Patent Law Weblog

recent posts

about

  • IPLAC Trade Secrets Seminar

    IPLACThe Intellectual Property Law Association of Chicago (IPLAC) will be holding its twenty-six annual Trade Secrets Seminar from 1:00 to 4:00 pm (Central) on April 21, 2016 at the John Marshall Law School in Chicago, IL.  The Seminar will offer a discussion on data privacy and trade secret protection by Jason Logue, Associate General Counsel at Publicis Groupe, and Walter Kawula of Hahn Loeser, and a recap of trade secret developments by Mark Halligan of FisherBroyles, LLP.

    The registration fee for the Seminar is $20 (IPLAC members), $30 (non-members), or $5 (students).  Those interested in registering can do so here.

  • An Inflectra Update: Janssen Requests an Expedited Trial

    By Andrew Williams —

    CelltrionAs we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody.  On Tuesday, April 12, counsel for Janssen submitted a letter to Judge Mark L. Wolf of the U.S. District Court for the District of Massachusetts, advising of the FDA's action.  Janssen also reported that Celltrion had notified it "that [defendants] intend to begin commercial sales of their biosimilar in no later than 180 days (on October 2, 2016), subject to certain reservations."  We already knew that Celltrion was not planning on selling its biosimilar before June 30, 2016, the date on which one of the asserted patents will expire.  However, even though this would suggest that Celltrion has now provided the statutory 180-day notice of commercial marketing, the letter was written in such a way as to suggest that Celltrion could launch earlier.  The outcome of the Amgen v. Apotex Federal Circuit appeal could impact this decision.

    JanssenNevertheless, counsel for Janssen also informed the Court that Plaintiffs would not seek a preliminary injunction.  This was prompted by comments from the Court during a February 9, 2016 conference, in which "the Court stated its general reluctance to issue a preliminary injunction and then issue a final decision on the merits at a later time".  Instead, Janssen requested that the Court expedite the trial slated for February 2017.  Plaintiffs suggested that the trial on the merits could occur in September 2016, "in order to have their claim for a permanent injunction of the '083 patent [U.S. Patent No. 7,598,083] resolved before defendants' threatened launch date."  They emphasized that if Celltrion launches, Plaintiffs would suffer irreparable harm.

    Plaintiffs supported this push for an earlier trial date with information that they had "compiled powerful evidence that the defendants' cell culture media infringe the '083 patent under the doctrine of equivalents ('DOE')."  At Janssen's behest, ExcellGene S.A., a Swiss biotechnology research firm, created precise copies of Celltrion's cell culture medium.  According to the letter, twelve ingredients fell outside the claimed ranges, so ExcellGene modified each of these "one after the other, so that they fell literally within the claimed range."  Plaintiffs reported that the differences between the relevant performance variables in these samples were "not substantial: '[N]one of the variant media tested . . . showed a significant difference in performance' compared to the defendants' cell culture media" (emphasis in original).  As such, according to Janssen, the Celltrion's cell culture media infringes under the DOE.

    Interestingly, Janssen suggested that it did not have time in the preceding week to meet and confer with Celltrion.  Therefore, there was no indication as to Celltrion's position regarding an expedited trial.  Nevertheless, Plaintiffs stated that they would submit a formal motion to support their request in the event that Celltrion opposes.  Further action on this matter should forthcoming shortly.

  • PTAB Denies IPR Petitions against Cold Spring Harbor Laboratory Patents

    By Kevin E. Noonan —

    Cold Spring Harbor LaboratoryCold Spring Harbor Laboratory (CSHL) is a storied institution in molecular biology, being the site of annual meetings related to this view of life since Schrodinger proposed to use quantitative methods to examine biology in the wake of the despair in physics occasioned by the use of nuclear weapons to end World War II.  Last month the Patent Trial and Appeals Board of the U.S. Patent and Trademark Office denied four petitions for inter partes review brought by Benitec Biopharma Limited against four CSHL patents directed to gene silencing methods using short hairpin RNA (shRNA).

    The four petitions were directed to related patents (U.S. Patent Nos. 8,153,776; 8,202,846; 8,383,599; and 8,829,264), wherein "[t]he ʼ599 patent issued from a continuation of application No. 10/055,797, filed Jan. 22, 2002 [and t]he '846, '776, and '264 patents derive from a continuation-in-part of Application No. 10/055,797 (Application No. 10/997,086, filed Nov. 23, 2004) and share substantially the same specification."

    The IPRs are identified by the following case numbers and illustrated by the following representative claims for each petition:

    Case IPR2016-00014  (Patent 8,202,846)

    Claim 1:

    1.  A method for attenuating expression of a target gene in a mammalian cell, the method comprising:
        introducing into a mammalian cell an expression vector comprising:
            (i) an RNA polymerase promoter, and
            (ii) a sequence encoding a short hairpin RNA molecule comprising a double-stranded region, wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,
        wherein the short hairpin RNA molecule is a substrate for Dicer-dependent cleavage and does not trigger a protein kinase RNA-activated (PK) response in the mammalian cell,
        wherein the double-stranded region of the short hairpin RNA molecule comprises a sequence that is complementary to a portion of the target gene, and
        wherein the short hairpin RNA molecule is stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner, and is expressed in the cell without use of a PK inhibitor, whereby expression of the target gene is inhibited.

    Case IPR2016-00015  (Patent 8,383,599)

    Claim 1:

    1.  A population of mammalian cells stably transfected or stably transduced with a library of expression constructs, wherein each expression construct encodes a short hairpin RNA, each expression construct comprising:
        (i) an RNA polymerase promoter, and
        (ii) a sequence encoding a short hairpin RNA molecule comprising a double-stranded region, wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,
        wherein the short hairpin RNA molecule is a substrate for Dicer-dependent cleavage and does not trigger a protein kinase RNA-activated (PKR) response in the mammalian cells,
        wherein the double-stranded region of the short hairpin RNA molecule comprises a sequence that is complementary to a portion of the target gene in the mammalian cells, wherein the target gene is an endogenous gene of the mammalian cells, and
        wherein said population of mammalian cells comprises cells in which the short hairpin RNA molecule is stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner without use of a PK inhibitor.

    Case IPR2016-00016  (Patent 8,153,776)

    Claim 1:

    1.  A method for attenuating expression of a target gene in a mammalian cell, the method comprising
        introducing into mammalian cells a library of RNA expression constructs, each expression construct comprising:
            (i) an RNA polymerase promoter, and
            (ii) a sequence encoding a short hairpin RNA molecule comprising a double-stranded region wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,
        wherein the short hairpin RNA molecule is a substrate for Dicer-dependent cleavage and does not trigger a protein kinase RNA-activated (PKR) response in the mammalian cell,
        wherein the double-stranded region of the short hairpin RNA molecule comprises a sequence that is complementary to a portion of the target gene, and
        wherein the short hairpin RNA molecule is stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner, and is expressed in the cell without use of a PK inhibitor, whereby expression of the target gene is inhibited.

    Case IPR2016-00017 (Patent 8,829,264)

    Claim 1:

    1.  A transgenic mouse comprising a germline or somatic cell, wherein the germline or somatic cell comprises a transgene, wherein the transgene comprises a sequence encoding a short hairpin RNA (shRNA) molecule,
        wherein the shRNA molecule comprises a double-stranded region, wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,
        wherein the shRNA molecule is a substrate for Dicer-dependent cleavage and dose not trigger a protein kinase RNA-activated (PK) response in the mammalian cell,
        wherein the double-stranded region of the shRNA molecule comprises a sequence that is complementary to a portion of a target gene, and
        wherein the shRNA molecule is stably expressed in said germline or somatic cell without use of a PK inhibitor and in an amount sufficient to attenuate expression of the target gene in a sequence specific manner.

    Similarly, the asserted prior art was the same:

    • Zamore et al., US 7,691,995, for anticipation under § 102(e);
    • Graham et al., US 6,573,099, for anticipation under § 102(b);

    and varying combinations of:

    Graham and/or Zamore, Tuschl et al., US 2002/0085356 A1; Fire et al., US 6,506,559; Harborth et al., 2001, Identification of essential genes in cultured mammalian cells using small interfering RNAs, 114 J. CELL SCI. 4557–4565; Parrish et al., 2000, Functional Anatomy of a dsRNA Trigger: Differential Requirement for the Two Trigger Strands in RNA Interference, 6 MOLECULAR CELL 1077–1087; Sijen et al., 2001, On the Role of RNA Amplification in dsRNA-Triggered Gene Silencing, 107 CELL 465–476; Green & Mathews, 1992, Two RNA-binding motifs in the double-stranded RNA-activated protein kinase, DAI, 6 GENES & DEVELOPMENT 2478–2490; Waterhouse et al., 2001, Gene Silencing As an Adaptive Defense Against Viruses, 411 NATURE 834; Symonds et al., US 7,345,025; Tian et al., 2000, Expanded CUG repeat RNAs form hairpins that activate the double-stranded RNA-dependent protein kinase PKR, 6 RNA 79–87; Svoboda et al., 2001, RNAi in Mouse Oocytes and Preimplantation Embryos: Effectiveness of Hairpin dsRNA, 287 BIOCHEM & BIOPHYS. RES. COMM. 1009–1104; Zernicka-Goetz et al., US 2003/0027783 A1; and/or Wianny & Zernicka-Goetz, 2000, Specific interference with gene function by double-stranded RNA in early mouse development, 2 NATURE CELL BIO. 70–75.

    In each case, the Board's decision begins with an express statement regarding claim construction:

    In an inter partes review, the Board interprets a claim term in an unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears.  37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016).  Under that standard, and absent any special definitions, we assign claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention,16 in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).  Only terms which are in controversy need to be construed, however, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).

    In the present matter, the parties do not dispute the meaning of any claim term nor, for the purposes of our decision, do we find that any term requires express construction.

    And in each case, the Zamore reference is defeated as prior art, because the Board agreed with the patentee that the reference was not supported by its priority document, and thus whatever was disclosed did not qualify as invention before the filing date (and constructive earliest invention date) of the patents at issue.  The Board notes that the Petitioner did not present testimonial evidence from an expert to support its position that the person having ordinary skill in the art would have appreciated that the Zamore inventors had possession of the invention claimed in the '995 patent at their earliest priority date based on the disclosure of provisional application 60/305,185.

    The grounds for rejecting Petitioner's arguments with regard to anticipation based on the Graham reference are specifically tailored to each claim set (e.g., the absence of any teachings in the reference of a transgenic mouse in the IPR directed towards the '264 patent).  In common in all these decisions is the disclosure in Graham of hairpin structures in the disclosed constructs as being a problem to be avoided rather than a feature to be exploited for regulating gene expression.  (And again, the Board notes the absence of expert testimony to support Petitioner's arguments regarding anticipation by the Graham reference.)

    Turning to the obviousness grounds, the Board notes that "Patent Owner contends that Petitioner's 'kitchen sink' approach obscures the bases for the underlying obviousness challenge and, thus, requests that we deny the Petition as violating the particularity provisions of 35 U.S.C. § 312(a)(3) and 37 C.F.R. § 42.22(a)(2)," which argument is "not without merit" according to the Board.  However, in each case the opinions set forth the limitations of the cited art as applied to the claims in each of the petitions, finding that in none of them had Petitioner carried its burden of establishing obviousness by a preponderance of the evidence.  Of note in this regard is the Board's treatment of the combination of the Svoboda, Zernicka-Goetz, and Wianny references for teaching gene silencing using shRNAs, and separately the combination of the Tuschl, Fire, and Parrish references for teaching the length of gene silencing shRNAs.  Regarding the first combination, the Board finds in each reference the deficiency that the reference does not teach a hairpin structure as required by the claims in any of the patents challenged in any of the IPRs.  With regard to the second set of combined references, the Board found similar deficiencies, but was also persuaded by the testimony (unchallenged, according to the Board) of CHSL's expert based on "the leading literature in the field [, which] would have taught away from using an expressed short hairpin molecule, which to have gene silencing activity, must first be processed in the cell."

    Finally, the Board found that Petitioner had not shown why the skilled worker would turn to the Tian or Green references, which are not directed "to the design of constructs for RNA interference", and that the Sijen reference (relating to C. elegans) are inapposite because these organisms do not possess the innate anti-viral response involving a double-stranded RNA activated protein kinase that the shRNA molecules and uses thereof are intended to avoid.

    These decisions illustrate what many believed would be the case:  the original high instance of patent claim invalidation by the Board was in large part an artifact of the selection process whereby the most egregious patents (having any commercial value) would be challenged first, and that biotech and pharma patents would be harder to invalidate due to the complexity of the technology and the generally thorough prosecution scrutiny to which patents in this area are subjected.  IPR proceedings against commercially important patents on inventions in the biotechnology and pharmaceutical space are sure to continue to increase in number, and these decisions contain lessons that both petitioners and patent owners would to well to learn.

  • Global Cash Access, Inc. v. NRT Technology Corp. (D. Nev. 2016)

    U.S. District Court Disagrees with PTAB

    By Joseph Herndon —

    District Court for the District of NevadaOn March 25, 2016, the U.S. District Court for the District of Nevada issued an Order in a case captioned Global Cash Access, Inc. v. NRT Technology Corp., and NRT Technologies, Inc., in which the District Court found the claims to be directed to an abstract idea.  This decision contradicts the U.S. Patent and Trademark Office's Patent Trial and Appeal Board's (PTAB) prior covered business method (CBM) decision, and makes it difficult to identify a standardized manner of applying the guidelines for determining patentable subject matter under 35 U.S.C. § 101.

    Procedurally, Plaintiff Global Cash Access, Inc. sued Defendants NRT Technology Corp. and NRT Technologies, Inc. for infringement of U.S. Patent No. 6,081,792, and other unfair trade practices.  Defendants then initiated administrative review proceedings before the PTAB, and the PTAB denied Defendants' petition for a CBM patent review on the basis that the claims more than likely satisfied 35 U.S.C. § 101.  We recently discussed the CBM decision (see "NRT Technology Corp. v. Everi Payments, Inc. (PTAB 2016)").

    Defendants have now filed a Motion to Dismiss in the District Court proceeding again alleging that the patent claims an abstract idea, and the District Court ruled opposite that of the PTAB, finding the patent claims to be ineligible under 35 U.S.C. § 101.

    The '792 patent subject matter

    The '792 patent describes an interesting function for use of automated teller machines ("ATMs") to issue receipts for a "purchase" that can be cashed in at designated locations for cash of the purchase.  A customer can obtain cash from an account via various processes such as an ATM process or a point-of-sale ("POS") process using both debit cards and credit cards.  In its "Description of the Prior Art," the '792 patent notes two so-called problems associated with obtaining cash from prior art ATMs (i.e., via an ATM network).  First, with respect to using a debit/ATM card, a bank typically imposes a daily limit on ATM cash withdrawals.  Second, with respect to using a credit card to obtain cash from an ATM, the '792 patent points out that people often do not recall the personal identification number ("PIN") that is required because they may not regularly use a credit card for that purpose.

    According to the '792 patent, neither of these problems is encountered when using the same cards to make purchases, which occur over a POS network, not an ATM network.  With respect to debit/ATM cards, "one can reach [his] ATM limit and not be able to obtain more cash that day from an ATM, but will still be able to purchase goods and services via a point-of sale transaction because of the distinct and separate limit for point-of-sale transactions."  With respect to credit cards, the '792 patent states that PINs are not typically required to make purchases.  (However, while not described in the '792 patent, as credit cards change over to the Chip-enabled technology, many credit card companies are requiring use of PINs).

    The '792 patent describes a method in which a cardholder first attempts to obtain money via a first type of transaction (i.e., conducted over an ATM network) and fails because he has exceeded his ATM daily limit or cannot remember the PIN for his credit card and subsequently and successfully obtains money via a second type of transaction (i.e., conducted via a POS network).  But, the cardholder does not obtain cash (or other valuable item) directly from the terminal when using the POS network.  Instead, the terminal informs a nearby money location (such as "cash windows or 'cages' within casinos or racetracks, front desks or concierges of hotels, ticket booths, will-call windows or customer service windows at stadiums, coliseums, theaters, stores, or amusement parks") of the approved transaction.  The terminal may also issue a "script" or "pre-receipt" for the cardholder to take to the money location.  At the money location, the cardholder exchanges the receipt for the cash.  In the preferred embodiment, a check drawn against the cardholder's account is issued at the money location and made payable to the money location owner.

    Claim 1 reads:

    A method of providing money or an item of value to an account-holder, the method comprising:
        identifying an account to a terminal;
        entering a personal identification number into the terminal;
        requesting money or an item of value based upon the account via a first type of transaction;
        forwarding the first type of transaction to a processor;
        forwarding the first type of transaction from the processor to a first network;
        forwarding the first type of transaction from the first network to a bank;
        making a denial of the first type of transaction due to exceeded pre-set limit;
        forwarding the denial to the processor;
        notifying the account-holder at the terminal of the denial of the first type of transaction, and asking the account-holder if they would like to request the money or item of value via a second type of transaction;
        requesting money or an item of value based upon the account via a second type of transaction;
        forwarding the second type of transaction to the processor;
        forwarding the second type of transaction from the processor to a second network;
        forwarding the second type of transaction from the second network to the bank;
        making an approval of the second type of transaction;
        forwarding the approval to the processor; and
        instructing a money location separate from the terminal to provide money or an item of value to the account-holder.

    Patentable Subject Matter at the PTAB

    The Defendants, NRT Technology, filed a petition to institute CBM review of the patent at the PTAB.  The PTAB found that the Petitioner oversimplified the challenged claims because the challenged claims are not directed simply to the idea of providing money to an account holder or using trial-and-error until success is achieved.  Rather, the claims are directed to particular methods of providing money to an account holder using an ATM via a POS transaction after an ATM transaction has failed.

    Further, the PTAB found that Petitioner's analysis omitted any consideration of the elements of the claims as ordered combinations to determine whether the additional elements transform the nature of the claims into a patent-eligible application.  The PTAB found that it was Petitioner's burden to do so.  Failing to meet this burden, the Petitioner was unable to show that the claims are more likely than not patent-ineligible.

    Because the information presented in the Petition did not demonstrate that it is more likely than not that any of the claims challenged is unpatentable, the Petition for instituting a CBM patent review was denied by the PTAB and no trial was instituted.

    Patentable Subject Matter at the District Court

    The District Court purported to follow the Supreme Court's two-part test to assess whether the patent covers an abstract idea, and stated that the '792 Patent claims a method that, on its face, is a well-established economic practice; the abstract idea of providing money or an item of value to an account-holder.

    The District Court found that using an alternative transaction to obtain cash is a longstanding economic practice that aligns with similar commercial practices deemed abstract by the Supreme Court.

    Regarding the inventive concept probe, the Plaintiff insisted that the '792 Patent improves existing ATM technologies in casinos by instructing one terminal to perform two different transactions to obtain cash.  But, the District Court noted that the specification described that such separate transactions existed well before the claimed invention.  As an example, individuals unable to obtain cash from an ATM would "still be able to purchase goods and services via a point-of-sale transaction," or could "proceed to a bank outlet to obtain the needed cash."  The District Court found that the claimed steps simply disclose that a second transaction occurs after a first is denied, and, just as where an account-holder needs to visit his or her bank outlet, requires an account-holder to obtain the cash from a separate location.  In short, contrary to Plaintiff's assertions and according to the District Court, Claim 1 does not enable an account holder to obtain cash from an ATM through a second transaction.

    The District Court thus found the '792 Patent to be patent-ineligible under § 101, and dismissed the patent infringement claims.

    The District Court noted that the PTAB previously found that Defendants had failed to show "that the claims are more likely than not patent-ineligible."  But, in the context of Defendants' Motion to Dismiss, the Court found that Defendants persuasively identified a distilled version of the claims at issue:  "offering an account-holder an alternative way to obtain cash or something of value  — i.e., when the first transaction is denied, offering to perform a second type of transaction to achieve the same results."

    The different holdings by the PTAB and District Court may just show the state of 35 U.S.C. § 101 today — determinations of patent eligible subject matter are somewhat random and highly subjective.  It may have been the case that the Petitioner in the PTAB proceeding did not prepare a solid challenge, and likely did not do itself any favors by failing to directly identify "the abstract ideas" in the claims.  However, on their face, the claims appear to recite enough details to withstand a § 101 challenge.  The District Court here encourages Defendants if at first you don't succeed, to develop a new "distilled version of the claims" and see if that works.

    Global Cash Access, Inc. v. NRT Technology Corp. (D. Nev. 2016)
    Order by District Judge Miranda M. Du

  • Members of Congress Seek NIH Hearing on Use of March-in Rights

        By Donald Zuhn —

    Washington - Capitol #3On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to "strongly encourage the NIH to use its [march-in] authority to hold a public hearing on the request put forth by certain public interest groups to help establish whether or not [the statutory] criteria [for the use of the NIH's march-in rights] are met in the case of Xtandi (enzalutamide)."  Enzalutamide is a synthetic, non-steroidal pure antiandrogen that was developed by the pharmaceutical company Medivation for the treatment of metastatic castration-resistant prostate cancer.

    NIHThe letter indicates that the drug was developed at the University of California, Los Angeles (UCLA) using taxpayer supported research grants from the U.S. Army and NIH, and that Japanese licensee Astellas currently "charg[es] Americans $129,000 for this drug, which sells in Japan and Sweden for $39,000, and in Canada for $30,000."  Noting that "[t]he 1980 Bayh-Dole Act gives federal agencies, including the NIH, the authority to license a patent when 'action is necessary to alleviate health or safety needs which are not reasonably satisfied' or if the invention is not 'available to the public on reasonable terms,'" the signatories to the letter state that "[w]e do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms."  The letter also notes that "despite [the Bayh-Dole Act] being in place for over 35 years, the NIH has never used this broad and powerful authority to protect consumers from excessive prescription drug prices."

    According to the signatories, a "public hearing on Xtandi by the NIH would help to provide insight into NIH's decision-making process on this case," as well as allow the public "to better understand [the NIH's] position on the use of march-in to address excessive prices."  The letter points out that as a result of the NIH's granting of a hearing in 2004 on Abbott Laboratories' Norvir (ritonavir), the price of ritonavir was lowered for public payors.

    The letter was signed by Representatives Lloyd Doggett (D-TX), Peter Welch (D-VT), Elijah E. Cummings (D-MD), Jan Schakowsky (D-IL), Rose DeLauro (D-CT), and Mark Pocan (D-WI), and Senators Bernard Sanders (I-VT), Al Franken (D-MN), Patrick Leahy (D-VT), Sheldon Whitehouse (D-RI), Elizabeth Warren (D-MA), and Amy Klobuchar (D-MN).

  • Court Report

            By Sherri Oslick —

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

    Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC
    1:15-cv-00964; filed October 22, 2016 in the District Court of Delaware

    • Plaintiffs:  Unimed Pharmaceuticals, LLC; Besins Healthcare Inc.; Besins Healthcare Luxembourg SARL
    • Defendant:  Amneal Pharmaceuticals, LLC

    Infringement of U.S. Patent Nos. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003), 8,729,057 ("Testosterone Gel and Method of Use," issued May 20, 2014), 8,741,881 (same title, issued June 3, 2014), 8,754,070 (same title, issued June 17, 2014), and 8,759,329 (same title, issued June 24, 2014), 9,125,816 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued September 8, 2015), 9,132,089 (same title, issued September 15, 2015) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.


    Pfizer Inc. et al. v. Mylan Inc. et al.
    1:15-cv-00960; filed October 22, 2016 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
    • Defendants:  Mylan Inc.; Mylan N.V.; Mylan Laboratories Ltd.; Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011), 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), and 8,975,242 ("Tigecycline Compositions and Methods of Preparation," issued March 10, 2015), licensed to Pfizer, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.


    Alcon Pharmaceuticals Ltd. et al. v. Akorn, Inc.
    1:15-cv-00948; filed October 21, 2016 in the District Court of Delaware

    • Plaintiffs:  Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
    • Defendant:  Akorn, Inc.

    Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis).  View the complaint here.


    Takeda Pharmaceutical Co. Ltd. et al. v. Aurobindo Pharma Ltd. et al.
    3:15-cv-07635; filed October 21, 2016 in the District Court of New Jersey

    • Plaintiffs:  Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.; Aurolife Pharma LLC

    Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011), and 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of plaintiffs' Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome).  View the complaint here.

  • Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)

    By Kevin E. Noonan —

    Genetic TechnologiesThe Federal Circuit affirmed the latest invalidation of genetic diagnostic claims last week, in Genetic Technologies Ltd. v. Merial L.L.C.  While consistent with (and expressly relying upon) recent Federal Circuit precedent on this question, this case presents additional aspects deleterious to genetic diagnostic method patent holders.

    The patent at issue, U.S. Patent No. 5,612,179, was granted on March 19, 1997, filed September 23, 1992, and expired March 18, 2014.  Claim 1 is representative:

    1.  A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
        a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
        b) analyzing the amplified DNA sequence to detect the allele.

    The case was originally filed by GTG in Colorado against several defendants; this action was then "severed and transferred to the District of Delaware."  Defendants moved to dismiss under Fed. R. Civ. Proc. 12(b)(6) for failure to state a claim, on the grounds that the claims were invalid under 35 U.S.C. § 101.  The District Court granted this motion based on Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1298 (2012), without performing claim construction.  Before the Federal Circuit, the parties stipulated that "claim 1 is representative of claims 2–25 and 33–36 of the '179 patent with respect to eligibility under § 101."

    The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Chief Judge Prost and Judge Taranto.  The opinion begins with a curiously detailed explication of the scientific basis of the invention, which is linkage disequilibrium, i.e., the genetic phenomenon that certain portions of the genome can, in some individuals, be inherited together at frequencies higher than would be expected at random.  As stated in the opinion:

    Claim 1 is thus broad in scope; it encompasses methods of detecting a coding region allele by amplifying and analyzing any linked non-coding region, which could be found within the same gene as the coding region, within a different gene, or within an intergenic region.

    The panel dismissed any procedural objections to the District Court's decision below, stating that "[w]e have repeatedly recognized that in many cases it is possible and proper to determine patent eligibility under 35 U.S.C. § 101 on a Rule 12(b)(6) motion," citing OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362 (Fed. Cir. 2015); Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n, 776 F.3d 1343, 1351 (Fed. Cir. 2014); and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014).  In addition, claim construction is not always required according to the opinion: "[C]laim construction is not an inviolable prerequisite to a validity determination under § 101," the panel states, citing Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1273 (Fed. Cir. 2012); see also Content Extraction, 776 F.3d at 1349."

    Turning to the substance of the case and calling the Supreme Court's Mayo/Alice test "well-established," the opinion applied the two steps of the test: 1) determining whether the claim is "directed to" a law of nature, natural phenomenon or abstract idea, and 2) determining whether the claim included an "inventive concept" (or "something more") that would render it patent eligible.  The panel found that the claim satisfied the first step of the inquiry:  "Claim 1 is directed to the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences — a law of nature."  Sub silentio, the opinion raised the issue of preemption:  "Claim 1 covers any comparison, for any purpose, of any non-coding region sequence known to be linked with a coding region allele at a multi-allelic locus . . . .  The '179 patent does not limit its scope to methods of detecting any particular alleles linked to any particular non-coding sequences, . . . .  Claim 1 broadly covers essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA" (emphasis added), and thus nicely introducing the second part of the analysis into its assessment of whether the first part of the Mayo/Alice test was satisfied.

    The opinion then reached the crux of the philosophical disapprobation of most diagnostic method claims:  "[t]he product of the method of claim 1 is information about a patient's natural genetic makeup — at least one coding region allele" (emphasis added), which depends on the existence of linkage disequilibrium, i.e., a natural law.  This, for the panel, made the claim "quite similar" to the invalidated claims at issue in Mayo, based on its reliance on a biological sample and with the identification of "allegedly newly discovered information about human biology" (despite of and ignoring all the other factual differences, including that all of the steps of the claimed methods in Mayo had actually been performed in the prior art).  Accordingly, the Federal Circuit agreed with the District Court that the fact that the claimed methods were dependent on a naturally occurring phenomenon was enough for these claims to be "directed to" a natural law.

    The panel also relied on the Court's Ariosa v. Sequenom decision, which involved "genetic testing method claims remarkably similar to the claim here" according to the Court.  And the panel took the opportunity to foreshadow its consideration of the second prong of its analysis by stating that "the patent claim focuses on a newly discovered fact about human biology (the linkage of coding and non-coding regions of DNA), [which] involves no creation [not strictly correct] or alteration of DNA sequences, and does not purport to identify novel detection techniques."

    The panel thus concluded that the claim is "directed to" a law of nature because "the sole function of the 'primer pair defining a DNA sequence which is in genetic linkage with [a multi-allelic] genetic locus' is to amplify a sequence of non-coding DNA in linkage disequilibrium with a sequence of coding DNA of interest" (a statement that acknowledges human effort to select appropriate primers and perform the amplification; while these considerations are important in making an assessment of the second prong they seem to beg the question when applied to determining whether the claims are "directed to" a law of nature).

    At last turning to the second prong, the panel applied the language from Mayo that "well-understood, routine, conventional activity previously engaged in by researchers in the field" is not sufficient to convert a natural law to a patent-eligible invention.  Applying the same logic the Court used in finding Sequenom's claims patent ineligible, the panel supported this conclusion (as it has in prior cases) with patentee's statements regarding such methods from the prosecution history in response to rejection under 35 U.S.C. § 112.  And the panel used its Ariosa decision as express precedential support for its conclusion:  "claim 1 of the '179 patent is directly comparable to the claims invalidated in Ariosa."

    The panel capped off its invalidating decision of GTG's claims by rejecting patentee's arguments regarding the "something more" its claims provide other than the natural law:  that the practice of the claimed methods enables detection of the linked (coding) allele, which is typically associated with (if not directly responsible for) a disease or genetic disorder.  This benefit the panel dismissed as a "mental step," supporting this determination with citations to the Court's precedents involving Section 101 invalidation of computer-related and business method claims.  This argument followed the same pattern as the rest of the court's analysis:  taking all the rest of the recited steps individually, the use of the genetic information becomes merely a mental step, which is isolation it well may be.  Ironically, the opinion cited Diamond v. Diehr in support of its "mental step" argument, missing the critical teaching from Diehr that claims cannot be deconstructed into their component steps but must be considered as a whole.  In addition, the opinion analogized the claims at issue here with the claims in Mayo, equating the expressly recited step here ("to detect the allele") with the "wherein" clauses that caused the Supreme Court to invalidate Prometheus's claims.

    In addition, the opinion reflects the difference between the state of the art when these claims were filed (the appropriate frame of reference for determining patent eligibility) with the current state of the art.  The opinion states that:

    The limitation "to detect the allele" merely asks the user to compare the non-coding sequence he has amplified and analyzed with a library of non-coding sequences known to be in linkage disequilibrium with certain coding region alleles.  This instruction to undertake a simple comparison step does not represent an unconventional, inventive application sufficient to make the claim patent-eligible.

    Of course, that "simple comparison step" was not simple in 1992; the claimed method enabled the comparison otherwise unavailable in the art.

    In this regard the panel once again relied upon its Ariosa decision, specifically claims 21 and 25 from U.S. Patent No. 6,258,540 that recited performing prenatal diagnosis in rejecting GTG's arguments for patent eligibility.  The opinion also cited In re BRCA1- & BRCA2-Based Hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) (another opinion by Judge Dyk), for the proposition that the combination of the "non-patent-eligible elements" of the claim with a comparison step was patent ineligible –- again, ignoring the Diehr rubric that claims should be interpreted as a whole.

    Finally, adding insult to injury the Court awarded costs to appellees.

    The important conclusion from this precedential opinion is not whether these claims are (or should be) patent eligible.  The case is important because it again affirms the procedural legitimacy of attacking the patent eligibility of claims using a motion to dismiss under Rule 12(b)(6), and without the court performing claim construction.  It also illustrates the importance of having the Supreme Court render an opinion in Ariosa; without the Court's intervention and clarification, the Ariosa opinion is sufficiently broad that no diagnostic method claim will be safe from the logic set forth in that case and in this opinion.  At least some members of the Federal Circuit clearly believe that their hands are tied and that they are compelled to come to conclusions such as the ones in this opinion based on binding Supreme Court precedent (even if Judge Newman believes that there is room in that precedent to distinguish cases such as Ariosa and presumably this one).  But until such time that the Court deems it proper to render such clarification, it is hard to see how patentees of diagnostic inventions can rely on the U.S. patent system for any protection.

    Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)
    Panel: Chief Judge Prost and Circuit Judges Dyk and Taranto
    Opinion by Circuit Judge Dyk

  • Conference & CLE Calendar

    CalendarApril 12, 2016 – "A Federal Trade Secrets Act? The Defend Trade Secrets Act of 2016" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CDT)

    April 13, 2016 – "Protecting Your IP Overseas: WIPO Services and Initiatives" (World Intellectual Property Organization, American Intellectual Property Law Association, and U.S. Patent and Trademark Office) – Nashville, TN

    April 14, 2016 – "Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal) — Selecting and Tailoring Evidence, Timing of Submission by Petitioner and Patent Owner, and Best Practices for Challenging Evidence" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 14, 2016 – "Evidence at the PTAB: New AIA Rules" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 15, 2016 – "Protecting Your IP Overseas: WIPO Services and Initiatives" (World Intellectual Property Organization, American Intellectual Property Law Association, and U.S. Patent and Trademark Office) – Atlanta, Georgia

    April 20, 2016 – "Patents After the AIA: Evolving Law and Practice – Part 2" (American Intellectual Property Law Association) – 12:30 to 2:00 pm (Eastern)

    April 21, 2016 – 32nd Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

    April 21, 2016 – "Navigating the New EU Unitary Patent System and Unified Patent Court — Strategic Considerations for U.S. Applicants and Patentees" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 21, 2016 – "Preparing for Patent Litigation: Practical Strategies for University Tech Transfer Offices" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    May 11, 2016 – "Patents After the AIA: Evolving Law and Practice – Part 3" (American Intellectual Property Law Association) – 12:30 to 2:00 pm (Eastern)

    May 18, 2016 – "The PTAB Front and Center at the Federal Circuit and the Supreme Court: The First Year of Appellate Review" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CDT).

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

  • Webinar on the PTAB Front and Center

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "The PTAB Front and Center at the Federal Circuit and the Supreme Court: The First Year of Appellate Review" on May 18, 2016 from 10:00 am to 11:15 am (CDT).  In this presentation, Patent Docs author and MBHB attorney Andrew Williams, Ph.D. and MBHB attorney James Lovsin will provide:

    • A review of the PTAB cases in which the Federal Circuit has vacated and remanded in order to determine best practices for appealing an adverse final written decision;
    • A look at the application of the "Broadest Reasonable Interpretation" standard for claim construction, and whether it is really that different from the "Plain and Ordinary Meaning" standard used by District Courts;
    • A discussion of the Federal Circuit's refusal to consider issues related to a decision to institute post-grant review proceedings, and whether it is consistent with the statute; and
    • An analysis of the arguments presented to the Supreme Court in the Cuozzo case, and a prediction of the outcome based on the oral hearing.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • Webinar on Unitary Patent System and Unified Patent Court

    Strafford #1
    Strafford will be offering a webinar/teleconference entitled "Navigating the New EU Unitary Patent System and Unified Patent Court — Strategic Considerations for U.S. Applicants and Patentees" on April 21, 2016 from 1:00 to 2:30 pm (EDT).  Dr. Hazel Ford of Finnegan Henderson Farabow Garrett & Dunner and Leythem A. Wall of Finnegan Europe will provide guidance to patent counsel on the new EU Unitary Patent System and the European Unified Patent Court and cover the nuts and bolts of the systems as well as strategic considerations for U.S. applicants and patentees with European portfolios.  The webinar will review the following issues:

    • What are the advantages and disadvantages of the EU Unitary Patent System? How does it differ from the current system?
    • What are the benefits and risks of the new Unified Patent Court?
    • What key considerations should companies and their counsel keep in mind as they navigate the new systems?
    What steps should patent counsel take to prepare for the new systems?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.