Patent Law Weblog

recent posts

about

  • AIA America, Inc. v. Avid Radiopharmaceuticals (Fed. Cir. 2017)

    By Kevin E. Noonan –

    Federal Circuit SealAs patent practitioners learned to their chagrin in the AMP v. Myriad Genetics case, sometimes broader Constitutional issues arise even in patent law.  This is also true of matters relating to the Bill of Rights; for example, the last time the Seventh Amendment was considered in the patent context was Markman v. Westview Instruments, Inc., resulting in the Supreme Court affirming the Federal Circuit's understanding that claim construction was not a matter invoking that Amendment's right to a jury to decide construction questions.  (Yes, those were more doctrinally peaceful times indeed.)  The Seventh Amendment has once more been raised as a patent-related issue in AIA America, Inc. v. Avid Radiopharmaceuticals in a decision by the Federal Circuit last week.  Once again the Federal Circuit held that the right to jury trial does not attach, in this case regarding a request for attorney's fees under 35 U.S.C. § 285, keeping in place a fee award to defendant Avid of $3,943,317.70.

    The case arose in the context of (Alzheimer's Institute of America) AIA's infringement lawsuit over U.S. Patent Nos. 5,455,169 and 7,538,258; the subject matter of these patents were nucleic acids comprising mutations (known in the art as "the Swedish mutation") associated with Alzheimer's disease onset; claims 1 from each patent are representative:

    From the '169 patent:

    1.  An isolated nucleic acid encoding human amyloid precursor protein 770 (APP No) including the nucleotides encoding codon 670 and 671 of human amyloid precursor protein 770, wherein the nucleic acid encodes asparagine at codon 670 and/or leucine at codon 671 or an isolated fragment of said nucleic acid having at least ten nucleotides and encoding at least positions 4 and 5 of SEQ ID NO:1.

    From the '258 patent:

    1.  A transgenic mouse whose genome comprises a nucleic acid encoding human amyloid precursor protein including the nucleotides encoding codon 670 and 671 of human amyloid precursor protein 770, or encoding the codons corresponding to these in other isoforms of APP, operably linked to a promoter, wherein the nucleic acid encodes an amino acid other than lysine at codon 670 and/or an amino acid other than methionine at codon 671 and, wherein the mouse expresses a human amyloid precursor protein or fragment thereof which has an amino acid other than lysine at codon 670 and/or an amino acid other than methionine at codon 671.

    As explained in the Federal Circuit's opinion, the provenance of these patents is muddy at best.  The sole named inventor, Dr. Mullan, had worked as a post-doctoral fellow in a London laboratory that had discovered the first genetic mutation associated with Alzheimer's disease (known as the "London mutation").  Due to a dispute between Dr. Hardy, the head of the London research lab, his institution (Imperial College), and its licensee (Athena Pharmaceuticals), Dr. Hardy did not pursue an insight that there was a separate mutation associated with Alzheimer's disease to be found in a Swedish family grouping, but rather sent DNA to Dr. Mullen, who had moved to the University of South Florida.  "To hide the involvement of Dr. Hardy and the Imperial [College] researchers," the patents-in-suit were filed solely in Dr. Mullan's name, as the facts were characterized in the Court's opinion.  This "scheme" also involved Dr. Hardy sending "false letters" to Imperial denying that Dr. Hardy had any involvement in the Swedish mutation's discovery, while at the same time maintaining to USF that the claimed invention had been made under Imperial's auspices who thus had the patent rights.  These prevarications were sufficiently artful that Dr. Mullan and AIA's founder, Ronald Sexton, were successful in having USF waive any rights to the invention.  (The opinion also describes Mr. Sexton's role as convincing Dr. Hardy and other Imperial College researchers that Imperial and Athena had "undervalued" their invention of the London mutation.)  As a consequence of these maneuverings, AIA was the sole assignee of the '169 and '258 patents.

    The District Court held a jury trial on the question of whether USF had knowingly waived its rights to the invention, which the jury found it had not (based at least in part on testimony by Dr. Hardy regarding the "conspiracy" through which he and Dr. Mullan and Mr. Sexton had denied both Imperial College's and USF's rights to the Swedish mutation invention).  Accordingly, the Court ruled that AIA lacked standing to sue on the '169 and '258 patents and entered judgment in favor of Avid; the Federal Circuit previously affirmed this decision in Alzheimer's Inst. of Am., Inc. v. Avid Radiopharmaceuticals, 560 F. App'x 996 (Fed. Cir. 2014).

    Thereafter the District Court considered Avid's motion for attorney's fees under § 285 and after "extensive briefing, evidence and declarations" and a hearing where "AIA was allowed to present arguments in opposition to the motion," awarded almost $4 million in fees to Avid.  AIA appealed, but (perhaps unwisely) not as to the amount awarded.

    The Federal Circuit affirmed, in an opinion by Judge Hughes, joined by Judges Newman and Lourie.  AIA's first argument was that it had a Seventh Amendment right to have a jury decide the facts from which a court could award attorney's fees.  The basis for this argument was that an attorney's fees award "is based in part or in whole on a party's state of mind, intent, or culpability," questions that only a jury should consider if a party does not waive her Seventh Amendment rights (the Court and AIA recognizing that there is no provision for trial by jury in the statute regarding fee awards under § 285).  The opinion parses the amendment to require a jury trial only for suits at common law (as opposed to suits in equity, using that archaic dichotomy of remedies and where to find them).  In modern practice, the Court recognizes a two-step process for determining whether the jury trial right applies: first, a court must "compare the statutory action to 18th-century actions brought in the courts of England prior to the merger of the courts of law and equity," citing Tull v. United States, 481 U.S. 412, 417 (1987).  Second, the court should "examine the remedy sought and determine whether it is legal or equitable in nature," with this prong of the test being "the more important of the two" pursuant to Supreme Court precedent.  Chauffeurs, Teamsters & Helpers, Local No. 391 v. Terry, 494 U.S. 558, 565 (1990).

    With regard to step one, the panel noted that attorney's fees could be pursued in English courts of both law and equity, but that when considered in the law courts "judges, not juries, determined attorney's fees."  This practice suggested to the Court that attorney's fees do not generally implicate legal rights and thus does not support AIA's position.  Regarding the second step, the panel differentiated cases where attorney's fees "are themselves part of the merits of an action" (exemplified in the opinion by cases where a lawyer makes a claim against a client for fees or under a contractual indemnification clause) and where the fees are part of a statutory "prevailing party" provision, where fees are considered an equitable remedy as being "collateral to and separate from the decision on the merits," citing Budinich v. Becton Dickinson & Co., 486 U.S. 196, 200 (1988).  Thus, the panel's application of the Tull test led to the conclusion that the requested remedy is equitable and thus does not implicate the Seventh Amendment's right to trial by jury.

    The opinion goes on to consider AIA's "state of mind" position, the panel stating that, if true then the Seventh Amendment protections could apply.  Unfortunately for AIA, the opinion finds AIA presented no authority that "once an issue is deemed equitable, a Seventh Amendment right to a jury trial may still attach to certain underlying determinations."  Under 18th Century English law (the Supreme Court's touchstone), a judge deciding a case in equity could refer factual matters to a jury but was not compelled to do so, even when considering the "state of mind" issues raised by AIA in its argument.  Finally, the panel found that AIA's position is "at odds with other statutory prevailing party provisions," citing Great Am. Fed. Sav. & Loan Ass'n v. Novotny, 442 U.S. 366, 375 (1979) (involving Title VII).

    The opinion then addressed AIA's second argument, that the District Court improperly considered evidence and made factual findings on its state of mind without having a jury make a predicate determination on these issues.  But the opinion sets forth the panel's belief that the cited Federal Circuit case law (Door-Master Corp. v. Yorktowne, Inc., 256 F.3d 1308 (Fed. Cir. 2001) and Jurgens v. CBK, Ltd., 80 F.3d 1566 (Fed. Cir. 1996)) only stood for the proposition that a court could not "make findings contrary to or inconsistent with the resolution of any issues necessarily and actually decided by the jury," which was not the case here.

    Finally the opinion rejected AIA's contention that it was denied due process, finding that it had ample opportunity to present its case, just not to a jury.

    Showing a capacity to learn from hard experience, this panel's opinion appropriately follows the manner with which the Supreme Court has considered similar issues (grounding its understanding of the Amendments and how they should be applied to procedural matter with reference to how related concepts were considered under 18th Century English law).  The decision also makes practical sense, insofar as motions for attorney's fees are made after a jury has rendered a verdict, and requiring that jury to make factual determinations on attorney's fees after sitting through a patent infringement trial seems unreasonable.  Moreover, insofar as there are situations, as here, where a patentee's behavior could be construed in a harsh and unfavorable light, it may be (paradoxically) more favorable to such a patentee to have a judge rather than a lay jury pass judgment (literally) by making a cash award to a prevailing defendant.  This may prove especially true if changing venue rules increase the likelihood that an infringement action will be brought in a defendant's home forum, where it can be expected that a lay jury might be more easily swayed to punish a patentee who can be painted with the brush of unnecessary and perhaps unjustified allegations of infringement against a local defendant and employer.

    AIA America, Inc. v. Avid Radiopharmaceuticals (Fed. Cir. 2017)
    Panel: Circuit Judges Newman, Lourie, and Hughes
    Opinion by Circuit Judge Hughes

  • Conference & CLE Calendar

    CalendarAugust 17-18, 2017 – "Advanced Patent Prosecution Workshop 2017: Claim Drafting & Amendment Writing" (Practising Law Institute) – San Francisco, CA

    August 22, 2017 – Semiconductor Customer Partnership Meeting (U.S. Patent and Trademark Office) – 1:00 to 5:00 pm (ET), Alexandria, VA

    August 24, 2017 – "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 29, 2017 – "The Evolving 5 W's of Global IP Enforcement: The Strategic Implications of Recent Global IP Law Developments" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    August 31, 2017 – "Navigating the Patent Prosecution Highway and Other Accelerated Filing Options — Evaluating the Different Options, Weighing the Benefits and Risks, Obtaining Patent Protection" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 12-13, 2017 – "Advanced Patent Prosecution Workshop 2017: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL\

    September 13-15 – FDA Boot Camp (American Conference Institute) – Boston, MA

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

  • ACI FDA Boot Camp

    ACIAmerican Conference Institute (ACI) will be holding the next session of it FDA Boot Camp conference on September 13-15 in Boston, MA.  ACI faculty will help attendees:

    • Master the basics of the application and approval processes for drugs, biologics, and devices;
    • Comprehend the intricacies of expedited approval, combination products, and companion diagnostics;
    • Develop a practical working knowledge of clinical trials for drugs and biologics;
    • Learn about labeling and how it serves as the transition between the approval process and the post-approval world;
    • Appreciate the complexities of pharmaceutical and biologic IP and the regulatory balance between brand name and generic products;
    • Analyze the emerging trends and how new legislation might impact FDA practice;
    • See the importance of cGMPs to the post-approval regulatory process;
    • Navigate off-label and new uses for drug products; and
    • Understand the impact of adverse events monitoring, signal detection, and product withdrawals.

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

    • Navigating the Approval Process for Drugs and Biologics;
    • Expedited Approval Process and Unique Considerations in the Approval of Combination Products and Companion Diagnostics;
    • Understanding the Clinical Trial Process for Drugs and Biologics
    • Drugs and Biologics: Labeling;
    • Patents, Trademarks, and Other IP Protections and Mechanisms;
    • Hatch-Waxman and BPCIA Overview;
    • Breaking News, Cases, Emerging Trends, and New Legislation Likely to Impact FDA Practice;
    • Threading the Needle: Navigating Off-Label/New Use;
    • Examining Current Good Manufacturing Practices and FDA's Authority and Procedure Regarding Recalls;
    • Adverse Events Monitoring, Pharmacovigilance and Risk Management.

    In addition, two pre-conference workshops will be offered on the afternoon of September 13, 2017, from 1:00 pm to 4:15 pm and 4:30 to 5:30, respectively.  The first workshop is entitled "FDA Fundamentals and What to Expect During a Sponsor Meeting with the FDA," and the second workshop is entitled "Ethics: Ethical Considerations Relevent to the Communications with the FDA."  One post-conference workshop on "Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute" will be offered on September 15, 2017 from 1:30 to 4:30 pm.

    An agenda for the conference and information regarding the workshops can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee is $2,295 (conference alone), $3,395 (conference and all three workshop).  Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's FDA Boot Camp.

  • USPTO Semiconductor Customer Partnership Meeting

    USPTO Building FacadeThe U.S. Patent and Trademark Office will be hosting a Semiconductor Customer Partnership Meeting from 1:00 to 5:00 pm (ET) on August 22, 2017 at the USPTO headquarters in Alexandria, VA.  This meeting will restart the Semiconductor Partnership between Technology Center 2800 and customers across the country with the goal to ensure that the USPTO is providing patents of the highest quality in this art unit.  During the meeting, participants will be able to interact with Office personnel in person, or alternatively, via webcast.  Topics for the Semiconductor Customer Partnership Meeting will include:

    • Details on Patent Quality programs from the Director of the Office Patent Quality Assurance, James Dwyer
    • Panel Discussion with topics including CPC and International Patent Cooperation
    • Patent Prosecution Topic from an external stakeholder

    Additional information about the meeting and instructions for attending can be found here.

  • Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

    By Andrew Williams —

    Federal Circuit SealIn the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case — can a reference product sponsor use discovery to obtain information from a biosimilar applicant if it does not receive a copy of the aBLA or other information about the manufacturing process as required by the BPCIA?  In Amgen v. Sandoz, the first case in this series, the Federal Circuit found that an aBLA applicant was not required to disclose its application and related information, but noted that such information could be accessed through discovery after an infringement suit is filed.  In the second installment, Amgen v. Apotex, the plot centered on the Notice-of-Commercial-Marketing provision, and did not focus significantly on the provisions of 42 U.S.C. § 262(l)(2)(A).  In this most recent case, the Court appears to have closed the discovery loophole it created, at least with respect to cases in which the requested information is not relevant to the asserted patents.  More importantly, reference product sponsors suffered another blow when the Court suggested that if a patent was not included in its paragraph (l)(3)(A) list, even if there was no reason to suspect that it might be relevant to the present case, the BLA holder could be precluded under 35 U.S.C. § 271(e)(6)(C) from ever asserting that patent (depending on what "under this section" turns out to mean).  Of course, this could lead to the unintended (or maybe intended) consequence of overly long patent lists containing every conceivable patent that could be related to the manufacture of biologics in situations when inadequate information has been provided.

    HospiraThis case stems from Hospira's subsection (k) biosimilar application seeking approval to market a version of Amgen's EPOGEN® drug product.  BLA 125545 was submitted in December 2014, and shortly thereafter Hospira provided its application to Amgen.  Nevertheless, it did not otherwise provide any additional manufacturing information.  On March 31, 2015, Amgen alerted Hospira that it had failed to comply with paragraph (l)(2)(A) of the BPCIA.  Hospira responded that the application contained sufficient information about both the product and the process of its manufacture.  Notwithstanding, the parties conducted the patent dance.  However, Amgen did not include any cell-culture patents on its paragraph (l)(3)(A) patent list because it alleged it could not "assess the reasonableness of asserting claims for infringement" without the requested information.

    AmgenAmgen ultimately filed suit on two patents in the U.S. District Court for the District of Delaware, U.S. Patent Nos. 5,756,349 and 5,856,298.  Relying on the Amgen v. Sandoz statement referenced above, Amgen sought discovery of the withheld information, including the composition of Hospira's cell-culture medium.  After Hospira refused to produce the information, the Court denied a motion to compel discovery filed by Amgen because the information sought had "essentially no relevance to the patents that are asserted."  Amgen sought interlocutory appeal and in the alternative mandamus under the All Writs Act.

    With regard to whether the Federal Circuit had jurisdiction, the Court looked to the collateral order doctrine to see if the appeal could be heard regardless of the fact that the judgement was not yet final.  The test, established by the Supreme Court, is that "the order must conclusively determine the disputed question, resolve an important issue completely separate from the merits of the action, and be effectively unreviewable on appeal from a final judgment."  Coopers & Lybrand v. Livesay, 437 U.S. 463, 468 (1978).  After acknowledging that the first two conditions were met, the Court concluded that the lower Court's order was not "effectively unreviewable."  In general, discovery rulings fall outside the collateral order doctrine because they are reviewable upon final judgement.  Moreover, this was not a case analogous to an order to unseal confidential information or deny a claim of immunity.  In essence, this was found to be a "run-of-the-mill discovery dispute," and therefore the Court determined it lacked jurisdiction.

    With regard to the request for mandamus, the Court noted that such a writ is a "drastic remedy reserved for the most 'extraordinary causes,'" citing Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367, 380 (2004).  Amgen's right to the issuance of a writ, according to Supreme Court precedent, centered on whether there was a "clear and indisputable" right to that relief.  The Court identified five potential avenues based on the BPCIA, but immediately shot down two or three of them.  The first — an injunction under federal law compelling the disclosures — was foreclosed in the Supreme Court's Sandoz v. Amgen decision.  The second — an injunction under state law compelling the disclosures — was left open by the Supreme Court, but Amgen had not sought a state law remedy in the Hospira case.  Third — suing the biosimilar applicant under the BPCIA and 35 U.S.C. § 271(e)(2) for failure to comply with the information disclosure provision — was also foreclosed by the Supreme Court.  The Court had explained in Sandoz that it was the act of submitting the aBLA to the FDA that gave rise to the artificial infringement, not the failure to comply with the provisions of the BPCIA.

    The final two potential avenues arise from the ability of the reference product sponsor to bring an infringement suit:  either pursuant to the list of patents created under paragraph (l)(3)(A) (avenue 4), or patents that "could" be identified in the case the aBLA is not disclosed (avenue 5).  The Court did not address avenue 5.  Rather, it noted that Amgen provided a patent list, and sued Hospira on two of the patents on that list.  However, neither of those patents related to cell-culture media.  The Federal Circuit back-peddled from its previous statement in Amgen v. Sandoz (that discovery would always be available) by claiming it had never intended to alter the Federal Rules of Civil Procedure.

    Importantly, the Court addressed a question that Practitioners have been wondering ever since the original Amgen v. Sandoz decision:  whether a reference product sponsor could assert a patent in the BPCIA context if it did not receive sufficient information from the biosimilar applicant about that patent.  For example, would Amgen have faced Rule 11 sanctions for asserting the cell-culture patent, considering it did not know if Hospira was indeed practicing the invention claimed therein?  The solution, according the Federal Circuit, is for a patent owner to include every patent that it could conceivably assert on its (l)(3)(A) list.  After all, the statute does not provide for sanctions if a patent is unreasonably listed.  In fact, it is the response from the biosimilar applicant in its "detailed statement" that could give rise to the reasonable basis for asserting the patent in litigation.  Moreover, Rule 11 only requires that a filing be "to the best of the person's knowledge, information, and belief, formed after an inquiry reasonable under the circumstances."  That belief could be based on an inquiry limited to the withholding of information.  As such, the Court concluded, "the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing as patent for which an applicant has not provided information under paragraph (l)(2)(A)."  Ultimately, therefore, the Court concluded that the denial of discovery did not undermine the BPCIA and that denial of the motion to compel was proper.

    Of course, this creates a chicken-and-the-egg situation.  If the biosimilar applicant does not disclose its relevant information, the reference product sponsor will not know what patents cover the non-disclosed material.  But if the sponsor will be unable to assert such a non-listed patent, it will be motivated to include every conceivable patent when it does create its list.  This has the potential of escalating the amount of paperwork needed to be exchanged during the patent dance.  Maybe the specter of responding to countless irrelevant patents will ultimately sway some biosimilar applicants to disclosure the information in the first place.  Or maybe the question will be resolved in the next installment of the "Amgen v." series of BPCIA cases.

    Before we leave this case, there is an update on the FDA approval process for the aBLA underlying this case.  We had reported in June that the FDA's Oncologic Drug Advisory Committee recommended approval of Hospira's aBLA (see "Biosimilars Update — Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval").  However, on June 22, 2017, Pfizer announced that it had received another Complete Response Letter (CRL) from the FDA.  And even though this CRL did not relate specifically to the manufacture of epoetin alfa, it will likely result in a delay of drug approval.  This is the second CRL that Pfizer received for this drug product application, thereby causing this application to be the longest between submission and approval (if it is, in fact, ultimately approved).  We will continue to monitor the situation and provide updates as warranted.  

    Amgen Inc. v. Hospira, Inc. (Fed. Cir, 2017)
    Panel:  Circuit Judges Dyk, Bryson, and Chen
    Opinion by Circuit Judge Dyk

  • News from Abroad — Briefing on Supplementary Protection Certificates for Medicinal Products

    What are SPCs?

    CVRIAA Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation1.

    The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union (CJEU).  Historically there have been numerous referrals to the CJEU on points of law relating to SPCs and this is expected to continue.  Some of the key decisions are discussed below.

    The SPC regime was introduced as a mechanism to compensate patent holders for loss in effective patent term resulting from the time taken to receive marketing authorisation for such products2.  However, regulatory delay is not of itself sufficient to justify the grant of SPCs.

    In particular, the relevant regulation provides that an SPC can be granted only for an "active ingredient".  This has been held to exclude substances that may enable or enhance the activity of a therapeutic ingredient, but which have no therapeutic effect of their own on the human or animal body.  Despite the clinical testing (and consequent regulatory delay) involved in developing such auxiliary substances, the CJEU has on two occasions3 held that they do not qualify for an SPC.  Similarly, it is not currently possible to obtain SPC protection for a medical device, irrespective of whether or not the marketing of such a device has been subject to regulatory delay.

    Where are SPCs available?

    SPCs are national rights: at present there is no such thing as a Europe-wide SPC.  Accordingly, individual applications must be made to national patent offices in countries where SPC protection is desired.

    SPC protection is available in all EU member states, namely:

    Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom4.

    SPCs in these countries are governed by EC Regulation 469/2009 ("the SPC Regulation" — excerpts of which are included as Annex 1).

    SPC protection is also available in the following non-EU States:

    • Norway and Iceland: these States are members of the European Economic Area (EEA), but not of the EU, and the governing legislation is the EU SPC Regulation.

    • Switzerland: Swiss SPCs are governed by legal provisions which are based on the EU SPC Regulation.  An SPC issued in Switzerland will also automatically take effect in Liechtenstein5.

    • Albania, Bosnia & Herzegovina, Macedonia, and Serbia: These are non-EU/EEA countries which may nonetheless be covered by a European patent application granted by the EPO.  SPC protection is available in these countries under national legal provisions.

    Similar provisions also exist in neighbouring jurisdictions including Russia and the Ukraine, and in other countries worldwide.  Those interested in rights in these jurisdictions can contact J A Kemp for more information.

    What scope of protection is provided by the SPC?

    The scope of an SPC is limited to the product of the relevant marketing authorisation.  It protects that product to the same extent as the patent on which the SPC is based ("the basic patent").  For example, if the basic patent covers the product per se, the SPC will also cover the product per se.  If the basic patent only covers a method of manufacturing or using the product, then the SPC will be similarly restricted.

    The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs6, provided of course that they are covered by the basic patent.

    The situation is less clear for active ingredients which are biological molecules.  A decision of the Norwegian Court of Appeal7 following an advisory opinion of the EFTA court8 recognised that it would be desirable for therapeutically equivalent variants of a biologic product to be covered by an SPC, but provided little guidance as to the extent of such coverage.  It is to be expected that this question will be referred to the CJEU.

    Subject to the scope of the basic patent, an SPC for a given active ingredient will cover any use of that active ingredient in a drug which is authorised before the SPC expires.  Subsequent marketing authorisations made after grant of an SPC will therefore extend the scope of the SPC, even when the later marketing authorisation is obtained by an entity unconnected with the owner of the SPC.

    Also, subject to the scope of the basic patent, an SPC will cover all subsequently authorised combinations of active ingredients containing the product at issue.9

    What additional term is provided by the SPC?

    An SPC takes effect at the end of the normal expiry term of the basic patent on which it is based, provided that the patent is maintained up to that point.

    For EU/EEA member states, the SPC will expire at whichever is the earlier of:

    • 15 years from the first Marketing Authorisation in the EU/EEA10

    • 5 years from the expiry of the basic patent

    The effective maximum term is therefore 5 years in addition to the term of the basic patent.

    For non-EU/EEA member states, the term is determined by reference to the local marketing authorisation.  For example, the term of a Swiss SPC is determined by reference to the date of the Swiss marketing authorisation.  Since this can issue later than the EU/EEA authorisation, the Swiss SPC for a medicinal product may have a longer term than the corresponding SPCs in the EU/EEA countries.

    It is possible to extend the term of an SPC by a further 6 months by providing clinical results obtained from an agreed paediatric investigation plan.  The request for extension may be filed at any time up to 2 years before normal SPC expiry.

    Further information is provided in J A Kemp's briefing note on the Paediatric Products Regulation, which is available upon request.

    Who should apply for the SPC?

    The Applicant for the SPC must own the basic patent, but need not hold the relevant marketing authorisation.  Thus, it is possible to secure an SPC based on a marketing authorisation held by a third party11.

    When should the SPC application be filed?

    An application for an SPC must be filed with the national Patent Office of the country concerned within the later of:

    • 6 months from the date on which the first authorisation to place the product on the market is granted in that country; or

    • 6 months from the date of grant of the basic patent.

    If the basic patent expires before marketing authorisation is achieved, it may not be possible to secure an SPC.  Under such circumstances, it may be worthwhile filing an application for an SPC before expiry of the patent and following up with the marketing authorisation when it is available.  However, the chances of persuading Patent Offices to grant an SPC under such circumstances would at best be uncertain12.

    What are the substantive requirements for obtaining SPCs?

    The requirements for grant of an SPC are set out in Article 3 of the SPC Regulation.

    • Article 3(a) requires that the product be "protected" by a basic patent.

    • Articles 3(b) and 3(d) require that the SPC be based on the first valid authorisation to place the product on the market as a medicinal product.

    • Article 3(c) requires that the product has not already been the subject of an SPC.

    Although these requirements may appear relatively simple, each has been subject to multiple referrals to the CJEU.  More detailed discussion is provided below.

    What is meant by "protected" by a basic patent?

    Perhaps surprisingly, to fulfill this requirement it is not sufficient that the product would hypothetically infringe the claims of the basic patent.  Unfortunately it is also not clear precisely what is sufficient.  There have been several referrals to the CJEU on this point, and it is expected that more will follow.

    The leading CJEU decisions are generally considered to be the "Medeva"13 and "Eli Lilly"14 decisions.

    In Medeva, the CJEU held that for the SPC to be granted, the active ingredient must be "specified in the wording of the claims of the basic patent".

    The decision in Medeva was made in the context of SPCs for a combination therapy.  Specifically, the patent had a claim to A, which would prevent an unauthorised third party from manufacturing and selling a medicinal product containing A and another active ingredient, B.  However, this was held not to support an SPC for the product A+B because B was not specified in any way in the wording of the claim.

    This has generally been interpreted to mean that a patent which claims product A and does not mention combination therapies cannot support an SPC for combinations of active ingredients containing A, e.g., an SPC for A+B 15.

    A subsequent CJEU decision16 has also confirmed that a patent which claims only a combination of A+B cannot be the basic patent for an SPC for A alone, despite the fact that sale of A may well, under some circumstances, infringe the patent under "contributory infringement" provisions.  This remains true even where the marketing authorisation is for a medicine comprising A and includes an indication that A may or should be used together with B.

    There has been much debate over the extent to which the reasoning in Medeva and other "combination" decisions should apply to single active ingredients.  Clearly the requirement that the active ingredient is "specified" will be satisfied if the basic patent contains a claim which specifically mentions the product at issue.  The situation is much less clear, though, when the claims of the basic patent embrace the product at without mentioning it specifically.

    In Eli Lilly, the CJEU explored this question in the specific context of a functionally defined active ingredient ("…an antibody which binds to <target>…").  It was held that a functional definition can in principle support an SPC, provided that the claims when construed in the context of the description relate "implicitly but necessarily and specifically" to the active ingredient.

    Although very little guidance was provided as to how to establish whether a claim meets this test, the referring UK Court17 interpreted the CJEU's intention to be that any general claim language which covers a single active agent, including a functional definition, will satisfy the requirements of Article 3(a) for an SPC directed to that active agent.  This remains the case even if there is no "individualised description" of the active ingredient elsewhere in the patent.  However, claims which embrace active ingredients only by virtue of open-ended language, such as "comprises", would not satisfy Article 3(a).

    Perhaps reflecting general frustration with the lack of clarity on this issue, the UK Court has made a further referral to the CJEU18 posing a deliberately open question:

    "What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"

    The facts of that particular case again concern a combination product, but it is hoped that the CJEU will take the opportunity to provide guidance on Article 3(a) in general terms.  Ideally the CJEU will also clarify other outstanding matters relating to Article 3(a), such as whether the claims of a basic patent can be amended after grant to cure a deficiency under Article 3(a).  This question has also been put to the CJEU in a previous referral19 but they declined to answer.

    What is meant by "a valid authorisation to place the product on the market as a medicinal product"?

    The CJEU has confirmed that an SPC for a given product should be based on the first authorisation for a drug containing the product even if this is a combination therapy which includes the product.  Thus, for example, an SPC for product A can be based on a patent claiming A and a marketing authorisation for a medicinal product containing A+B.20  This may be important for vaccine products, where marketing authorisations often relate to combinations of multiple active ingredients.  An SPC granted under such circumstances will cover all products containing product A approved before the SPC expires.

    How many SPCs may be granted for a given product or patent?

    Although Article 3(c) of the SPC Regulation suggests that only one SPC can be granted for a given product, it has long been the case that if two basic patents are owned by different Patentees, each Patentee can secure an SPC.  Under such circumstances, both SPCs can be based on the same marketing authorisation.

    If two patents which cover a given product are held by a single Patentee, only one SPC is available.  The Patentee must choose which patent to use to support the SPC.  Considerations which may apply when determining which patent to choose will include the relative vulnerability of the patents to any validity challenge and the duration of the SPC available from each patent.  If, however, the two patents are held by different entities, each patent can support a separate SPC.

    In general, it is also possible to have multiple SPCs granted for multiple different products on the basis of the same basic patent, provided that each product is protected by the basic patent21.

    An exception to this principle has however been set out by the CJEU in two cases22, both of which relate to a scenario in which an SPC has already been granted for a single active ingredient A, and a later application is filed for an SPC for a combination containing that active ingredient, A+B.  The CJEU has held that the later SPC should not be granted in these circumstances.

    However, the reasoning of the CJEU in both cases appears to have been influenced by a finding that the single active ingredient was the "sole" or "core" of the invention underlying the basic patent, and so they were reluctant to award a further SPC for the combination.  It is unclear whether the exception would also apply if the combination represented a separate inventive advance disclosed within the same patent, or indeed if the combination had been presented in a separate patent.

    Which Marketing Authorisation is the first Marketing Authorisation?

    Article 3(d) of the SPC Regulation requires that an SPC be based on the first authorisation to place a drug on the market as a medicinal product (the earliest marketing authorisation).  The proper identification of the earliest marketing authorisation may be an issue when a patent protecting a second or subsequent medical use of a particular drug is used as the basis for an SPC application.

    Historically it had been thought that a patent to a new medical use of a drug could form the basis of an SPC, but that SPC had to be based on the earliest marketing authorisation for that drug, even if the earliest authorisation was for a different disease or condition from that specified in the patent.23  In practice, reference to the earliest marketing authorisation often meant that any resultant SPC would have a zero term, because of the maximum SPC term of 15 years from first marketing authorisation in the EU.

    However, in the landmark "Neurim" decision24, the CJEU indicated that under certain circumstances it is possible to base an SPC application on an authorisation which is not the first marketing authorisation to place a particular drug on the market.

    The facts in Neurim were that an earlier authorisation had been issued for a veterinary use.  The CJEU held that this should not preclude grant of an SPC based on a later authorisation for a completely separate human use.  However, the phrasing used by the CJEU was more general, stating that the "first" authorisation for the purposes of Article 3(d) is the "first" authorisation "which comes within the limits of the protection conferred by the basic patent".  That is, an earlier authorisation which is outside the scope of the basic patent should not be taken into account.

    There has been much debate over how broadly the principles outlined in Neurim should be applied, with the various national patent offices diverging to a significant extent.  For example, some offices apply Neurim very narrowly, such that the SPC will only be granted if the earlier authorisation is veterinary and the later authorisation is for a different indication in humans.  Many offices apply a broader interpretation, such that the SPC is granted provided the later authorisation is for any different indication.  However, some offices apply Neurim very broadly, such that an SPC may be granted if the later authorisation differs from the earlier in any way, including e.g., the formulation of the active ingredient, the administration or dosage regime, or the specific patient population to be treated.

    Perhaps unsurprisingly therefore, this point is the subject of yet another CJEU referral25.  The UK Court has specifically requested clarification as to whether Neurim may apply if the later authorisation is for a new formulation of a previously authorised active ingredient.

    In the meantime, however, it may be possible for Patentees to obtain SPCs on the basis of:

    a) a patent to a downstream development of a known drug, for example a patent for a new medical use or a new formulation of a known active ingredient; and

    b) a second or subsequent marketing authorisation for a medicinal product containing the active ingredient at issue.

    Such SPCs may be granted if:

    (i) the downstream patent does not cover the medicinal product specified in the original marketing authorisation; and

    (ii) the second or subsequent marketing authorisation is the first authorisation for a medicinal product which is protected by the downstream patent.

    Further information on SPCs based on patents for downstream developments of a known drug can be found in J A Kemp's briefing on the Neurim decision, which is available upon request.

    Is it possible for a third party to challenge the grant of the SPC?

    Even where there is no formal mechanism to do so, most national patent offices will consider observations filed by a third party against an application for an SPC.  Such observations may draw the Examiner's attention to deficiencies in the application with respect to compliance with the substantive requirements of the SPC Regulation.

    Such observations may slow (or even prevent) grant of the SPC application.  After grant, the validity of an SPC may be challenged in the national courts on the same grounds.

    The validity of the basic patent underlying an SPC may of course also be challenged separately via all normal routes (EPO opposition, national revocation action etc.).  Should the patent be revoked, any SPC or SPC application based upon it is automatically invalidated.

    —————————————————————————————————————————-

    1 SPCs are also available for active substances in plant protection products, but these are not the focus of this briefing.

    2 The purpose is thus similar to Patent Term Extensions (PTE) available in, e.g., USA and Japan, but unlike those systems an SPC is not an extension of a patent, it is a separate right.

    3 C-431/04 MIT (a bioerodible matrix) & C-210/13 Glaxosmithkline (an adjuvant in a vaccine).

    4 The UK is expected to implement a corresponding national provision even in the event of a 'hard' Brexit, and thus SPCs should remain available in the UK.

    5 Swiss marketing authorisations also automatically take effect in Liechtenstein, which unlike Switzerland is an EEA member.  Thus, this must be taken into account when determining the first authorisation in the EU/EEA.  See comments on additional term provided by an SPC below.

    6 C-392/97 Farmitalia.

    7 Pharmaq v Intervet 15-170539ASD-BORG/01.

    8 Similar status to the CJEU for matters referred by the national courts of the EEA states: Norway, Iceland, Liechtenstein.

    9 C-322/10 Medeva, C-422/10 Georgetown and C442/11 Novartis v. Actavis.

    10 The CJEU confirmed in C-471/14 that the relevant date of an EU Marketing Authorisation is the date on which notification of the authorisation is made to the holder (typically a few days later than the Commission Decision granting the authorisation).  This may result in extra days of SPC term, although some national patent offices have yet to correct the term of SPCs granted prior to the CJEU decision.  A further referral (C-492/169) from the Hungarian Courts asks whether such correction is required.  A hearing date has not yet been set.

    11 C-181/95 Biogen V SKB explicitly endorsed this view.

    12 A pending CJEU referral (C-567/16) asks the specific questions whether an "end of procedure" notice (indicates an MA is imminent) is sufficient to support an SPC and, if not, whether the absence of a full MA can be remedied later.  A hearing date has not yet been set.

    13 C-322/10.

    14 C-493/12.

    15 [2012] EWCA Civ 523 Medeva BV v Comptroller General of Patents.

    16 C-518/10 Yeda.

    17 [2014] EWHC 2404 (Pat) Eli Lilly.

    18 C-121/17 Teva v Gilead – hearing date not yet set.  Request for expedition was refused in April 2017.

    19 C-577/13 Actavis v Boehringer.

    20 C-322/10 Medeva and C-422/10 Georgetown.

    21 C-484/12 Georgetown.

    22 C-443/12 Actavis v Sanofi, C-577/13 Actavis v Boehringer.

    23 C-202/05 Yissum.

    24 C-130/11 Neurim.

    25 C-tbc Abraxis Bioscience – hearing date not yet set.

    —————————————————————————————————————————-

    Annex 1

    Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (selected provisions)

    Article 1

    Definitions

    For the purposes of this Regulation, the following definitions shall apply:

    (a)    'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

    (b)    'product' means the active ingredient or combination of active ingredients of a medicinal product; […]

    Article 2

    Scope

    Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.

    Article 3

    Conditions for Obtaining a Certificate

    A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

    (a)    the product is protected by a basic patent in force;

    (b)    a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

    (c)    the product has not already been the subject of a certificate;

    (d)    the authorisation referred to in point (b) is the first authorization to place the product on the market as a medicinal

    Article 4

    Subject matter of protection

    Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

    Article 5

    Effects of the certificate

    Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

    […]

    This article was reprinted with permission from J A Kemp.

  • Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (D. Mass. 2017)

    District Court Finds Diagnostic Claims to Be Directed to Patent Ineligible Subject Matter

    By Donald Zuhn —

    District Court for the District of MassachusettsLast week, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, District Judge Indira Talwani of the U.S. District Court for the District of Massachusetts dismissed a complaint filed by Plaintiffs Athena Diagnostics, Inc., Isis Innovation Ltd., and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V. ("Athena") that two diagnostic tests developed by Defendants Mayo Collaborative Services, LLC and Mayo Clinic ("Mayo") infringed Athena's U.S. Patent No. 7,267,820.  Mayo had filed a Renewed Motion to Dismiss Athena's complaint, arguing that that the '820 patent was invalid under 35 U.S.C. § 101 because the claimed method applies routine and conventional techniques to a law of nature.

    The '820 patent relates to the diagnosis of Myasthenia Gravis, a chronic autoimmune disorder.  In particular, the methods of the '820 patent allow for the diagnosis of the 20% of Myasthenia Gravis patients who do not have acetyle choline receptor autoantibodies, by detecting muscle specific tyrosine kinase ("MuSK") autoantibodies instead.  The inventors of the '820 patent had discovered that a portion of Myasthenia Gravis patient population had IgG antibodies that bind the N-terminal domains of MuSK, a receptor located on the surface of neuromuscular junctions.  Claims 6-9 of the '820 patent, which depend directly or indirectly from claims 1-3, were at issue in the case.  Claims 1-3 and 6-9 are set forth below:

    1.  A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).

    2.  A method according to claim 1 wherein said method comprises the steps of:
        a) contacting said bodily fluid with muscle specific tyrosine kinase (MuSK) or an antigenic determinant thereof: and
        b) detecting any antibody-antigen complexes formed between said receptor tyrosine kinase or an antigenic fragment thereof and antibodies present in said bodily fluid, wherein the presence of said complexes is indicative of said mammal suffering from said neurotransmission or development disorders.

    3.  A method according to Claim 2 wherein said antibody-antigen complex is detected using an anti-IgG antibody tagged or labeled with a reporter molecule.

    6.  A method according to claim 3 whereby the intensity of the signal from the anti-human IgG antibody is indicative of the relative amount of the anti-MuSK autoantibody in the bodily fluid when compared to a positive and negative control reading.

    7.  A method according to claim 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).

    8.  A method according to claim 7 wherein said label is a radioactive label.

    9.  A method according to claim 8 wherein said label is 125I.

    Mayo moved to dismiss Athena's complaint on the ground that the '820 patent seeks to claim a law of nature and uses techniques that are standard in the art.  Athena argued that the asserted claims of the '820 patent are not directed to a law of nature because those claims require the use of a non-naturally occurring protein, 125I-MuSK, and that applying various known types of procedures to a non-naturally occurring protein transforms the claim and makes it patent eligible.

    In deciding whether the asserted claims of the '820 patent are directed to patent-ineligible subject matter, the District Court applied the two-step analysis set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int'l.  In the first step, the court determines whether the claims are directed to a law of nature, natural phenomenon, or abstract idea.  If the answer to this first inquiry is "yes," then the court must determine whether the elements of the claim individually, or as an ordered combination, transform the nature of the claim into a patent-eligible application.  Noting that the Supreme Court in Mayo described the second inquiry "as a search for an 'inventive concept' – i.e., an element or combination of elements that is 'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself," the District Court indicated that "[a]t step two, more is required than well-understood, routine, conventional activity already engaged in by the scientific community."

    With respect to the step one inquiry, Mayo argued that the law of nature to which the '820 patent was directed was that the bodily fluid of some people with Myasthenia Gravis have autoantibodies to MuSK.  Athena countered that "the claims are not directed to MuSK . . . [i]nstead, the claims recite using a man-made chemically-modified version of MuSK [i.e., 125I-MuSK] to form a specific complex that does not occur in nature."  In determining that the asserted claims are directed to a patent ineligible law of nature under § 101, the District Court explained that:

    Although the patented method uses man-made 125I-MuSK, the use of a man-made complex does not transform the subject matter of the patent.  The focus of the claims of the invention is the interaction of the 125I-MuSK and the bodily fluid, an interaction which is naturally occurring.  The purpose of the patent is to detect whether any antibody-antigen complexes are formed between the 125I-MuSK receptor and the antibodies "present in said bodily fluid."  . . .  Counter to Plaintiffs' argument, because the patent focuses on this natural occurrence, it is directed to a patent-ineligible concept.

    The District Court also noted that "[c]ontrary to Plaintiffs' argument, the '820 patent is not a composition patent directed at the creation of the 125I-MuSK auto-antibody complex [but r]ather, the patent is directed at a method for the diagnosis of a disease."

    The District Court also compared the asserted claims in the instant case to those in Mayo, pointing out that in Mayo, "a man-made substance was administered to a person, and the by-product of the metabolization of that man-made substance was observed," and in the instant case, "a man-made substance (125I-MuSK) is administered to a sample of bodily fluid, and the by-product (125I-MuSK autoantibodies) is observed."  The District Court found further support for its step one determination in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1372 (Fed. Cir. 2015), noting that in Ariosa, the only subject matter that was new and useful was the discovery of the presence of cffDNA in maternal plasma or serum, and that "[l]ikewise, what is new and useful here is the discovery that some patients with Myasthenia Gravis have MuSK autoantibodies in their bodily fluid."  Finally, the District Court distinguished the instant case from Rapid Litig. Mgmt., Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016), stating that in contrast with the methods at issue in CellzDirect, "the desired outcome of the Plaintiffs' method is the detection of MuSK autoantibodies" and Athena's claimed method "does not produce something useful beyond that diagnosis."

    With respect to step two of the Mayo/Alice inquiry, Mayo argued that the '820 patent uses well-known techniques for identifying the presence of autoantibodies to MuSK and therefore does not contain an inventive concept.  In particular, Mayo pointed to the '820 patent specification, which states that "[i]ondination and immunoprecipitation are standard techniques in the art."  Athena countered that at the time the invention was made, the step of "detecting" autoantibodies was neither well understood nor routine, that the step of contacting MuSK or a MuSK epitope with a suitable label was novel, and although iodination and immunoprecipitation are standard techniques in the art, none of these steps are routine when applied to proteins.  The District Court concluded that Athena's argument was "unavailing," noting that "[n]one of the complexity to which Plaintiffs cite is described or claimed in the patent," and adding that "[o]n its face, the patent claims a process for detecting autoantibodies, not a process for creating the 125I-MuSK."

    Having decided that the answer to step one of the Mayo/Alice inquiry was "yes," and further, that the asserted claims of the '820 patent lack an inventive concept, the District Court granted Mayo's Renewed Motion to Dismiss.

    Memorandum & Order by District Judge Talwani

  • Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2017)

    By Donald Zuhn —

    Federal Circuit SealLast week, in Enzo Biochem Inc. v. Applera Corp., the Federal Circuit determined that the District Court for the District of Connecticut accurately interpreted the Federal Circuit's decision in Enzo Biochem, Inc. v. Applera Corp. (Enzo II), 780 F.3d 1149 (Fed. Cir. 2015), concerning the proper construction of the claims in U.S. Patent No. 5,449,767, and correctly analyzed the doctrine of equivalents argument of Plaintiffs-Appellants Enzo Biochem, Inc., Enzo Life Sciences, Inc., and Yale University ("Enzo").  The District Court had found that the Federal Circuit's decision in Enzo II applied to all of the claims in the '767 patent, and not just claim 1 as Enzo had asserted, and had rejected Enzo's argument that the claims covered direct detection (in addition to indirect detection) under the doctrine of equivalents.  The Federal Circuit affirmed both determinations by the District Court.

    The opinion begins by noting that the Federal Circuit had considered the infringement action between Enzo and Defendants-Appellees Applera Corp. and Tropix, Inc. ("Applera") on three separate occasions over thirteen years.  The dispute began in 2004, when Enzo filed suit against Applera alleging infringement of six patents, including the '767 patent.  The '767 patent is directed to the use of nucleotide probes to detect the presence of a particular DNA or RNA sequence in a sample or to identify an otherwise unknown DNA sequence.  Such detection occurs via hybridization of the probes with the DNA or RNA sequence of interest, wherein hybridization of the probe and target sequence may be directly detected (by using a labeled probe) or indirectly detected (by using a secondary chemical agent that is bound to the labeled probe).

    After a jury found that Applera infringed claims 1, 8, 67, 68, and 70 of the '767 patent, Applera appealed, arguing that the District Court had erred in construing the claims to only cover indirect detection.  The Federal Circuit in Enzo II reversed, concluding that "the inventors were claiming only indirect detection," and therefore that the District Court had erred in construing the claims to cover both direct and indirect detection.  On remand, the District Court granted Applera's motion for summary judgment of noninfringement, determining that Enzo II applied to all of the claims of the '767 patent and rejecting Enzo's doctrine of equivalents argument.  Enzo appealed the District Court's judgment to the Federal Circuit.

    With respect to Enzo's argument that the District Court incorrectly interpreted the Federal Circuit's decision in Enzo II as applying to all of the claims of the '767 patent, with Enzo asserting that Enzo II should only apply to claim 1, the panel concluded that:

    [A]fter carefully parsing our decision, the district court correctly interpreted Enzo II.  As the district court explained, Enzo II consistently refers to the "claims" at issue in that appeal, which extended beyond claim 1 to include claims 8, 67, 68, and 70.  . . .  For example, our opinion in Enzo II, after acknowledging that Enzo had asserted claims 1, 8, 67, 68, and 70, states that the district court "erred in its claim construction by finding that the claims at issue covered direct detection" [emphasis in original].

    As for Enzo's argument that Applera infringed claims 1 and 8 under the doctrine of equivalents, the panel notes that "[t]he district court explained that the patent 'describes its method of indirect detection as a superior means of detection as compared to direct detection, with 'detection capacities equal to or greater than products which utilize' direct detection,'" and determined that "Enzo's attempt to reframe its infringement case under the doctrine of equivalents runs headfirst into our decision in Enzo II," where the Federal Circuit found that the claims covered only indirect detection.  As a result, the opinion concludes that "Enzo's attempt to incorporate direct detection methods now through the doctrine of equivalents fails."

    Finding that the District Court properly interpreted Enzo II as applying to all of the claims of the '767 patent, and further, that the District Court correctly held that Applera's accused products using direct detection did not infringe Enzo's '767 patent claiming indirect detection, the Federal Circuit affirmed the District Court's judgment.

    Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2017)
    Nonprecedential disposition
    Panel: Chief Judge Prost and Circuit Judges O'Malley and Wallach
    Opinion by Circuit Judge O'Malley

  • News from Abroad — EPO Applies Doctrine of Plausibility to Small Molecule Pharmaceuticals

    EPOIn Decision T 488/16, the Boards of Appeal of the European Patent Office (BoA) have revoked EP 1 169 038, which protected the blockbuster protein tyrosine kinase (PTK) inhibitor dasatinib (Sprycel®).  The only request on file — a single claim directed to dasatinib per se or a salt thereof — was found to lack inventive step in view of the absence of evidence in the application as filed (and the common general knowledge) which rendered the activity of dasatinib in inhibiting PTK "plausible".  A general statement in the application as filed that "Compounds described in the following Examples have been tested in one or more of these assays, and have shown activity" was not by itself considered enough to render it credible to the skilled person that the described compounds were PTK inhibitors.  In the absence of a plausible disclosure of activity against PTK in the specification as filed, the objective technical problem was defined by the Board of Appeal as merely "the provision of a further chemical compound".  The extensive clinical data which became available after the filing date of the patent evidencing biological activity was not taken into account when determining inventive step.

    The Boards of Appeal of the European Patent Office have for many years imposed a requirement that claims for large molecules (e.g., proteins) must be supported by a plausible disclosure of biological activity in the application as filed (see, for example, T 1329/04).  A similar requirement for a plausible disclosure of activity in the original specification has also been required to support medical use claims (see, for example, T 0609/02).  However, this Decision indicates that the Boards are willing to apply the same strict standards when assessing claims for small molecule drugs per se.

    This article was reprinted with permission from J A Kemp.

  • Conference & CLE Calendar

    CalendarAugust 8, 2017 – Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET) on

    August 10-11, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 11-12, 2017 – Invention-Con 2017 (U.S. Patent and Trademark Office) – Alexandria, VA

    August 14-15, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 17-18, 2017 – "Advanced Patent Prosecution Workshop 2017: Claim Drafting & Amendment Writing" (Practising Law Institute) – San Francisco, CA

    August 24, 2017 – "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 29, 2017 – "The Evolving 5 W's of Global IP Enforcement: The Strategic Implications of Recent Global IP Law Developments" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    August 31, 2017 – "Navigating the Patent Prosecution Highway and Other Accelerated Filing Options — Evaluating the Different Options, Weighing the Benefits and Risks, Obtaining Patent Protection" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 12-13, 2017 – "Advanced Patent Prosecution Workshop 2017: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL

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