• Life Sciences Top 49

    By Donald Zuhn

    IPO #2Last month, the Intellectual Property Owners Association (IPO) announced the release of its 31st annual list of the top 300 organizations receiving U.S. patents.  Patent Docs Readers may recall that the U.S. Patent and Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."

    The IPO compiled its list by counting the number of utility patents granted during 2013 that listed an organization or a subsidiary as the owner on the printed patent.  The IPO notes that if an assignment to an organization or its subsidiary was recorded after the patent was printed, the patent was not counted, and further, that patents that were granted to two or more organizations jointly were attributed to the organization listed first on the patent.  The IPO also noted that 277,835 patents were issued in 2013, which was an increase from the 253,155 patents that issued in 2012.  The top fifteen companies on the IPO Top 300 are listed below (click on table to expand):

    2013 Top 15
    Falling out of the Top 15 in 2013 were Seiko Epson Corp. and Toyota Jidosha K.K., which dropped to 19th and 22nd, respectively.  Replacing those companies in the Top 15 were Google, Inc. and Apple, Inc.

    As in past years, Patent Docs used the IPO's list of top patent holders to compile a list of the top "life sciences" companies and organizations receiving U.S. patents in 2013.  In the past seven years, the number of life sciences companies and organizations making the list has gone from 51 in 2006 to 47 in 2007, 43 in 2008, 47 in 2009, 56 in 2010, 53 in 2011, 50 in 2012, and 49 last year.  Each organization's IPO top 300 ranking for 2013 is indicated in the "2013 IPO Rank" column; the IPO top 300 ranking for 2012 (if available) is indicated in the "2012 IPO Rank" column; and the change in number of patents from 2012 is indicated in "+/- from 2012."  The Life Sciences Top 49 is listed below (click on table to expand):

    2013 Top 49Life sciences companies and organizations that failed to make the IPO top 300 in 2013 after making it in 2012 included Dongbu Hitek Co., Ltd. (#224 on the IPO top 300 for 2012), DSM IP Assets B.V. (273), AstraZeneca AB (288), and Toray Industries Inc. (296).  Life sciences companies new to this year's list are indicated in green text.

    Please note that some of the companies and organizations listed above may be involved in work outside the life sciences sector, and therefore, a portion of the patents granted to these companies and organizations may be directed to other than life sciences-related inventions.  In addition, our list is a little inclusive in that we included medical device companies.

    For additional information regarding this topic, please see:

    • "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
    • "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
    • "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
    • "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
    • "IPO Releases List of Top 300 Patent Holders," May 22, 2008
    • "IPO Posts List of Top 300 Patent Holders," April 20, 2007

  •         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. Panacea Biotec, Ltd.
    1:14-cv-01064; filed June 26, 2014 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
    • Defendant:  Panacea Biotec, Ltd.

    Infringement of certain of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of Panacea's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00111; filed June 26, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals, Inc.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00820; filed June 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,465,504 ("Substituted 3,5-Diphenyl-1,2,4-Triazoles and Their Use as Pharmaceutical Metal Chelators," issued October 15, 2002) and 6,596,750 (same title, issued July 22, 2003) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exjade® (deferasirox, used for the treatment of chronic iron overload due to blood transfusions).  View the Delaware complaint here.

    Shire LLC et al. v. Ranbaxy Inc. et al.
    1:14-cv-00827; filed June 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Shire LLC; Shire Development LLC; Supernus Pharmaceuticals Inc.
    • Defendants:  Ranbaxy Inc.; Ohm Laboratories Inc.; Ranbaxy Laboratories Ltd.

    Infringement of U.S. Patent Nos. 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title, issued November 2, 2004) based on Ranbaxy's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.

    Pfizer Inc. et al. v. CFT Pharmaceuticals LLC
    2:14-cv-00714; filed June 20, 2014 in the Eastern District of Wisconsin

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; Pfizer Manufacturing Holdings LLC; PF Prism CV
    • Defendant:  CFT Pharmaceuticals LLC

    Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of CFT's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00106; filed June 20, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

  • CalendarJuly 9, 2014 – "Nautilus and Limelight: The Supreme Court Keeps Chipping Away at Patentees" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    July 9-11, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    July 20-22, 2014 – 2014 Annual Meeting & Conference (National Association of Patent Practitioners) – Alexandria, Virginia

    July 22, 2014 – "America Invents Act: Patent Strategies and Reforms Counsel Needs to Know" (Commercial Law WebAdvisor) – 1:00 to 2:30 pm (Eastern)

    July 24, 2014 – "Protecting IP Rights After Limelight Networks v. Akamai: Implications for Divided Patent Infringement and Inducement — Prosecuting and Litigating Patent Claims Following the New Supreme Court Decision" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 30, 2014 – "Ask the Office: New Guidance on Functional Claiming" (American Bar Association Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    July 30, 2014 – "Alice Corp. v. CLS Bank: Patent Eligibility of Software-Related Inventions" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Protecting IP Rights After Limelight Networks v. Akamai: Implications for Divided Patent Infringement and Inducement — Prosecuting and Litigating Patent Claims Following the New Supreme Court Decision" on July 24, 2014 from 1:00 to 2:30 pm (EDT).  Sona De and Gene W. Lee of Ropes & Gray will provide guidance to patent counsel on the impact of the new Limelight Networks Inc. v. Akamai Techs. Inc. decision on patent litigation and prosecution, and discuss the divided infringement loophole and outline steps to protect IP rights.  The webinar will review the following questions:

    • What are the implications of the Limelight Networks Inc. v. Akamai Techs. Inc. decision for infringement claims?
    • What best practices in patent claim drafting can counsel employ to minimize the risk of infringement?
    • What is the impact of the decision for method claims?

    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.

  • Commercial Law WebAdvisor
    Commercial Law WebAdvisorwill be offering a webinar entitled "America Invents Act: Patent Strategies and Reforms Counsel Needs to Know" on July 22, 2014 from 1:00 to 2:30 pm (Eastern).  Aaron D. Charfoos of Dykema Gossett PLLC will examine the changes to the patent system introduced by the AIA, as well as strategies in-house counsel and other attorneys advising businesses can employ to put themselves at an advantage when applying for and challenging patents.  The webinar will address the following topics:

    • How the America Invents Act altered the landscape of obtaining and challenging patents,
    • How the change from a “first-to-invent” to a “first-to-file” system affects how patents are awarded,
    • Steps counsel and businesses need to take to secure the earliest possible filing date,
    • New ways to challenge patents after they issue, specifically Inter Partes Review (IPR) and Covered Business Method Review (CBMR),
    • Procedural benefits to IPR and CBMR compared to civil proceedings, and
    • Other litigation assessment strategies.

    The registration fee for the webinar is $299.  Those interested in registering for the webinar, can do so here.

  • ABAThe American Bar Association (ABA) Section of Intellectual Property Law will be offering a live webinar entitled "Ask the Office: New Guidance on Functional Claiming" on July 30, 2014 from 1:00 to 2:30 pm (ET).  Christopher Alan Bullard of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P. will moderate a panel consisting of Nathan James Prepelka of The Webb Law Firm, Alysa N. Youngson of MH2 Technology Law Group, and Andrew Hirshfeld of the U.S. Patent and Trademark Office.  The panel will discuss the following topics:

    • The impact of the new training materials on patent examination,
    • The quality of issued patent claims, and
    • How to avoid potential pitfalls associated with functional claiming.

    This webinar will provide attendees with an opportunity to pose questions about the new examiner training on functional claim language.  Attendees who have questions about this topic, should send their questions to the panel moderator, Chris Bullard (cbullard@oblon.com), by July 8, 2014.

    The registration fee for the webcast is $150 for members and $195 for the general public.  Those interested in registering for the webinar, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Alice Corp. v. CLS Bank: Patent Eligibility of Software-Related Inventions" on July 30, 2014 from 1:00 to 2:30 pm (EDT).  Michael L. Kiklis and Stephen G. Kunin of Oblon Spivak McClelland Maier & Neustadt will examine the Supreme Court's Alice Corp. v. CLS Bank Int'l decision and its impact on patent eligibility for software-related inventions, and discuss what counsel to companies need to do to get patent protection for inventions implemented in computer software.  The webinar will review the following questions:

    • What does the Supreme Court's decision mean for patent eligibility for software-related inventions?
    • How can patent litigation defendants take advantage of the guidance for Section 101 challenges?
    • What best practices should counsel employ to protect software-related inventions?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by July 18, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  •         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. Par Pharmaceutical Inc.
    1:14-cv-00789; filed June 20, 2014 in the District Court of Delaware

    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 Par's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used to treat hyponatremia).  View the complaint here.

    Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals Inc. et al.
    1:14-cv-00791; filed June 20, 2014 in the District Court of Delaware

    • Plaintiff:  Amarin Pharmaceuticals Ireland Ltd.
    • Defendants:  Omthera Pharmaceuticals Inc.; AstraZeneca Pharmaceuticals LP

    Infringement of U.S. Patent No. 8,663,662 ("Stable Pharmaceutical Compositions and Methods of Using Same" issued March 4, 2014) based on AstraZeneca's anticipated marketing and sale of their recently FDA-approved Epanova™ (mixture of polyunsaturated free fatty acids derived from fish oils for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia).  View the complaint here.

    Avanir Pharmaceuticals Inc. v. Ranbaxy Laboratories Ltd. et al.
    1:14-cv-00792; filed June 20, 2014 in the District Court of Delaware

    • Plaintiff:  Avanir Pharmaceuticals Inc.
    • Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.

    Infringement of U.S. Patent Nos. 7,659,282 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued February 9, 2010) and 8,227,484 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued July 24, 2012) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Avanir's Nuedexta® (dextromethorphan hydrobromide/quinidine sulfate, used to treat pseudobulbar affect).  View the complaint here.  [NB: The complaint was voluntarily dismissed 10 days after it was filed.]

    Senju Pharmaceutical Co. et al. v. Metrics, Inc. et al.
    1:14-cv-03962; filed June 20, 2014 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Metrics, Inc.; Pharmaceuticals, Inc.; Mayne Pharma Group Ltd.; Mayne Pharma (USA), Inc.; Coastal Pharmaceuticals, Inc.

    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), and 8,754,131 (same title, issued June 17, 2014) following a Paragraph IV certification as part of Metrics' 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.


    Otsuka Pharmaceutical Co. v. Intas Pharmaceuticals Ltd. et al.
    1:14-cv-03996; filed June 20, 2014 in the District Court of New Jersey

    • Plaintiff:  Otsuka Pharmaceutical Co.
    • Defendants:  Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc.; Accord Healthcare Ltd.; Astron Research Ltd.; Hetero Labs Ltd.

    Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

    Medicine Store Pharmacy Inc v. AfGin Pharma LLC
    3:14-cv-02255; filed June 20, 2014 in the Northern District of Texas

    • Plaintiff:  Medicine Store Pharmacy Inc d/b/a RXpress Pharmacy
    • Defendant:  AfGin Pharma LLC

    Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,329,734 ("Topical Therapy for Migraine," issued December 11, 2012) based on RXpress' manufacture and sale of its "Migraine Cream" product(s).  View the complaint here.

  • Judge Randall Rader Says Goodbye at BIO

    By Kevin E. Noonan

    BIO International ConventionLast week, Judge Randall R. Rader, until recently Chief Judge of the Court of Appeals for the Federal Circuit, opened a day-long session on Intellectual Property Law by saying farewell.  In a speech at varying times passionate and wistful, the Judge (who is widely viewed as a strong proponent of patent law and thus appreciated by many in the biotechnology community) spoke at length about the Court and his involvement in it, and its unique place in this country and the world regarding its signal influence on U.S. patent law.

    Judge RaderEschewing the podium for a handheld microphone and the floor in front of the audience, Judge Rader started his talk by "confessing" that in thinking about his speech (beginning "ten minutes" before he began speaking) he couldn't think of any jokes from his repertoire that were appropriate (indicating, as he said, that he would have to dive into his remarks "humorless" and that "maybe I am the joke").  He then recounted at length the day more than thirty years ago when he met with Howard Markey, then Chief Judge of the Court of Customs and Patent Appeals, in his Senate office.  The topic: the Federal Courts Improvement Act, the bill that would establish the Federal Circuit.  The Judge remembered the "passion and vigor" with which Chief Judge Markey advocated for the new Circuit Court, and his belief that U.S. patent law needed to be "invigorated" to enable patents to "work uniformly across the nation" in stimulating the economy by encouraging and protecting innovation.  From that day to this Judge Rader confessed to being a convert to Judge Markey's vision.

    Turning from the Court of Chief Judge Markey to the Court as it is, Judge Rader engaged in a little institutional "psychoanalysis," saying that the Court has a dual personality with regard to patent law.  On the one hand, the Judge said, the Court was established and has the characteristics of a court of special expertise in patent law.  In what was perhaps a nuanced reference to Seventh Circuit Chief Judge Woods comments last year that the other Circuits were just as capable of deciding patent law cases as the Federal Circuit (based on the judges' technical expertise or lack of it), Judge Rader admitted that many judges are not patent law experts when they join the Court but "hearing 5-10 cases a month" quickly engenders expertise.  This forms the Court's "mission" or "agenda" or "responsibility" to ensure uniformity in the law geographically and strength of innovation policy.  This mission was something Judge Markey believed in, and Judge Rader and other members of the Court continue to do so.  In this regard the Judge mentioned a study by Professor Rebecca Eisenberg at NYU that showed that, of the twenty most influential cases decided in the Court's first decade, Judge Markey wrote eighteen of them.  On the other hand, according to Judge Rader there are members of the Court who believe that the Federal Circuit should decide cases more dispassionately without any particular concern for the development or consistency of patent law itself; he invited audience members "who know the judges" to draw up their own lists regarding into which camp the current judges fall.

    Judge Rader then spent a few minutes discussing the consequences of the Federal Circuit's special focus on patent law and that having such dedicated subject matter jurisdiction created a "great responsibility" of patent appeals, that make this Court different from the other Circuit Courts and mitigates against the Federal Circuit just being a "decisional body" that handles these questions like other courts.  He pointed out that the position of the Court in the judicial hierarchy is unique — the U.S., in creating the Federal Circuit made a policy choice to place expertise on technology in the intermediate appellate court level.  This is different than the case in Great Britain, he said, where that role is at the trial court level, consistent with the common law model that appellate courts are intended to correct errors not to make decisions in the first instance.  In contrast, in Germany the final decision is made by a court with expertise at the top of the judicial foodchain.  One advantage of the German model, he noted, was that it does not occasion some of the tensions between a court having expertise (the Federal Circuit) that is then reviewed by a court without expertise (the Supreme Court), which he acknowledges is "doing its best within a different culture" to apply the law but that it occasionally leads to "contradictory" results (which was the closest the Judge came to criticizing the Supreme Court or its recent spate of "contradictory" decisions).  And, exhibiting his intellectual breadth, the Judge noted the difference between the French Revolution (where the outcome was to kill all the judges with ties to the overthrown monarchy and structure a government where no one "with significant decisional authority" was placed over the people so that the legislature makes policy) with the American Revolution (which elevated judges to equal authority with the other branches of government so they can "overrule" the other branches when necessary, although the Judge did caution that he might not have said "overrule").  By "historical accident," Judge Rader said, the U.S. created a system where patent expertise was placed with the appellate court, leaving another review level above them without such expertise that creates tension between the two courts, making it sound almost inevitable that the current situation between the two Courts would eventually arise.

    Finally, with regard to the Court's unique qualities and characteristics, Judge Rader cited its national jurisdiction, where the Federal Circuit "speaks in review and enunciates principles that are applied nationally."  This is a "vast responsibility" imposed on the Court, in view of the impact of its decisions on "in every similar factual situation" that may occur for each case it decides, in view of how the law the Federal Circuit enunciates affects "the largest economy in the world" and hence the global economy.  Judge Rader also noted that the Court's expertise and influence extends to all district court judges in the nation, and cited the interest among seventy-five district court judges who have "stepped forward" to be involved in programs to strengthen their skills in presiding over patent litigation, and the influence of the Court in this process.

    With respect to patent litigation Judge Rader encouraged the lawyers making up the majority of the audience to address the system's "greatest weakness" that could be "potentially fatal":  the expense of a patent trial.  He asserted that any good trial lawyer will say that within a very short time after litigation commences she would be able to identify "95%" or even "98%" of the documents and other evidence needed to make her case.  Instead, the Judge accused the bar of looking for the smoking gun e-mail where the plaintiff admits to defects in her patent or the defendant admits to having to copy the patented invention.  This turns trials into "passion plays," according to Judge Rader, and greatly increases the costs of all patent trials despite the non-existence of such evidence in most cases.

    Judge Rader took no questions; instead, be ended his remarks by exhorting members of the bar to "assume a role" and exercise "leadership" in improving the patent system.  He said that he believed that the bar is "just as important as the courts in addressing the problems of cost and complexity," and that "we are in this together."  "May you be up to your responsibility as I know the Federal Circuit judges will be up to theirs" was how he ended his talk, to a standing ovation and great well-wishes for his future.

    Unless Judge Rader's significance on the Court, and the significance of his departure are not appreciated, a few quotes from his remarks in a recent case (when it had become evident that the zeitgeist had turned against patenting and patent law) should serve as a bittersweet reminder:

    Too often patent law is misunderstood as impeding more than promoting innovation.  This academic proposition, called the tragedy of the Anti-commons in some scholarly presentations, suggests that exclusive rights impede the flow of information and limit experimentation that might lead to the next generation of technological advance.  Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698 (1998).

    In the first place, in an era of empirical research, one might ask the reason that this academic notion has never actually been verified.  Although studied, no research has substantiated this alleged attack on the patent system.  In fact, "the effects predicted by the anti-commons hypothesis are not borne out in the available data."  Timothy Caulfield, Human Gene Patents: Proof of Problems?, 84 Chi.-Kent L. Rev. 133, 137 (2009); see also American Association for the Advancement of Science, INTERNATIONAL INTELLECTUAL PROPERTY EXPERIENCES: A REPORT OF FOUR COUNTRIES 12 (2007) (finding the results of a 2006 survey of U.S. and Japanese researchers "offer very little evidence of an 'anticommons problem'" and that "IP-protected technologies remain relatively accessible to the broad scientific community").  Surveys of academic researchers have revealed that "only 1 percent . . . report having to delay a project, and none abandoned a project due to others' patents."  Wesley M. Cohen & John P. Walsh, Real Impediments to Academic Biomedical Re-search, in 8 INNOVATION POLICY AND THE ECONOMY 1, 10-11 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds. 2008), available at http://www.nber.org/~marschke/mice/Papers/cohenwalsh.pdf (citing John P. Walsh et al., The View from the Bench: Patents, Material Transfers and Biomedical Research, 309 SCIENCE 2002 (2005)).  In other words, patents on research tools and biomedical innovations do not significantly slow the pace of research and do not deter researchers from pursuing promising projects.

    The reason that patents have not been proven to impede more than stimulate technological advance is simple:  it does not happen.  It does not happen for several reasons.  First, experiments advancing technology rarely, if ever, generate commercial value.  Thus patent owners have little, if any, incentive to license or inhibit research.  Stated otherwise, even if a patent owner wanted to sue or license potential researchers, experiments do not produce income or a source of damages.  See id. at 12.

    Second, in the modern age of technology, the character of technological advance has changed.  The era when the Bell Labs or some other tech center could hire the most promising engineers and essentially invent everything for the world has passed.  With the vast specialization of all fields of research, advances in technology require great cooperation.  A new product or a new direction in biotechnology or electronics will be produced by cooperation between a professor in Chengdu, China, a young programmer in Bangaluru, India, an engineer at a large corporation in Munich, Germany, a graduate student at Tokyo University, and a team at a small start-up company in Silicon Valley.  The patent system can help inform each of them of the other and bring together their incremental advances to achieve the next generation of progress in some tiny corner of human progress.

    Thus, patents properly remain a tool for research and experimentation because the system encourages publication and sharing of research results.  Disclosure of how to make and use the invention is the "quid pro quo" of the patent grant.  See JEM Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 142 (2001).  In exchange for disclosure, the inventor receives a limited term of exclusivity to benefit from commercialization of his invention.  Without this promise of exclusivity, researchers at corporations would be forced to turn to secrecy as the best protection for their inventions.  Even academic researchers may delay publication of results in order to maintain an edge over the competition, Cohen & Walsh, supra at 14, and the race to the patent office helps counteract this tendency toward secrecy by rewarding earlier disclosure.  "The information in patents is added to the store of knowledge with the publication/issuance of the patent.  . . .  [It] is not insulated from analysis, study, and experimentation for the twenty years until patent expiration."  Classen, 659 F.3d at 1072.  Rather, information shared through patent applications is immediately available for others to build upon.  It speeds the progress of scientific endeavor.  In other words, the patent system's modern benefits facilitate experimentation far more than any hypothetical inhibition.

    Momenta v. Amphastar (Fed. Cir. 2012) (see "Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals, Inc.: 'The Rest of the Story'").

    Judge Rader was a Senate staffer and as Chief Counsel or Minority Chief Counsel for the Senate Subcommittee on the Constitution and the Subcommittee on Patents, Trademarks, and Copyrights.  He was appointed to the Court of Claims by President Reagan in 1988.  Elevated to the Federal Circuit in 1990 by President George H.W. Bush, Judge Rader served as Chief Judge from September 2010 until a few weeks ago.  In addition to his judicial role, the Judge has been an active teacher both in the U.S. and abroad and is one of the authors of the most widely used casebook for U.S. patent law, entitled Cases and Materials on Patent Law.

  • By Donald Zuhn

    BIO International ConventionAt last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took part in a BIO session that provided some of the Office's initial observations regarding written comments submitted to date on the MyriadMayo guidance memorandum that was issued on March 4, 2014.  Mr. Hirshfeld began the presentation by noting that the Office was eager to receive public feedback on the Guidance, including examples of claims that might be presented in supplemental guidance the Office expected to issue after the July 31 deadline for submitting comments.

    USPTO SealBefore turning to several additional exemplary claims for which the Office was seeking public input, Mr. Hirshfeld addressed several issues involving the Guidance that had been raised in comments already received by the Office.  First, in response to comments that suggested the Guidance be limited to Myriad, he noted that while the Office had considered limiting the Guidance to Myriad, it instead responded to requests from examiners for more comprehensive guidance.  Despite the negative response to the Guidance from the patent community, Mr. Hirshfeld still felt that the Office's approach was the right one.  He also explained that the Office's intent in the Guidance was to inform examiners that terms such as "isolated" did not have a per se meaning.  In other words, the recitation of, for example, an "isolated nucleic acid molecule" conveyed neither per se patent eligibility nor per se patent ineligibility on the "nucleic acid molecule."

    In response to comments suggesting that the Office had created a new legal standard with its use of a "significantly different" requirement in the Guidance, Mr. Hirshfeld noted that this was not the Office's intent.  Instead, he explained that the "significantly different" standard in the Guidance was only a teaching tool for examiners.

    Finally, with respect to comments that were critical of the Guidance for overlooking the importance of functional differences in establishing patent eligibility, Mr. Hirshfeld pointed out that this was an area where there was a lot of common ground between the Office and critics of the Guidance.  He noted that the Office had received significant feedback on this issue and that the Office agreed that functional differences need to be taken into account when assessing patent eligibility, stating that "there is room between Funk Brothers and Chakrabarty."  However, Mr. Hirshfeld admitted that the Office has been struggling with claims reciting a single product (as opposed to combinations) in which the product differs functionally, but not structurally, from a naturally occurring product.  As for combination claims, Mr. Hirshfeld noted that significant public feedback had been received and that much of it disagreed with the Office's handling of such claims.  He acknowledged that the Office "could be doing more on our end."  Finally, with respect to derivatives of natural products, Mr. Hirshfeld indicated that it was not the Office's intent to render all derivatives patent ineligible, and he suggested that "a lot of clarity was needed on this."

    Mr. Hirshfeld closed his portion of the presentation by pointing out that the Office had received a lot of feedback criticizing Funk Brothers and Mayo as not being good law, and asking the Office to not apply these cases.  In response, he noted that Office did not intend to ignore any cases, and suggested that "we need to draw the right lines" instead.

    Ms. Cohan followed Mr. Hirshfeld's presentation by providing seven exemplary claims "for discussion purposes."  The exemplary claims that were presented are as follows:

    1.  Isolated nucleic acid comprising a sequence that has at least 90% identify to SEQ ID NO: 1 and contains at least one sequence modification relative to SEQ ID NO: 1.

    2.  Polypeptide comprising an amino acid sequence that has at least 90% identity to SEQ ID NO: 2 and contains at least one sequence modification relative to SEQ ID NO: 2.

    3.  A nucleic acid comprising SEQ ID NO: 1 and a fluorescent label attached to the nucleic acid.

    4.  A chimeric or humanized antibody to Antibiotic L.

    5.  Purified Antibiotic L.

    6.  Antibiotic L, which is expressed by recombinant yeast.

    7.  A human or fully human antibody to Antibiotic L.

    During her presentation, Ms. Cohan noted that the Office was trying to resolve how applicants could establish patent eligibility by showing differences in function or use (as opposed to the Guidance's focus on structural differences).  In particular, she posed the question of whether a difference in function or use would by itself constitute a marked difference, and invited public comment on the issue.

    Following Ms. Cohan's presentation, Mr. Hirshfeld opened the floor for questions.  In response to a question about whether a course correction was needed, Mr. Hirshfeld noted that the Office would be issuing iterations to the guidance, and whether such iterations could be considered a course correction would be in the eye of the beholder.  He reiterated, however, that clarity was needed with respect to derivatives of natural products, functional language, and combination claims.  Mr. Hirshfeld also stated that "no one should leave here today thinking we are not making changes," declaring that "we will be making changes."

    Another attendee asked the Office to consider taking a different approach with the Guidance.  Noting that the patent community is dealing with a negative Supreme Court, she suggested that the Office "push back wherever you can," adding that if the Office "buy[s] into what the Supreme Court says, then you're going to damage the biotech industry."  Those in attendance responded with a round of applause.

    In a post-Convention discussion with Mr. Hirshfeld and Ms. Cohan, Patent Docs was informed that the claims presented at the BIO Convention have now been posted on the Guidance webpage as part of seven-slide PowerPoint presentation.  Mr. Hirshfeld explained that the Office posted the claims on the Guidance webpage in order to obtain feedback from the public.  Slide 3 of the presentation provides the following factual assumptions for the seven claims that were presented at BIO:

    • Antibiotic L is a naturally occurring protein produced by a particular bacterial species.  It exhibits antibiotic activity in nature (e.g., it kills other bacterial species in its natural environment).

    • SEQ ID NO: 1 is the naturally occurring DNA sequence that encodes Antibiotic L.

    • SEQ ID NO: 2 is the naturally occurring amino acid sequence of Antibiotic L.

    • Some "fluorescent labels" are naturally occurring.

    • Antibodies to Antibiotic L are naturally occurring in wild coyotes, but not in humans or mice.

    Mr. Hirshfeld noted that the Office's inclination was that the seven claims presented at the BIO Convention were examples of things that, in the right context, would be patent eligible.  He indicated that the Office was now tasked with formulating supplemental guidance that provided the right context for these claims (provided that these claims make it into the supplemental guidance) as well as any other claims that might make it into the supplemental guidance.

    For additional information regarding this topic, please see:

    • "USPTO Extends Deadline for Providing Feedback on Myriad-Mayo Guidance," June 27, 2014
    • "BIO International Convention 2014 Preview — Part II," June 22, 2014
    • "Guest Post: USPTO Public Forum on Patent Guidance: My Thoughts as a Speaker and Attendee," June 11, 2014
    • "Guest Post: Myriad — An Obvious and Patent-Friendly Interpretation," June 4, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part IV," May 22, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part III," May 15, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part II," May 14, 2014
    • "Guest Post: How to Patent Grapefruit Juice — The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part I," May 11, 2014
    • "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
    • "Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)," March 18, 2014
    • "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014