• CalendarOctober 29, 2015 – "Provisional Patent Applications: Preserving IP Rights — Assessing Whether to Use and Strategies to Leverage Provisional Applications Under the First-to-File System" (Strafford) – 1:00 to 2:30 pm (EST)

    October 29, 2015 – "Patent Prosecution After Akamai: Exploring the Contours of 'Control and Direction'" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    November 5, 2015 – "Objective Evidence in IPRs: Demonstrating Sufficient Nexus — Linking Evidence and Merits of Claimed Invention, Leveraging Prosecution Declarations" (Strafford) – 1:00 to 2:30 pm (EST)

    November 12, 2015 – "Leveraging Experts for USPTO Prosecution and PTAB — Developing Strong Patentability Records to Strengthen Claims Against IPR and PGR Challenges" (Strafford) – 1:00 to 2:30 pm (EST)

    November 16-17, 2015 – Patent Litigation 2015 (Practising Law Institute) – New York, NY

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Provisional Patent Applications: Preserving IP Rights — Assessing Whether to Use and Strategies to Leverage Provisional Applications Under the First-to-File System" on October 29, 2015 from 1:00 to 2:30 pm (EST).  Dale S. Lazar and Timothy W. Lohse of DLA Piper LLP (US) will discuss provisional patent applications, their benefits and limitations, and best practices for leveraging the applications. The panel will examine when and why provisional applications should be used and the issue of tying non-provisional patent applications to provisional applications.  The webinar will review the following questions:

    • Under what circumstances will a patent claimant get the most out of a provisional patent application?
    • What are the benefits and limitations of using a provisional patent application?
    • What are the important considerations when determining whether and when to use a provisional application?

    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.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Leveraging Experts for USPTO Prosecution and PTAB — Developing Strong Patentability Records to Strengthen Claims Against IPR and PGR Challenges" on November 12, 2015 from 1:00 to 2:30 pm (EST).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner; Jonathan R.K. Stroud, Chief Patent Counsel, Unified Patents; and Wen Li, Ph.D. of Finnegan Henderson Farabow Garrett & Dunner will provide guidance for patent counsel on leveraging the use of experts in patent prosecution and at the PTAB to develop and strengthen patentability records, and offer best practices on how and when to use experts in patent prosecution to strengthen claims against inter partes review (IPR) and post-grant review (PGR) challenges.  The webinar will review the following questions:

    • How can practitioners use experts during prosecution to strengthen the patent application against the threat of post-grant challenges?
    • How can practitioners leverage expert declarations in the POPR (Patent Owner Preliminary Response)?
    • How can practitioners introduce strong grounds for patentability under §§ 103 and 112 in the prosecution history so that IPRs and PGRs are either denied or ineffective against the challenged claims?

    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.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Objective Evidence in IPRs: Demonstrating Sufficient Nexus — Linking Evidence and Merits of Claimed Invention, Leveraging Prosecution Declarations" on November 5, 2015 from 1:00 to 2:30 pm (EST).  Michael J. Flibbert and Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on demonstrating nexus between objective evidence of non-obviousness and the claimed invention, and offer best practices using analysis and explanation to link objective evidence to the merits of the claimed invention.  The webinar will review the following questions:

    • How can patent counsel strategically use prosecution declarations supporting positions of non-obviousness in the POPR (Patent Owner Preliminary Response)?
    • What advantage can be gained from understanding how the courts and the examiners are applying the nexus test?
    • What steps should patent owners and their counsel take to link through analysis and explanation objective evidence to the merits of the claimed invention?

    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.

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Patent Prosecution After Akamai: Exploring the Contours of 'Control and Direction'" on October 29, 2015 from 2:00 to 3:00 pm (ET).  Stephen Durant of Schwegman, Lundberg & Woessner; Ken Hobday, Vice President and Assistant General Counsel, Fiserv; and Michelle Holoubek of Sterne Kessler Goldstein & Fox will investigate the new environment for patent prosecution in software, Internet, and IT technologies in the aftermath of this summer’s Federal Circuit decision in Akamai v. Limelight.  The webinar will review the following questions:

    • Which inventions call for taking advantage of the new more liberal standard under which multiple defendants can together practice all the claims of a patent and be found guilty of direct infringement? Or should patent prosecutors stick to a conservative approach and continue to draft claims so that a single actor can perform all steps?
    • Will including more implementation details in a patent application, such as system protocols, potentially ensnare infringers that would otherwise be seen as separate parties? How will that interact with Alice issues?
    • How to approach opinion work — and design around advice regarding non-infringement — when there is no developed case law on the new standard?

    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.

  • By Donald Zuhn

    Ariosa DiagnosticsOn Monday, Appellee Ariosa Diagnostics, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc").  In its response, Ariosa argues that in affirming 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)"), the Federal Circuit "faithfully applied Supreme Court precedent."

    Characterizing claim 1 of the '540 patent as "purport[ing] to broadly cover using routine laboratory methods to detect naturally-occurring paternally-inherited nucleic acid of fetal origin in maternal serum or plasma," Ariosa argues that the panel's analysis of this claim "is exactly what the Supreme Court has mandated and its conclusion is controlled by the Supreme Court's directive that a 'process that focuses upon the use of a natural law' must 'also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself,'" quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc.  Ariosa also criticizes the language of claim 1 as being "circular and devoid of content," explaining that:

    The claim recites a method for detecting naturally-occurring paternally inherited nucleic acid whose only step (aside from making more copies of the nucleic acid) is detecting the naturally-occurring paternally inherited nucleic acid.  This is little more than a claim to the natural phenomenon itself — and thus it is hardly surprising that the panel found this claim fails to recite anything "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself" [quoting Mayo].

    In particular, Ariosa points out that claim 1 recites:  "A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises . . . detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample" (emphasis in brief).

    Noting that Sequenom argued in its petition that the panel misinterpreted Mayo and that the panel decision is contrary to the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. and Diamond v. Diehr, Ariosa counters that "[t]o the contrary, it is Appellants — not the panel — that misinterpret Mayo, misapply Myriad, and misread Diehr."  In support of this position, Ariosa argues that:

    Appellants' only legal argument (as opposed to their dire policy-based prognostications) in favor of rehearing en banc is that Mayo, Myriad and Diehr must be read as teaching that "a combination of known steps that incorporates or is motivated by an unpatentable natural phenomenon is nonetheless patentable if that combination 'considered as a whole' was not routine before the patent disclosed it."  Yet Appellants' misreading of those precedents amounts to nothing short of a wholesale revision of the Supreme Court's two-part test for determining whether a claim recites patent-eligible subject matter [cite omitted].

    With respect to Mayo and Myriad, Ariosa argues that "Appellants propose a rule under which the first person to claim a process in which any steps are added to a newly discovered natural phenomenon can obtain a patent because, 'considered as a whole,' combining the new discovery with those steps was not 'routine' — because no one had done it before."  Ariosa suggests, however, that:

    Appellants fail to recognize that the patentability of the claims in Mayo did not turn on whether the natural phenomenon recited in the claims was newly discovered.  Rather, Mayo held that the prohibition on patenting a natural phenomenon cannot be overcome by combining that phenomenon with additional steps that "consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately." [quoting Mayo].  Nowhere did Mayo suggest, let alone hold, that this rule does not apply to a newly discovered natural phenomenon.

    As for Myriad, Ariosa notes that in relying on "Myriad's statement that 'the first person with knowledge' of a natural phenomenon is in a better position to claim applications of that knowledge," Sequenom cites no other language from that opinion.  Moreover, according to Ariosa:

    [T]he language adds nothing to their argument.  Even if Drs. Lo and Wainscoat were "in an excellent position" to claim an application of their discovery of cffDNA in maternal serum and plasma, they did not do so.  Instead, they procured broad claims that merely point to that discovery and instruct one to "copy" the DNA and "detect" the DNA.

    Ariosa concludes its response by asserting that Sequenom's argument is also contrary to Diehr.  Although "Diehr . . . lies at the heart of Appellants' contention that simply adding any method steps to a newly discovered natural phenomenon renders that discovery patentable," Ariosa contends that "Diehr says no such thing."  According to Ariosa, "[t]he asserted claims of the '540 patent are fundamentally different [from those in Diehr].  They 'start and end with a naturally occurring phenomenon' and the method steps between those end points are 'conventional, routine, and well understood applications in the art.'"

    Asserting that "there is no reason for this appeal to be reheard en banc and, moreover, no basis on which this Court should disturb the panel's conclusion," Ariosa concludes that Sequenom's petition should be denied.

  • By Donald Zuhn –-

    USPTO SealIn a Federal Register notice published earlier this month (80 Fed. Reg. 60367), the U.S. Patent and Trademark Office announced a change in practice for the correction of errors in foreign priority claims.  Under the change in practice, applicants wishing to correct errors in a foreign priority claim after the time periods set forth in 37 C.F.R. § 1.55 will have to file a petition under 37 C.F.R. § 1.55(e) and pay the petition fee under 37 C.F.R. § 1.17(m) (currently $1,700 for large entities) in order to do so.  Pursuant to 37 C.F.R. § 1.55, foreign priority claims are to be corrected by the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior application.

    Prior to the change in practice, the USPTO handled the correction of domestic and foreign priority claims differently.  For domestic priority claims, applicants had to file a petition for an unintentionally delayed benefit claim under 37 C.F.R. § 1.78 and pay the petition fee, and once the petition was granted, the Office would publish a corrected patent application publication.  For foreign priority claims, the Office did not previously require the petition and fee, and would not publish a corrected patent application publication.  According to the notice, the Office's rationale for the dissimilar treatment was that prior to enactment of the Leahy-Smith America Invents Act (AIA) the prior foreign patent application did not affect the effective prior art date of a U.S. patent application publication.  However, under the AIA, a U.S. patent or patent application publication may be effective as prior art as of the filing date of an earlier foreign application.  The Office has therefore concluded that "the rationale for not requiring a petition to correct an error in the application number of a foreign priority claim is no longer appropriate."

    The Office's notice indicates that the change in practice with respect to correction of foreign priority claims takes effect on November 5, 2015.  The notice also indicates that any corrections to the foreign application number in a foreign priority claim that were previously accepted will not affected by the change in practice.

  • By Andrew Williams

    Supreme Court Building #2On October 19, 2015, the Supreme Court granted certiorari in two related cases:  Halo Electronics, Inc. v. Pulse Electronics, Inc. (Supreme Court docket number 14-1513) and Stryker Corp. v. Zimmer, Inc. (Supreme Court docket number 14-1520).  The issue on appeal in the Halo case was limited to Question 1 presented in the petition:

    QUESTION PRESENTED:

    1.  Whether the Federal Circuit erred by applying a rigid, two-part test for enhancing patent infringement damages under 35 U.S.C. § 284, that is the same as the rigid, two-part test this Court rejected last term in Octane Fitness, LLC v. ICON Health & Fitness, Inc., 134 S. Ct. 1749 (2014) for imposing attorney fees under the similarly-worded 35 U.S.C. § 285.

    In the Stryker case, the questions that will be considered are:

    1.  Has the Federal Circuit improperly abrogated the plain meaning of 35 U.S.C. § 284 by forbidding any award of enhanced damages unless there is a finding of willfulness under a rigid, two-part test, when this Court recently rejected an analogous framework imposed on 35 U.S.C. § 285, the statute providing for attorneys' fee awards in exceptional cases?

    2.  Does a district court have discretion under 35 U.S.C. § 284 to award enhanced damages where an infringer intentionally copied a direct competitor's patented invention, knew the invention was covered by multiple patents, and made no attempt to avoid infringing the patents on that invention?

    Of course, Octane Fitness was one of the more significant Supreme Court cases in recent history.  That case, along with the other 2013-2014 term cases of Highmark, Alice and Nautilus, was seen as addressing the so-called "patent troll" problem.  After Octane Fitness, district courts had much greater flexibility in awarding attorney's fees to the prevailing party, and Highmark made it more difficult to overturn that award on appeal.  And even though Octane and Highmark apply equally to both prevailing plaintiffs and defendants, it was seen as a victory for parties facing abusive patent litigation from non-practicing patent owning entities.

    The relevant statute in the present case(s), on the other hand, only applies to one set of parties — accused infringers.  The relevant text of this section of the statute reads:  "In either event the court may increase the damages up to three times the amount found or assessed."  As a comparison, the text of the statute at issue in Octane Fitness (35 U.S.C. § 285) reads:  "The court in exceptional cases may award reasonable attorney fees to the prevailing party."  The enhanced damages statute has been interpreted as containing a "willfulness" requirement, even though no such words appear in the statute.  See, e.g., In re Seagate Tech., LLC, 497 F.3d 1360, 1368 (Fed. Cir. 2007) (en banc) ("Absent a statutory guide, we have held that an award of enhanced damages requires a showing of willful infringement.").  This may begin to give a clue as to why cert was granted in this case.

    However, as the questions presented suggest, the Federal Circuit had developed a similar two-part test to assess willfulness as had been used to determine whether a case was exceptional, both containing a subjective and objective component.  In the case of 35 U.S.C. § 285, the Federal Circuit had held that a case is only exceptional when "both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless," absent misconduct in litigation or in securing the patent.  See Brooks Furniture Mfg. v. Dutailier, Inc., 393 F.3d 1378 (Fed. Cir. 2005).  Similarly, the Federal Circuit in Seagate had held that a finding of willfulness required a showing that the defendant (1) "acted despite an objectively high likelihood that its actions constituted infringement of a valid patent," and that (2) "this objectively-defined risk (determined by the record developed in the infringement proceeding) was either known or so obvious that it should have been known to the accused infringer."  One of the difficulties though, as Halo outlined in its petition, is that almost any accused infringer can "concoct a defense," such as "arguing the patent is invalid as obvious under 35 U.S.C. § 103 by using the advantage of hindsight to locate and combine bits and pieces from prior publications to yield the invention."  Another problem, as noted by Judges O'Malley and Hughes in dissent from the Federal Circuit's denial of Halo's petition for rehearing en banc, is that the "evidentiary wall . . . erected between the objective and subjective portions of the inquiry," "preclude[s] consideration of subjective bad faith — no matter how egregious — from informing" the objective prong inquiry.

    It would seem, therefore, by looking at the Supreme Court's reasoning in Octane, that the outcome of this case is certain.  The Octane Court did away with the rigid two-part test, and instead introduced a flexible standard for finding a case exceptional — whether it stands out from other cases.  However, the comparison of the Octane case to that of enhanced damages does not take into account the presumed undercurrent of the Octane case — that attorney's fees can be used to assist lower courts in deterring abusive patent litigation.  No such similar outrage has been expressed in the mainstream media about blatant patent infringers that flout the legitimate intellectual property rights of patent holders.  In fact, in the petition, Halo stressed that "[p]atents are the most valuable assets that many small businesses possess–they are often started with a valuable idea and little else."  However, as we have seen, if such small businesses asset their patent rights before being able to commercialize their products, they are labelled as "non-practicing entity," or worse, "patent trolls."  And, we cannot overlook the fact that if the standard to obtain enhanced damages is relaxed, truly nefarious NPEs will be able to use this to their advantage when attempting to extract settlements from accused infringers.  As a result, even though the present case(s) should be dictated by Octane Fitness, it will be interesting to see if the political climate will cause the Court to treat these two similar statutes differently.

    Patent Docs will continue to monitor this case and provide any updates as warranted.

  •         By Sherri Oslick

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

    Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC
    1:15-cv-06700; filed July 30, 2015 in the Northern District of Illinois

    • Plaintiffs:  Mylan Pharma Acquisition Ltd.; Mylan Teoranta; Mylan Institutional LLC
    • Defendant:  Fresenius Kabi USA, LLC

    Infringement of U.S. Patent No. 5,866,591 ("Stable Formulations of Remifentanil," issued February 2, 1999) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Mylan's Ultiva® (remifentanil hydrochloride for injection, used as an analgesic agent during the induction and maintenance of general anesthesia for inpatient and outpatient procedures, as an analgesic for continuation into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner, and in a postoperative anesthesia care unit or intensive care setting as an analgesic component of monitored anesthesia care in adult patients).  View the complaint here.

    Janssen Pharmaceutica N.V. et al. v. FERA Pharmaceuticals, LLC
    1:15-cv-05997; filed July 30, 2015 in the Southern District of New York

    • Plaintiffs:  Janssen Pharmaceutica N.V.; Janssen Pharamceuticals, Inc.; Janssen Research & Development, LLC
    • Defendant:  FERA Pharmaceuticals, LLC

    Infringement of U.S. Patent No. 6,407,079 ("Pharmaceutical Compositions Containing Drugs Which Are Instable or Sparingly Soluble in Water and Methods for Their Preparation," issued June 18, 2002) following a Paragraph IV certification as part of FERA's filing of an ANDA to manufacture a generic version of Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections).  View the complaint here.

    Sanofi-Aventis U.S. LLC et al. v. Genentech, Inc. et al.
    2:15-cv-05685; filed July 27, 2015 in the Central District of California

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Regeneron Pharmaceuticals, Inc.
    • Defendants:  Genentech, Inc.; City of Hope

    Declaratory judgment of invalidity and noninfringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) in conjunction with Sanofi-Aventis' manufacture and sale of its Praluent® product (alirocumab, usedfor the treatment of adult patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol).  View the complaint here.


    Alcon Pharmaceuticals Ltd. et al. v. Dr. Reddys Laboratories, Inc. et al.
    3:15-cv-05756; filed July 24, 2015 in the District Court of New Jersey

    • Plaintiffs:  Alcon Pharmaceuticals Ltd.; Alcon Laboratories, Inc.; Alcon Research, Ltd.
    • Defendants:  Dr. Reddys Laboratories, Inc.; Dr. Reddys Laboratories, Ltd.

    Infringement of U.S. Patent Nos. 6,284,804 ("Topical Suspension Formulations Containing Ciprofloxacin and Dexamethasone," issued September 4, 2001) and 6,359,016 (same title, issued March 19, 2002) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Alcon's Ciprodex® (0.3% ciprofloxacin and 0.1% dexamethasone sterile otic suspension).  View the complaint here.

  • CalendarOctober 20, 2015 – "Trust Everybody, but Cut the Cards" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    October 20, 2015 – "Will My Patent Make Cents? How Courts and the USPTO Affect Patent Portfolio Value" (American Bar Association (ABA) Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    October 22, 2015 – "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinion" (Strafford) – 1:00 to 2:30 pm (EDT)

    November 16-17, 2015 – Patent Litigation 2015 (Practising Law Institute) – New York, NY

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