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  • Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen

    By Kevin E. Noonan —

    Supreme Court Seal A little more than one year after the Supreme Court issued its opinion on the patent-eligibility of (business) method claims in Bilski v. Kappos, the Court has granted certiorari in one case (Prometheus Laboratories, Inc.  v. Mayo Collaborative Services) and may consider two others (Classen Immunotherapies, Inc. v. Biogen Idec. and Association for Molecular Pathology v. U.S. Patent and Trademark Office) relating to diagnostic methods.  The Court handed down its decision in Bilski on the last day of the 2010 term (June 28, 2010), and shortly thereafter granted certiorari, vacated the Federal Circuit opinion, and remanded both the Prometheus and Classen cases.  The Federal Circuit decided the Prometheus case on remand on December 17, 2010, and on June 20, 2011, the Court again granted certiorari.  Since the question of patent eligibility is completely dependent on the scope and meaning of properly construed claims (see "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?"), a comparison of the claims in Prometheus, Myriad, and Classen might shed some light on the reasoning used by the Federal Circuit in arriving at the answers to the patent-eligibility question posed in each of these cases.

    Federal Circuit Seal Perhaps the most clear-cut decision by the Federal Circuit involves the method claims in the patents at issue in the Myriad case.  These claims all require the steps of "analyzing" or "comparing" a mutated BRCA gene sequence with the wildtype, "normal" sequence without any express claim language requiring that either sequence be determined as part of the claim:

    U.S. Patent No. 5,709,999:

    1.  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

    U.S. Patent No. 5,710,001:

    1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

    U.S. Patent No. 5,753,441:

    1.  A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

    U.S. Patent No. 6,033,857:

    1.  A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

    2.  A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

    Significantly, other diagnostic method claims, including ones using antibodies to detect altered BRCA proteins, were not recited in the complaint and thus not at issue.  Also not recited in these claims were "additional, transformative steps," including "the steps of (1) extracting DNA from a human sample, and (2) sequencing the BRCA DNA molecule, . . . steps [that] necessarily precede the step of comparing nucleotide sequences."

    The Federal Circuit panel unanimously agreed that these claims do not satisfy the "machine or transformation" (MOT) test under Bilski.  These claims "recite[] nothing more than the abstract mental steps necessary to compare two different nucleotide sequences:  look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position," according to Judge Lourie's majority opinion.  Also significant for the Court is that the specification required the term "sequence" to refer "more broadly to the linear sequence of nucleotide bases of a DNA molecule" per se.  The panel found that Myriad's method claims can be satisfied (i.e., infringed) by "mere inspection" alone, and thus encompass merely an abstract idea.

    In contrast, on remand, the Federal Circuit found the claims in Prometheus to satisfy the MOT test and thus recite patent-eligible subject matter, whether the claim recites an affirmative administration step or not:

    U.S. Patent No. 6,355,623:

    1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
        (a)  administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

        (b)  determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

        wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

        wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
        (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,

        wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and

        wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    The distinction between the claims in Myriad and claim 1 of the '623 patent can be appreciated in light of the difference in what is being detected in each claim:  a naturally occurring nucleic acid in the Myriad claims and an administered drug or its metabolite in Prometheus.  Insofar as patent eligibility for method claims must either satisfy the Bilski machine or transformation test or otherwise not be so abstract as to entirely preempt an abstract idea, law of nature, or natural phenomenon, the absence of the drug or its metabolite without administration of the drug would appear to provide the Federal Circuit with its rationale regarding the patent eligibility of claim 1 of the '623 patent.  Claim 46 of the '623 patent does not have an affirmatively recited administration step.  However, the "detecting" step recites that 6-thiopurine or one of its metabolites is performed on "a subject administered [one of the recited] drug[s]," again encompassing only those patients who have been transformed by drug administration.  It would seem that the Court refused to exalt form over substance in making a distinction between claims that recite administration of the drug to a subject and claims that are restricted to detecting a drug or its metabolites only in that subset of subjects to whom the drug has been administered; in either case, the Federal Circuit discerned a transformation.  Neither of these considerations are likely to be before the Supreme Court, however, since defendant's certiorari petition focused on the purported interference with the practice of medicine and the non-inventiveness of the portions of the claim that recited the transformation step.  In this regard it should be remembered that the case that raised this aspect of medical diagnostic method claims, Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), was like Myriad, directed at detecting a naturally occurring metabolite, homocysteine, and not an administered drug as in the Prometheus claims.

    The most surprising Federal Circuit decision relating to diagnostic method claims is the most recent, in the Classen case.  There, a divided panel (Judge Newman joined by Chief Judge Rader, with Judge Moore dissenting) found a distinction between the claims of U.S. Patent No. 5,723,283:

    A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

    Which the majority found not to be patent-eligible, with the claims of U.S. Patent Nos. 6,420,139 and 6,638,739 (claim 1 of the '739 patent being representative):

    1.  A method of immunizing a mammalian subject which comprises:
        (i)  screening a plurality of immunization schedules, by
            (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and

            (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),

        (ii)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

    Which the panel found were patent-eligible.  Judge Moore, on the other hand, found no difference.  The difference appears to be in whether the determination of an appropriate immunization schedule directs an affirmative (and transformative) step or steps.  In the '283 claim, the majority construed the scope of the claim to encompass mere comparison of the results of immunization schedules that produce a conclusion (i.e., information) without any further steps in the claimed method.  The claims in the '739 patent, in contrast, require that an appropriate immunization schedule be determined, and then that a mammal or mammals be immunized according to that schedule to achieve the beneficial result of immunization with the least "incidence, prevalence, frequency or severity" of deleterious side effects.

    Seen in this light, the question can be framed (according to Supreme Court precedent) as whether immunizing according to different immunization schedules in the '283 patent is considered "mere data gathering" activity and could be performed by evaluating previously performed immunizations, and whether the immunization step recited in the '739 patent can be considered to be "insignificant post-solution activity."  It is evident that the first proposition is better supported that the second; as in the Myriad claims, the structure of the '283 patent claim encompasses activity (immunization according to a plurality of immunization schedules) not performed in the practice of the claimed method (as opposed to the comparison, in this view the only active step in the claim).  The immunization step in the '739 patent claim is harder to construe as "insignificant post-solution activity" since the claim is directed towards "a method for immunizing a mammalian subject."

    This analysis may seem like an exercise in counting dancing angels on the head of a pin, but it is the path set out by the Supreme Court in Benson v. Gottschalk, Parker v. Flook, Diamond v. Diehr, and Bilski v. Kappos (and for some members of the Court and commentators, LabCorp).  While Judge Moore recites a common-sense conclusion that the scope of the '283 and '739 claims should not logically be different, they must be when considered under the relevant Supreme Court rubrics, which give significance (no matter how undeserved) to these distinctions.  That is not to say that reciting the immunization step should be enough to render the '739 patent claims patent eligible, but like drug administration in Prometheus, immunization is transformative (as Judge Moore recognized by expressly equating immunization with drug administration).

    Perhaps another way of performing the analysis is to recognize that another salient difference between the Myriad claims and the '283 claim in Classen on the one hand, and the Prometheus claims and the '739 patent claims in Classen, on the other, is that the former claims involve producing intangible information, while the latter use the information to direct the claim practitioner to perform a tangible, transformative step.  Claims that produce information may not be patent-ineligible per se (see "Patenting Information"); however, as in Bilski (and Benson and Flook) they are more likely to raise patent eligibility concerns.  Indeed these considerations arose in the concurring Justices' opinion in Bilski:

    For even when patents encourage innovation and disclosure, "too much patent protection can impede rather than 'promote the Progress of . . . useful Arts.'" Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U. S. 124, 126–127 (2006) (BREYER, J., dissenting from dismissal of certiorari).  . . .  Patents "can discourage research by impeding the free exchange of information," for example, by forcing people to "avoid the use of potentially patented ideas, by leading them to conduct costly and time-consuming searches of existing or pending patents, by requiring complex licensing arrangements, and by raising the costs of using the patented" methods.  Id., at 127.

    While the Supreme Court gave the Federal Circuit precious little time or opportunity to flesh out its patent eligibility jurisprudence after the Bilski v. Kappos decision by granting certiorari in Prometheus, the Supreme Court's Bilski decision provided no clear instruction for resolving the different results in the Prometheus and Classen cases.  Thus, its guidance may be necessary (provided that such guidance is more "pellucid" than the Court's opinion in Bilski).

    For biotechnology, it remains the case that including active, technology-dependent steps in method claims is prudent, and to draft claims that minimize the likelihood that the invention will be characterized as merely an "abstract idea."

  • President Signs AIA into Law; USPTO Begins Implementation of Act

    President Signs HR1249

    By Donald Zuhn —

    On Friday, President Obama signed the Leahy-Smith America Invents Act (H.R. 1249) into law.  In a press release issued after the signing, the White House said the legislation would "help American entrepreneurs and businesses bring their inventions to market sooner, creating new businesses and new jobs."  President Obama noted that he was pleased to sign the Act, adding that "[t]his much-needed reform will speed up the patent process so that innovators and entrepreneurs can turn a new invention into a business as quickly as possible."

    USPTO Seal The U.S. Patent and Trademark Office responded to the signing by updating the website the Office recently established to provide information and seek input on the implementation of the Leahy-Smith America Invents Act (AIA).  New information being provided on the website includes a seven-page table of effective dates provided under the AIA.  Among the effective dates listed in the table are:

    • September 16, 2011 — micro-entities established under § 10 of AIA
    • September 26, 2011 — prioritized examination fee of $4,800 established under § 11 of AIA
    • September 26, 2011 — 15% surcharge on all fees charged or authorized under Title 35 imposed under § 11 of AIA
    • November 15, 2011 — additional fee of $400 for non-electronic filing of applications (other than design, plant, or provisional applications) established under § 10 of AIA
    • September 16, 2012 — inventor's oath or declaration provisions under § 4 of AIA take effect
    • September 16, 2012 — third-party submission provisions under § 8 of AIA take effect
    • September 16, 2012 — supplemental examination provisions under § 12 of AIA take effect
    • September 16, 2012 — post-grant review provisions under § 6 of AIA take effect
    • March 16, 2013 — first-inventor-to-file provisions under § 3 of AIA take effect
    • March 16, 2013 — derivation proceedings provisions under § 3 of AIA take effect

    The Office's AIA website also provides the following timeline of major milestones under the legislation:

    Timeline - Major Milestones
    With respect to the 15% surcharge on all fees charged or authorized under Title 35, the Office has posted the new fee schedule that will take effect on September 26, 2011.  The current fee schedule can be found here.

    Finally, the Office's AIA website provides a list of upcoming AIA-related events, which includes an American Conference Institute (ACI) webinar on the AIA by Commissioner Robert Stoll on September 27, 2011 at 1:00 pm (ET).  Registration for the webinar is complimentary; those interested in registering can do so here.

  • Federal Circuit Denies Petition for Rehearing in AMP v. USPTO

    Myriad On Friday, the Federal Circuit (presumably) denied Defendants' petition for panel rehearing in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  Unlike the Court's earlier notice regarding denial of Plaintiffs'/Appellees' petition, this notice did not identify the party (but Defendants' petition was the only one pending).  In their petition, counsel for Defendants asserted a single grounds for rehearing, of points of law and fact overlooked or misapprehended by the Court (see "Defendants File Petition for Panel Rehearing").  In particular, Defendants' petition asked the Court to review the standing issue based on their allegation that Dr. Harry Ostrer, the only plaintiff found to have standing, no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing" upon invalidation of the Myriad patents.  It also asked the Court not to vacate the panel decision even if it found that Plaintiff Dr. Ostrer no longer had standing.

    Either party could now ask the Court to rehear the case en banc, or could file petitions for certiorari with the Supreme Court.  It is likely that the Court will decide the Prometheus Laboratories, Inc. v. Mayo Collaborative Services case before reaching the invalidated method claims in Myriad, but the Court could review the Federal Circuit panel's decision on the composition of matter claims this term.

  • Court Report

    By Sherri Oslick —

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

    Takeda Pharmaceutical Co. et al. v. Accord Healthcare, Inc.
    1:11-cv-06360; filed September 12, 2011 in the Southern District of New York

    • Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
    • Defendant:  Accord Healthcare, Inc.

    Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.


    Novartis AG et al. v. Accord Healthcare, Inc. USA et al.
    1:11-cv-01631; filed September 9, 2011 in the District Court of the District of Columbia

    • Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
    • Defendants:  Accord Healthcare, Inc. USA; Intas Pharmaceutical Ltd.

    Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Novartis' Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.


    Abbott Laboratories et al. v. Hospira Inc.
    1:11-cv-00795; filed September 9, 2011 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Wisconsin Alumni Research Foundation
    • Defendant:  Hospira Inc.

    Infringement of U.S. Patent No. 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Hospira's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.


    Flamel Technologies S.A. v. Anchen Pharmaceuticals, Inc.
    1:11-cv-02570; filed September 9, 2011 in the District Court of Maryland

    Infringement of U.S. Patent No. 6,022,562 ("Medicinal and/or Nutritional Microcapsules for Oral Administration," issued February 8, 2000) following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of GSK's Coreg® CR (carvedilol, used to treat congestive heart failure).  View the complaint here.


    GlaxoSmithKline LLC v. Mylan Inc. et al.
    1:11-cv-00789; filed September 8, 2011 in the District Court of Delaware

    • Plaintiff:  GlaxoSmithKline LLC
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Impax Laboratories Inc.

    Infringement of U.S. Patent Nos. 5,565,467 ("Androstenone Derivative," issued October 15, 1996), 5,846,976 (same title, issued December 8, 1998), and 5,998,427 ("Androstenones," issued December 7, 1999) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of GSK's Avodart® (dutasteride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate) and GSK's Jalyn® (dutasteride and tamsulosin hydrochloride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate).  View the complaint here.


    Cephalon Inc. et al. v. Sandoz Inc.
    1:11-cv-00782; filed September 6, 2011 in the District Court of Delaware

    • Plaintiffs:  Cephalon Inc.; Cephalon France
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent No. 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Sandoz's amendment of its ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    September 19-20, 2011 – Tech Transfer Summit Europe*** (Tech Transfer Summit Ltd.) – Paris, France

    September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

    September 21-22, 2011 – Forum on European Pharmaceutical Regulatory Law*** (C5) – Brussels, Belgium

    September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

    September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

    September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NYNew York, NY

    September 28, 2011 – The Impact of Stanford v. Roche on Private Party Transactions:  Inventor Ownership and Government Rights Under Bayh-Dole (American Bar Association) – 1:00 – 2:30 PM (ET)

    September 28, 2011 – USPTO Post-Grant Proceedings After New Patent Reform Law (Strafford) – 1:00 – 2:30 PM (EDT)

    October 3-4, 2011 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – Bethesda, MD

    October 4-5, 2011 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) –

    October 5-6, 2011 – Biotech Patenting*** (C5) – London, UK

    October 14, 2011 – Patent Reform: Impact and Strategy for University Research and Tech Transfer (Technology Transfer Tactics) – 1:00 – 5:00 PM (Eastern)

    October 24-26, 2011 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, UK

    October 25-26, 2011 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

    October 25, 2011 – Innovation and Commerce — Global Legal Considerations (U.S. Patent and Trademark Office and Federal Circuit Bar Association) – Tokyo, Japan

    October 26, 2011 – A Discussion with Robert Stoll of the USPTO (Association of Intellectual Property Firms) – 1:00 – 2:00 PM (EDT)

    October 26-27, 2011 – Joint Judicial Conference (U.S. Court of Appeals for the Federal Circuit and Tokyo Intellectual Property High Court) – Tokyo, Japan

    November 9, 2011 – Optimizing Relations with the USPTO: All the Questions You Always Wanted to Ask and Could Never Get Answers For (Association of Intellectual Property Firms) – 12:30 – 1:30 PM (EST)

    November 2-4, 2011 – Biotechnology from the Ground Up (Management Forum and JNB Marketing & Events) – San Diego, CA

    November 30 to December 1, 2011 – Advanced Forum on Biotech Patents*** (American Conference Institute) – Boston, MA

    December 6-7, 2011 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

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

  • Paragraph IV Disputes Conference

    San Francisco #1 American Conference Institute (ACI) will be holding its next Paragraph IV Disputes conference on December 6-7, 2011 in San Francisco, CA.  The conference will allow attendees to:

    • Pinpoint patents that may be vulnerable to a Paragraph IV challenge;
    • Demystify an ANDA applicant's Orange Book strategy and dissecting a challenger's obligations under Paragraph IV;
    • Understand the FTC's current position on pay-for-delay settlements and anticipating any antitrust concerns stemming from agreements between brand names and generics;
    • Master the intricacies of litigation with multiple ANDA filers;
    • Weigh the benefits and risks of an at-risk launch and minimizing downstream risk;
    • Identify the legal and ethical impact that Therasense will have on the affirmative defense of inequitable conduct;
    • Explore the ramifications of increased generic versus generic litigation in the quest for the prize of 180-day exclusivity;
    • Navigate the evolving case law surrounding double patenting obviousness and formulating litigation strategies based on the prior art analysis; and
    • Scrutinize labeling controversies and determining whether a use code expansion is reasonable.

    Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Pre-suit due diligence strategies: The branded perspective on proactively anticipating Paragraph IV challenges;
    • Certifying under Paragraph IV: Identifying the ANDA applicant's pre-suit considerations and obligations;
    • Let the games begin: The start of the Paragraph IV law suit — Pleadings and considerations;
    • New standards and controversies in double patenting type obviousness: Repercussions for Paragraph IV challenges;
    • No holds barred: Fighting for or defending against the coveted 180 day exclusivity stay;
    • A view from the bench on Paragraph IV litigation;
    • Carve outs and inducement controversies: Examining the intersection between a drug's patent and its label;
    • The post-Therasense world: Pleading and defending against inequitable conduct allegations under the heightened standard for materiality and intent — to be presented in part by Patent Docs author Dr. Donald Zuhn; and
    • Damages and injunctions: Exploring the consequences and conundrums of launching at risk.

    In addition, a pre-conference boot camp entitled "Biosimilars Through the Hatch-Waxman Lens: Anticipating Litigation Challenges and Understanding the Evolving Landscape" will be offered from 1:00 pm to 5:00 pm on December 5, 2011, and a post-conference master class entitled "Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-names and Generic Companies — A Hands-on, Practical Approach" will be offered from 2:00 pm to 5:00 pm on December 7, 2011.  The master class will offer presentations on the following topics:

    • FTC keynote: Pay for delay settlements — presented by Commissioner J. Thomas Rosch of the Federal Trade Commission; and
    • Obtaining optimal terms and minimizing antitrust concerns when settling Paragraph IV disputes.

    The agenda for the Paragraph IV Disputes conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference Institute The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and either pre-conference boot camp or post-conference master class), or $3,495 (conference, pre-conference boot camp, and post-conference master class).  Those registering by October 12, 2011 will receive a $300 discount and those registering by November 4, 2011 will receive a $200 discount.  In addition, Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of the Paragraph IV Disputes conference.

  • Webinar on Impact of Leahy-Smith America Invents Act on University Research and Tech Transfer

    Technology Transfer Tactics will be offering a two-part webinar providing "Patent Reform: Impact and Strategy for University Research and Tech Transfer" on October 14, 2011 from 1:00 – 5:00 PM (Eastern).  Charles Macedo of Amster, Rothstein and Ebenstein, LLP; Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP; Randi Isaacs, In-House Patent Counsel for Emory University's Office of Technology Transfer; and Brad Brockbank of Segue Consulting will focus on the specifics of the new law and the strategies needed to apply it successfully.  The first session will provide a detailed review of all key provisions and their likely effects and the second session will offer expert guidance on key changes in operations, procedures, and decision-making.

    The registration fee for the webinar is $297 for both sessions or $197 for one session.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Webinar on Post-Grant Proceedings under Leahy-Smith America Invents Act

    Strafford #1 Strafford will be offering a webinar entitled "USPTO Post-Grant Proceedings After New Patent Reform Law" on September 28, 2011 from 1:00 – 2:30 PM (EDT).  Scott McKeown of Oblon Spivak McClelland Maier & Neustadt and Kevin Laurence of Stoel Rives will provide guidance for counsel to IP owners and inventors on the new America Invents Act's post-grant system, including post-grant review proceedings, special transitional post-grant review of business method patents and supplemental examinations.  The webinar will review the following questions:

    • What are the grounds for post-grant challenges now?
    • How will current reexamination practice change?
    • What are the new options, how will they be implemented, and when?
    • How do the changes of the Leahy-Smith America Invents Act alter the strategic use of post grant proceedings parallel to litigation?
    • What are the relevant deadlines and best practices?

    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.

  • Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011)

    By Kevin E. Noonan —

    Star Scientific The Federal Circuit reaffirmed the primacy of the factual disclosures used to establish obviousness, and how deficiencies thereof can defeat an obviousness claim, in reversing an invalidity determination in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.  It also showed how persistently defendants pursue the tarnish of inequitable conduct even under circumstances where the Federal Circuit has held that no inequitable conduct occurred.

    The patents-in-suit, U.S. Patent Nos. 6,202,649 and 6,425,401 (filed as a continuation of the '649 patent), were directed to methods for curing tobacco in a way that reduced the amount of a carcinogen, tobacco-specific nitrosamines (TSNAs), in the cured product used in cigarettes and other tobacco-containing products.  The patents were specifically directed to "indirect" flue curing with gas or propane heaters.  Former methods used "direct" flue curing that mixed the exhaust gasses with the tobacco, but this resulted in an oxygen-free environment that fostered the growth of bacteria on the leaves, leading to production by the bacteria of the carcinogenic TSNAs.  The patented methods can be used with either direct or indirect curing methods by using "controlled conditions" involving humidity, temperature, rate of temperature exchange, carbon monoxide levels, carbon dioxide levels, oxygen levels, and how the tobacco plants are arranged in the curing shed.  The claims specify "controlling conditions" by "determining and selecting" the "appropriate" values for these variables that results in the reduction of TSNA production "at least one").  However, the patents admit that the choice of these conditions are "more art than science," so need to choose the appropriate combination of these variables; however, the important consideration is maintaining an aerobic environment that prevents bacterial growth.

    Claims 4 and 12 of the '649 patents are set forth for the Court as being representative (emphasis in the opinion):

    4.  A process of substantially preventing the formation of at least one nitrosamine in a harvested tobacco plant, the process comprising:
        drying at least a portion of the plant, while said portion is uncured, yellow, and in a state susceptible to having the formation of nitrosamines arrested, in a controlled environment and for a time sufficient to substantially prevent the formation of said at least one nitrosamine;
        wherein said controlled environment comprises air free of combustion exhaust gases and an airflow sufficient to substantially prevent an anaerobic condition around the vicinity of said plant portion; and
        wherein said controlled environment is provided by controlling at least one of humidity, temperature, and airflow.

    12.  The process according to claim 4, wherein the treatment time is from about 48 hours up to about 2 weeks.

    The lawsuit arose after R.J. Reynolds (RJR) acquired previous licensee Brown and Williamson and terminated the license.  In addition, RJR has its own patents (referenced in the opinion as the Peele reference), issued as U.S. Patent No. 6,805,134 that specified a "not direct" heat source and curing in the absence of nitrocv oxide gas, which was performed by retrofitting direct cure barns into indirect-cure barns.

    As an initial matter, the District Court granted summary judgment that the '649 and '401 patents were not entitled to priority to a provisional application, based on disclosure in the provisional that the claimed methods utilized an air flow of "at least 28,000 cubic feet per meter (CFM)" whereas the common specification of the '649 and '401 patents specified an air flow of "approximately 25,000 CFM."  As a consequence, the District Court was able to consider intervening art to be prior art, and to decide that the patentee did not disclose the best mode (based on development of the commercial embodiment (and acknowledged best mode) in the period between the provisional and non-provisional filing dates.

    In an earlier decision, the Federal Circuit reversed a finding that the claims were indefinite for reciting the term "anaerobic condition" and reversed a finding of inequitable conduct for failure to disclose a purported prior art reference (termed the "Burton letter").  Despite this decision, the District Court permitted defendants to display a slide (below) during closing argument showing a shadowy person disclosing information to the PTO examiner but holding the disputed Burton letter reference behind his back, during part of closing argument relating to invalidity rather than inequitable conduct.

    Burton Slide
    The jury delivered a verdict of non-infringement and invalidity based on obviousness, anticipation, indefiniteness, and failure to disclose the best mode.  The obviousness determination was based on a prior art scientific journal review relating to methods for air curing and a published Japanese patent.  In view of the District Court's decision on the priority question, the jury applied the method disclosed in the Peele '134 patent as well as the practice of methods at two farms (Spindletop and the Brown farm) as a public use (the Brown tobacco farm being under contract to RJR).  The indefiniteness determination was directed at the term "controlled environment," which the Court found as a matter of law was incapable of being construed because the disclosed "controlled environment" conditions overlapped with "conventional" curing conditions so that the skilled worker could not understand the difference.  The best mode determination was based squarely on the District Court's priority determination, since it was uncontested that the best mode commercial embodiment was not disclosed and had been developed prior to the non-provisional filing dates.  Finally, the jury found that there was no infringement, based on oxygen levels in RJR's barns alleged to be infringing.  The District Court denied Star's motions for JMOL of these adverse decisions.

    Federal Circuit Seal The Federal Circuit, in an opinion by Chief Judge Rader, joined by Judge Linn and by Judge Dyk in part, who dissented as to the Court's decision to reverse invalidation for indefiniteness, reversed the District Court's grounds for invalidating the '649 and '401 patents, and affirmed the District Court's denial of JMOL on the jury's non-infringement decision.  The Federal Circuit also reversed the finding that the '649 and '401 patents were not entitled to the provisional filing date, on the basis that the specification satisfied the priority standard:  that the specification disclosed an adequate written description and enabled the patents' claims.

    This part of the opinion was supported by an intervening decision by the USPTO in a reexamination of the '649 and '401 patents that these patents were entitled to the priority date (although the PTO found certain of the claims were invalid for obviousness).  The Court based its decision on language in the provisional specification that the recited air flow speed (in CFM) could "vary according to conditions and may be determined on a routine basis," and thus held that the District Court had improperly narrowed the claim scope based on later examples in the non-provisional application.

    As a consequence of the Court granting the priority date of the provisional application to the '649 and '401 patents the best mode violation evaporated, since it was equally undisputed that the commercial method was not known at the time the provisional application was filed.  Another consequence, germane to anticipation and obviousness is that the Peele '134 patent was not prior art that could be asserted against the patents in suit.

    In reversing the District Court's indefiniteness determination, the majority opinion cites Datamize LLC v. Plumtree Software Inc. for the standard that a claim must be "insolubly ambiguous" or "not amenable to construction" to be found indefinite.  However, the majority cautioned that "[a]bsolute clarity [is] not required" and that the term at issue — "controlled environment" — does not require disclosure of exact values for the various parameters because the skilled worker would understand the variable and empirical nature of determining these conditions.  In this the opinion cites language from the Peele '134 patent — owned by RJR — consistent with its interpretation of the understanding of the worker skilled in the art.

    Regaring obviousness, the Court disagreed with jury verdict that the references render the claims obvious.  The opinion characterized the Japanese patent as being directed at improving fast curing to avoid "nasty odor" (an advantage not related to TSNA production) and found the Wiernik reference to be inconclusive on whether bacteria were involved in TSNA production.  In addition, the opinion notes that neither reference discusses exhaust gases or anaerobic conditions.  Thus, the Court found that there would be no motivation (or in the mantra approved by the KSR Court, "reasoned basis") for the skilled worker to combine these references to arrive at a solution to the problem of TNSA production during tobacco curing.  The Court also found significant evidence of secondary considerations, including:  a recognized, unmet need in the art for reducing TSNA in cured tobacco; unsuccessful attempts (i.e., failure) by others to solve this recognized problem; purported unexpected results (never expressly set forth in the opinion); and commercial success (ironically for RJR, using the lucrative B&W licenses as evidence thereof).

    The Court reversed the jury's anticipation finding as to the Peele method because it was no longer prior art in view of the earlier priority date.  The two "public uses" were not prior art, because the Court found that the "Spindletop" use involved tobacco cured before treatment in the drying shed (so that it was not "uncured" tobacco, as required by the claims).  The "Brown farm" use did not anticipate, according to the Court's opinion, because the reported test results were below the detection threshold for TNSAs and thus provided no evidence that this method satisfied the specifically recited range of TSNA reduction required by the claims.

    Finally, the Court upheld the non-infringement decision based on the jury's prerogative to believe one (RJR's) expert over another (Star's), and that the evidence did not establish that no reasonable jury could come to such a decision (i.e., the District Court properly denied Star's JMOL motion).

    The Court also refused to deny Star's appeal on evidentiary rulings permitting (inter alia) display of the "shadowy figure" slide (although the Court found its use "troubling"), because Star did not show harm resulting from the objectionable evidence.

    Judge Dyk dissents in part, arguing that the patents are invalid for indefiniteness — in his view, the specification did not sufficiently distinguish the "controlled" conditions from "conventional" conditions and thus did not "particularly point out and distinctly claim" the invention so that the skilled worker could not ascertain the metes and bounds of infringing behavior.

    Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Federal Circuit 2011)
    Panel: Chief Judge Rader and Circuit Judges Linn and Dyk
    Opinion by Chief Judge Rader; opinion concurring-in-part and dissenting-in-part by Circuit Judge Dyk

  • Federal Circuit Denies Plaintiff(s)’ Petition for Rehearing in AMP v. USPTO

    By Kevin E. Noonan —

    ACLU Yesterday, the Federal Circuit denied Plaintiffs' petition for panel rehearing in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  In their petition, counsel for Plaintiffs/Appellees asserted two grounds for rehearing, of points of law and fact overlooked or apprehended by the Court (see "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO").  First, the petition contended that the Court "failed to consider whether the DNA fragments claimed in these patents are products of nature."  Second, the Court was alleged to have erred by not finding that two other named Plaintiffs, the American College of Medical Genetics and specifically named plaintiff Ellen Matloff, satisfied the standards for standing enunciated by the Court.

    Myriad The Court did not address Defendants' petition for panel rehearing.  That petition asked the Court to review the standing issue based on their allegation that Dr. Harry Ostrer, the only plaintiff found to have standing, no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing" upon invalidation of the Myriad patents.

    The one certain consequence of the filing of Plaintiffs' petition is that any petition for certiorari will be delayed, making it likely that the Supreme Court will decide the Prometheus Laboratories, Inc. v. Mayo Collaborative Services case before reaching the invalidated method claims in Myriad.

    For additional information regarding this and other related topics, please see:

    • "Defendants File Petition for Rehearing in AMP v. USPTO," August 30, 2011
    • "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO — Update," August 29, 2011
    • "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 28, 2011
    • "CyberSource and the Tragedy of Bad Analogies," August 24, 2011
    • "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?" August 23, 2011
    * "WFU Law Professor Says Federal Circuit Failed as "Keeper of the Constitution" in AMP v. USPTO," August 22, 2011
    • "AMP v. USPTO: Standing," August 4, 2011
    • "AMP v. USPTO: Judge Bryson's Opinion," August 3, 2011
    • "AMP v. USPTO: Judge Moore's Concurring Opinion," August 2, 2011
    • "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2011)," August 1, 2011
    • "Standing in AMP v. USPTO: The Plot Thickens," July 29, 2011
    • "Federal Circuit Issues Decision in AMP v. USPTO," July 29, 2011
    • "Myriad Writes to Federal Circuit on Standing Issue," July 28, 2011
    • "AMP v. USPTO: Oral Argument at the Federal Circuit," April 4, 2011
    • "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
    • "Curiouser and Curiouser," February 16, 2011
    • "AMP v. USPTO — Briefing Update III," February 8, 2011
    • "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
    • "AMP v. USPTO: Appellees' Brief," January 12, 2011
    • "AMP v. USPTO — Briefing Update II," December 16, 2010
    • "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
    • "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
    • "AMP v. USPTO — Briefing Update," December 14, 2010
    • "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
    • "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
    • "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
    • "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
    • "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
    • "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
    • "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
    • "AMP v. USPTO — Briefing Update," November 1, 2010
    • "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
    • "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
    • "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
    • "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
    • "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
    • "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
    • "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
    • "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
    • "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
    • "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
    • "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
    • "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
    • "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
    • "Round One Goes to the ACLU," March 29, 2010
    • "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010