• IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Amgen v. Sandoz: What Now?" on September 2, 2015 from 2:00 to 3:00 pm (ET).  Krista Carver of Covington & Burling; Kevin Nelson of Duane Morris; and Elizabeth Weiswasser of Weil, Gotshal & Manges LLP will discuss:

    • Branded company strategy now that an innovator may have only six months notice before a biosimilar launch; the implications of having no information about the biosimilar maker’s patent strategy or manufacturing process; the new importance of competitive intelligence;
    • Biosimilar launch strategy, including the pros & cons of the BPCIA pathway – will any biosimilar aspirants still choose to go the BPCIA route?; the importance of due diligence and assessing at-risk launches;
    • New litigation dynamics outside the BPCIA, including crucial preliminary injunction battles, discovery, licensing, damages and willfulness; and
    • The next front and the end game: en banc at the Federal Circuit? How will this all end up?

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Foley & LardnerFoley & Lardner will be offering a web conference entitled "PTAB Proposed Rule Changes: What's In and What's Out?" on August 27, 2015 from 12:00 to 1:00 pm (Eastern).  Stephen Maebius and Paul Hunter of Foley & Lardner LLP will review the changes to post-grant proceedings proposed by the U.S. Patent and Trademark Office on August 19, 2015 and discuss the potential impact on PTAB proceedings and legislation currently being debated in Congress.

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Patent Reform in the US Congress: An Overview of Current Legislation" on September 2, 2015 from 12:00 – 1:00 pm (Eastern).  Sharon Israel of Mayer Brown, LLP will moderate a panel consisting of AIPLA Executive Director Lisa Jorgenson, Barbara Fiacco of Foley Hoag, LLP, and Kevin Rhodes of 3M Innovative Properties Co.  The panel will examine pending legislation in the House and the Senate and how each bill proposes to address a number of significant issues, including pleadings requirements, discovery limits, fee-shifting and recovery, AIA Trial proceedings, customer stays, transparency in patent ownership, and bad faith demand letters.

    The registration fee for the program is $35 (unlimited attendees per site; no CLE available).  Those interested in registering for the program, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "IP Agreements: Structuring Indemnification and Limitation of Liability Provisions to Allocate Infringement Risk" on September 1, 2015 from 1:00 to 2:30 pm (EDT).  Kenneth A. Sprang of Washington International Business Counsel, Daniel Winston of Choate Hall & Stewart, and Jeremy Younkin of Foley Hoag will prepare counsel to IP owners, licensees and licensors to protect their interests by allocating infringement risks during negotiations of indemnification and limitation of liability provisions in an IP agreement, and offer best practices for negotiating and structuring these provisions to allocate risk.  The webinar will review the following questions:

    • What IP-specific issues should be considered when structuring indemnification and limitation of liability provisions in IP agreements?
    • What are the most commonly disputed issues when negotiating indemnification and what are some effective strategies for resolving them?
    • What approaches should counsel use to protect a client's interests when negotiating an indemnification provision?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • By Kevin E. Noonan

    In the 1977 Yale Law School Holiday Pageant there was a skit about the Supreme Court, with a song sung to the tune of Cole Porter's "Another Opening, Another Show" from the musical Kiss Me Kate:

    Another opening, another term
    A chance to show that no precedent's firm
    Another opening of another term

    That parody irresistibly comes to mind with many of the Supreme Court's patent decisions (no matter how hard the Court appears to want to create the impression of consistency, Mayo and Diehr are irreconcilable) and no more so when considering the Court's end-of-term decision in Kimble v. Marvel Enterprises where the Court let stand its fifty-year ban on royalties post patent expiry (Brulotte v. Thys Co., 1964).

    Marvel EnterprisesThe facts do not provide any equities to the licensee, Marvel:  the case arose regarding U.S. Patent No. 5,072,856 to Kimble for a toy that simulated the web-shooting devices used by the fictional Spiderman.  As any child or pop culture fan knows, Marvel is the purveyor of all things Spiderman, owning the rights to the character, comic books, movies, and ancillary merchandise.  Kimble attempted to license his invention to Marvel, but they chose to copy the invention, bringing their own version of the toy to market.  The parties settled Kimble's resulting patent infringement lawsuit on terms wherein Marvel purchased the patent for a lump sum (~$500,000) plus a 3% royalty; the settlement contained no limit on this royalty obligation with regard to patent expiry.  According to the opinion, the parties were purportedly unaware of the Brulotte rule that precluded Kimble from receiving royalties after the '856 patent expired, but (once purportedly apprised of the existence of the rule) Marvel brought a declaratory judgment action against paying post-expiry royalties in which it prevailed.

    The Court affirmed Marvel's victory in an opinion by Justice Kagan, joined by Justices Scalia, Kennedy, Ginsberg, Breyer and Sotomayor; Justice Alito dissented, in an opinion joined by the Chief Justice and Justice Thomas.  While the opinion acknowledged that the Brullote rule had been the subject of judicial and scholarly criticism (citing Scheiber v. Dolby Labs., Inc., 293 F. 3d 1014, 1017–1018 (CA7 2002) (Posner, J.) and Ayres & Klemperer, Limiting Patentees' Market Power Without Reducing Innovation Incentives: The Perverse Benefits of Uncertainty and Non-Injunctive Remedies, 97 Mich. L. Rev. 985, 1027 (1999)), the majority refused to overrule it.  The reason is stare decisis seasoned with the Court's penchant for finding Congressional intent for "balance" in patent law, saying that "[i]n crafting the patent laws, Congress struck a balance between fostering innovation and ensuring public access to discoveries."  In a sentence that will resonate (badly) with patent attorneys in the throes of the consequences of the Court's recent foray into subject matter eligibility, the opinion justifies letting the Brullote rule stand saying "[t]his Court has carefully guarded that cut-off date, just as it has the patent laws' subject-matter limits" based on the public interest.  This is reflected in other examples of its precedent consistent with Brulotte, including situations where it has prevented, inter alia, parties from agreeing not to challenge a patent (citing Scott Paper Co. v. Marcalus Mfg. Co., 326 U. S. 249 (1945); Edward Katzinger Co. v. Chicago Metallic Mfg. Co., 329 U. S. 394, 400–401 (1947) and Lear, Inc. v. Adkins, 395 U. S. 653, 668–675 (1969)).

    The majority found the statutory basis for the Brulotte rule in the patent term (Sec. 154) which limits the term within which the patentee can exercise the right to exclude; thereafter the patent quid pro quo demands the invention to be freely available to the public.  The Court recognizes that "[t]he Brulotte rule, like others making contract provisions unenforceable, prevents some parties from entering into deals they desire" and that royalty plans like the one in Brulotte (and here) can have advantages including "draw[ing] out payments over time and t[ying] those payments, in each month or year covered, to a product's commercial success."  The majority also recognized the traditional justification, that "[a] more extended payment period, coupled (as it presumably would be) with a lower rate, may bring the price the patent holder seeks within the range of a cash-strapped licensee," the opinion analogizing the situation with purchasing a consumer product on an installment plan.  Alternatively, the opinion recognizes that "such an extended term may better allocate the risks and rewards associated with commercializing inventions — most notably, when years of development work stand between licensing a patent and bringing a product to market."

    Nevertheless, the Court majority believes the principle of limiting the exclusive right to the statutory term is sufficiently important to require patentees and their licensees to "find ways around Brulotte" using other means.  These include deferred payments on royalties earned during the patent term (Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U. S. 100, 136 (1969)) or extending royalties until the last-to-expire of a patent portfolio.  Also permitted would be licensing non-patent rights — such as "know-how" or trade secrets (no matter how closely tied to the patent).  "Finally and most broadly, Brulotte poses no bar to business arrangements other than royalties — all kinds of joint ventures, for example — that enable parties to share the risks and rewards of commercializing an invention" according to the opinion.

    The majority rejected Kimble's argument that these situations be subjected to a "case-by-case," "rule of reason" approach.  This is where the Court most directly resorts to stare decisis principles, stating that "[o]verruling precedent is never a small matter."  The benefits of not doing so include that "it promotes the evenhanded, predictable, and consistent development of legal principles, fosters reliance on judicial decisions, and contributes to the actual and perceived integrity of the judicial process," citing Payne v. Tennessee, 501 U. S. 808, 827–828 (1991).  But in doing so the Court adopts Justice Brandeis' view that "it is usually 'more important that the applicable rule of law be settled than that it be settled right.'"  Burnet v. Coronado Oil & Gas Co., 285 U. S. 393, 406 (1932) (which besides being contrary to the Court's role in actually trying to interpret the laws to effectuate congressional intent, it also must be noted that Justice Brandeis' statement was made in a dissenting opinion and thus not the basis for the Burnet decision.)

    And in a statement that will negatively resonate with those hoping that the Court recognize the error of its thinking regarding subject matter eligibility, the opinion states that "[a]ccordingly, an argument that we got something wrong — even a good argument to that effect — cannot by itself justify scrapping settled precedent."  Rather, the majority believe that "[t]o reverse course, we require as well what we have termed a 'special justification' — over and above the belief 'that the precedent was wrongly decided,'" citing Halliburton Co. v. Erica P. John Fund, Inc., 573 U. S. ___, ___ (2014) (slip op., at 4).

    The majority opinion also states that stare decisis is more important when the Court interprets a statute because the party can "take their objections across the street" and have Congress change the law, citing Patterson v. McLean Credit Union, 491 U. S. 164, 172–173 (1989).  In this case, the majority perceives that Congress has declined this opportunity repeatedly ("long congressional acquiescence"), citing the implementing statutes for the GATT/TRIPS agreements as well as specific bills introduced (but never enacted) aimed at changing the law to abrogate the Brullotte rule.

    Other reasons contained in the majority opinion for refusing to overrule Brulotte include the special characteristics of cases at the nexus between property law and contract law, where the majority believe stare decisis principles to be "at their acme" because such precedents are used by parties when "ordering their affairs."  This reasoning harkens back to the sentiment that the Court should not upset "settled expectations: "[s]o long as we see a reasonable possibility that parties have structured their business transactions in light of Brulotte, we have one more reason to let it stand" (reasoning woefully absent when the Court rendered its Myriad decision).  In addition, the majority believes that Brulotte remains consistent with other precedent supporting "bright line" patent term expiry and that the rule (according to the majority) remains "workable" in practice, particularly when compared with antitrust law.

    The Court majority acknowledges the scholarly consensus that post-expiration royalties can have pro-competitive effects.  But in their view this a patent case, not an antirust case (where the Court has been more flexible due to the dynamic nature of antitrust law), and the public interest trumps: "[s]o in deciding whether post-expiration royalties comport with patent law, Brulotte did not undertake to assess that practice's likely competitive effects.  Instead, it applied a categorical principle that all patents, and all benefits from them, must end when their terms expire."  (This categorical approach is consistent with the Court's views regarding subject matter eligibility.)  And, "[s]o if Kimble thinks patent law's insistence on unrestricted access to formerly patented inventions leaves too little room for pro-competitive post-expiration royalties, then Congress, not this Court, is his proper audience."

    Appeals to innovation, the "wellspring of patent policy," and the rule's harm to innovation provide no help:  "[n]either Kimble nor his amici have offered any empirical evidence connecting Brulotte to decreased innovation; they essentially ask us to take their word for the problem.  And the United States, which acts as both a licensor and a licensee of patented inventions while also implementing patent policy, vigorously disputes that Brulotte has caused any 'significant real-world economic harm,'" citing the government's amicus brief.

    Justice Alito disagreed, characterizing Brulotte as " a clear case of judicial overreach" and saying that in his view the rule was based not on patent law but on antitrust principles that have been "debunked."  Regarding the rationale for the majority opinion, Justice Alito writes that "[o]ur traditional approach to stare decisis does not re­quire us to retain Brulotte's per se rule.  Brulotte's holding had no basis in the law.  Its reasoning has been thoroughly disproved.  It poses economic barriers that stifle innova­tion.  And it unsettles contractual expectations."

    There is one aspect of this opinion that rankles:  the majority's inability not to reference its recent subject matter eligibility decisions as if they were not only properly decided but that they are a proper exercise of the Court's gatekeeping role.  While either of these propositions may be correct (although the latter is likelier than the former), this self-satisfying (and self-satisfied) dicta was not only unnecessary:  it is guaranteed to percolate into the district courts and the Federal Circuit (which can no longer be trusted to speak truth to power when it comes to patent law as it should be) and the PTO, becoming another justification for the legitimate scope of patent rights to be constricted to the point that patents no longer are able to promote progress.  These views threaten not only progress but American competitiveness, raising the question:  when your global advantage is the ingenuity of your population why would anyone think restricting the ability to protect innovation from predation by copiers (foreign and domestic) is a good idea?

    Kimble v. Marvel Entertainment, LLC (2015)
    Opinion of the Court by Justice Kagan, joined by Justices Scalia, Kennedy, Ginsburg, Breyer, and Sotomayor; dissenting opinion by Justice Alito, joined by Chief Justice Roberts and Justice Thomas

  • By Andrew Williams

    USPTO SealMore than a year ago, then-Deputy Director Michelle K. Lee posted on the Director's Forum Blog that the USPTO was seeking feedback on PTAB trial proceedings established by the Leahy-Smith America Invents Act ("AIA") (see "Deputy Directory Lee Announces the Request for Written Comments to Help Improve PTAB Proceedings").  The Office outlined 17 issues, or questions, on which it was most interested in receiving public comments.  On May 19, 2015, the Office published a first "Final Rules" package of amendments that were described as being more ministerial in nature (see "Final 'Ministerial' Rule Amendments for Practice Before the PTAB").  Today, current Under Secretary of Commerce for Intellectual Property and Director of the USPTO Michelle K. Lee announced on her blog that the second rules package would be introduced in the form of a Notice of Proposed Rulemaking, which will publish in the Federal Register on August 20, 2015.  These proposed rules, however, are currently available here.  She also asked that comments to these proposed rules be submitted by October 19, 2015.

    The one thing that is striking after reviewing the questions and issues for which comments were requested, the actual comments (at least as abstracted by the Office) and the responses from the Office, is how little will actually change.  In fact, the most common response to all of the comments was that the Office is satisfied with things as they are, whether through the original promulgated rules or through the evolution of procedures and practice via the issuance of final written decisions or other opinions by the Board.  This was certainly not because the large majority of comments were wholly positive — indeed, the comments suggesting that no change be made were few and far between.  Instead, most comments were constructive, providing feedback in the areas in which stakeholders believed change was needed.  Nevertheless, almost all of the comments about the Board were positive in the approach that it was taking — seeking feedback from the community and being as deliberate in developing a framework for these relatively new proceedings.  Still, it would have been nice to see a few more suggestions or comments adopted.

    Patent Owner Preliminary Response

    This is not to say that there are no changes being proposed — to the contrary, there are some significant changes to which all practitioners will need to pay attention.  Probably the biggest shift is the allowance of new testimonial evidence to accompany a Patent Owner Preliminary Response.  To prevent the pendulum from swinging too far to the patent owner's advantage (if that is even possible), the Board is also proposing that petitioners may seek leave to file a reply to the preliminary response.  This will of course alleviate or lessen the concern of patent owners attempting to avoid institution in the first place.  However, it will come at a cost of potentially front-loading the proceedings with preliminary filings.  The proposed text for the IPR section of the CFR reads as follows (with roughly equivalent language proposed for the PGR proceedings):

    § 42.107  Preliminary response to petition
        (a)  The patent owner may file a preliminary response to the petition.  The response may set forth the reason why no inter partes review should be instituted under 35 U.S.C. 314 and can include supporting evidence.  The preliminary response is subject to the word count under § 42.24.

    * * *

        (c) [Reserved]

    * * *

    § 42.108  Institution of inter partes review.

    * * *

        (c)  Sufficient groundsInter partes review shall not be instituted for a ground of unpatentability unless the Board decides that the petition supporting the ground would demonstrate that there is a reasonable likelihood that at least one of the claims challenged in the petition is unpatentable.  The Board's decision will take into account a patent owner preliminary response where such a response is filed, but supporting evidence concerning disputed material will be viewed in the light most favorable to the petitioner for purposes of deciding whether to institute an inter partes review.  If the patent owner submits supporting evidence with its preliminary response, the petitioner may seek leave to file a reply to the preliminary response in accordance with § 42.24(c).

    Word Count

    Another proposal that has the potential to cause a significant change is the switch from page limits for certain papers to limitations on word count (as can be observed in the above-proposed language).  Specifically, the Board is proposing to implement a word count limitation for petitions, patent owner preliminary responses, patent owner responses, and petitioner's replies.  The rationale provided is to cut down or avoid abuses of page count limits by manipulating claim charts.  In fact, the Office suggested that this change will streamline administrative review and reduce the number of non-compliant petitions requiring correction.  In other words, petitioners will now be able to include arguments in claim charts, as it will still count in word count limitations.  The specific amendments to 37 C.F.R. § 42.24 are:

    • Petition requesting inter partes review: 14,000 words.
    • Petition requesting post-grant review: 18,700 words.
    • Petition requesting covered business method patent review: 18,700 words.
    • Petition requesting derivation proceedings: 14,000 words.
    • The word counts for a patent owner preliminary response to a petition are the same as the word count for the petition.
    • The word counts for a patent owner response to petition are the same as the word counts for the petition.
    • Replies to patent owner responses to petitions: 5,600 words.

    Oral Hearing

    The Office is proposing to require at least seven days before oral argument for exchange of exhibits, as opposed to five, to provide additional time for the parties to resolve disputes.

    Rule 11-Type Certification

    The Office is proposing the addition of a certification requirement that would mirror that of Rule 11 for Federal district court litigation.  This would revise Section 42.11 to include a requirement for representations to the Board, and would provide for sanctions for violating this requirement.  In some ways, such a requirement has always existed for attorneys because they are beholden to the Office of Enrollment and Discipline.  But this proposed rule, and proposed penalty, would go above and beyond the ethical requirements.  Specifically, the new section will read:

    § 42.11 Duty of candor; signing papers; representations to the Board; sanctions.
        
    (a) Duty of candor.  Parties and individuals involved in the proceeding have a duty of candor and good faith to the Office during the course of a proceeding.
        (b) Signature.  Every petition, response, written motion, and other paper filed in a proceeding must be signed by at least lead counsel or designated backup counsel under § 42.10 in the attorney's or registered practitioner's name–or by a party personally if the party is unrepresented.  The Board may expunge any unsigned submission unless the omission is promptly corrected after being called to the counsel's or party's attention.
        (c) Representations to the Board.  By presenting to the Board a petition, response, written motion, or other paper–whether by signing, filing submitting, or later advocating it–an attorney, registered practitioner, or unrepresented party certifies that to the best of the person's knowledge, information, and belief, formed after an inquiry reasonable under the circumstances:
            (1) It is not being presented for any improper purpose, such as to harass, cause unnecessary delay, or needlessly increase the cost of the proceeding;
            (2) The claims, defenses, and other legal contentions are warranted by existing law or be a non-frivolous argument for extending, modifying, or reversing existing law or for establishing new law;
            (3) The factual contentions have evidentiary support; and
            (4) The denials of factual contentions are warranted on the evidence.
        (d) Sanctions – – (1) In general. If, after notice and a reasonable opportunity to respond, the Board determines that paragraph (c) of this section has been violated, the Board may impose an appropriate sanction on any attorney, registered practitioner, law firm, patent agent, or party that violated the rule or is responsible for the violation.  Absent exceptional circumstances, a law firm must be held jointly responsible for a violation committed by its partner, associate, or employee.
            (2) Motion for sanctions.  A motion for sanctions must be made separately from any other motion and must describe the specific conduct that allegedly violates paragraph (c) of this section. The motion must be authorized by the Board under § 42.20. Prior to seeking authorization to file a motion for sanctions, the moving party must provide written notice to the other party of the basis for the proposed motion. A motion for sanctions must not be filed or be presented to the Board if the challenged paper, claim, defense, contention, or denial is withdrawn or appropriately corrected within 21 days after service of such notice or within another time the Board sets. If warranted, the Board may award to the prevailing party the reasonable expenses, including attorney's fees, incurred for the motion.
            (3) On the Board's initiative. On its own, the Board may order an attorney, registered practitioner, law firm, or party to show cause why conduct specifically described in the order has not violated paragraph (c) of this section.
            (4) Nature of a sanction. A sanction imposed under this rule must be limited to what suffices to deter repetition of the conduct or comparable conduct by others similarly situated and should be consistent with § 42.12.
            (5) Requirement for an order. An order imposing a sanction must describe the sanctioned conduct and explain the basis for the sanction.
        (e) Inapplicability to discovery. This rule does not apply to disclosures and discovery requests, responses, and objections.

    Claim Construction Standard

    Finally, the Board is proposing a change to the Broadest Reasonable Interpretation standard for construing claims, but it is not the change that most of us were hoping for.  In fact, the Board affirmed the use of the BRI standard in all but the most limited circumstances.  Curiously, instead of responding to the comments that pointed out the BRI was contrary to the intent of Congress, the Board relied heavily on the In re Cuozzo case.  In that case, the Federal Circuit found that Congress "implicitly approved" of the BRI standard in enacting the AIA.  However, the Court went on to conclude that Congress authorized the Patent Office to prescribe its own regulations, including the claim construction standard.  Therefore, reliance on Cuozzo is curious, because that case could easily be read as permitting the Patent Office to adopt a different standard at this time.

    Nevertheless, no sweeping changes were proposed.  Instead, the Board responded to a comment that the rules should be changed such that the BRI standard would not apply to claims that will expire before a final written decision is issued.  Now, the various rules will read:  "A claim in an unexpired patent that will not expire before a final written decision is issued shall be given its broadest reasonable construction in light of the specification of the patent in which it appears."

    We will provide additional commentary on the proposed rules and the Director's blog post in the upcoming days, and we will of course monitor any developments and report on them as warranted.

  • By Donald Zuhn

    SequenomEarlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last week, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention.

    Sequenom begins by asserting that the panel's decision raises the following question of exceptional importance:

    Is a novel method patent-eligible under §101 where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates her to apply a new combination of previously known techniques to the phenomenon; and (3) she thereby achieves a previously unknown and impossible result?

    According to Sequenom:

    The panel decision in this case reads recent Supreme Court precedent to create an existential threat to patent protection for an array of meritorious inventions.  It avowedly holds that "groundbreaking" new diagnostic methods that "make[] a significant contribution to the medical field" are ineligible for a patent whenever they (1) incorporate the discovery of a natural phenomenon, and (2) the techniques involved in putting that discovery to its first practical use were individually known beforehand.  See Op. 10, 16.  In other words, the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel.

    Sequenom notes that although the individual techniques involved in the claimed methods were known, "no one had been practicing them in the combination disclosed in the patent," and moreover, that "the material the patent taught the world how to test had previously been discarded as waste" (emphasis in petition).

    As discussed in the petition, the inventors (Drs. Dennis Lo and James Wainscoat) discovered that cell-free fetal DNA (cffDNA) was circulating in the blood of pregnant mothers, and that this knowledge could be used to create a maternal blood test for certain fetal genetic traits and abnormalities.  The petition states that the discovery of cffDNA in maternal blood "was a profound breakthrough," noting that "their Lancet article describing it has since been cited about a thousand times."  As for the claimed invention, Sequenom states that:

    The patent specifically claimed a method of (1) fractionating a pregnant mother's blood, (2) amplifying the genetic material in the serum/plasma, and (3) identifying paternally inherited material as a means of testing for fetal characteristics or medical conditions.  It is undisputed that no one was previously practicing these steps in combination because they were in fact discarding the relevant materials as waste.  The techniques involved were known, but their combination as taught in the ’540 patent was anything but conventional; indeed, the convention was essentially the opposite [internal citations omitted].

    However, the Federal Circuit panel that heard the appeal (Circuit Judges Reyna, Linn, and Wallach) determined that the asserted claims failed the two-step test for patent eligibility set forth in Mayo.  According to Sequenom:

    The panel's core reasoning was that, "[f]or process claims that encompass natural phenomenon, the process steps . . . must be new and useful."  And because researchers already knew how to (1) fractionate blood; (2) amplify DNA in serum or plasma; and (3) detect characteristics in amplified DNA, the method impermissibly added only "well-understood, routine, and conventional activity" to the natural phenomenon Lo and Wainscoat discovered [internal citations omitted].

    In arguing for rehearing en banc, Sequenom contends that:

    The panel's decision misinterprets Mayo both by failing to read that decision in light of the key Supreme Court precedent that Mayo endorses and by reaching a result the Supreme Court has twice disavowed in recent opinions.  Neither Mayo's holding, nor even its dicta, compel the panel's conclusion — a conclusion that threatens dire consequences for biomedicine as a field and patent law as a whole.

    In the first of two reasons why the Federal Circuit should grant rehearing en banc, Sequenom argues that "[t]he panel's decision misinterprets Mayo by ignoring Diehr and Myriad to reach a consequence that Mayo quite clearly did not intend."  With respect to Diehr, Sequenom notes that each of the techniques recited in the claimed method was already known and practiced, but they were not practiced in combination.  Sequenom argues that the claimed method in the '540 patent "is just like that in Diehr, and not at all like that in Mayo," adding that "[t]he natural phenomenon Drs. Lo and Wainscoat discovered motivated them to teach a new method that no one was practicing, and whose combined steps were in fact the opposite of the 'conventional' approach, even if each individual technique involved was 'well-understood' on its own" (emphasis in petition).  Sequenom also argues that:

    [T]he panel's difficulty in reconciling existing Supreme Court precedent is reflected in the fact that its ruling does not even mention Diehr, and — perhaps more importantly — makes no effort at all to address whether the combination of steps taught in the '540 patent was "routine" activity at the time of the patent.  This is accordingly the simplest basis on which the full Court can intervene to prevent the bizarre result of "excluding a meritorious invention from the patent protection it deserves" based on an over-reading of Mayo that will take many other deserving inventions down with it [emphasis in petition].

    While asserting that "Mayo clearly suggested that 'a new way of using an existing drug' would be eligible for patent protection under §101," Sequenom observes that "under the panel's test, that cannot be true:  The drug is known, the means of administering it are known, and the only new insight is the (unpatentable) natural law that the drug treats a disease no one previously knew it treated."  According to Sequenom, "[t]he test Diehr sets out solves this problem by showing exactly why such applications remain perfectly patentable — they would in combination be non-routine and non-conventional uses of known techniques to accomplish new results that are motivated by an insight about the natural world."

    As for the second reason why the Federal Circuit should grant rehearing en banc, Sequenom states that:

    The full Court's intervention is particularly necessary because, if this Court does not step in and draw this line, the panel's rule threatens to swallow many more meritorious inventions along with this one.  The core of nearly every major innovation is the discovery of a fact about the natural world that motivates inventors to combine existing techniques to achieve new practical results.

    Sequenom also argues that "the problem goes well beyond diagnostics or even medicine:  If combining conventional techniques in an unconventional fashion, motivated by a discovery about nature’s laws, is unpatentable subject matter, it is hard to see how any process claim can survive" (emphasis in petition).  The petition also suggests that following the panel decision, the only way protect a "field-changing invention" like that of the '540 patent will be to keep it a secret for as long as possible, which Sequenom contends "benefits no one, especially in fields like medicine where collaborative sharing of basic research is so fundamental to progress and the timely development of life-saving interventions."  Gazing into the crystal ball, Sequenom suggests that:

    [T]hose seeking new vaccines, new uses for existing drugs, new noninvasive tests, or other biomedical innovations will quite likely conclude that the game is no longer worth the candle.  And who could blame them:  They could revolutionize their field, teach their colleagues a method that is the diametric opposite of the conventional wisdom, create a practical test that confers enormous medical benefits on society, have their research cited close to a thousand times, and yet still be denied a patent because their previously unknown method relies on too fundamental a discovery they made about the natural world [emphasis in petition].

    Sequenom argues that "[n]othing requires this anomalous result," adding that "[t]his patent is radically different from those recently rejected under §101 because it claims a combination of steps that no one in the field was previously practicing and does not purport to (and did not in fact) preempt all uses of the natural discovery that motivated it" (emphasis in petition).  Sequenom concludes by stating that "[t]he full Court should take this opportunity to protect patent law's fundamental principles from being eroded by results neither the Supreme Court nor Congress could possibly have intended."

  • By Donald Zuhn

    IPO #2Last week, in Immersion Corp. v. HTC Corp., the Intellectual Property Owners Association (IPO) filed a brief as amicus curiae in support of Plaintiff-Appellant Immersion Corp.  In that case, the District Court for the District of Delaware construed 35 U.S.C. § 120 to prohibit filing a continuation application on the day its immediate parent granted, contrary to established U.S. Patent and Trademark Office practice.  The District Court also refused to grant the Office any deference in the matter.

    In its brief, the IPO asserts that the Federal Circuit "should hold that continuations that are filed on the day that the parent patent issues should be able to claim priority to the parent application's priority date."  In support of this assertion, the IPO argues that the District Court's decision contravened more than 150 years of patent practice tracing back to the 1863 Supreme Court case of Godfrey v. Eames, notes that another District Court reached the opposite conclusion, and points out that the Office has consistently interpreted § 120 to permit continuations that are filed on the same day that a parent patent issues.  The IPO also argues that Office's interpretation is entitled to deference.  Finally, the IPO concludes by providing an idea of the impact the District Court's decision will have on patentees if allowed to stand.

    With regard to Godfrey, the IPO notes that the case involved a patent that issued from a second application that was filed on the same day that the first application was withdrawn by the patentee.  The defendant argued that by the second application lost entitlement to the first application's priority date.  However, the Supreme Court disagreed, holding that "if a party choose to withdraw his application for a patent . . . intending at the time of such withdrawal to file a new petition, and he accordingly do so, the two petitions are to be considered as parts of the same transaction, and both as constituting one continuous application, within the meaning of the law."  The IPO concludes that "per the rule in Godfrey, a continuation filed on the same day as its parent application's withdrawal is entitled to the parent's priority date."  The IPO also argues that:

    Under the Godfrey rule, an application filed on the same day as its parent application's withdrawal constitutes a "continuous" application entitled to the parent's priority date. Therefore, § 120 should be interpreted in a similar manner for patented applications such that a continuation application can claim priority if it is filed on the same day that its parent application issues as a patent.

    In support of this argument, the IPO notes that "the legislative history [concerning § 120] says nothing about overruling Godfrey or changing its rule that allows continuation applications to be filed on the same day that the parent application is withdrawn or matures into a patent."

    The IPO also notes that "the only other district court to address the specific issue presented in this case has held that a continuation application can be filed on the day that the parent application issues as a patent without a loss of priority."  According to the IPO, that other court, the District Court for the Western District of Wisconsin, decided in MOAEC, Inc. v. MusicIP Corp., 568 F. Supp. 2d 978 (W.D. Wis. 2008), "that the same day filing satisfied the 'copendency requirement' of § 120 because the Patent Office has consistently defined 'before' to mean 'not later than.'"

    As for the Office's interpretation of § 120, the IPO points out that the Office's guidance regarding copendency can be found in M.P.E.P. § 211.01(b)(I), which states:

    Copendency is defined in the clause which requires that the later-filed application must be filed before: (A) the patenting of the prior application; (B) the abandonment of the prior application; or (C) the termination of proceedings in the prior application.  If the prior application issues as a patent, it is sufficient for the later-filed application to be copending with it if the later-filed application is filed on the same date, or before the date that the patent issues on the prior application [emphasis added in IPO brief].

    The IPO argues that the above interpretation is entitled to deference, contrary to the Delaware District Court's determination, explaining that:

    The district court's holding that no Chevron deference is due requires one to adopt faulty logic, namely, that the statute requires action 'before' a given instant in time when that moment in time is not necessarily ascertainable.  Indeed, the statute and the regulations are silent about the precise time when a patent application is considered to issue.  Thus, there is ambiguity as to when a patent application must be filed to be 'before' a patent issues on the parent application.

    The IPO explains further that "'patenting' could occur on the issue date when the clock strikes twelve o'clock in the morning, when the Patent Office opens, when the patentee is first sent a copy of the issued patent, when the patent is published in the Official Gazette, or at any other time on the issue date," and further that "a continuation application could be filed a day, a minute, a second, or even a fraction of a second before the patent issues (whenever that is deemed to be) and still be filed 'before' patenting."  The IPO argues that "[g]iven the large potential for confusion caused by the statute's reference to 'before' and the various alternatives for when 'patenting' could occur, the Patent Office's decision to interpret 'before' to mean 'not later than,' see M.P.E.P. § 711.02(c), is eminently reasonable."

    In discussing the impact of the Delaware District Court's decision, the IPO indicates that it is "concerned that the district court's decision in this case will have the effect of divesting patentees of valuable rights to which, but for the change in law effected by the district court, they are entitled."  In quantifying this impact, the IPO notes that an analysis conducted at the IPO's request by Ocean Tomo determined that "as of May 1, 2015, of the 1,474,712 in-force patents that resulted from continuation applications, fully 12,300 have a filing date that is the same as the issue date of the parent."  The IPO also notes that this figure is conservative in that it does not take into account patents that resulted from parent applications that were abandoned or terminated on the day that the patent application was filed or that had an ancestor filed on the same day its parent was issued, abandoned, or terminated.  According to Ocean Tomo, an estimated 30,000 additional patents could fall into these latter categories.

    The IPO brief concludes by stating that:

    Amicus Curiae's members and others have relied on an interpretation of § 120 that is at odds with the district court's decision under review.  If the Court were to affirm that decision, it would call into question the validity of a sizable number of issued patents — patents that were prosecuted in a manner consistent with Patent Office practice and Supreme Court precedent dating back over 150 years.  There is no reasonable justification for (and no countervailing benefits supporting) such a capricious, harmful departure from long-standing practice.

  •         By Sherri Oslick

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

    Eli Lilly and Company et al. v. Lupin Pharmaceuticals, Inc. et al.
    1:15-cv-01047; filed July 6, 2015 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
    • Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

    Infringement of U.S. Patent Nos. 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), 8,807,861 (same title, issued August 19, 2014), and 8,993,520 ("Method and Composition for Transdermal Drug Delivery," issued March 31, 2015) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.

    Gilead Sciences, Inc. et al. v. Lupin Pharmaceuticals, Inc. et al.
    1:15-cv-01956; filed July 1, 2015 in the District Court of Maryland

    • Plaintiffs:  Gilead Sciences, Inc.; Hoffmann-LaRoche Inc.; F. Hoffmann-LaRoche Ltd.; Genentech, Inc.
    • Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Atlantis Holdings S.A.; Lupin Ltd.

    Infringement of U.S. Patent No. 5,763,483 ("Carbocyclic Compounds," issued June 9, 1998) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Genentech's Tamiflu® (oseltamivir phosphate, used to treat uncomplicated acute illness due to influenza infection in patients one year or older who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients one year or older).  View the complaint here.

    Erfindergemeinschaft UroPep GbR v. Eli Lilly and Company et al.
    2:15-cv-01202; filed July 1, 2015 in the Eastern District of Texas

    • Plaintiff:  Erfindergemeinschaft UroPep GbR
    • Defendants:  Eli Lilly and Company; Brookshire Brothers Inc.

    Infringement of U.S. Patent No. 8,791,124 ("Use of Phosphodiesterase Inhibitors in the Treatment of Prostatic Diseases," issued July 29, 2014) based on Lilly's manufacture and sale of its Cialis® product (tadalafil) for the treatment of benign prostatic hyperplasia (BPH).  View the complaint here.

    Salix Pharmaceuticals, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.
    1:15-cv-00109; filed June 26, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Salix Pharmaceuticals, Inc.; Dr. Falk Pharma GmbH;
    • Defendants:  Mylan Pharmaceuticals, Inc.; Mylan, Inc.; Mylan, Inc.

    Infringement of U.S. Patent Nos. 6,551,620 ("Pellet Formulation for the Treatment of the Intestinal Tract," issued April 22, 2003), 8,337,886 (same title, issued December 25, 2012), 8,496,965 (same title, issued July 30, 2013), and 8,865,688 ("Compositions and Methods For Treatment of Bowel Diseases With Granulated Mesalamine," issued October 21, 2014) following a paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Salix's Apriso® (mesalamine, used for the maintenance of remission of ulcerative colitis in adults).  View the complaint here.

  • CalendarAugust 20, 2015 – "Inducement to Infringe in Patent Litigation: Protecting IP Rights — Lessons from Commil USA v. Cisco Sys. Inc. and Leveraging Opinions of Counsel" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 24, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Santa Clara, CA

    August 26, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Dallas, TX

    August 27, 2015 – "Meet the New Boss. Same as the Old Boss? Not Even Close under New Mayo/Alice Regime for § 101" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    August 27, 2015 – "Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    August 28, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Alexandria, VA

    September 10, 2015 – Biotech Patent Law Road Show (American Intellectual Property Law Association) – Boston, MA

    September 10-11, 2015 - "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL

    September 15-17, 2015 – World IP Forum (Intellectual Professionals LLP) – Bangkok, Thailand

    September 17, 2015 – "Professional Negligence: Real-Life Case Studies in IP Malpractice & How to Avoid Them" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    September 18, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – San Francisco, CA

    September 22, 2015 – "The Evolving World of Biosimilars Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 24, 2015 – "Trade Secrets and Cybersecurity: Protecting Intellectual Property, Mitigating Loss and Navigating Legal Responses" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    September 24-25, 2015 – Seminar on European Patent Law (Grünecker) – Munich, Germany

    September 27-29, 2015 – 43rd Annual Meeting (Intellectual Property Owners Association) – Chicago, IL

    October 2, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – New York, NY

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