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  • Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?

    (And If So, Would That Address Justice Breyer's Concerns in Mayo v. Prometheus)?

    By Kevin E. Noonan —

    Prometheus LaboratoriesSometimes solutions to thorny issues are within our grasp if only we looked in the right place.  The Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. raises the specter of the Court throwing out the patent system baby in order to preserve the medical community's bathwater, with (paradoxically) the prospect of fatally harming both.  It is clear that trying to address these issues through a reasoned explication of patent law is like trying to teach the proverbial donkey to count (or perhaps trying to explain compound interest to a disinterested teenager).  So instead, perhaps the way to address the concern that patents may somehow "harm" a medical practitioner's ability to treat patients is to give doctors what they want — a "get out of jail free" card for infringement.

    This has been done before, of course, to address patent claims directed to methods for performing eye surgery.  The patent, U.S. Patent No. 5,080,111 to Dr. Pallin, was being asserted (Pallin v. Singer, 1996 WL 274407 (D. Vt., Mar. 28, 1996)) against medical doctors and eye clinics in the mid-1990's and prompted swift Congressional action (relative to the glacial pace of patent reform over the past three Congresses).  The measure that ultimately passed, introduced by Senator Bill Frist of Tennessee (himself a physician) was codified as 35 U.S.C. § 287(c):

    35 U.S.C. 287 Limitation on damages and other remedies; marking and notice.

                                                                * * *

    (c)(1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

    (2) For the purposes of this subsection:
        (A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.
        (B) the term "medical practitioner" means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.
        (C) the term "related health care entity" shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.
        (D) the term "professional affiliation" shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner pro- vides the medical activity on behalf of, or in association with, the health care entity.
        (E) the term "body" shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.
        (F) the term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.
        (G) the term "State" shall mean any state or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.

    (3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), where such activities are:
        (A) directly related to the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), and
        (B) regulated under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Clinical Laboratories Improvement Act.

    (4) This subsection shall not apply to any patent issued based on an application the earliest effective filing date of which is prior to September 30, 1996.

    The policy justification for the bill was, as eloquently expressed by Senator Frist, because "innovations in surgical and medical procedures do not require the midwifery of patent law."  As enacted into law, the bill reflects a carefully crafted ("narrowly tailored") balance between the concerns of the medical community and the patent community, particularly the biotechnology community.  For example, "biotechnology patents" are expressly excluded from the exemption; such patents are defined (under 35 U.S.C. § 103(b)) as "a process of genetically altering of inducing a single or multi-celled organism" or "cell fusion procedures yielding a cell line that expresses a specific protein" or "methods of using a product produced" by the above processes.  Also not exempt are individuals involved in the commercialization of "a machine, manufacture, or composition of matter" related to a medical activity.  Importantly, the provision does not exempt commercial clinical labs, including ones regulated under CLIA, who perform medical diagnostic methods.

    Expressly and by implication, these exclusions to the exemption do not include clinical laboratory services provided in a physician's office, and the statute is expressly directed to the "performance of a medical activity," which is defined as "a medical or surgical procedure on a body."  The statute does not include "diagnostic methods" within this definition of a "medical activity," but this is not an instance where the absence can be used to read anything into the legislative history, because the excluded provision was in fact in a different bill that was not considered by Congress.  But (perhaps) significantly the exclusions to the exemption eschew mention of only one category of patent-eligible subject matter, methods.

    Including diagnostic methods (limited to those performed in a physician's office) to the exemption might address the policy concerns raised by Justice Breyer in Mayo (and before that in Laboratory Corp. v. Metabolite Labs., Inc.).  Such balancing of policy concerns has been done in the other patent law provisions, such as the safe harbor provisions of 35 U.S.C. § 271(e)(1); there, the policy purpose was to permit generic drug makers to prepare for market entry upon innovator drug patent expiration (ignoring for the moment the real effect of providing strong incentives for generic companies to utilize the provisions of § 271(e)(2) to challenge those patents rather than waiting for them to expire).  It is thus possible to read the law as containing (sub silentio, to be sure) diagnostic methods within the scope of the safe harbor.

    Commentators are almost uniform in rejecting this interpretation, however, believing that Congress must more expressly enunciate the exemption in order for it to be effective.  See, Sirjani & Keyhani, "35 U.S.C. 287(C): Language Slightly Beyond Intent," 3 Buffalo Intellect. Prop. Law J. 13 (Fall 2005); Rundle, "The Physician's Immunity Statute: A Botched Operation or a Model Procedure?" 34 Iowa J. Corp. L. 943 (Spring 2009); Hu and Mallin, "Medical Method Patents: Treating 'The Physicians' Immunity Statute,'" 23 Syr. Sci Technol. Law Reporter 63 (Fall 2010).  In part, this conclusion is based on the phrase "medical or surgical procedure on a body," which is interpreted to exclude assays of blood, urine, tissue, or other biological samples that are taken from a body.

    Washington - Capitol #5Should Congress deign to make inclusion of medical diagnostic methods within the scope of the exemption, such an action would comport with Justice Breyer's invitation at the end of the Mayo opinion ("[a]nd we must recognize the role of Congress in crafting more finely tailored rules where necessary").  Congress also has the opportunity to act (without having to take up the measure anew), having scheduled and held hearings on "technical" amendments to the Leahy-Smith America Invents Act that create the possibility for additional fine tuning of the patent system.  Perhaps Congress could take up this issue, and while it's at it complete revision to 35 U.S.C. § 101.  That provision of the statute now includes Section 23 (the Weldon amendment provisions: "Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism"), and it could readily be further amended to expressly recite that diagnostic method claims are patent eligible subject matter.  Coupled with revisions to § 287(c) to expressly exempt clinical laboratory services provided by physicians (and not commercial clinical labs), this legislative scheme might reduce the temperature of those whose concern over the possibility that patent protection might inhibit medical services delivery has created the greater likelihood that innovation will be harmed by a lack of patent protection (or worse, that disclosure will decline, reducing the pace of innovation).

    It is clear that the philosophical disconnect between the Supreme Court and the Federal Circuit (and the failure of the Supreme Court to credit the Federal Circuit's particular area of expertise in deciding over the past decade to assert its hierarchical prerogatives over the lower court) has disrupted the system envisioned by Congress in creating the specialized appellate court.  Accordingly, it is now time for Congress to impose by legislation the corrective measures needed to restore American patent law to its position in "promoting the Progress of . . . the Useful Arts."

  • SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012)

    By James DeGiulio —

    SmartGeneIn an opinion issued only ten days after the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. ("Prometheus"), the District Court for the District of Columbia is believed to be the first to apply the Prometheus decision to invalidate diagnostic method patents.  In finding the claims-at-issue in two patents held by Advanced Biological Laboratories, SA ("ABL") to be directed to unpatentable subject matter, District Court Judge Beryl A. Howell provides an analysis under Prometheus, but also provides an invalidation analysis applying other tests, including the machine-or-transformation ("MOT") test.  While Prometheus is cited throughout Judge Howell's opinion, that case is treated more as a "guidepost" in applying previous tests, as are other touchstone decisions in Benson, Flook, Diehr, and Bilski.  By comparing and contrasting the claims at issue in these cases, as well as others from the Federal Circuit, Judge Howell provides an early roadmap for § 101 analysis, although at times it is unclear precisely what lends the ABL claims to one case rather than another.  However, what is clear from Prometheus according to Judge Howell is that the Supreme Court has fully endorsed the performing of a "threshold test" by the district court as to patentable subject matter, confirming that a ruling of unpatentable subject matter under § 101 is appropriate, and preferred, in total isolation from the other provisions of the Patent Act.

    The dispute between SmartGene and ABL began in 2007 when ABL brought a patent infringement suit against SmartGene in the Eastern District of Texas.  That suit was dismissed for lack of personal jurisdiction in 2008, and within a month, SmartGene responded by filing the instant declaratory judgment suit, requesting a finding of non-infringement, invalidity, and unenforceability as to U.S. Patent Nos. 6,081,786 and 6,188,988.  In February 2009, the suit was stayed pending a series of six reexaminations, but restarted in October 2011, after the parties filed a joint motion to lift the stay.  SmartGene filed a motion for partial summary judgment in December 2011, alleging that the '786 and '988 patents encompassed patent ineligible subject matter under 35 U.S.C. § 101 and Bilksi v. Kappos.  A hearing on the pending motion, as well as claim construction, was held in March.

    Both the '786 and '988 patents relate "to a system, method, and computer program for guiding the selection of therapeutic treatment regimens for complex disorders . . . by ranking available treatment regimens and providing advisory information," as defined by the patentee.  Both patents are based on the same specification and disclosure, and relate to methods (i.e., processes) and systems for an interactive, computerized program for guiding the selection of therapeutic treatment regimens for a patient based on input provided by a physician.  Claim 1 of the '786 patent is representative of the subject matter at issue:

    1.  A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising:
        (a)  providing patient information to a computing device comprising:
            a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition;
            a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition;
            a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and
        (b)  generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient; and
        (c)  generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules.

    SmartGene contended that the '786 and '988 patents are directed to patent ineligible subject matter, and thus invalid, because they are directed to abstract ideas and mental processes, and fail the MOT test articulated in Bilski.  ABL responded that the claims at issue are not directed to an abstract idea, and while the MOT test is "not the sole test for patentability," the '786 and '988 patents satisfy that test.  In its opposition motion, ABL summarized the invention as follows:

    Element (a) specifies that the physician provide patient information to the computing device which includes prior therapeutic treatment regimen information.  This information is then processed against a first knowledge base that contains different treatment regimens and a second knowledge base of expert rules.  The computing device then generates available treatments along with advisory information for those treatments.  By providing the patient information to the system and allowing interaction with the physician, the Patents describe how therapeutic treatment regimens can be listed with corresponding advisory information.

    The patents also contain "system" claims, which ABL sought to have read as means-plus-function claims, in an effort to tie the claimed methods to the disclosed "computing device" structures in the specification.  Following ABL's claim construction, Judge Howell found (in a footnote) that the distinction between the claim type has no bearing on the standard of review for patentable subject matter, citing In re Meyer (CCPA 1982).

    District Court for the District of Columbia SealThe legal standard section of the opinion cites only Supreme Court decisions weighing patentability under § 101, including Diehr, Bilski, Benson, and finally Prometheus.  Judge Howell latches onto the unpatentability of Einstein and Newton's theories, but closes the section with the policy justification that "too broad an interpretation of this exclusionary principle could eviscerate patent law.  For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."

    Judge Howell takes a stepwise and comprehensive approach to evaluating the patentability of the claims under § 101, with the analysis comprising:  (A) examining § 101 as a "threshold" inquiry into patent validity; (B) reviewing Supreme Court caselaw "guideposts" on the subject of patent subject matter eligibility; (C) examining whether the '786 and '988 patents satisfy the MOT test; (D) determining whether the patents constitute eligible subject matter irrespective of the MOT test; and finally (E) examining the parties' claim construction proposals to inform its § 101 analysis.  According to the District Court, ABL's patent claims fail to show patentable subject matter under all five analyses.

    As an initial matter, Judge Howell decided that it was appropriate to rule on the patentability of ABL's claims before first construing the claims.  In reaching this conclusion, Judge Howell noted the cases favoring this approach, including Bilski and CLS Bank v. Alice Corp. Pty. Ltd. (D.D.C. 2011), but also recognized the Federal Circuit's recent hostility toward the application of this "threshold" test in isolation by district courts, as embodied in MySpace and Classen.  Judge Howell found the answer in Prometheus, where the Supreme Court "explicitly rejected" the ability of §§ 102, 103, and 112 to provide any "screening function" with regard to the patentability of subject matter.  As such, she holds that "this Court treats the § 101 subject matter patentability inquiry as the threshold inquiry for patent validity."

    Following the lead of Bilski and Prometheus, Judge Howell evaluates the Benson, Flook, and Diehr trilogy of opinions as "guideposts" provided by the Supreme Court in considering exceptions to patent subject matter eligibility under § 101.  After summarizing the relevant holdings from each case, Judge Howell provides her interpretation of the Prometheus Court, which "distilled the guideposts from its earlier section 101 cases" into warnings about "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art,'" "upholding patents that claim processes that too broadly preempt the use of a natural law," and the requirement of an "inventive concept" comprising other elements "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

    The "mental process" characteristics of the instant claims are determinative of unpatentable subject matter, according to Judge Howell.  She finds that the "patents-in-dispute do no more than describe just such an abstract mental process engaged in routinely, either entirely within a physician's mind, or potentially aided by other resources in the treatment of patients."  Judge Howell contrasts Diehr, stating that these claims "involves no 'transformation of an article' nor a 'step-by-step method for accomplishing such [transformation],'" instead noting similarities with Flook as a mere a recitation of abstract steps.  The District Court is seemingly most persuaded by the analogous case In re Meyer, where claims directed to gathering neurological testing data, imputing it into a computer, and using a formula to evaluate certain neurological functions were found to be an "attempt to patent a mathematical algorithm rather than a process for producing a product as in [Diehr]."  ABL could not distinguish its claims from Meyer, instead stating that the purpose of the invention is to provide a doctor with more information than the physician could have in his or her mind, leading the District Court to find these claims even more abstract than in Meyer, which "at least involved a mathematical algorithm."

    The opinion proceeds to evaluate each step of the method in the context of precedent, as was done in Prometheus.  The District Court notes that all of the claim steps are typically conducted as mental steps by a doctor, including "guiding the selection of a therapeutic treatment regimen for a patient" (when a patient describes his/her ailments to the doctor), "providing patient information to a computing device comprising [three knowledge databases]" (documenting the patient's symptoms and medical history in a medical chart, and consulting literature), and "generating in said computing device a ranked listing of available therapeutic treatment regimens" (mentally evaluating the benefits and counter-indicators of each treatment option).  The last step, "generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules," is interpreted as a doctor generating a treatment plan for a patient.  Thus, the claim was found to add nothing to the process that doctors do not already regularly engage in mentally when evaluating and treating patients.  The District Court finally evaluates claim 1 as a whole, finding the four steps as abstract ideas that are commonly performed by medical professionals in evaluating, considering, and constructing treatment options for a patient presenting a specific medical condition.  Following Prometheus, the claim consists of "well understood, routine, conventional activity already engaged in by the scientific community," and is thus lacking the "inventive concept" required to transform unpatentable abstract ideas into patentable applications.

    After finding ABL's claims unpatentable under Prometheus, the District Court confirms the unpatentability of the claims under the MOT test.  Judge Howell addresses the Supreme Court's negative treatment of the MOT test in Prometheus, finding that it was only the "Federal Circuit's application of that test" that was rejected in Prometheus, not the test itself, and it remains a "useful investigative tool."  According to the District Court, to satisfy the MOT test under the Supreme Court's application, the "transformation" itself must require the claimed process.  The transformation in Prometheus, which satisfied the MOT test according to the Federal Circuit, transformed the human body (by thiopurine treatment) and the blood (by analyzing metabolite levels), but neither transformation required the claimed process, and thus was deemed "irrelevant" by the Supreme Court.  ABL's argument that its claims "transform the patient's body" suffer the same fate, and cannot be saved by reciting a generic "computing device."  The ABL "computing device" is not a "particular machine" with any specific programming or algorithms, and in no way limits the claims, leading to the conclusion that it is merely extra-solution activity.  The District Court finds that Federal Circuit case law such as Dealertrack and Cybersource "is clear that allowing a process to become patentable simply because it is computer aided and constitutes a practical application would render the subject-matter eligibility criteria contained in section 101 meaningless."

    Finally, Judge Howell looks to the ABL's proposed construction for confirmation of her holdings.  Naturally, as the patentee, ABL seeks to have the claim terms construed as broadly as possible, including no limitations on terms such as "database," "patient information," and "knowledge base."  These constructions, akin to Benson, would yield a claim that was "so abstract and sweeping as to cover both known and unknown uses," and would thus foreclose innovation in this area if found valid.  Since ABL's motions and construction were filed before the Supreme Court's opinion in Prometheus was published, ABL's reliance upon the Federal Circuit's previous opinion could certainly explain the relative ease in which Judge Howell was able to find the claims unpatentable.  ABL became an easy target in its choice of claim constructions and characterizations that were effectively overruled by the Supreme Court, which made Judge Howell's ultimate decision much easier.  The patent community has now had some time to digest the "new" criteria from Prometheus, so it remains to be seen how claim construction arguments will be customized to avoid the pitfalls seen in SmartGene.  Regardless, since Prometheus (at least according to one judge) has granted total discretion to the district court to determine patentable subject matter under § 101, it is likely that challenges to subject matter patentability at the district court level will increase in frequency.

    SmartGene, Inc. v. Advanced Biological Laboratories, SA (D.D.C. 2012)
    Opinion by District Judge Beryl A. Howell

  • USPTO News Briefs

    By Donald Zuhn —

    PPH Program between USPTO and HIPO Becomes Permanent

    Hungarian Intellectrual Property OfficeOn Thursday, the U.S. Patent and Trademark Office announced that the USPTO and the Hungarian Intellectual Property Office (HIPO) had signed a Memorandum of Understanding making the Patent Prosecution Highway (PPH) program between the offices permanent.  The program permits an applicant having an application whose claims have been allowed by HIPO to fast track the examination of an application before the USPTO, or vice versa, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from the USPTO (or HIPO) that at least one claim in an application is patentable may request that HIPO (or the USPTO) fast track the examination of corresponding claims in the corresponding application in that office.  The USPTO also announced that the two offices set forth in the Memorandum of Understanding a common desire to implement further developments of the PPH program.

    Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of twenty PPH programs with other patent offices.  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Intellectual Property Office (HIPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), the Norwegian Industrial Property Office (NIPO), China's State Intellectual Property Office (SIPO), and the Icelandic Patent Office (IPO).  The USPTO has also established eleven PCT-PPH programs with other patent offices:  IP Australia, APO, SIPO, EPO, NBPR, JPO, KIPO, the Nordic Patent Institute (NPI), ROSPATENT, SPTO, and the Swedish Patent and Registration Office (PRV).  Additional information regarding the various PPH and PCT-PPH programs can be found here.


    USPTO Alerts Users to Firefox Issue

    EFS-WebLast fall, the U.S. Patent and Trademark Office informed EFS-Web and Private PAIR users that two recent Java updates (Java 7 and Java Update 29) were incompatible with the software used for authentication on both systems (see "USPTO News Briefs," November 17, 2011).  Over the weekend, the Office distributed another e-mail alert to users, noting that the Mozilla Foundation, a non-profit organization that owns the Mozilla Corporation, which in turn coordinates releases of the Mozilla Firefox web browser, announced that the Firefox browser would start blocking older versions of the Java plug-in from running.  As a result, when accessing the EFS-Web as a Registered eFiler or when accessing Private PAIR with Firefox, users may receive an error message on the Authentication Page stating: "Java Not Enabled."  The Office recommends that users upgrade to the latest version of Java, Version 6 Update 31, in order to avoid such problems.


    USPTO Expands Patent Law School Clinic Certification Pilot Program

    USPTO SealLast week, the U.S. Patent and Trademark Office announced the expansion of the Patent Law School Clinic Certification Pilot Program to include an additional ten schools for the upcoming academic year.  Under the pilot program, law students are permitted to practice patent law before the Office under the guidance of a law school faculty clinic supervisor.  In particular, students in the program can expect to draft and file a patent application and respond to an office action.

    The Patent Law School Clinic Certification Pilot Program was begun in 2008 with six law schools, and was expanded to include ten more schools in 2010 (some of the participating schools allow students to practice before the Office in both patents and trademarks and others allow students to practice before the Office in trademarks only).  The sixteen participating law schools are:  University of Akron School of Law; American University, Washington College of Law; University of Connecticut School of Law; The George Washington University School of Law; Howard University School of Law; The John Marshall School of Law; University of Maine School of Law; University of Maryland School of Law; University of New Hampshire School of Law; North Carolina Central University School of Law; University of Puerto Rico School of Law; University of Richmond – Richmond School of Law; Rutgers Law School – Newark       Vanderbilt College of Law; West Virginia University School of Law; and William Mitchell College of Law.  Additional information regarding the pilot program can be found here.

    In its announcement, the Office indicated that it will be accepting submissions from interested law schools until June 1, 2012.  Each law school accepted into the pilot program must meet and maintain requirements for certification in order for student practitioners to practice before the USPTO.

  • Court Report

    By Sherri Oslick —

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

    Medicis Pharmaceutical Corp. et al. v. Stiefel Laboratories, Inc. et al.
    2:12-cv-01746; filed March 20, 2012 in the District Court of New Jersey

    • Plaintiffs:  Medicis Pharmaceutical Corp.; Dow Pharmaceutical Sciences, Inc.
    • Defendants:  Glaxosmithkline PLC; Stiefel Laboratories, Inc.

    Infringement of U.S. Patent No. 6,387,383 ("Topical Low-Viscosity Gel Composition," issued May 14, 2002) based on defendants' manufacture and sale of VeltinTM(antibiotic/retinoid gel, used to treat acne).  View the complaint here.


    Alkermes Pharma Ireland Limited v. Actavis Inc. et al.
    1:12-cv-00323; filed March 16, 2012 in the District Court of Delaware

    • Plaintiff:  Alkermes Pharma Ireland Limited
    • Defendants:  Actavis Inc.; Actavis South Atlantic LLC

    Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Abbott Laboratories et al. v. Watson Pharmaceuticals Inc. et al.
    1:12-cv-00324; filed March 16, 2012 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida; Watson Pharma Inc.

    Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.


    Shire Development LLC et al. v. Osmotica Pharmaceutical Corp.
    1:12-cv-00904; filed March 16, 2012 in the Northern District of Georgia

    • Plaintiffs:  Shire Development LLC; Shire Pharmaceutical Development Inc.; Cosmo Technologies Ltd.; Giuliani International Ltd.
    • Defendant:  Osmotica Pharmaceutical Corp.

    Infringement of U.S. Patent No. 6,773,720 ("Mesalazine Controlled Release Oral Pharmaceutical Compositions," issued August 10, 2004) following a Paragraph IV certification as part of Osmotica's filing of an ANDA to manufacture a generic version of Shire's Lialda® (mesalamine, used to induce remission in patients with active, mild to moderate ulcerative colitis).  View the complaint here.


    Celgene Corp. et al. v. Actavis South Atlantic LLC
    2:12-cv-01688; filed March 16, 2012 in the District Court of New Jersey

    • Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
    • Defendant:  Actavis South Atlantic LLC

    Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

  • Conference & CLE Calendar

    CalendarApril 9, 2012 – Mayo v. Prometheus (Law Seminars International) – 2:30 – 3:30 pm (Eastern)

    April 16-18, 2012 – Intellectual Property Counsels Committee (IPCC) Spring Conference & Meeting (Biotechnology Industry Organization) – Austin, TX

    April 17, 2012 – 28th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    April 18, 2012 – European Biotech Patent Law Update (D Young & Co.) – 7:00 am and 12:00 pm (EDT)

    April 18, 2012 – Patent Term Adjustments and Extensions: Recent Developments (Strafford) – 1:00 – 2:30 pm (EDT)

    April 24, 2012 – Patent Law in Light of Mayo v. Prometheus: Claims to Laws of Nature Are Not Patentable (American Bar Association) – 1:00 – 2:30 pm (EDT)

    April 24-25, 2012 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

    April 26, 2012 – Moving From First to Invent to First to File: Understanding the Opportunities and Challenges (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

    May 1, 2012 – Prometheus in the Post-Bilski Age: Patentable Subject Matter Under Continued Attack (Strafford) – 1:00 – 2:30 pm (EDT)

    May 2, 2012 – Patent Prosecution under the AIA: Strategies for Before, During and After the Transition to First-Inventor-to-File (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    May 3, 2012 – In-Depth Analysis of Mayo v. Prometheus: What it Means for the Future of Medical Diagnostic Patents (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

    May 22-23, 2012 – Biosimilars*** (American Conference Institute) – New York, NY

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

  • TTT Webinar on Mayo v. Prometheus

    Technology Transfer Tactics will be offering a webinar providing an "In-Depth Analysis of Mayo v. Prometheus: What it Means for the Future of Medical Diagnostic Patents" on May 3, 2012 from 1:00 – 2:00 pm (Eastern).  Patent Docs author Dr. Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will dissect the Supreme Court's decision, help attendees understand how to adjust patent strategy in light of this development, and guide attendees in drafting future claims.  The webinar will cover the following topics:

    • Review the Supreme Court decision's implications on future Federal Circuit rulings, including Myriad;
    • Provide guidance on the criteria required to establish subject matter patent eligibility;
    • Unveil practical strategies for drafting claims in compliance with the ruling's interpretation; and
    • Discuss what lessons can be learned from the decisions for future patentability challenges.

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Webinar on Prometheus in the Post-Bilski Age

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Prometheus in the Post-Bilski Age: Patentable Subject Matter Under Continued Attack" on May 1, 2012 from 1:00 – 2:30 pm (EDT).  Stephen T. Schreiner of Goodwin Procter and Marcus T. Hall of Winston & Strawn will prepare patent counsel to argue patentability under 35 U.S.C. § 101, discuss the impact of recent Federal Circuit and ITC decisions — including the Supreme Court's Prometheus ruling, and offer best practices for patent seekers to meet subject matter eligibility requirements.  The webinar will review the following questions:

    • What criteria are required to establish subject matter eligibility for patents?
    • How have the decisions since Bilski impacted patent eligibility?
    • What lessons can be learned from the decisions for future patentability challenges?
    • What strategies should patent applicants employ to improve the likelihood of a successful patent application?

    An interactive Q&A session will follow the presentation.

    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.

  • ABA Teleseminar on Mayo v. Prometheus

    ABAThe American Bar Association (ABA) will be offering a teleseminar entitled "Patent Law in Light of Mayo v. Prometheus: Claims to Laws of Nature Are Not Patentable" on April 24, 2012 from 1:00 – 2:30 pm (EDT).  James R. Myers, Ching-Lee Fukuda, and Jane T. Gunnison of Ropes & Gray LLP will examine the Mayo v. Prometheus opinion and will clarify patent eligibility as a subject matter under Section 101 of the Patent Act.

    The registration fee for the webcast is $169 (for either the telephone seminar or audio webcast options).  Those interested in registering for the teleseminar, can do so here, by calling 800-CLE-NEWS (800-253-6397), or by faxing an order form to 215-243-1664.

  • Webinar on Patent Prosecution under the AIA

    AIPLAThe American Intellectual Property Law Association (AIPLA) will be offering a webinar entitled "Patent Prosecution under the AIA: Strategies for Before, During and After the Transition to First-Inventor-to-File" on May 2, 2012 from 12:30 – 2:00 pm (Eastern).  Joseph D. Matal, Judiciary Committee Counsel to Senator Jon Kyl, will discuss changes in 35 U.S.C. § 102 under the Leahy-Smith America Invents Act, and what constitutes prior art, as well as provide insight on the legislative process that created the AIA, and legislative history that produced the Act.  Courtney Brinckerhoff of Foley & Lardner LLP will discuss how to prepare for the transition to the "first-inventor-to-file" system in the AIA, and provide strategies that patent practitioners and their clients can adopt now, before the act goes into effect.

    The registration fee for the program is $145 (AIPLA member rate) or $175 (non-member rate).  Those interested in registering for the program, can do so here.

  • USPTO to Assess After Final Consideration Pilot Program

    By Donald Zuhn —

    USPTO SealOn Monday, the U.S. Patent and Trademark Office announced that it will be implementing a new After Final Consideration Pilot (AFCP) program, which will allow applicants and examiners to work together in after final situations to move applications toward allowance.  In particular, the AFCP program provides examiners with a limited amount of non-production time to consider responses filed following a final rejection.  For utility, plant, and reissue applications, the limited amount of non-production time will be three hours (design applications will be afforded one hour).  According to the Office's announcement of the new program, "[e]xaminers will be encouraged to use their professional judgment to decide whether a response can be fully considered, including any additional search required, within the time limit in order to determine whether the application is in condition for allowance."

    The Office has created a separate webpage for the new AFCP program, which indicates that the term of the pilot program is currently planned for the third quarter of 2012.  The Office's AFCP webpage also includes a link to notice providing guidelines for the consideration of responses after final rejection under the AFCP program.  The notice indicates that "[o]nce a final rejection that is not premature has been entered in an application, there is no right to unrestricted further prosecution," but "[i]n limited situations further amendments or arguments may be considered."  The notice lists six situations in which a response after final rejection should be entered:

    1.  The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action.
    2.  The amendment places the application in condition for allowance by rewriting objected-to claims in independent form.
    3.  The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search.
    4.  The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims.
    5.  The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search.
    6.  The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]

    The notice indicates that when an examiner determines that "the nature and extent of the amendments or arguments presented in the response can be fully considered within the limited amount of time authorized by the [AFCP]," the examiner should consider the after final response, and when the examiner determines otherwise, the examiner "should treat the response according to current practice, without non-production time authorized."  The notice also indicates that an allowance is not a required end result for an examiner to be afforded the additional amount of non-production time to consider an after final response.  The notice, however, provides two limitations to the above.  In particular, examiners will not be allotted non-production time in situations 1 and 2 above, because such amendments are normally to be entered under current after final practice, and examiners will get two hours of non-production time if an interview is conducted (examiners will still get three hours of total time, with one hour being credited for the interview).

    The Office notes that it will be assessing the new pilot program to determine whether the additional time for after final consideration of applications will lead to an increase in allowances and a decrease in the number of Requests for Continued Examination that are filed.