Pharma Inc. et al. v. Fresenius Kabi USA LLC
    1:15-cv-00080; filed January 23, 2015 in the District Court of Delaware

    • Plaintiffs:  Astellas Pharma Inc.; Astellas US LLC; Astellas Pharma US Inc.
    • Defendant:  Fresenius Kabi USA LLC

    Infringement of U.S. Patent Nos. 6,107,458 ("Cyclic Hexapeptides Having Antibiotic Activity," issued August 22, 2000) and 6,774,104 ("Stabilized Pharmaceutical Composition in Lyophilized Form," issued August 10, 2004) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Astellas' Mycamine® (micafungin sodium, used for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; esophageal candidiasis; and prophylaxis of Candida infections in hematopoietic stem cell transplant recipients).  View the complaint here.

    Eli Lilly and Company v. Fresenius Kabi USA, LLC
    1:15-cv-00096; filed January 23, 2015 in the Southern District of Indiana

    Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

    Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC
    2:15-cv-00139; filed January 23, 2015 in the District Court of Nevada

    • Plaintiffs:  Spectrum Pharmaceuticals, Inc.; University of Strathclyde
    • Defendant:  Amneal Pharmaceuticals LLC

    Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer).  View the complaint here.


    Teva Pharmaceuticals USA, Inc. et al. v. Dr. Reddys Laboratories, Ltd. et al.
    2:15-cv-00471; filed January 22, 2015 in the District Court of New Jersey

    • Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
    • Defendants:  Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.

    Teva Pharmaceuticals USA, Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
    2:15-cv-00472; filed January 22, 2015 in the District Court of New Jersey

    • Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
    • Defendants:  Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon S.R.O. Blansko

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,800,808 ("Copolymer-1 Improvements on Compositions of Copolymers," issued September 1, 1998) based on defendants' filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the Dr. Reddys complaint here.

  • Conference & CLE Calendar

    CalendarFebruary 5, 2015 – "On Sale and Public Use Bars to Patentability After AIA — Minimizing the Risk of Patent Ineligibility or Invalidation" (Strafford) – 1:00 to 2:30 pm (EST)

    February 5, 2015 – "After Teva: How Will Patent Litigation Change?" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    February 12, 2015 – "USPTO Section 101 Guidelines:  Part 1" (American Intellectual Property Law Association) – 12:30 – 2:15 pm (Eastern)

    February 12, 2015 – "Overcoming Sect. 101 Rejections Post-Alice Corp. — Leveraging USPTO Guidance and Recent Decisions to Meet Sect. 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

    February 19, 2015 - "Readjusting the USPTO 101 Guidance for Life Science Inventions to Alice and Public Input: Are We There Yet?" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    February 25, 2015 – "Prevailing Before the PTAB 'Death Squad': Practical Considerations for Petitioners and Patent Holders" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    February 26, 2015 – "Coordinating Post-Grant Patent Opposition in Europe and the U.S. — Navigating Timing, Grounds for Opposition, Discovery, and Amendments to Maximize Protection in Both Jurisdictions" (Strafford) – 1:00 to 2:30 pm (EST)

    March 4-5, 2015 – Medical Device Patents (American Conference Institute) – Chicago, IL

    March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

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

  • IPO Webinar on Teva v. Sandoz

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "After Teva: How Will Patent Litigation Change?" on February 5, 2015 beginning at 2:00 pm (ET).  Paul Berghoff of McDonnell Boehnen Hulbert & Berghoff LLP, Andrei Iancu of Irell & Manella LLP, and Kevin Rhodes of 3M Innovative Properties Co. will untangle the predictions and give their own best analysis regarding the impact of the Supreme Court's decision in Teva v. Sandoz on patent litigation.

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Webinar on Overcoming § 101 Rejections Post-Alice

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Overcoming Sect. 101 Rejections Post-Alice Corp. — Leveraging USPTO Guidance and Recent Decisions to Meet Sect. 101 Patent Eligibility Requirements" on February 12, 2015 from 1:00 to 2:30 pm (EST).  Charles Bieneman of Bejin Bieneman; Denise M. Kettelberger, Ph.D., of Sunstein Kann Murphy & Timbers; and Katherine M. Kowalchyk, Ph.D., of Merchant & Gould will provide guidance for patent counsel for overcoming §101 rejections, and review recent case law and USPTO guidance on §101 patent eligibility and offer strategies to address §101 rejections.  The webinar will review the following questions:

    • What impact has the Alice Corp. decision had on §101 rejections?
    • What guidance does the USPTO’s memorandum on Preliminary Examination Instructions in light of Alice Corp. provide?
    • What other strategies should patent counsel implement to overcome §101 rejections?
    • How can patent counsel guide applicants in reducing the likelihood of rejection?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees

    By Kevin E. Noonan —

    Washington - Capitol #6Last week, what is described as "a broad coalition" representing patent holders and inventors sent a letter to Representatives Bob Goodlatte (VA, 6th) and John Conyers (MI, 13th), Chairman and Ranking Member, respectively, of the House Judiciary Committee; and Senators Chuck Grassley (R-IA) and Patrick Leahy (D-VT), Chairman and Ranking Member, respectively, of the Senate Judiciary Committee, regarding the potential for "patent reform" legislation in this Congress.

    The letter begins with the groups bona fides, that the signatories "represent the majority of the nation's patent holders and inventors," and a reminder that they represent "thousands of organizations that employ millions of workers in the United States."  The letter then gets right to the point:  first, that "the future of the U.S. economy, including domestic job growth and our competitive advantage in the global economy" requires a strong patent system that not only provides incentives for inventors to inventor but "protects their inventions from unfair copying by others."

    De reguerre, the letter expresses appreciation for the hard work of the committee and a desire to work together.  But the letter also promises that the coalition "will continue to strongly oppose legislation that would weaken the overall patent system and thereby diminish innovation and job creation in the U.S."  The letter also points out that the legal landscape has changed since Rep. Goodlatte introduced his whimsically named "Innovation Act" (H.R. 3309) in the last Congress.  These changes include the five patent cases decided by the Supreme Court in 2014 (Alice, Nautilis, Limelight, Octane Fitness and Highmark), which "are already making it easier to defeat patents, including the kind of patents that often are asserted in abusive litigation, and disincentivizing the bringing of meritless claims."  Also noted are the IPR and CBM provisions of the Leahy-Smith America Invents Act, which "increase patent quality and reduce abusive practices"; the effects of these provisions (which "allow anyone to challenge patents in a fast, relatively inexpensive proceeding before the [] PTAB") "are only now beginning to take hold."  The availability of these provisions have affected litigation, wherein district court judges "are now granting 80% of all motions to stay patent litigation" for patents involved in such proceedings.  Evidence for the effectiveness of IPR and CBM proceedings before the PTAB as illustrated by the statistics that "more than 2,300 patents" have been challenged in the two years since the PTO began implementation, and "fully 75% of the involved claims have been found unpatentable and only about 20% of all patents have survived the proceedings with no changes."

    The letter also cites the changes adopted by the Judicial Conference of the United States raising the pleadings standards for patent cases and limiting discovery to what is "proportional to the needs of the case," which the letter asserts will "reduc[e] the ability of patent plaintiffs to use unnecessary discovery requests to drive up [litigation] costs for defendants in an effort to force unwarranted settlements."  These changes are expressly directed to provisions of H.R. 3309 intended to have just those effects.

    Finally, the letter notes the efforts of the Federal Trade Commission and states attorneys general to "combat abusive patent demand letters and protect small businesses and consumers from unscrupulous practices" and the settlements imposed on MPHJ Technology investments by the FTC and N.Y. State attorney general.

    The letter concludes that "[t]aken together, these judicial and administrative developments, and the plunge in the patent litigation rate, have fundamentally changed the landscape under which patent legislation should be considered."  These developments should be considered "[a]s Congress considers potential changes to the patent system that threaten the constitutionally-guaranteed property rights of innovators."  While again pledging their support "to make improvements to patent law that protect small business, consumers, and the general public from abusive patent litigation," the letter promises that its signatories will "zealously guard[] the United States' competitive edge as the dominant global leader in innovation."

    This letter is a refreshing, robust and impassioned defense of the U.S. patent system, which has become the whipping boy for every politician, editor, and putative technology pundit (as well as not a few misguided Supreme Court Justices) over the past ten years.  It's about time.

    * These include companies such as Amgen, Dolby Laboratories, Qualcomm, Tessera Technolgies, Alexion Pharmaceuticals, AstraZeneca Pharmaceuticals, DuPont, Biogen Idec, Genzyme, Sunovion Pharmaceuticals, Monsanto, Bayer Crop Science, Celgene, DSM North America, and Merck & Co.; industry groups including BIO, Arizona BioIndustry Association, BioFlorida, San Diego Inventors Forum, Colorado Bioscience Association, CURE – Connecticut United for Research Excellence, BayBio,  SoCalBio, IEEE-USA, Medical Device Manufacturers Association, National Small Business Association, National Venture Capital Association, PhRMA, Small Business Technology Council, Indiana Manufacturers Association, Massachusetts Biotechnology Council, and the North Carolina Biosciences Organization; universities and university groups, including Association of American Universities,  Association of Public Land Grant Universities, Cedar Sinai Medical Center,  Colorado School of Mines, and WARF.

  • Big Ten Lobbies Congress to Tread Lightly on “Patent Reform”

    By Kevin E. Noonan —

    Big TenOne of the frustrations for participants in the patent wars of the early 21st Century has been the failure of many of the most vulnerable stakeholders to take a stand against overreaching proposals by proponents of a crisis atmosphere in patent enforcement (such as the Goodlatte bill, H.R. 3309, ironically entitled "The Innovation Act" passed by the House of Representatives in the last Congress).  Having been spared passage of this bill in the Senate (purportedly by the trial lawyers, who pointedly told the Democratic leadership that they would lose the lawyers support in the midterm elections should the bill pass), at least members of the Big Ten conference of universities have gotten the message.  In a letter to Rep. Sean Duffy (WI 7th) sent January 20th, the presidents and chancellors of all thirteen of the conference's universities* argued against a repeat in this Congress of the provisions in the Goodlatte bill.

    Washington - Capitol #5After pledging to wish to work with Congress, the letter notes that technology transfer from universities "has brought about hundreds of billions of dollars in economic activity and over three million jobs in the past thirty years nationwide" and that the only way to reap those benefits is to have "a strong defensible patent" to protect the investment needed for commercializing university inventions.  Enacting a bill like the Goodlatte bill "would [make] using the courts to enforce any patent much more difficult," according to the letter, specifically calling out the "loser pays" and joinder provisions as being particularly problematical.  These provisions "would have the effect of making patent licensing negotiations more complex and likely discourage at least some of [the conference's] members from licensing their inventions at all."  Litigation would be restricted to those "legitimate patent owners" with "deep pockets" because of the attorneys' fees risk.

    The letter reassures the Representative that the Big Ten does not approve of those "who abuse the patent system," and pledges support for "narrow legislation that targets those individuals."  But "[u]nless patent holders are able to defend and assert their patents," the letter warns that the value of the patent system [will be] eroded and fewer businesses will be willing to license and develop these patents into the new products, new drugs and medical devices that will improve the quality of life and increase economic growth" in America.

    This is a good beginning, but clearly much more must be done to counter those lobbying groups whose masters would like nothing less than to inhibit small patent owners and universities from being able to enforce them against those who would rather just expropriate the technology (as was done before passage of the Bayh-Dole Act in 1980).

    * These include Phyllis M. Wise, Chancellor, University of Illinois at Urbana-Champagne; Mark Schlissel, President, University of Michigan; Michael V. Drake, President, The Ohio State University; Michael A McRobbie, President, Indiana University; Eric W. Kaler, President, University of Minnesota; Eric J. Barron, President, Pennsylvania State University; Sally Mason, President, University of Iowa; Harvey Perlman, Chancellor, University of Nebraska-Lincoln; Walla D. Loh, President, University of Maryland; Lo Anna K. Simon, Michigan State University; Morton O. Schapiro, President, Northwestern University; Robert L. Barchi, President, Rutgers University; and Rebecca M. Blank, Chancellor, University of Wisconsin-Madison.

  • USPTO Issues Post-Alice Abstract Idea Examples

    By Michael Borella —

    USPTO SealOn January 27, the USPTO provided its promised set of examples of patent-eligible and patent-ineligible claims relating to the abstract idea exception to 35 U.S.C. § 101, in light of Alice Corp. v. CLS Bank.  These examples are intended to be used in conjunction with the Office's 2014 Interim Guidance on Patent Subject Matter Eligibility.  While the latter document includes examples of claims that were considered by the Supreme Court or Federal Circuit, some of the new examples are hypothetical claims designed to illustrate the contours of § 101.

    Out of the eight example claims, four are considered by the Office to be patent-eligible, while four are not.  Additionally, five of these claims appear to be identical to those of particular Federal Circuit cases, two claims are based on particular Federal Circuit cases, and one claim appears to be fashioned by the Office for purposes of example.  (Actually, more than eight claims are provided, as some of the examples include distinct method, computer-readable media, and/or system claims; but for purposes of this discussion we will consider only one claim per example, as statutory category does not impact the analysis of patent-eligibility of any claim.)

    These example claims may prove useful when prosecuting applications before the Office, or in IPR proceedings.  However, it is unlikely that courts will give deference to the Office's reasoning in this memo, to the extent that it goes beyond that of the Supreme Court or Federal Circuit.

    With respect to business method claims, these examples provide little additional insight.  The Office does not provide an example of an eligible business method, perhaps because the Supreme Court and Federal Circuit have yet to find any business method patent-eligible since Alice.

    However, with respect to computer-implemented claims, these examples elucidate the difference between the recent Ultramercial v. Hulu and DDR Holdings v. Hotels.com cases.  The former indicates that adding a limitation such as "the Internet" to an otherwise disembodied method claim will not render that claim patent-eligible, while the latter holds that making a fundamental change to how a networked server operates is patent-eligible.  Consequently, applicants and patentees may focus their § 101 arguments on the similarities between their claims and those of DDR, as well as the differences between their claims and those of Ultramercial.

    Another notable point in these examples is that the two claims based on particular Federal Circuit cases are both based on pre-Alice cases, and the Office provides narrower versions of each herein.  It appears that the Office may be walking back from their analysis of these cases in the 2014 Interim Eligibility Guidance, where the Office suggested that these claims would survive review under Alice.

    Eligible Example 1: Isolating and Removing Malicious Code from Electronic Messages

    A computer-implemented method for protecting a computer from an electronic communication containing malicious code, comprising executing on a processor the steps of:
        receiving an electronic communication containing malicious code in a computer with a memory having a boot sector, a quarantine sector and a non-quarantine sector;
        storing the communication in the quarantine sector of the memory of the computer, wherein the quarantine sector is isolated from the boot and the non-quarantine sector in the computer memory, where code in the quarantine sector is prevented from performing write actions on other memory sectors;
        extracting, via file parsing, the malicious code from the electronic communication to create a sanitized electronic communication, wherein the extracting comprises
        scanning the communication for an identified beginning malicious code marker,
        flagging each scanned byte between the beginning marker and a successive end malicious code marker,
        continuing scanning until no further beginning malicious code marker is found, and
        creating a new data file by sequentially copying all non-flagged data bytes into a new file that forms a sanitized communication file;
        transferring the sanitized electronic communication to the non-quarantine sector of the memory; and
        deleting all data remaining in the quarantine sector.

    This claim recites a method for protecting a computer from electronic communication (e.g., email) that potentially includes malicious code (e.g., a computer virus).  While the communication is in quarantined memory, the computer scans the communication for a beginning malicious code marker and an end malicious code marker, flagging all bytes between these markers.  The computer then creates a new version of the communication without the flagged bytes, releases it from the quarantine memory, and deletes the original version of the message.

    According to the Office, "[t]he claim is directed towards physically isolating a received communication on a memory sector and extracting malicious code from that communication to create a sanitized communication in a new data file," and [s]uch action does not describe an abstract concept" similar to those of Bilski v. Kappos or Alice.  Instead, the claim is "inextricably tied to computer technology."  Consequently, the claim is patent-eligible, and there is no need to carry out the two-prong patent-eligibility analysis of Alice.

    Eligible Example 2: E-Commerce Outsourcing System/Generating a Composite Web Page

    This example claim is that of DDR Holdings, LLC v. Hotels.com, a case that we have already discussed in detail (see this previous analysis for a presentation of the claim).  The claim is directed to "automatically generating and transmitting a web page in response to activation of a link using data identified with a source web page having certain visually perceptible elements."

    In the Office's view, this claim "does not recite a mathematical algorithm; nor does it recite a fundamental economic or longstanding commercial practice."  Instead, it "addresses a business challenge (retaining website visitors) that is particular to the Internet."  But unlike business method claims that merely recite the performance of a business practice over the Internet, the claim is "necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks."

    The Office suggests that the claim is patent-eligible, and that there is no need to carry out the two-prong patent-eligibility analysis of Alice.  However, the Office also notes that in the actual case, the Federal Circuit found that additional limitations in the claim amounted to more than just applying an abstract idea on the Internet, and therefore the claim would pass the second-prong of the Alice test.

    Eligible Example 3: Digital Image Processing

    A computer-implemented method for halftoning a gray scale image, comprising the steps of:
        generating, with a processor, a blue noise mask by encoding changes in pixel values across a plurality of blue noise filtered dot profiles at varying gray levels;
        storing the blue noise mask in a first memory location;
        receiving a gray scale image and storing the gray scale image in a second memory location;
        comparing, with a processor on a pixel-by-pixel basis, each pixel of the gray scale image to a threshold number in the corresponding position of the blue noise mask to produce a binary image array; and
        converting the binary image array to a halftoned image.

    This claim is based on that of Research Corporation Technologies Inc. v. Microsoft Corp., a pre-Alice Federal Circuit decision, but recites a more specific variation of the invention.  Particularly, the claim recites "generating a blue noise mask and using that blue noise mask to halftone a gray scale image."

    Due to the iterative mathematical operations of the claim, and because mathematical operations are examples of abstract ideas, the Office concludes that this claim is directed to an abstract idea.  Notably, the Office indicated that the background of the patent defines generation of the blue noise mask to be a mathematical operation, which is a suggestion to applicants that what they say in the specification may have a role in determining the patent-eligibility of their claims.

    Applying the second prong of the Alice test, the Office notes that the claim's recitation of generic processor and memory elements "is not sufficient to transform a judicial exception into a patentable invention."  However, the claim also recites "comparing the blue noise mask to a gray scale image to transform the gray scale image to a binary image array and converting the binary image array into a halftoned image," which "tie the mathematical operation (the blue noise mask) to the processor's ability to process digital images."  Further (and again looking to the patent's specification), the Office states that, when viewed as an ordered combination, "the steps recited in addition to the blue noise mask improve the functioning of the claimed computer itself," as well as digital image processing technology.  In particular, the claimed invention "allows the computer to use to less memory than required for prior masks, results in faster computation time without sacrificing the quality of the resulting image as occurred in prior processes, and produces an improved digital image."  As a result, the claim would pass the second prong of the Alice test, and therefore be patent-eligible.

    Eligible Example 4: Global Positioning System

    A system for calculating an absolute position of a GPS receiver and an absolute time of reception of satellite signals comprising:
        a mobile device comprising a GPS receiver, a display, a microprocessor and a wireless communication transceiver coupled to the GPS receiver, the mobile device programmed to receive PN codes sent by a plurality of GPS satellites, calculate pseudo-ranges to the plurality of GPS satellites by averaging the received PN codes, and transmit the pseudo-ranges, and
        a server comprising a central processing unit, a memory, a clock, and a server communication transceiver that receives pseudo-ranges from the wireless communication transceiver of the mobile device, the memory having location data stored therein for a plurality of wireless towers, and the central processing unit programmed to:
        estimate a position of the GPS receiver based on location data for a wireless tower from the memory and time data from the clock,
        calculate absolute time that the signals were sent from the GPS satellites using the pseudo-ranges from the mobile device and the position estimate,
        create a mathematical model to calculate absolute position of the GPS receiver based on the pseudo-ranges and calculated absolute time,
        calculate the absolute position of the GPS receiver using the mathematical model, and
        transmit the absolute position of the GPS receiver to the mobile device, via the server communication transceiver, for visual representation on the display.

    This claim is based on that of SiRF Technology Inc. v. International Trade Commission, another pre-Alice Federal Circuit decision.  Like the previous claim, this example claim is narrower than that of the claim at issue in the case.  The claim recites ways to "improve GPS techniques by enabling the mobile GPS receiver to determine its position more accurately and improve its signal-acquisition sensitivity to operate even in weak-signal environments."

    Applying the Alice test, the Office finds that that claim recites "mathematical operations (e.g., calculating pseudo-ranges and absolute times, and the mathematical model)" which fall into the category of abstract ideas.

    In regard to the second prong of the test, the Office notes that merely reciting a generic CPU, memory and clock adds nothing to the patent-eligibility of the claim.  But, these elements act in concert with the claimed mobile device "to improve an existing technology (global positioning) by improving the signal-acquisition sensitivity of the receiver to extend the usefulness of the technology into weak-signal environments and providing the location information for display on the mobile device."  When viewed as a whole, these features amount to significantly more than the abstract idea.  Therefore, the claim is patent-eligible.

    Ineligible Example 5: Digital Image Processing

    This example claim is that of Digitech Image Tech., LLC v. Electronics for Imaging, Inc., a post-Alice case that we have already discussed in detail (see this previous analysis for a presentation of the claim).  The claim is directed to "generating first data and second data using mathematical techniques and combining the first and second data into a device profile."

    The Office notes that the claim is directed to an abstract idea because it "simply describes the concept of gathering and combining data by reciting steps of organizing information through mathematical relationships."  Due to the fact that the claim does not recite any additional elements beyond this abstract idea, the claim is not patent eligible.

    Ineligible Example 6: The Game of Bingo

    This example claim is that of Planet Bingo, LLC v. VKGS LLC, another post-Alice case that we have already discussed in detail (see this previous analysis for a presentation of the claim).  The claim involves "an automated Bingo system having the ability to print sets of numbers on tickets . . . , track the sale of the tickets and to validate winning tickets."

    The Office indicates that the claim recites computerized steps of "managing a game of Bingo, including for example inputting and storing two sets of Bingo numbers, assigning a unique player identifier and control number, and verifying a winning set of Bingo numbers," and that these steps recite a way of organizing human activity similar to those of Bilski and Alice.  Therefore, the claim is directed to an abstract idea.

    While the claim also recites "a computer with a central processing unit (CPU), memory, a printer, an input and output terminal, and a program," these generic computer components merely instruct one to implement the abstract idea on a computer.  With no further meaningful limitations, the claim amounts to no more than the abstract idea itself.

    Ineligible Example 7: E-Commerce providing Transaction Performance Guaranty

    A method, comprising:
        receiving, by at least one computer application program running on a computer of a safe transaction service provider, a request from a first party for obtaining a transaction performance guaranty service with respect to an online commercial transaction following closing of the online commercial transaction;
        processing, by at least one computer application program running on the safe transaction service provider computer, the request by underwriting the first party in order to provide the transaction performance guaranty service to the first party,
        wherein the computer of the safe transaction service provider offers, via a computer network, the transaction performance guaranty service that binds a transaction performance guaranty to the online commercial transaction involving the first party to guarantee the performance of the first party following closing of the online commercial transaction.

    This claim is from buySAFE, Inc. v. Google, Inc., another post-Alice Federal Circuit decision.  The Office describes the claim as reciting "methods for conducting reliable transactions in an e-commerce environment."

    In applying the Alice test, the Office finds that "the steps of creating a contract, including receiving a request for a performance guaranty (contract), processing the request by underwriting to provide a performance guaranty and offering the performance guaranty" describe the creation of a contractual relationship, similar to the abstract idea of Bilski.  The Office also notes that "narrowing the commercial transactions to particular types of relationships or particular parts of that commercial transaction (e.g., underwriting) would not render the concept less abstract."  As a result, the claim is directed to an abstract idea.

    Applying the second prong of Alice, the Office concludes that "the claim limitations in addition to the abstract idea include a computer application running on a computer and the computer network."  These recitations of generic computer technology do not amount to more than the abstract idea itself, and consequently the claim is not patent-eligible.

    Ineligible Example 8: Distribution of Products over the Internet

    This example claim is that of Ultramercial v. Hulu, a post-Alice case that we have already discussed in detail (see this previous analysis for a presentation of the claim).  The claim is directed to "distributing products covered by intellectual property, such as copyright, over a telecommunications network by allowing a consumer to choose to view or interact with a sponsor's message in exchange for access to copyrighted material."  For instance, one may be required to watch an advertisement before viewing an online video.

    In applying the Alice test, the Office finds that the claim "describes the concept of using advertising as an exchange or currency," which is similar to the claimed subject matter of Bilski.  Thus, the claim is directed to an abstract idea.

    With respect to the second prong of the test, the additional limitations of "accessing and updating of an activity log . . . only represent insignificant pre-solution activity," while "requiring a consumer request and restricting public access is insignificant pre-solution activity."  Further, recitation of "the Internet" is "simply an attempt to limit the abstract idea to a particular technological environment."  Thus, the claim is not patent-eligible.

  • Myriad Throws in the Towel

    By Kevin E. Noonan —

    MyriadIn the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed suit against six genetic diagnostic test providers (Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp) and was itself sued in declaratory judgment actions by three others (Quest, Invitae, and Counsyl) (see "Myriad Genetics Sues LabCorp over BRCA Gene Testing").  On Myriad's motion, the Judicial Panel on Multidistrict Litigation consolidated five of these actions (involving Ambry Genetics, GeneDx, Quest Diagnostics (infringement), and Quest and Counsyl (declaratory judgment) in the District of Utah (Myriad's "home court") under 28 U.S.C. § 1407 under the caption In Re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (see "Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court").  The Panel decision also noted that other cases, such as the ones involving Invitae Corp. and LabCorp, could be consolidated as "potential tag-along actions."

    As it turned out, Utah District Court Judge Shelby denied Myriad's preliminary injunction motion, on the grounds that Myriad was unlikely to prevail on the merits regarding the asserted claims (*) in view of the Supreme Court's Myriad opinion (see "Utah Judge Denies Myriad's Preliminary Injunction Motion").  This decision was affirmed by the Federal Circuit last month in an opinion that left little more for the District Court to do than consider motions for judgment by the infringement defendants and declaratory judgment plaintiffs (see "In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)").

    And it also turns out that that won't be necessary, at least for Ambry Genetics, LabCorp, Invitae, and Pathway Genomics (this company was sued by Myriad in June 2014 and was not part of the consolidated case), all of whom issued a press release announcing that the action as to them had settled.  (Another defendant, Gene-by-Gene, settled early in 2014 on essentially the same terms announced by these defendants.)  The press releases, using similar language, stated that Myriad's infringement allegations had been dismissed "with prejudice" and that each of the parties had received a "covenant not to sue" by Myriad.  The only financial considerations announced were that each party would bear its own costs of the litigation, which Myriad may count as a "win" in view of its potential liability under even more recent Supreme Court precedent (Octane Fitness v. ICON Health & Fitness and Highmark v. Allcare Health Management); this is particularly true of the Pathmark settlement, insofar as Myriad sued Pathmark after both the District Court's opinion denying its preliminary injunction and the Supreme Court lowered the threshold for attorneys' fees in patent litigation.

    It can be reasonably expected that Myriad will settle with the remaining defendants/DJ plaintiffs, ending a series of cases that changed the landscape for biotechnology patenting.  It is hard for even an evenhanded observer not to be tempted to ask, "Are you happy now, Myriad?"

    Myriad's patents on its BRCA gene technology begin to expire early next year.

    * The specific claims Myriad alleges are infringed include the following:  claim 6 of U.S. Patent No. 5,709,999; claims 6, 16 and 17 of  U.S. Patent No. 5,709,999; claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441; claims 29 and 30 of U.S. Patent No. 5,837,492; claim 4 of U.S. Patent No. 6,033,857; claims 2, 3 and 4 of U.S. Patent No. 5,654,155; claims 2, 3, 4, 5, 6, and 7 of U.S. Patent No. 5,750,400; claim 5 of U.S. Patent No. 6,951,721; and claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497.  Missing from the complaint against Gene by Gene were allegations of infringement of claims 32 and 33 of U.S. Patent No. 6,051,379 asserted in the complaint Myriad filed against Ambry Genetics.  Similar combinations of these claims were asserted against the other defendants.

  • House Fly Genome Sequenced

    By Kevin E. Noonan —

    10The phylogenetic Order Diptera comprises the "true" flies (defined as having a single pair of wings arising from the thorax) and is first found in the fossil record in the Middle Triassic (~245 million years ago).  It is one of the most evolutionarily successful, comprising 120,000 known species and thought to encompass almost twice that number.  The group comprises a number of species associated with humans and with human diseases, including a number of mosquito species (Culex, Aedes, Anopheles), the tsetse fly (Glossina morsitans) and the common house fly, Musca domestica.  While some mosquito species and the tsetse fly genome have been determined previously, only last October an international and interdisciplinary group* disclosed the house fly genome.  The house fly is particularly important for human health, being capable of transmitting  more than 100 human diseases.  These include:  salmonellosis, anthrax, ophthalmia, shigellosis, typhoid fever, tuberculosis, cholera and infantile diarrhea; protozoan infections including amebic dysentery; helminthic infections including pinworms, roundworms, hookworms and tapeworms; and viral and rickettsial infections.

    The house fly genetic complement was known to be contained in five autosomes and an X/Y pair of sex chromosomes.  The Y chromosome contains the male dominant factor, M, but there are house fly strains known to have translocated the M factor onto any one of the 5 autosomes (and even in some cases the X chromosome); these "autosomal M" males are usually XX, but M-factor mutants exist that can be female determinants.

    The report, published in Genome Biology ("Genome of the house fly, Musca domestica L., a global vector of diseases with adaptations to a septic environment," 15: 466) sequenced six adult females of aabys strain; the sequenced genome size is 691 Mb and was found to contain 15,345 genes, of which 14,180 genes were predicted from open reading frames and 1,165 comprised "non-coding" genes.  Overall the  genes from the house fly shared ~64% identity with genes from the fruit fly Drosophila melanogaster, one of the most well-studied animal species and the best-characterized member of the Diptera.

    Genic characteristics of the house fly genome

    Feature

    Count

    Mean length

    Genes

    15,345

    13,553

    Transcripts

    18,779

    2,097

    mRNA

    17,508

    2,221

    tRNA

    947

    74

    Single exon transcripts

    2,566

    797

    Exons

    67,886

    431

    Introns

    52,875

    3,889

     Compared with Drosophila, the group reported detection of 49% of the predicted housefly genes to be single copy orthologs, and another 37% to comprise conserved paralogous groups, with the remaining 1,934 genes (14%) having no homologs in the Drosophila genome.  Fifty-two percent of house fly genomic DNA was found to be made up of interspersed repeats, one genomic feature that distinguishes this species from Drosophila melanogaster.  Also, about one-half of the house fly interspersed repeats are class II transposons (capable of excision and reintegration into the fly chromosomes).  Gene ontology analysis found that 12.1% of the genes were involved in single-organism processes and another 12% in cellular processes; 11.4% were metabolic genes and 10.8% were involved in biological regulation.  The most abundant cellular components were cell (32.6%) and organelle (29.2%).  The most abundant molecular processes were binding (48.1%) and catalytic activity (28.9%).  Overall, these breakdowns in gene ontology showed a very similar distribution to genes in Drosophila.

    The significant differences between the house fly and Drosophila genomes involved "immune-relates" genes, genes for olefaction and genes for detoxification.  Regarding the immune-related genes, the house fly has 771 such genes, compared with 416 in Drosophila.  The putative function of these genes involved "recognition proteins that identify pathogen-associated molecular patterns, proteins that belong to signaling pathways that activate the transcriptional response to infection, and effector molecules that kill pathogens," all of which relate to similar genes in other insect species.  While immune signaling genes and their pathways are conserved compared with Drosophila, there have been "substantial increases" in both gene copy number and genic diversity for genes involved in recognition and effector components (including in particular genes, such as Nimrod and thioester-containing proteins, Teps, involved in phagocytosis, wherein there has been a large expansion of such genes in houseflies compared with Drosophila).  Of the effector protein genes, four classes of antimicrobial genes (attacins, diptericins, cecropins, and defensins) are shared with Drosophila; these have expanded in housefly (29 genes vs. 19 in Drosophila).

    Another gene type having expanded in houseflies compared with Drosophila are metabolism/detoxification genes, comprising the three groups of cytochrome P450s, esterase/hydroxylases, and conjugation enzymes.

    cytochrome P450s  -  146 genes (84 in Drosophila), 11 pseudogenes, largest expansion in the CYP4 (43%) and CYP6 (46%) families

    esterase/hydroxylases  -  92 genes (phosphodiesterase, acetylcholinesterase, thioesterase, carboxylesterase, metallophosphoesterase, neuropathy target esterase and palmitoyl-protein thioesterase) distributed as 39 carboxylic-ester hydrolases (EC 3.1.1), 10 thioester hydrolases (EC 3.1.2), three phosphoric-monoester hydrolases (EC 3.1.3) and 40 phosphoric-diester hydrolases (EC 3.1.4)

    conjugation enzymes  -  33 GST genes/3 spice variants (33/11 in Drosophila)

    The Report also contains the sequences for genes involved in fast synaptic transmission, members of the cys-loop ligand-gated ion channel (cysLGIC) superfamily, with 23 subunit-encoding genes (the same as Drosophila).  These genes are important, according to the Report, as being targets for insecticides and may provide a rational basis for designing new and more effective and/or specific insecticides against the house fly.

    Also reported were chemoreceptor genes in the house fly genome, which include odorant binding proteins (OBP, 87 genes in house fly/52 genes in Drosophila), odorant receptors (OR, 85 genes (86 transcripts) in house fly/60 genes (62 transcripts) in Drosophila), gustatory receptors (GR, 79(103)/60(68)), and ionotropic receptors (IR, 110/65), with the species sharing evolutionary-conserved genes in this category but also showing rapid evolution of genes and pseudogenes: "while there are roughly equal numbers of gene losses and pseudogenes in each species, M. domestica has duplicated and retained more genes in each family.  These gene subfamily expansions are particularly prominent in the candidate gustatory receptors, especially those implicated in perception of bitter tasting compounds."  And "M. domestica also has large expansions of ORs related to [] receptors involved in repulsion from aversive chemicals in larvae and in perception of a male-produced pheromone."  From these data the report concludes that "M. domestica has evolved an expanded repertoire of chemoreceptors and associated proteins compared with D. melanogaster.  This expansion is mostly associated with gustation, specifically perception of bitter tasting compounds" and that "[i]t may be that the more diverse and potentially toxic food sources and larval habitats of M. domestica have led to retention and specialization of gene duplicates in these receptor gene subfamilies."

    Another interesting aspect of house fly biology is sex determination and sex-biased gene expression and evolution.  The group reports sequencing of "Md-traD alleles of 22 to 24 individuals from 7 populations sampled across Europe, North America, Asia, Africa and Australia," finding Md-traD alleles on all continents; "[s]urprisingly," according to the report, the same molecular signatures in Md-traD alleles were found in all populations tested, "but different alleles for the non-dominant form, containing insertions or deletions in exon 3."

    FIG
    Premature translation termination occurs in exon 2b and exon 3 mutants in males, while these lesions are "skipped" in mutant females.  With regard to sex-based expression, the report tested 10,096 genes with expression levels high enough to compare sex-related expression patterns, and found 113 having male-biased expression and 81 have female-biased expression, with no significant differencs found in the various gene ontology categories noted above.  This is a substantial difference from Drosophila, which show a ten-fold higher level of sex-based expression.

    The report also notes that the house fly has five actin genes (to four in Drosophila) that have high sequence homology with Drosophila genes, and several miRNA loci, showing transporting/processing/function genes conserved with Drosophila.

    The report ends with a statement that might be applied to every advance in the genomics field with regard to the hoped-for consequences of this work:

    The availability of the house fly genome should accelerate the pace of research on this important vector of human and animal diseases.  The house fly genome provides a rich resource for enabling work on innovative methods of insect control, for understanding the mechanisms of insecticide resistance, genetic adaptation to high pathogen loads, host parasitoid interactions, and for exploring the basic biology of this important pest.

    * The interdisciplinary group included scientists from Cornell University, Washington University School of Medicine, the University of Groningen, the University of Zurich, the University of Illinois/Champagne-Urbana, Auburn University, the University of Houston, the National Institutes of Health, the University of Tennessee, Harvard University, and University College, London

  • Court Report

            By Sherri Oslick —

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

    Tris Pharma Inc. v. Par Pharmaceutical Inc. et al.
    1:15-cv-00068; filed January 21, 2015 in the District Court of Delaware

    • Plaintiff:  Tris Pharma Inc.
    • Defendants:  Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

    Infringement of U.S. Patent Nos. 8,062,667 ("Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," issued November 22, 2011), 8,287,903 ("Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product," issued October 16, 2012 to), 8,465,765 (same title, issued June 18, 2013), 8,653,033 (same title, issued October 22, 2013), and 8,778,390 (same title, issued July 15, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Tris' Quillivant XR® (methylphenidate hydrochloride oral solution, used to treat attention deficit hyperactivity disorder, distributed by Pfizer).  View the complaint here.

    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Mylan Pharmaceuticals Inc.
    1:15-cv-00010; January 21, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation).  View the complaint here.

    Teva Pharmaceuticals USA Inc. v. AstraZeneca Pharmaceuticals LP et al.
    1:15-cv-00050; filed January 19, 2015 in the District Court of Delaware

    • Plaintiff:  Teva Pharmaceuticals USA Inc.
    • Defendants:  AstraZeneca Pharmaceuticals LP; Amylin Pharmaceuticals LLC

    Declaratory judgment of non-infringement of U.S. Patent Nos. 7,297,761 ("Pharmaceutical Compositions containing Exendins," issued November 20, 2007) and 7,741,269 ("Exendins and Exendin Agonists for Weight Reduction and Obesity," issued June 22, 2010) based on Teva's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of AstraZeneca's Byetta® (exenatide injection, used to improve blood sugar control in adults with Type II diabetes, when used with diet and exercise).  View the complaint here.

    Laboratoire HRA Pharma v. Teva Pharmaceuticals USA Inc.
    1:15-cv-00045; filed January 16, 2015 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 8,426,392 ("Method for Providing Emergency Contraception," issued April 23, 2013), 8,512,745 ("Ulipristal Acetate Tablets," issued August 20, 2013), and 8,735,380 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Laboratoire's Ella® (ulipristal acetate, used for emergency contraception to prevent pregnancy within five days after unprotected intercourse or a known or suspected contraceptive failure).  View the complaint here.

    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Teva Pharmaceuticals USA Inc. et al.
    1:15-cv-00048; filed January 16, 2015 in the District Court of Delaware

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim Pharmaceuticals Inc.
    • Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation).  View the complaint here.

    Shionogi & Co., Ltd. et al. v. Aurobindo Pharma Ltd. et al.
    1:15-cv-00478; filed January 16, 2015 in the Northern District of Illinois

    • Plaintiffs:  Shionogi & Co., Ltd.; Shionogi Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.

    Shionogi & Co., Ltd. et al. v. Aurobindo Pharma Ltd. et al.
    3:15-cv-00319; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiffs:  Shionogi & Co., Ltd.; Shionogi Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,247,402 ("Crystal Form of Pyrrolidylthiocarbapenem Derivative," issued August 21, 2012) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Shionogi's Doribax® (doripenem injection, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis).  View the NDIL complaint here.

    Senju Pharmaceutical Co., Ltd. et al. v. Apotex Inc. et al.
    1:15-cv-00336; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Senju Pharmaceutical Co., Ltd. et al. v. Paddock Laboratories, LLC et al.
    1:15-cv-00337; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Paddock Laboratories, LLC; L. Perrigo Co.; Perrigo Co.

    The complaints in these cases are identical.  Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), 8,754,131 (same title, issued June 17, 2014), 8,871,813 (same title, issued October 28, 2014), and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the Apotex complaint here.

    Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
    1:15-cv-00335; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 8,871,813 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued October 28, 2014) and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

    Supernus Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc. et al.
    2:15-cv-00326; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiff:  Supernus Pharmaceuticals, Inc.
    • Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

    Infringement of U.S. Patent Nos. 8,298,576 ("Sustained-Release Formulations of Topiramate," issued October 30, 2012,), 8,298,580 (same title, issued October 30, 2012), 8,663,683 (same title, issued March 4, 2014), and 8,877,248 (same title, issued November 4, 2014 following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Supernus' Trokendi XR® (topiramate extended-release, used to treat certain types of seizures).  View the complaint here.

    Supernus Pharmaceuticals, Inc. v. TWI Pharmaceuticals, Inc. et al.
    1:15-cv-00369; filed January 16, 2015 in the District Court of New Jersey

    • Plaintiff:  Supernus Pharmaceuticals, Inc.
    • Defendants:  TWI Pharmaceuticals, Inc.; TWI International LLC

    Infringement of U.S. Patent Nos. 7,722,898 ("Modified-Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued May 25, 2010), 7,910,131 ("Method of Treating Seizures Using Modified Release Formulations of Oxcarbazepine," issued March 22, 2011), 8,617,600 ("Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued December 31, 2013), and 8,821,930 (same title, issued September 2, 2014) following a Paragraph IV certification as part of TWI's filing of an ANDA to manufacture a generic version of Supernus'Oxtellar XR (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age).  View the complaint here.

    Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al.
    1:15-cv-00044; filed January 15, 2015 in the District Court of Delaware

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendants:  Apotex Corp.; Apotex Inc.

    Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  View the complaint here.

    Alcon Laboratories, Inc. et al. v. Akorn, Inc.
    2:15-cv-00285; filed January 14, 2015 in the District Court of New Jersey

    • Plaintiffs:  Alcon Laboratories, Inc.; Alcon Pharmaceuticals Ltd; Senju Pharmaceutical Co., Ltd; Mitsubishi Chemical Corp.
    • Defendant:  Akorn, Inc.

    Infringement of U.S. Patent No. 6,114,319 ("Compositions Containing Difluprednate," issued September 5, 2000) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Alcon's Durezol® (difluprednate ophthalmic emulsion, used to treat pain and swelling following eye surgery).  View the complaint here.

    Sumitomo Dainippon Pharma Co., Ltd. et al. v. Emcure Pharmaceuticals Ltd. et al.
    2:15-cv-00280; filed January 14, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
    • Defendants:  Emcure Pharmaceuticals Ltd.; Emcure Pharmaceuticals USA, Inc.

    Sumitomo Dainippon Pharma Co., Ltd. et al. v. InvaGen Pharmaceuticals, Inc.
    2:15-cv-00281; filed January 14, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
    • Defendants:  InvaGen Pharmaceuticals, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,532,372 ("Imide Derivatives, and Their Production and Use," issued July 2, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Sumitomo's Latuda® (lurasidone hydrochloride, used to treat depressive episodes associated with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate and used for the treatment of schizophrenia).  View the Emcure complaint here.

    Horizon Pharma Ireland Ltd. et al. v. Paddock Laboratories, LLC et al.
    1:15-cv-00368; filed January 13, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
    • Defendants:  Paddock Laboratories, LLC; Perrigo Co.

    Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

    Johnson Matthey Inc. et al. v. Pfizer, Inc. et al.
    2:15-cv-00014; filed January 13, 2015 in the Eastern District of Virginia

    • Plaintiffs:  Johnson Matthey Inc.; Johnson Matthey Pharmaceutical Materials, Inc.
    • Defendants:  Pfizer, Inc.; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.

    Declaratory judgment of noninfringement and invalidity of U.S. Patent No. 6,124,363 ("Dofetilide Polymorphs," issued September 26, 2000) based on plaintiffs' filing of a DMF (drug master file) with the FDA for the manufacture of a generic version of Pfizer's Tikosyn® (dofetilide, used for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm and for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm).  View the complaint here.