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  • Innovation Act Passed By House — A Closer Examination

    By Andrew Williams —

    House FloorAs we reported earlier today, the House of Representatives passed H.R. 3309, the Innovation Act, by a 325 – 91 vote.  There was support for the bill from both parties, with 195 Republicans and 130 Democrats voting for the bill.  On the other hand, more Democrats were opposed to the bill, with 64 Democrats and only 27 Republicans voting against it.  Nine Republicans and six Democrats did not take part in the vote.

    The House took up the matter as a Committee of the Whole in the morning, and proceeded with one hour of general debate on the bill from the Judiciary Committee (see "'Non-Practicing Lawmakers' — The Mark-up of H.R. 3309 (Innovation Act)").  Interestingly, both supporters and opponents of the bill looked to the impact it would have on small businesses, with the former arguing that the bill is necessary to protect small companies, while the latter pointed to the unintended consequences the bill will have for small businesses.  For example, it was pointed out that the fee-shifting provision would likely favor wealthy parties; while at the same time "chilling" small inventors from pursuing legitimate patent infringement claims.  The House then considered eight amendments.  Two of these amendments were adopted via voice vote during debate.  In the first of these, Rep. Polis of Colorado proposed including the identification of "the ultimate parent entity of the claimant" within the list of pre-suit notification requirements necessary to allege willful infringement.  The second was offered by Rep. Jackson Lee of Texas, and provided for a study on the impact of this legislation on the ability of individuals and small businesses to protect exclusive rights to inventions and discoveries, and specifically on its impact on women, veterans, and minorities.

    The votes on the remaining six amendments were postponed until debate on all of the amendments was concluded.  Only two of these amendments were approved via recorded vote.  The first was a manager's amendment introduced by Rep. Goodlatte of Virginia, the Chairman of the House Committee on the Judiciary.  This amendment should be somewhat good news for readers of this blog.  In addition to some technical corrections, Rep. Goodlatte created an exception to the new staged-discovery requirements for any cause of action for which resolution within a specified period of time would necessarily affect the rights of a party with respect to a patent.  The amendment specifically calls out Hatch-Waxman litigation brought pursuant to 35 U.S.C. § 271(e), but would presumably impact biosimilar litigation also.  In addition, actions alleging competitive harm would be exempted from these discovery requirements, such as when a preliminary injunction is sought to redress harm from a competitor.  Finally, the amendment specified that the parties could opt out of these discovery requirements voluntarily.  The only other amendment to be adopted via recorded vote was introduced by Rep. Rohrabacher of California.  This amendment removed the provision in the Innovation Act that would have done away with § 145 actions, by which a patentee can bring an action in district court (allowing for the introduction of new evidence) to challenge a rejection of a patent application by the Board.  A similar amendment was proposed during the mark-up of the Innovation Act in committee, where it was opposed by Rep. Goodlatte and ultimately defeated.

    The remaining four amendments were not adopted by the House.  In the first of these, Rep. Watt of North Carolina proposed an amendment to the fee-shifting provision, which would have allowed a judge to consider dilatory or other abusive tactics by a prevailing party in determining whether an awarded fee should be reduced or denied.  Second, Rep. Massie of Kentucky proposed striking section 5 of the bill, which would have eliminated the "customer-suit exception" provision.  Third, Rep. Jackson Lee proposed expanding the definition of covered customers in the same section 5 to include all small businesses as long as its annual revenue does not exceed $25 million.  Finally, Rep. Conyers of Michigan and Rep. Watt proposed a substitute amendment, which would have replaced the entire Innovation Act with a different bill entitled the "Deceptive Patent Practices Reduction Act."  This substitute bill appeared to contain the provisions that the Democrats on the Judiciary Committee were able to support, and did not contain many of the more controversial provisions as judged by comments from the patent community.  Interestingly, this "Deceptive Patent Practices Reduction Act" appears to be more closely aligned to the "Patent Transparency and Improvements Act of 2013," which Sen. Leahy introduced in the Senate as a "companion" piece to the Innovation Act.

    The "Innovation Act" will next move on to the Senate, where Sen. Leahy's aforementioned "Patent Transparency and Improvements Act of 2013" is already pending (see "Yet Another 'Patent-Troll' Bill – Senator Leahy Introduces Patent Transparency and Improvements Act").  It will be interesting to see which version the bill the Senate actually considers and ultimately votes on.  This will, of course, be an indication of whether a true "reform" bill will come out of this current Congress.  However, the common thread running through today's debate was that this is still a bill in progress, even though it passed by an overwhelming margin.  Perhaps there is hope that a more measured bill will be ultimately agreed upon by both the House and Senate, and that if a bill does become law, it will be more narrowly tailored to address the perceived "patent troll" problem that is the alleged impetus behind these legislative efforts in the first place.

  • House Passes H.R. 3309 (Innovation Act) — Updated

    By Andrew Williams —

    House of Representatives SealThe House of Representatives earlier today passed H.R. 3309, the Innovation Act, by a 325 – 91 vote.  Before voting on the bill, the House spent several hours debating and voting on a number of amendments.  Other than a technical amendment introduced by Rep. Goodlatte (R-VA), the only other amendment approved by the House was introduced by Rep. Rohrabacher (R-CA), preserving 35 U.S.C. § 145, which allows a patent applicant to sue in district court to obtain a patent after a USPTO rejection.  We will provide more detailed coverage of the House vote and the Innovation Act later today.

    UPDATE:  In addition to the two amendments referred to above, which were approved via recorded vote, the House also adopted two amendments to the bill via voice vote during debate.  The first of these was introduced by Rep. Polis (D-CO), and included language requiring claimants to provide additional disclosure information in any pre-suit notification to be entitled to claim willful infringement.  The second requires the Director to conduct a study regarding the economic impact of provisions of the Innovation Act on the ability of individuals and small businesses owned by women, veterans, and minorities to protect their "constitutionally guaranteed exclusive right" in their inventions, and was introduced by Rep. Jackson Lee (D-TX).

  • Myriad Genetics Sues LabCorp over BRCA Gene Testing

    By Kevin E. Noonan —

    MyriadThe very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina.  Myriad sued LabCorp on Tuesday in the District of Utah, Central Divisions (Case No. 2:13-cv-01069-BCW; complaint).  Myriad's complaint in this case is similar to Myriad's complaints against other defendants, albeit being limited solely to BRCA gene claims, and once again, Myriad is joined by the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, and Endorecherche Inc.

    This Complaint alleges that:

    With knowledge of Plaintiffs' patents, Defendant began offering its BRCA1 and BRCA2 testing as part of its cancer-testing menu on December 2, 2013.  On information and belief, Defendant offers stand-alone tests comprising full gene sequencing and deletion/duplication analyses for the BRCA 1 and BRCA 2 genes.

    LabCorpMyriad alleges infringement by Labcorp's "making, manufacturing, promoting, marketing, advertising, distributing, offering for sale and selling and/or causing to be offered or sold at least certain BRCA1/2 Comprehensive Analysis (BRCAssureSM ) products."  The specific claims Myriad alleges are infringed include the following:  claim 6 of U.S. Patent No. 5,709,999; claim 6, 16 and 17 of U.S. Patent No. 5,747,282; claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441; claims 29 and 30 of U.S. Patent No. 5,837,492; claim 4 of U.S. Patent No. 6,033,857; claims 2, 3 and 4 of U.S. Patent No. 5,654,155; claims 2, 3, 4, 5, 6, and 7 of U.S. Patent No. 5,750,400; claims 32 and 33 of U.S. Patent No. 6,051,379; claim 5 of U.S. Patent No. 6,951,721; claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497; and claims 1, 5, 6, 8, 11, 14, 17, 20, 23, 26, 27, 32, 33, 35, 38, 39, 41, 44, 45, and 82 from U.S. Patent No. 6,083,698.

    This complaint is unlike several of Myriad's earlier complaints, particularly with regard to the claims asserted from the '698 patent.  In particular, claim 73 from the '698 patent (set forth below) is not asserted here:

    73.  A chip array having "n" elements for performing allele specific sequence-based techniques comprising:
        a solid phase chip and
        oligonucleotides having "n" different nucleotide sequences,
        wherein "n" is an integer greater than one, p1 wherein said oligonucleotides are bound to said solid phase chip in a manner which permits said oligonucleotides to effectively hybridize to complementary oligonucleotides or polynucleotides,
        wherein oligonucleotides having different nucleotide sequence are bound to said solid phase chip at different locations so that a particular location on said solid phase chip exclusively binds oligonucleotides having a specific nucleotide sequence, and
        wherein at least one oligonucleotide is an oligonucleotide that is an isolated nucleotide that hybridizes to either a normal or a mutant BRCA1 gene selected from the group consisting of:
        a first oligonucleotide for detecting a deletion of a nucleotide in intron 6 at nucleotide number 421-2 of a BRCA1 gene sequence, wherein said first oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 421-2 of the BRCA1 gene,
        a second oligonucleotide for detecting a deletion of two nucleotides at nucleotide number 815 of a BRCA1 gene sequence, wherein said second oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 815 of the BRCA1 gene,
        a third oligonucleotide for detecting an insertion of 10 nucleotides at nucleotide number 926 of a BRCA1 gene sequence, wherein said third oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 926 of the BRCA1 gene,
        a fourth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 1506 of a BRCA1 gene sequence, wherein said fourth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 1506 of the BRCA1 gene,
        a fifth oligonucleotide for detecting a mutation of one nucleotide at nucleotide number 2034 of a BRCA1 gene sequence, wherein said fifth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2034 of the BRCA1 gene,
        a sixth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 770 of a BRCA1 gene sequence, wherein said sixth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2428 of the BRCA1 gene,
        a seventh oligonucleotide for detecting an amino acid change from tryptophan to a stop codon at codon 1508 of a BRCA1 gene sequence, wherein said seventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4643 of the BRCA1 gene,
        an eighth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5053 of a BRCA1 gene sequence, wherein said eighth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5053 of the BRCA1 gene,
        an ninth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5210 of a BRCA1 gene sequence, wherein said ninth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5210 of the BRCA1 gene,
        a tenth oligonucleotide for detecting an insertion of 12 nucleotides at nucleotide number 5396+40 in intron 20 of a BRCA1 gene sequence, wherein said tenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5396+40 of the BRCA1 gene,
        an eleventh oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5150 of a BRCA1 gene sequence, wherein said eleventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5150 of the BRCA1 gene,
        a twelfth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 1262 of a BRCA1 gene sequence, wherein said twelfth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 3904 of the BRCA1 gene,
        a thirteenth oligonucleotide for detecting an amino acid change from tyrosine to stop at nucleotide number 903 of a BRCA1 gene sequence, wherein said thirteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 903 of the BRCA1 gene, and
        a fourteenth oligonucleotide for detecting a detecting an amino acid change from threonine to proline at nucleotide number 4164 of a BRCA1 gene sequence, wherein said fourteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4164 of the BRCA1 gene.

    While the following '698 claims are asserted here (and not in cases against other defendants):

    1.  An isolated oligonucleotide that hybridizes to either a normal or a mutant BRCA1 gene selected from the group consisting of:
        a first oligonucleotide for detecting a deletion of a nucleotide in intron 6 at nucleotide number 421-2 of a BRCA1 gene sequence, wherein said first oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 421-2 of the BRCA1 gene,
        a second oligonucleotide for detecting a deletion of two nucleotides at nucleotide number 815 of a BRCA1 gene sequence, wherein said second oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 815 of the BRCA1 gene,
        a third oligonucleotide for detecting an insertion of 10 nucleotides at nucleotide number 926 of a BRCA1 gene sequence, wherein said third oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 926 of the BRCA1 gene,
        a fourth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 1506 of a BRCA1 gene sequence, wherein said fourth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 1506 of the BRCA1 gene,
        a fifth oligonucleotide for detecting a mutation of one nucleotide at nucleotide number 2034 of a BRCA1 gene sequence, wherein said fifth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2034 of the BRCA1 gene,
        a sixth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 770 of a BRCA1 gene sequence, wherein said sixth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2428 of the BRCA1 gene,
        a seventh oligonucleotide for detecting an amino acid change from tryptophan to a stop codon at codon 1508 of a BRCA1 gene sequence, wherein said seventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4643 of the BRCA1 gene,
        an eighth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5053 of a BRCA1 gene sequence, wherein said eighth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5053 of the BRCA1 gene,
        an ninth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5210 of a BRCA1 gene sequence, wherein said ninth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5210 of the BRCA1 gene,
        a tenth oligonucleotide for detecting an insertion of 12 nucleotides at nucleotide number 5396+40 in intron 20 of a BRCA1 gene sequence, wherein said tenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5396+40 of the BRCA1 gene,
        an eleventh oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5150 of a BRCA1 gene sequence, wherein said eleventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5150 of the BRCA1 gene,
        a twelfth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 1262 of a BRCA1 gene sequence, wherein said twelfth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 3904 of the BRCA1 gene,
        a thirteenth oligonucleotide for detecting an amino acid change from tyrosine to stop at nucleotide number 903 of a BRCA1 gene sequence, wherein said thirteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 903 of the BRCA1 gene, and
        a fourteenth oligonucleotide for detecting a detecting an amino acid change from threonine to proline at nucleotide number 4164 of a BRCA1 gene sequence, wherein said fourteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4164 of the BRCA1 gene.

    5.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a TG at nucleotide number 815 by specifically hybridizing to the region encompassing the nucleotide number 815 of the BRCA1 gene.

    6.  An isolated wild type allele specific oligonucleotide according to claim 5 having the sequence 5'GAC GGA TGT AAC AAA TA 3', SEQ ID NO:7, or the sequence complementary thereto.

    8.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of an insertion at nucleotide number 926 by specifically hybridizing to the region encompassing the nucleotide number 926 of the BRCA1 gene.

    11.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of an A at nucleotide number 1506 by specifically hybridizing to the region encompassing the nucleotide number 1506 of the BRCA1 gene.

    14.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 2034 by specifically hybridizing to the region encompassing the nucleotide number 2034 of the BRCA1 gene.

    17.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 2428 by specifically hybridizing to the region encompassing the nucleotide number 2428 of the BRCA1 gene.

    20.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 4643 by specifically hybridizing to the region encompassing the nucleotide number 4643 of the BRCA1 gene.

    23.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a G at nucleotide number 5053 by specifically hybridizing to the region encompassing the nucleotide number 5053 of the BRCA1 gene.

    26.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a T at nucleotide number 5210 by specifically hybridizing to the region encompassing the nucleotide number 5210 of the BRCA1 gene.

    27.  An isolated wild type allele specific oligonucleotide according to claim 26 having the sequence SEQ ID NO:32, or the sequence complementary thereto.

    32.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a deletion at nucleotide number 5150 by specifically hybridizing to the region encompassing the nucleotide number 5150 of the BRCA1 gene.

    33.  An isolated wild type allele specific oligonucleotide according to claim 32 having the sequence SEQ ID NO:40, or the sequence complementary thereto.

    35.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a deletion at nucleotide number 3904 by specifically hybridizing to the region encompassing the nucleotide number 3904 of the BRCA1 gene.

    38.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a G at nucleotide number 903 by specifically hybridizing to the region encompassing the nucleotide number 903 of the BRCA1 gene.

    39.  An isolated wild type allele specific oligonucleotide according to claim 38 having the sequence SEQ ID NO:50, or the sequence complementary thereto.

    41.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a C at nucleotide number 4164 by specifically hybridizing to the region encompassing the nucleotide number 4164 of the BRCA1 gene.

    44.  The isolated oligonucleotide according to claim 1 further comprising a label bound thereto.

    45.  The isolated oligonucleotide according to claim 44 wherein the label is selected from the group consisting of a radiolabel, a fluorescent label a bioluminescent label, a chemiluminescent label, an enzyme label and a ligand label.

    82.  A kit comprising a carrier means being compartmentalized to receive in close confinement one or more container means, and at least one container means,
        wherein at least one container means contains the oligonucleotide of claim 1.

    Myriad and its co-plaintiffs demand a jury trial, and request judgment of patent infringement, a preliminary and permanent injunction, an accounting and damages, delivery for destruction of all "products" that infringe any of the asserted claims, a finding of willful infringement, and a request for attorneys' fees, enhanced damages, and costs of suit.

    The scorecard now stands at six patent infringement lawsuits pending in the District of Utah, against Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp, and three declaratory judgment actions by Quest, Invitae, and Counsyl, pending in various California district courts (see links below).

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

    • "Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
    • "Where Do We Stand?" October 31, 2013
    • "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
    • "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
    • "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
    • "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
    • "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
    • "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
    • "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
    • "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
    • "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
    • "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
    • "Ambry Responds to Myriad Lawsuit," August 7, 2013
    • "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
    • "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
    • "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
    • "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

  • 23andMe Named in Class Action Lawsuit

    By Kevin E. Noonan —

    23andMeThings are getting worse for genetic diagnostics company 23andMe.  On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing"), on Wednesday the company was named in a class action lawsuit in the U.S. District Court for the Southern District of California (13-CV-2847H; complaint).  The action was brought on behalf of Lisa Casey, "an individual" in the class, and on behalf of "tens or hundreds of thousands of women" who may have used the PGS testing service.  Representing the class plaintiffs is Mark Ankcorn of the Ankcorn law firm, whose website characterizes the practice as "fighting for consumers since 1993" (when, apparently, Mr. Ankcorn passed the California bar).

    The suit alleges that 23andMe "falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service ("PGS") as providing "health reports on 240+ conditions and traits," "drug response," "carrier status," among other things, despite the fact that "there is no analytic or clinical validation of the PGS for its advertised uses."  The asserted facts supporting these allegations are taken, frequently as direct quotes, from the FDA's Warning Letter.  For example, the complaint cites the letter for alleging that:

    • Beginning in July 2009, FDA worked diligently with Defendant to try to help Defendant comply with regulatory requirements regarding safety and effectiveness and to obtain marketing authorization for the PGS device.

    • "To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the [FDC] Act, 21 U.S.C. § 360(k)."

    • After more than 14 face-to-face meetings, hundreds of email messages, and dozens of written communications between Defendant and FDA concerning the public health consequences of inaccurate results from the PGS device, FDA has concluded, "…even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses…"

    • "The risk of serious injury or death is known to be high when patients are either non-complaint or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported."

    The complaint recites 23andMe's advertising that it characterizes as "[material] representations" class action plaintiffs allege are fraudulent:

    • "Learn hundreds of things about your health.  Using your DNA information, 23andMe helps you know more about your health so you can take an active role in managing it.  With reports on over 240+ health conditions and traits, here are a few of the things you'll learn about you."

    • "Plan for the future. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family."

    • "Living well starts with knowing your DNA."

    • "Health tools – Document your family health history, track inherited conditions, and share the knowledge."

    • "Drug response – Arm your doctor with information on how you might respond to certain medications."

    • "Below are a few examples [diabetes, arthritis, coronary heart disease, breast cancer, plavix, lactose intolerance] where we can help you learn more.  And when you know more, you can make better lifestyle choices, look out for common conditions and take steps toward mitigating serious diseases."

    (https://www.23andme.com/health/ Accessed 11/26/13)

    In addition to fraudulently representing that its PGS tests can provide relevant health and genetic information to individuals, the complaint also alleges that "Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless."

    As a consequence:

    Plaintiff alleges that, in committing the wrongful acts alleged herein, Defendant, in concert with its subsidiaries, affiliates, and/or other related entities and their respective employees, planned, participated in and furthered a common scheme to induce members of the public to purchase the PGS by means of misleading, deceptive and unfair representations, and that Defendant participated in the making of such representations in that it disseminated those misrepresentations and/or caused them to be disseminated.

    and

    Defendant's misrepresentations and practices injured and caused Plaintiff and Class members to lose money or property in that they purchased an expensive product with the expectation that it was scientifically supported.

    The class encompasses "[a]ll persons in any of the 50 United States and District of Columbia who purchased a 23andMe Saliva Collection Kit and Personal Genome Service within the Class Period."  The complaint also alleges facts relating to numerosity of class members, typicality (of the named plaintiff), and commonality and predominance of "[w]ell-defined, common legal or factual questions [that] affect all class members."  The complaint also asserts that acting as a class is superior to having the class members act individually.

    The suit alleges liability under the California Business and Professional Code §§ 17200 as an "unlawful, unfair or deceptive business act or practice and unfair, deceptive, untrue or misleading advertising" (Count 1:" the "unfair" and "fraudulent" prongs; Count 2: the "unlawful" prong) and §§ 17500 ("false and misleading advertising"; Count 3); the California Civil Code §§ 1750 and 1770 (Count 4); breach of warranty of merchantability and fitness for a particular purpose (Count 5); unjust enrichment (Count 6);"deceit by concealment" under California Civil Code §§ 1709 and 1710 (Count 7); and negligent misrepresentation (Count 8).  They ask the court to enjoin 23andMe's advertising, and to provide "full restitution" to class members (estimated as being at least five million dollars).  Plaintiffs demand a jury trial, punitive damages, costs of suit and pre- and post-judgment interest.

    Under plaintiffs' theory, even compliance with the FDA's requirements will not absolve 23andMe from the alleged liability; plaintiffs contend that their injury arose by 23andMe's representations made without FDA approval, and that these were fraudulent because the company did not have scientific evidence sufficient to satisfy the FDA that the tests were reliable and thus were not legally capable of making those representations.  And of course if the company cannot satisfy the FDA, the court can impose an injunction against 23andMe continuing to make its claims for (or to provide) the PGS test.

    It has been a bad few weeks for 23andMe.  If their recent luck holds, next Myriad will sue them (since their tests include determinations of the risk of breast and ovarian cancer due to BRCA gene mutations).

  • In re Eaton (Fed. Cir. 2013)

    By Donald Zuhn —

    Federal Circuit SealOn November 22, the Federal Circuit reversed a determination by the Patent Trial and Appeal Board affirming the rejection of the claims 1, 8-11, and 14 of U.S. Application No. 11/145,716 as anticipated by DE Patent No. 10053155 A1 ("Jungkeit") and as obvious in view Jungkeit and U.S. Patent No. 6,107,349.  The '716 application is directed to a method of treating psoriasis by administering a multiple vitamin supplement composition, wherein the claims at issue in the appeal recite a vitamin supplement composition of folic acid, vitamin B12, and vitamin B6.  Representative claim 1 recites:

    1.  A method of treating psoriasis by administering to a person a vitamin supplement composition comprising at least about 25 micrograms to about 2,200 micrograms of folic acid, at least about 25 micrograms to about 2,500 micrograms of vitamin B12, and at least about 0.5 milligrams to about 20 milligrams of vitamin B6, wherein said composition is essentially free of anti-oxidants.

    With respect to the limitation that the composition be "essentially free of anti-oxidants," the '716 application discloses that:

    By "essentially free" it is meant that the vitamin composition should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement.  The presence of lower amounts of antioxidants would not render the vitamin composition of the present invention ineffective or of reduced effectiveness.

    The '716 application also discloses that "among the antioxidants especially to be avoided is added vitamin C."

    The Examiner rejected the claims at issue as anticipated by Jungkeit, which discloses the use of a multivitamin preparation for the treatment of psoriasis, wherein the multivitamin preparation contains vitamin B1, vitamin B2, nicotine amide, dexpanthenol, biotin, folic acid, vitamin B6, vitamin B12, vitamin C, and vitamin E (vitamin C and vitamin E being known antioxidants).  The Examiner also rejected the claims at issue as being obvious in view of Jungkeit and the '349 patent, the latter of which discloses the use of a composition comprising vitamin E, evening primrose oil, and B-complex vitamins to treat psoriasis.  The Board affirmed the Examiner's rejections, finding that the '716 application defines the phrase "essentially free of anti-oxidants" to "allow antioxidants as long as they do not damage or inactivate the B12 or folic acid," adding that the '716 application could be "reasonably interpreted to allow for 200 μg of vitamin C" because "Jungkeit's composition containing 200 μg of vitamin C was effective [at] treat[ing] psoriasis."

    In reversing the Board's affirmance of the Examiner's rejections, the Federal Circuit begins by noting that "Jungkeit actually discloses 200 mg of Vitamin C" (emphasis in opinion), and not 200 μg as asserted by the Examiner and repeated by the Board.  Momentarily setting aside this "clear factual error," the opinion indicates that the Board's affirmance, and the Examiner's rejections, turn on the meaning of the claim limitation "essentially free of antioxidants."  While the opinion acknowledges that "the Board correctly determined that 'essentially free' of antioxidants means a composition that 'should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement," and that "[t]he Office appears to agree that the construction further requires that the amount of antioxidant 'would not render the vitamin composition of the present invention ineffective or of reduced effectiveness,'" the panel states that "[a] review of the Board's decision reveals that the Board was not faithful to this construction."  In particular, the opinion indicates that:

    To anticipate, it is not enough for the prior art composition to have an amount of antioxidant that merely allows the composition to be "effective."  To anticipate, the prior art compositions must have an amount of antioxidant that does not result in "reduced effectiveness."  Substantial evidence supports the Board's finding that "Jungkeit treated psoriasis with a composition comprising B6, B12, and folic acid in the requisite amounts." . . .  However, substantial evidence does not support the Board's finding that Jungkeit's composition is "essentially free of antioxidants."  The Board and the examiner have not analyzed the prior art for reduced effectiveness.

    • • •

    In short, the fact that Jungkeit's composition is not "ineffective" does not mean that it reads on the "essentially free of antioxidants" limitation.  To fall within the scope of the claims, the prior art composition must also not have a reduced effectiveness due to the presence of antioxidants.  The Office has not established that the cited references disclose compositions whose effectiveness is not reduced at all due to the presence of the antioxidants.

    (emphasis in original).

    According to the Court, "[t]he Board's decision is particularly problematic given a clear factual error appearing in both the examiner's and the Board's analysis of Jungkeit."  In particular, the panel notes that "Jungkeit discloses 200 milligrams of vitamin C — not 200 micrograms, as stated by the examiner," and adopted by the Board.  The opinion points out that "[w]hen the reasoning repeatedly adopts such a misstatement, substantial evidence cannot support a finding that Jungkeit met the 'essentially free of antioxidants' element," adding that "the Board's factual error regarding the amount of antioxidant present in Jungkeit [also] taints its obviousness conclusion."  As a result of this factuial error, and the Office's failure to establish that the amount of antioxidants used in the prior art compositions did not reduce their effectiveness in treating psoriasis, the panel reversed the Board's anticipation and obviousness determinations, and remanded the case.

    In re Eaton (Fed. Cir. 2013)
    Panel: Chief Judge Rader and Circuit Judges Lourie and Moore
    Per curiam opinion

  • Court Report

            By Sherri Oslick —

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

    Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc.
    2:13-cv-07184; filed November 27, 2013 in the District Court of New Jersey

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Pharma AG; Aventisub II Inc.
    • Defendant:  Roxane Laboratories, Inc.

    Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
    1:13-cv-01973; filed November 25, 2013 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Pharma AG; Aventisub II Inc.
    • Defendant:  Roxane Laboratories Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE39,198 ("Heteroarylpiperidines, Pyrrolidines and Piperazines and Their Use as Antipsychotics and Analgesics," issued July 18, 2006), licensed to Novartis, following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia).  View the Delaware complaint here.


    Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc.
    1:13-cv-01979; filed November 26, 2013 in the District Court of Delaware

    Declaratory judgment that Par's Paragraph IV certifications are improper, null, void, and without legal effect (because Par did not have an accepted ANDA application) and also infringement of U.S. Patent Nos. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) and 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) in conjunction with Par's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used hyponatremia).  View the complaint here.

    Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc.
    2:13-cv-07178; filed November 26, 2013 in the District Court of New Jersey

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

    Invitae Corp. v. Myriad Genetics, Inc
    3:13-cv-05495; filed November 26, 2013 in the Northern District of California

    Declaratory judgment of noninfringement and invalidity of U.S. Patent Nos. 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,033,857 (same title, issued March 7, 2000), 6,051,379 ("Cancer Susceptibility Mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for Determining the Haplotype of a Human BRCA1 Gene," issued October 4, 2005), 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof," issued July 31, 2007), 7,470,510 ("Methods for Diagnosing Cancer and Determining a Susceptibility for Developing Cancer," issued December 30, 2008), 7,622,258 ("Screening Methods and Sequences Relating Thereto," issued November 24, 2009), 7,838,237 (same title, issued November 23, 2010), 7,670,776 ("MYH Gene Variants and Use Thereof," issued March 2, 2010), and 7,563,571 (same title, issued July 21, 2009) based on Invitae's use and and sale of its BRCA1 and BRCA2 gene testing analytical services.  View the complaint here.


    University of Utah Research Foundation et al. v. Invitae
    2:13-cv-01049; filed November 25, 2013 in the District Court of Utah

    • Plaintiffs:  University of Utah Research Foundation; Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche; Myriad Genetics
    • Defendant:  Invitae

    Infringement of U.S. Patent Nos. 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,033,857 (same title, issued March 7, 2000), 6,051,379 ("Cancer Susceptibility Mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for Determining the Haplotype of a Human BRCA1 Gene," issued October 4, 2005), 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof," issued July 31, 2007), 7,470,510 ("Methods for Diagnosing Cancer and Determining a Susceptibility for Developing Cancer," issued December 30, 2008), 7,622,258 ("Screening Methods and Sequences Relating Thereto," issued November 24, 2009), 7,838,237 (same title, issued November 23, 2010), 7,670,776 ("MYH Gene Variants and Use Thereof," issued March 2, 2010), and 7,563,571 (same title, issued July 21, 2009) based on Invitae's use and and sale of its BRCA1 and BRCA2 gene testing analytical services.  View the complaint here.

    Shire LLC et al. v. Apotex, Inc. et al.
    1:13-cv-01965; filed November 21, 2013 in the District Court of Delaware

    • Plaintiffs:  Shire LLC; Shire Development LLC; Supernus Pharmaceuticals Inc.
    • Defendants:  Apotex, Inc.; Apotex Corp.

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

    Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly and Company et al.
    2:13-cv-08567; filed November 20, 2013 in the Central District of California

    • Plaintiff:  Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Defendants:  Eli Lilly and Company; Lilly USA LLC

    Infringement of U.S. Patent No. 8,133,903 ("Methods of Use of Inhibitors of Phosphodiesterases and Modulators of Nitric Oxide-Reactive Oxygen Species, and Metalloproteinases in the Treatment of Peyronie's Disease, Arteriosclerosis and Other Fibrotic Diseases," issued March 13,2012) based on Eli Lilly's manufacture and sale of its Cialis® product (tadalafil, used  on an as-needed basis to treat erectile dysfunction).  View the complaint here.

  • Conference & CLE Calendar

    CalendarDecember 3, 2013 – "Post-AIA Preissuance Prior Art Submissions at the USPTO — Best Practices for Third-Party Challenges to Patent Applications and for Monitoring Competition" (Strafford) – 1:00 to 2:30 pm (EST)

    December 4, 2013 – Congress on Biotech & Pharma Patenting*** (C5 (UK)) – London, UK

    December 5, 2013 – Forum on Biosimilars*** (C5 (UK)) – London, UK

    December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

    December 10-11, 2013 – Advanced Forum on Patent Litigation*** (American Conference Institute) – New York, NY

    December 10-11, 2013 – International Patent Litigation (IBC Legal) – London, UK

    December 12, 2013 – "Using Competitive Technical Intelligence Techniques to Assess University Patents" (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

    December 12, 2013 – "Patent Exhaustion and Licensing Strategies — Leveraging Recent Decisions for Structuring Patent Licenses and Resolving Litigation" (Strafford) – 1:00 to 2:30 pm (EST)

    December 16, 2013 – "Means-Plus-Function Patent Claims After the AIA — Assessing Benefits and Risks, Surviving AIA's PGRs, IPRs and Reissue" (Strafford) – 1:00 to 2:30 pm (EST)

    January 8-12, 2014 – National CLE Conference (Law Education Institute, Inc.) – Vail, CO

    January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

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

  • ACI Conference on Patent Reform

    New York #2American Conference Institute (ACI) will be offering its 3rd Comprehensive Guide to Patent Reform from January 22-23, 2014 in New York, NY.  The conference will cover practice pitfalls and new procedural advantages by participating in discussions on such topics as:

    • Adapting to the first-to-file system and developing advanced techniques to ensure issuance of robust patents;
    • Determining the fate of "best mode," and analyzing the pros and cons of utilizing trade secret protection;
    • Incorporating increased due diligence practices pre-issuance to compensate for the expansion of "prior art";
    • Utilizing supplemental re-examination proceedings and preparing for third party pre-issuance attacks;
    • Obtaining the optimal result in Inter Partes Review proceedings;
    • Bracing for the implementation of Post-Grant Review proceedings, and benefiting from Covered Business Methods procedures;
    • Analyzing the impact of patent reform on Hatch-Waxman litigation; and
    • Surveying and exploring the effects of proposed legislation targeting "non-practicing entities."

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

    • USPTO keynote address: The USPTO's efforts to implement AIA provisions impacting patent prosecution — to be presented by Janet Gongola, Associate Commissioner for Patent Examination Policy, U.S. Patent & Trademark Office;
    • Straddling the first-to-invent/first-to-file gap: Changing company protocols, cautiously approaching amendments, and strategies for promoting likelihood of issuance;
    • Through the AIA prior art looking glass — Understanding the global wonderland of prior art, and utilizing preissuance submissions, supplemental examination, ex parte reexamination, and reissue;
    • USPTO Address: Detailing how the new post-grant opposition procedures have impacted patenting, and updating on the implementation of the post-grant review proceedings — to be presented by Hon. James Donald Smith, Chief Administrative Patent Judge, Patent Trial and Appeal Board, U.S. Patent & Trademark Office;
    • Innovative practice resources for meeting with success during inter partes review;
    • Red skies on the horizon — Tracking developments of covered business method proceedings and preparing for the era of the post-grant review;
    • Examining the impact of patent reform on Hatch-Waxman litigation and the brand/generic wars;
    • Interactive open floor discussion on proposed legislation on "non-practicing entities"; and
    • The showdown over diagnostic methods — Obtaining patent protection from the PTO under the AIA despite the Supreme Court's nebulous view of a “product of nature."

    In addition, a pre-conference workshop entitled "Patent Reform 101: A Primer on the Fundamental Provisions of the America Invents Act" will be offered from 9:00 am to 12:00 pm on January 22, 2014, and a post-conference workshop entitled "Interactive Working Group Session: A Hypothetical Invention Being Patented Under the AIA" will be offered from 9:00 am to 12:00 pm on January 24, 2014.

    An agenda for the conference can be found here (Day 1) and here (Day 2).  More information regarding the workshops can be found here and 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 InstituteThe registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,495 (conference and two workshops).  Those registering by December 13, 2013 will receive a $200 discount.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, 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 Patent Reform conference.

  • LEI National CLE Conference

    SkiingLaw Education Institute, Inc. (LEI) will be holding the 31st Annual National CLE Conference on January 8-12, 2014 in Vail, Colorado.  The Intellectual Property program of the conference will offer presentations on a number of topics, including:

    • Patent Markets: The Buying, Selling and Brokering of Patent Assets
    • The Ongoing Saga of Induced Infringement
    • Damages and Remedies in Patent Litigation
    • Hot Tips in Patent Prosecution and Inter Partes Review Post — AIA
    • What’s Keeping Corporate Counsel Awake at Night
    • A Dialogue Between Bench and Bar — panel to include Hon. Kathleen M. O’Malley, U.S. Court of Appeals for the Federal Circuit, and Hon. Faith Hochberg, U.S. District Court for the District of New Jersey

    Law Education Institute (LEI)An agenda and list of speakers for the Intellectual Property program of the conference can be found here.

    The registration fee for the conference is $745.  Those registering by December 15, 2013 will receive a $100 discount.  Those interested in registering for the conference can do so by calling 888-860-2531, by faxing a registration form to 303-860-0624, or online here.  Information about lodging and skiing can be found here.

  • Happy Thanksgiving from Patent Docs

    ThanksgivingThe authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 29th.