• By Kevin E. Noonan

    Human Embryonic Stem CellLast Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human embryonic stem cell (hESC) patenting, by holding that prohibitions against patents on hESCs only apply to such cells derived from embryos that had the potential to develop into a human being.  This left as patent eligible in Europe hESCs produced from "parthenotes," embryos stimulated to decide (and produce hESCs) without fertilization.

    The case was brought by ISCO over the UK government's rejection of these two patent applications:

    • Application GB0621068.6, entitled 'Parthenogenetic activation of oocytes for the production of human embryonic stem cells', claiming methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the claimed methods, and

    • Application GB0621069.4, entitled 'Synthetic cornea from retinal stem cells', claiming methods of producing synthetic cornea or corneal tissue, which involve the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and product-by-process claims to synthetic cornea or corneal tissue produced by these methods.

    ISCO appealed a decision by a Hearing Officer of the United Kingdom Intellectual Property Office, affirmed by the High Court of Justice (England and Wales), Chancery Division (Patent Court) that the claims of ISC's patent application are unpatentable under the proscription of the ECJ against hESC patenting in its earlier Brüstle (C‑34/10, EU:C:2011:669) decision.  It will be remembered that in 2011 the ECJ held that hESCs are not patent-eligible subject matter on the grounds that stem cell patents were "contrary to ethics and public policy" because they required "industrial use" of human embryos, the position originally taken by the ECJ advocate-general, Judge Yves Bot.  That case was brought by Greenpeace in German federal court over a German patent to the University of Bonn involving methods for deriving neural cells from hESCs (DE 197568664 C1).  The German federal court ruled for Greenpeace in 2006, and the university appealed to the German supreme court.  That court decided that it needed to refer the question to the ECJ, since German law was closely patterned on European Union guidelines for biotechnology patenting.  In the ECJ's decision in 2011, "human embryo" was interpreted broadly:

    [A]ny human ovum must, as soon as fertilised, be regarded as a "human embryo" within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive, if that fertilisation is such as to commence the process of development of a human being.

    And the ECJ further decided that a "totipotent" or "pluripotent" human embryonic stem cell falls within the definition of a human embryo, deciding that these cells' capacity to develop into many or all human tissues was sufficient for them to qualify as a "human embryo."  Even the use of established hESC lines fell within the scope of that proscription, according to the ECJ, because the production of the claimed product (hESC) "necessitates the prior destruction of human embryos" by "the removal of a stem cell from a human embryo":

    Accordingly, [] an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos.  In that case too, the view must be taken that there is use of human embryos within the meaning of Article 6(2)(c) of the Directive.  The fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant.

    The ECJ in the most recent action considered again the application of the meaning of the term "human embryos" in Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ 1998 L 213, p. 13).  This issue arose as a Question Presented by the UK court to the ECJ, as follows:

    Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term 'human embryos' in Article 6(2)(c) of Directive 98/44 … ?

    ISCO distinguished the Brüstle decision on the grounds that the basis for the ECJ's decision in the Brüstle case was that the hESCs were "capable of commencing the process of development which leads to a human being."  ISCO argued that its cells did not satisfy that requirement, because ISCO's cells "cannot undergo such a development process."  Thus, ISCO argues that these cells should be capable of being patented under the Biotechnology Directive (Directive 98/44).

    The Comptroller also identified the Brüstle decision as controlling, and maintained that "the key issue is what the Court meant in the judgment in Brüstle [] by organism 'capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.'"  The judgment notes that the Comptroller admitted that "the written observations lodged with the Court in that case [Brüstle] may have inaccurately presented the scientific and technical background relating to parthenogenesis."

    In its decision*, the ECJ set forth its understanding of the question asked by the national court to be "whether Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and development to a certain stage have been stimulated by parthenogenesis constitutes a 'human embryo' within the meaning of that provision."  The Court concluded that the basis for the Brüstle decision was to prohibit patenting of embryos, or cells derived from embryos that are "'capable of commencing the process of development of a human being."  However, here the parthenogenetic human embryos did not have that capability (being limited to development to the blastocysts stage) and thus these embryos and hESC's derived from them did not satisfy the criterion relied upon by the Brüstle court to exclude those cells from patent eligibility.  As stated in the judgment, "where a non-fertilised human ovum does not fulfil that condition, the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a 'human embryo', within the meaning and for the purposes of the application of Directive 98/44," wherein "[b]y where such an ovum does have the inherent capacity of developing into a human being, it should, in the light of Article 6(2)(c) of that directive, be treated in the same way as a fertilised human ovum, at all stages of its development."

    The Court's opinion was framed as an answer to the national court's referred question:

    In view of the foregoing considerations, the answer to the question referred is that Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo', within the meaning of that provision, if, in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.

    And its judgment, binding throughout the EU, was worded as follows:

    Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo', within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.

    Whether parthenogeneticly produced hESCs are useful for anything other than laboratory research will determine whether this decision does anything to limit the extent to which the Brüstle decision impedes progress in hESC-dependent areas like human regenerative medicine.

    *  The judgment of the Grand Chamber of the Court, made up of Judges Skouris (President), Lenaerts (Vice-President), Tizzano, Silva de Lapuerta, Ilešič and Vajda (Presidents of Chambers), Rosas, Borg Barthet, Malenovský, Toader, Safjan (Rapporteur), Šváby and Biltgen.  Also represented before the Court were representatives of the governments of Poland, France, Portugal, Sweden, the United Kingdom and the European Commission.

  • By Donald Zuhn

    USPTO Closed on December 26

    USPTO SealThe U.S. Patent and Trademark Office issued a notice today informing stakeholders that the Office will be closed on Friday, December 26, 2014.  The notice indicated that December 26 will be considered to be a Federal holiday within the District of Columbia under 35 U.S.C. § 21 and 37 C.F.R. §§ 1.6, 1.7, 1.9, 2.2(d), 2.195, and 2.196, and therefore, that "[a]ny action or fee due on these days will be considered as timely . . . if the action is taken, or the fee paid, on the next succeeding business day on which the USPTO is open," which is Monday, December 29, 2014.


    USPTO to Hold Trade Secret Symposium

    The U.S. Patent and Trademark Office announced that it will be holding a Trade Secret Symposium from 9:00 am to 3:00 pm on January 8, 2015.  The symposium, which will provide an opportunity for members of the public to hear from representatives of academia, government, legal practice and industry on important trade secret issues facing innovators today, will take place in the Madison Auditorium South at the USPTO Headquarters in Alexandria, Virginia.  Topics to be covered at the symposium include legislative proposals regarding trade secret protection, the challenges to estimating losses due to trade secret theft, the intersection of patents and trade secrets, issues in civil litigation involving trade secrets, international considerations, and the response to trade secret theft in the U.S.  Additional information regarding the symposium can be found here.


    USPTO Unveils New Website

    The U.S. Patent and Trademark Office has unveiled a beta version of its new website.  The Office noted that it polled hundreds of users to create the new website design, which makes it easier to access services and accomplish tasks.  The website is also more mobile friendly.  A YouTube video on the website's new features can be found here.  The Office is also seeking public comments regarding the website redesign.  The last redesign of the Office's website took place in June of 2009 (see "USPTO Issues Beta Release of New Website").


    USPTO Launches New Assignment Search

    The U.S. Patent and Trademark Office has launched a new assignment search tool.  According to the Office, the tool is part of President Obama's Open Data and Open Government initiatives to improve data transparency and accessibility.  The tool offers more search fields and filters than the prior version of the Assignments on the Web for Patents (AOTW-P) tool.  The Office is seeking public feedback regarding the new search tool.

  • The University of Southern California (USC) Gould School of Law has created an infographic that provides some highlights in the history of patent law, starting at around 500 B.C. and including the first ever recorded document that granted rights to an individual and the establishment of the U.S. patent act in 1790.  Additional information regarding the infographic can be found here.

    image from onlinellm.usc.edu

  •         By Sherri Oslick

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

    Eli Lilly and Company et al. v. Amneal Pharmaceuticals LLC
    1:14-cv-01474 filed December 11, 2014 in the District Court of Delaware

    • Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrus DDS Pty Ltd.
    • Defendant:  Amneal Pharmaceuticals LLC

    Eli Lilly and Company et al. v. Amneal Pharmaceuticals LLC
    1:14-cv-02025; filed December 10, 2014 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrus DDS Pty Ltd.
    • Defendant:  Amneal Pharmaceuticals LLC

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), and 8,807,861 (same title, issued August 19, 2014) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone).  View the S.D. Indiana complaint here.

    Duke University et al. v. Sandoz, Inc. et al.
    1:14-cv-01034; filed December 10, 2014 in the Middle District of North Carolina

    • Plaintiffs:  Duke University; Allergan, Inc.
    • Defendants:  Sandoz, Inc.; Akorn, Inc.; Hi-Tech Pharmacal Co., Inc.; Actavis, Inc.; Watson Laboratories, Inc.; Actavis Pharma, Inc.

    Duke University et al. v. Apotex, Inc. et al.
    1:14-cv-01028; filed December 9, 2014 in the Middle District of North Carolina

    • Plaintiffs:  Duke University; Allergan, Inc.
    • Defendants:  Apotex, Inc.; Apotex Corp.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,906,962 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued December 9, 2014), licensed to Allergan, based on defendants' anticipated launch of a generic version of Allergan's Latisse® (bimatoprost ophthalmic solution, 0.03%, used to treat inadequate or not enough eye lashes).  View the Apotex complaint here.


    AstraZeneca AB v. Aurobindo Pharma Ltd. et al.
    1:14-cv-01469; filed December 9, 2014 in the District Court of Delaware

    • Plaintiff:  AstraZeneca AB
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

    Teva Women's Health, Inc. et al. v. Famy Care Ltd. et al.
    1:14-cv-09637; filed December 5, 2014 in the Southern District of New York

    • Plaintiffs:  Teva Women's Health, Inc.; Teva Branded Pharmaceutical Products R&D, Inc.
    • Defendants:  Famy Care Ltd.; Mylan Pharmaceuticals, Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception).  View the complaint here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation — Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues" on January 8, 2015 from 1:00 to 2:30 pm (EST).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Jennifer M.K. Rogers of Shumaker & Sieffert, and Margaret J. Sampson of Vinson & Elkins will provide guidance to patent counsel on understanding the types of activity that may lead to a finding of inequitable conduct and practical tactics to avoid inequitable content in patent prosecution, and examine arguments that have worked to avoid a finding of inequitable conduct.  The webinar will review the following questions:

    • What are the most common assertions defendants make when raising the inequitable conduct defense?
    • What are best practices prosecutors and litigators should employ when pursuing and defending inequitable conduct allegations?
    • What guidance do post-Therasense decisions provide on how inequitable conduct will be treated?

    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.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Preparing for and Navigating PTAB Appeals Before the Federal Circuit — Conducting PTAB Trials With Eye to Appeal, Determining Errors for Appeal, Understanding PTO Practice and Federal Circuit Law" on January 22, 2015 from 1:00 to 2:30 pm (EST).  Erika H. Arner and Michael J. Flibbert of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on preparing a PTAB case for appeal to the Federal Circuit, and offer strategic tips for conducting a PTAB trial with an eye to appeal and best practices for prevailing on appeal.  The webinar will review the following issues:

    • How the Federal Circuit will address potential review issues
    • The Federal Circuit's early guidance on standing to appeal
    • Strategies in PTAB proceedings to build a record and preserve issues for appeal

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by January 9, 2015 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Post-Grant and Litigation — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" on January 29, 2015 from 1:00 to 2:30 pm (EST).  Kevin Jakel od Unified Patents and Michael L. Kiklis of Oblon Spivak McClelland Maier & Neustadt will provide patent counsel with a broad-based view of defending against patent trolls, and discuss third-party solutions and provide a deep dive into specific troll strategies.  The webinar will review the following questions:

    • What third-party solutions are available?
    • What factors should be considered when determining if and when to use a third-party solution?
    • What defenses are available to companies facing patent troll claims?
    • What strategies can companies implement to minimize the impact of patent assertions?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by January 9, 2015 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • By Michael Borella and Andrew Williams

    TrollThe press has been all too eager to decry the so-called "broken" U.S. patent system and the alleged "scourge" of non-practicing entities (NPEs).  However, few if any articles attempt to provide an even-handed analysis of these issues.  Recently, Jon Potter and Julie Samuels published a piece in Roll Call, urging Congress to pass comprehensive patent reform legislation to clamp down on NPEs, while James Bessen, in The Atlantic, lauded the Supreme Court's recent Alice Corp. v. CLS Bank Int'l decision for already having a deleterious impact on business method patents.  Samuels was formerly of the Electronic Frontier Foundation (EFF), a group with an anti-patent agenda.

    The need for patent reform has arguably diminished.  Three decisions handed down by the Supreme Court last year, Alice, Octane Fitness, LLC v. Icon Health & Fitness, Inc., and Nautilus, Inc. v. Biosig Instruments, Inc., each addressed one of the alleged weakness in the patent system that so-called trolls are thought to exploit.  These cases have been credited for the drop in patent litigation seen since the end of the Court's last term.  Moreover, the Patent Trial and Appeals Board ("PTAB") has been accused of becoming a patent "death squad" because of the large number of inventions that it has recently found to be unpatentable.

    These articles, therefore, appear to be desperate attempts to flame the anti-patent fervor that existed last year.  As we have come to expect, both articles present only one side of the story, and do not consider the negative consequences that further anti-NPE legislation could bring about, and that the Alice decision has already produced.  Further, the authors make unsupported assertions, draw questionable conclusions, and exhibit a profoundly flawed understanding of patent law.

    For example, as with similar articles, the Potter and Samuels's article starts from the presupposition that "our patent system is out of balance," citing the Alice decision for support.  The unsuspecting reader will assume that this is a forgone conclusion.  Nevertheless, it is through their explanation of how this decision and proposed legislation are meant to "solve" the supposed crisis, the authors reveal a lack of understanding of the historical and philosophical basis of the patent system.

    To that point, the authors equate "trolls" with NPEs (non-practicing entities).  The term NPE, however, encompasses all entities that do not manufacture products, including most universities, research institutions, and individual inventors.  Interestingly, Ms. Samuels's previous organization, the EFF, accused universities of fueling the patent troll problem.  Patent asserting organizations have been acknowledged by most, including the White House, to serve an important role as mediator between such NPEs and operating companies often necessary to commercialize inventions.  In fact, the United States' patent system purposefully encourages such actions by making patent property rights freely assignable and eschewing a "working" requirement.  This philosophy goes back to the framers of the Constitution, and allows the patent system to be accessible to everyone, not just those with abundant resources.

    Potter and Samuels go on to assert, without citing any support, that NPEs "grievously injure innovators, bankrupt small companies, and waste judicial resources."  Yet, the current functioning patent system is essential to the business models of these same innovators and small companies.  Without patents, the innovations of a small software company can be easily reverse engineered and copied by larger players with more market clout, or foreign companies with lower overheads.  Trademarks, copyrights, and trade secrets do little to help in these situations.

    In addition, the authors fail to consider the fact that these "innovators" and "small companies" (or any defendant in a patent litigation case for that matter), might actually infringe a valid patent.  If so, should they be allowed to freeload off the labor of others without penalty just because the patent at issue encompasses a business method or software, or happens to be owned by an NPE?

    Bessen states that a recent the Government Accountability Office ("GAO") report "attributed 89 percent of the increase in patent litigation [in the 2007-2011 time frame] to software patents."  This report, however, conflated actual software patents and business method patents, collectively referring to both as "software patents."  In fact, the GAO found that "operating companies brought most of the patent infringement lawsuits from 2007 to 2011."  Additionally, the report indicated that the number of defendants in software and business method patent litigation increased 89 percent, but the number of lawsuits increased more modestly.  According to the report, the increase in the number of patent lawsuits in 2011 "was most likely influenced by the anticipation of changes in the 2011 Leahy-Smith America Invents Act (AIA), which made several significant changes to the U.S. patent system, including limiting the number of defendants in a lawsuit, causing some plaintiffs that would have previously filed a single lawsuit with multiple defendants to break the lawsuit into multiple lawsuits."

    Of course, even if there was an increase in software patent litigation, it would have likely been a reflection of the increased importance of software in our everyday lives.  The 2007-2011 time frame tracks the rise of the smartphone and always-on computing, dramatic growth in social media, and a multimedia streaming revolution led by Netflix and YouTube, among other factors.  Like it or not, software is now an integral part of our personal and professional lives, as we carry our laptops, tablets, phones, e-readers, and digital fitness trackers with us whether we are going to work or on vacation.  An increase in the number of software patents granted, as well as an increase in software patent litigation, is a natural consequence of the ubiquity of software.

    Certainly, no one is denying that there are bad actors that abuse the litigation system both with regard to intellectual property rights and otherwise.  However, elevating this minority of cases to be representative of the norm is not a reason to dispense with the entire system.  In fact, Bessen's methodologies for assessing the cost of so-called patent trolls have been called into question.  See, e.g., Schwartz & Kesan, Analyzing the Role of Non-Practicing Entities in the Patent System, Cornell Law Review, Vol. 99:2, pp. 425-56 (2014).  As a result, the implications that can be drawn from the data with regard to the impact of NPEs on the system are dubious at best.

    With respect to the Alice decision, both sets of authors ignore the damage that this case has already caused to the patent system.  Under Alice, when determining whether a patent claim meets the statutory requirements for patent-eligibility, one must determine whether the claim is directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea.  If so, then one determines whether any additional claim elements transform the claim into a patent-eligible application that amounts to significantly more than the ineligible concept itself.

    This two-prong test has been widely criticized for its vagueness and subjectivity.  The Supreme Court refused to define what it meant by the term "abstract idea," leading to consternation among patentees, patent attorneys, and even federal judges.  For instance, Judge Wu of the United States District Court for the Central District of California criticized Alice for setting forth an "I know it when I see it" test.  Judge Pfaelzer, a colleague of Judge Wu, wrote that the Supreme Court's patent-eligibility cases "often confuse more than they clarify [and] appear to contradict each other on important issues."

    The Supreme Court also blurred the lines between the assessment of patent-eligibility and other patentability requirements.  The patent law requires that, among other things, claims must be novel and non-obvious, as well as encompassing patent-eligible subject matter.  In 1981, the Supreme Court clarified that each of these inquiries were separate and distinct, and that it was "inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis."  Alice, as well as its 2012 predecessor case Mayo Collaborative Servs. v. Prometheus Labs., Inc., turned this notion around.  Now, when conducting a patentable subject matter review, claims can be analyzed element by element and compared to prior art.

    As many commentators have articulated since the Mayo opinion was handed down, determining whether the breadth of a claim is appropriate is better served by conducting the well-understood and more objective and established analyses of novelty and obviousness.  Despite the lack of any suggestion from Congress that patent-eligibility is to be used for these purposes, the Supreme Court, now followed by the Federal Circuit, has made patentable subject matter a perverse weapon for the unsupported rejection and invalidation of claims.

    The well-understood obviousness analysis asks whether the differences between the claimed invention and the prior art would have been obvious to one of ordinary skill in the art.  The Alice test, for a claim that incorporates a preexisting algorithm or a longstanding practice, inquires if the claim adds "significantly more" to that algorithm or practice.  The substantive difference between the two is that the obviousness test is grounded using prior art as a reference point for what is known, while the Alice test is not.  This eliminates much of the objectivity from the Alice analysis, putting thousands of patents in a state of legal uncertainty.  The "validity" of such patents may depend on which judge or panel conducts the test.

    Bessen goes as far as to suggest that while the Alice decision is limiting the number of granted business method patents, it hasn't gone far enough to similarly limit software patents.  But why should we view patents in such sweeping terms, with the connotation that business method and software patents are inherently bad?  Patents are either valid or invalid, regardless of the technology claimed therein.

    Furthermore, the implication that software should not warrant patent protection unfairly singles out one of the greatest drivers of the U.S. economy over the last forty years.  A major aspect of innovation is to make products and services faster, cheaper, and better.  The patent system is intended to incentivize individuals and organizations to publicly disclose such inventions, and as a result receive a limited exclusive-use property right thereover.  Despite contentions of the deleterious impact of a "broken" patent system on the software industry, the computer and information industry as a whole continues to grow, as evidenced by recent record-breaking stock values, billion-dollar acquisitions, and successful initial public offerings. A broad exclusion of computer-implemented inventions is illogical and disregards the fundamental tradeoff on which the system is based.

    Graphic of troll (above) by JNL was modified (cropped) from a graphic available at the Wikipedia Commons, pursuant to the Free Art License.  Any use of the modified graphic is subject to the same license.

  •         By Sherri Oslick

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

    Eli Lilly and Company v. Sandoz Inc.
    1:14-cv-02008; filed December 5, 2014 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 Sandoz's 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.

    Fresenius Medical Care Holdings, Inc. v. Lotus Pharmaceutical Co., Ltd. et al.
    1:14-cv-14345; filed December 5, 2014 in the District Court of Massachusetts

    • Plaintiff:  Fresenius Medical Care Holdings, Inc.
    • Defendants:  Lotus Pharmaceutical Co., Ltd.; Alvogen Pine Brook, Inc.

    Fresenius Medical Care Holdings, Inc. v. Lotus Pharmaceutical Co., Ltd et al.
    2:14-cv-07612; filed December 5, 2014 in the District Court of New Jersey

    • Plaintiff:  Fresenius Medical Care Holdings, Inc.
    • Defendants:  Lotus Pharmaceutical Co., Ltd; Alvogen Pine Brook, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the D. Mass. complaint here.

    Allergan Inc. et al. v. Wilshire Pharmaceuticals Inc.
    1:14-cv-01461; filed December 4, 2014 in the District Court of Delaware

    • Plaintiffs:  Allergan Inc.; Vistakon Pharmaceuticals LLC
    • Defendant:  Wilshire Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 8,664,215 ("Ocular Allergy Treatments with Alcaftadine," issued March 4, 2014), licensed to Allergan, following a Paragraph IV certification as part of Wilshire's filing of an ANDA to manufacture a generic version of Allergan's Lastacaft® (alcaftadine ophthalmic solution 0.25%, used for the prevention of itching associated with allergic conjunctivitis).  View the complaint here.

    Novartis Pharmaceuticals Corp. v. Amneal Pharmaceuticals, LLC et al.
    2:14-cv-07557; filed December 3, 2014 in the District Court of New Jersey

    • Plaintiff:  Novartis Pharmaceuticals Corp.
    • Defendants:  Amneal Pharmaceuticals, LLC; Amneal-Agila, LLC; Mylan Inc.; Mylan Institutional Inc.

    Novartis Pharmaceuticals Corp. v. Sagent Pharmaceuticals, Inc.
    2:14-cv-07556; filed December 3, 2014 in the District Court of New Jersey

    Novartis Pharmaceuticals Corp. v. Par Sterile Products, LLC et al.
    2:14-cv-07558; filed December 3, 2014 in the District Court of New Jersey

    • Plaintiff:  Novartis Pharmaceuticals Corp.
    • Defendants:  Par Sterile Products, LLC; Par Pharmaceutical Companies, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the Amneal complaint here.