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  • Belden Inc. v. Berk-Tek LLC (Fed. Cir. 2015)

    By Andrew Williams —

    Federal Circuit SealDo you want the good news or the bad news first?  Well, the good news is that the Federal Circuit has begun reversing PTAB decisions on the merits for IPR proceedings.  To be fair, in the Microsoft case, the Federal Circuit remanded because the claim construction was not reasonable — and therefore could not be the broadest reasonable interpretation.  But on November 5, 2015, in Belden Inc. v. Berk-Tek LLC, the appeals court reversed the trend of affirming every Board decision related to the prior art and reversed a PTAB's obviousness determination.

    That brings us to the bad news, at least for Patent Owners.  The Federal Circuit held as obvious two claims that had been affirmed by the PTAB as patentable.  In other words, despite having the reputation of being a patent "death squad," the Board was told by the Federal Circuit that it was not invalidating enough claims (at least in this case).  Moreover, the Federal Circuit sanctioned the introduction of new affidavit testimony by the Petitioner after the Patent Owner had submitted its last response and expert testimony.  The Court did explain that the Board did not err in determining that the new evidence was limited to responding to assertions of the Patent Owner's expert.  Nevertheless, in view of the fact that no expert testimony accompanied the original petition, this case amounts to an all-around unwelcome decision for Patent Owners.

    As this case turns on obviousness, at least a cursory understanding of the technology is important.  The patent at issue, Belden's U.S. Patent No. 6,074,503, discloses and claims "a method of making a cable by passing a core and conducting wires through one or more dies, bunching the wires into grooves on the core, twisting the bunch to close the cable, and jacketing the entire assembly."  The problems solved by this invention included how to align the conducting wires to the core, and how to prevent the core from twisting independently during the process.  Claim 1 reads:

    1.  A method of producing a cable, comprising steps of:
        passing a plurality of transmission media and a core through a first die which aligns the plurality of transmission media with surface features of the core and prevents twisting motion of the core;
        bunching the aligned plurality of transmission media and core using a second die which forces each of the plurality of transmission media into contact with the surface features of the core which maintain a spatial relationship between each of the plurality of transmission media;
        twisting the bunched plurality of transmission media and core to close the cable; and
        jacketing the closed cable.

    Fig. 4 from the patent shows an assembly containing three dies (the two squares and the cone-like structure), and Figure 2 represents a cross-section of the resulting cable.

    Figures
    Claim 4 was grouped with claim 1 because it only contained the additional limitation that the core be "extruded," such that the surface features of the core align with the plurality of transmission media.  Claims 2 and 3 were grouped together because they both required the third die (represented as the biggest square in Fig. 4 above).  Finally, claims 5 and 6 were grouped because they both required that the transmission media be "twisted pairs of insulated conductors."

    Obviousness

    The Board instituted trial after Berk-Tek's predecessor in interest (Nexans, Inc.) filed a petition asserting anticipation and obviousness based on seven prior art references.  For the four original claims (claims 1-4), the Patent Office sided with the Petitioner and invalidated the claims as obvious.  For the remaining 2 claims, however, the Board concluded that, even though all of the elements were known in the art, the petitioner had not established that there was a reason to combine them.

    On appeal, the Federal Circuit found that there was substantial evidence for the Board's conclusion that claims 1-4 were obvious.  One of the primary references was a Japanese patent (Japanese Patent No. 19910, or JP '910).  Belden argued that this reference was only related to making transmission lines, but the Board noted that, among other things, the title of the JP '910 was "A method of manufacturing plastic insulated communication cables."  The PTAB also concluded that a particular board in the Japanese reference could have been used to prevent the twisting of the core.  Moreover, the Board cited to the expert report of Mr. Baxter, which included reasons why a skilled artisan would have so modified the board.  The Federal Circuit agreed that there was substantial evidence to make this conclusion.

    With regard to claims 2 and 3, Belden did not dispute that two additional prior art references disclosed a third die.  Instead, it asserted that there was no reason to combine this third die with JP '910.  However, the Board had cited to the reference in the KSR decision to predictable variations.  In other words, the Supreme Court had required consideration of factors such as "design incentives and other market forces" in determining whether a skilled artisan would have recognized the potential benefits and pursued the particular variations.  Because the PTAB made the appropriate inquiry, including considering the expert report of Mr. Baxter, the Federal Circuit was satisfied that there was substantial evidence for the Board's conclusion.

    As mentioned, the Federal Circuit disagreed with the Board with regard to claims 5 and 6, even giving it the deference that it deserved.  The PTAB had found that two pieces of prior art could be combined to teach or suggest these claims.  However, it did not think that there was any motivation to so combine these teachings.  The Federal Circuit disagreed, stating that the conclusion in the Final Written Decision did not "withstand[] scrutiny through the lens of governing law."  First, the Board had concluded that JP '910 only taught conductors that were not insulated.  However, the Federal Circuit noted that the Board had already determined that JP '910 disclosed aligning the wires with the core, and how to do so.  This alignment problem, the Court explained, did not depend on whether the wires were insulated.  A prior art reference must be considered for everything it teaches, and is not limited to the particular invention described.  In addition, the Board had found compelling the patent owner's argument that if the conductors were insulted, the final jacketing step would have been redundant.  However, the Federal Circuit pointed out that the final step did not require that the jacketing be insulted.  Finally, the patent owner had made an argument that modifying JP '910 to included twisted pairs would destroy the circular shape of the wire.  Again, the Federal Circuit pointed out that the claims did not require a circular shape.

    The most significant aspect of the Federal Circuit's decision with regard to claims 5 and 6 is that it did not vacate and remand for the Board to make the appropriate finding.  Instead, it found that the record was already sufficient to reverse the Board because the petitioner had apparently proven by a preponderance of the evidence that the claims were obvious.  For good reason, the opinion is silent about whether the same would have been true under the clear and convincing standard used by district courts.  A patent owner found in a similar situation would be wise to consider this case and convince the Federal Circuit why the Board had substantial evidence to reach the conclusion that it did.

    Motion to Exclude

    Belden also lost its challenge of the Board's denial to exclude the Baxter declaration submitted after the Patent Owner's response.  Belden had argued that the information presented in the declaration could have been, and should have been, included with the petition.  Instead, as the argument goes, Berk-Tek essentially "sandbagged" the patent owner with its reply.  Correspondingly, the patent owner complained that it lacked a fair opportunity to respond.  Nevertheless, the Federal Circuit rejected all of these arguments.

    For the first argument, the Court noted that Mr. Baxter responded to the Patent Owner response, and to the declaration submitted by Berk-Tek's expert, Mr. Clark.  Of course, little mention was made of the fact that the same arguments could have been presented before the patent owner was required to file a response, and why therefore did Mr. Clark's declaration essentially white-wash the omission.

    With regard to the second argument, the Federal Circuit pointed out that the Patent Owner had plenty of opportunity to respond.  These opportunities included, for example:

    • It had the ability to cross-examine the expert and filed observations;
    • It could have moved to exclude the declaration;
    • It could have disputed the substance of the declaration at the oral hearing;
    • It could have moved to submit a surreply;
    • It could have requested that the Board waive or suspend the regulations preventing the Patent Owner an opportunity to respond.

    For its part, the Board did hold the petitioner to a "response-only" standard for the new evidence, and ensured that the prima facie obviousness case did not rely on any new evidence.  It also provided for cross-examination and submission of observations.  Moreover, Belden moved to exclude the declaration (which the Board considered but obviously rejected).  Because the Patent Owner took advantage of several of the opportunities, it was irrelevant that the other potential opportunities did not occur.

    The take away lesson for a patent owner is to argue for as many of these alternatives as possible should a petitioner in the future undertake a similar strategy.  Of course, this does set up a potential gamesmanship opportunity for petitioners.  And, unfortunately for Belden, the guidance provided by the Federal Circuit was of little use for the patent owner in this case.

    Belden Inc. v. Berk-Tek LLC (Fed. Cir. 2015)
    Panel: Circuit Judges Newman, Dyk, and Taranto
    Opinion by Circuit Judge Taranto

  • Inphi Corp. v. Netlist, Inc. (Fed. Cir. 2015)

    By Michael Borella —

    Many patent attorneys have a visceral, disapproving reaction to negative claim limitations — elements that specify what a claim does not cover.  While a line of Federal Circuit cases has established that negative limitations are acceptable in some situations, there still is a wide gap between claiming "a binary value that is not zero" versus "a kitchen utensil that is not a fork."  In a recent decision, a Federal Circuit panel has shed more light on when such limitations can be employed without violating the written description requirement.

    NetlistInphi filed a request for inter partes reexamination in the U.S. Patent and Trademark Office (USPTO) of Netlist's U.S. Patent No. 7,532,537.  During these proceedings, Netlist amended the claims to overcome cited art, and in doing so introduced a negative limitation to an independent claim.  The examiner allowed the claims.

    Inphi then appealed to the USPTO's Patent Trial and Appeal Board (PTAB), alleging that the negative limitation resulted in the claim being invalid for lack of written description in the specification under 35 U.S.C. § 112, paragraph 1.  The PTAB affirmed the examiner's allowance, and Inphi appealed to the Federal Circuit.

    Claim 1 of the '537 patent recites:

    A memory module comprising:
        a plurality of memory devices, each memory device having a corresponding load; and
        a circuit electrically coupled to the plurality of memory devices and configured to be electrically coupled to a memory controller of a computer system, the circuit selectively isolating one or more of the loads of the memory devices from the computer system, the circuit comprising logic which translates between a system memory domain of the computer system and a physical memory domain of the memory module, wherein the system memory domain is compatible with a first number of chip selects, and the physical memory domain is compatible with a second number of chip selects equal to twice the first number of chip selects, wherein the plurality of memory devices comprises double-data rate (DDR) dynamic random-access memory (DRAM) devices and the chip selects of the first and second number of chip selects are DDR chip selects that are not CAS, RAS, or bank address signals.

    The italicized portion of claim 1 contains the negative limitation at issue, which excludes three specific types of signals.  Chip selects are typically control lines that select one or more chips out of several attached to a bus, and may be used to refer generically to the signals carried thereon.

    DRAM stores data in banks of rows and columns, analogous to a spreadsheet.  Thus, each unit where data is stored can be addressed by a row and a column.  CAS stands for column address strobe, a signal that specifies a column address.  Similarly, RAS stands for row address strobe, a signal that specifies a row address.  The combination of CAS and RAS signals allows each unit in a bank of the DRAM matrix to be addressed.  Bank address signals, on the other hand, specify which of the banks is being addressed.

    InphiInphi contended that the negative limitation was not supported by the specification of the '537 patent, and thus constitutes new matter.  In support of this notion, Inphi cited a 2012 Federal Circuit case, Santarus, Inc. v. Par Pharm., Inc., which held that "[n]egative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation."

    The PTAB identified "three parts of the specification of the '537 patent upon which it relied in finding that the negative claim limitation was reasonably supported."  In a nutshell, these parts, according to the PTAB, distinguish between chip select lines in general and CAS, RAS and bank address signals.  As a result, the '537 patent implicitly supports embodiments in which a chip select is not carrying CAS, RAS, or bank address signals.

    In its review, the Federal Circuit stated that "[w]hether a patent claim satisfies the written description requirement of 35 U.S.C. § 112, paragraph 1 depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed."  Inphi argued that a "reason to exclude" in Santarus "requires something more than properly describing alternative features of the patented invention."  Netlist took the position that "the written description requirement is satisfied when alternative features are properly described."  The Court framed the issue as "whether properly describing alternative features — without articulating advantages or disadvantages of each feature — can constitute a reason to exclude under the standard articulated in Santarus."

    The Court held that "reason to exclude" is satisfied by an express description of the disadvantages of the excluded features, or an express description of the advantages of the claimed invention without these features.  However, such descriptions are not necessary to meet the requirements of § 112 paragraph 1 for negative claim limitations.  Doing so, in the Court's view, would improperly "articulate a new and heightened standard for negative claim limitations."  As such, a "reason to exclude" can be provided by "properly describing alternative features of the patented invention."  The "reason to exclude" of Santarus is sufficient, but not necessary.

    The Court warned, however, "[t]hat is not to say that in all cases, a patentee may arbitrarily dissect its invention by amending the claims in order to avoid the prior art."  For instance, if the specification prohibits a particular negative claim limitation, addition of that limitation will render the claim invalid.

    Once again, the Federal Circuit has explained how careful specification drafting can allow the patentee more claiming flexibility down the road.  For instance, if three features of a claim, A, B, and C, are optional, one can state in the specification that zero or more of A, B, and C may be present, in any combination or permutation.  As a result, a negative claim limitation with any of A, B, and/or C can be added during prosecution or post-grant proceedings.

    Inphi Corp. v. Netlist, Inc. (Fed. Cir. 2015)
    Panel:  Circuit Judges O'Malley, Reyna, and Chen
    Opinion by Circuit Judge O'Malley

  • News from Abroad: The UPC: to Opt Out or Not to Opt Out, That Is the Question

    By Liz Cohen —

    Unified Patent CourtDid you know that in the Unified Patent Court (UPC) a patentee will be able to get an injunction covering a market much bigger than the entire USA, in a procedure that lasts no longer than a year, at a hearing which lasts a day, by Judges who will largely be without the benefit of expert testimony or discovery?  And if it all goes badly wrong a patentee could lose its patent for almost the whole of Europe all at once?

    If this sounds scary, then you probably haven't paid enough attention to the new patent litigation system which will be shortly coming into effect in Europe.  Current estimates suggest that the new Unified Patent Court will be open for business in the first half of 2017, and whilst there is provision for a transitional period for at least the first seven years of its existence, crucially, if owners of European Patents do nothing before the system comes into effect, their existing and pending European Patents automatically become part of the system.

    During the transitional period and for a short time before the UPC comes into existence (known as the sunrise period), a proprietor of a granted European patent and all future European patents can choose to register an opt out of the UPC for the patent.  There is a fee payable for doing so and each patent must be opted out individually by the proprietor (or proprietors if applicable).  It is understood that the opt-out could last for the life of the patent.

    So why might a patentee choose to opt out its European Patent?  For many patentees the reason is simple: the system is just too untried and untested to risk putting the crown jewels at its mercy. Whilst the governing Treaty and the latest draft of the rules provide some comfort as to how future patent litigation is intended to be carried out in the new court system, until the court starts rendering decisions, and those decisions are considered by the new Court of Appeal in Luxemburg, a patentee simply does not know what stance the Judges of the UPC will take on weighty issues such as claim construction, preliminary injunctions or final relief.  There is also the issue of opening up your patent to the possibility of a pan European revocation action.  With this in mind and recognising that a patentee has the ability to opt its patent back in (although a patentee can only opt out and back in again once), some patentees have indicated that they intend to opt out their patents, wait and see how the system beds down and opt back in, only when it would be beneficial for obtaining pan European relief.

    Sounds sensible.  So what's the downside to opting out?  Well, there is a school of thought that thinks that the wording of the transitional provision provides that, if during the period of the opt out, a third party starts a revocation or declaration of non-infringement proceedings under the patent in a national court for which the patent is designated, then this will block the patentee's ability to opt back into the UPC system when it chooses.  As a result, a patentee may find that as a result of its opting out decision and the subsequent action of a third party, it is permanently excluded from the UPC system for the life of the patent.  Further a decision not to opt out of the system does not necessarily mean that the UPC has exclusive jurisdiction over the opted out patent.  The wording of the transitional provision appears to explicitly provide for national proceedings to take place in relation to a non-opted out patent during the transitional period arguably providing competitors with many more options as to where and how to challenge a patent that has not been opted out.  Finally, those more seasoned litigators, who are used to creating law and testing legal systems, can see the downside of not having an opportunity to stress test the UPC system in those early years.  Surely, they say, that unless the system is used, we will never know whether it is any good and a viable option for us in the future?

    Despite many years of doubt about whether a pan European Patent Litigation Court would ever come to fruition, the reality is that it is coming and soon.  The transitional provisions, introduced in recognition of the fact that the system was not even in contemplation when many patent proprietors chose to apply for patents in Europe provides some options for patentees and challengers of patents in the immediate future.  However, once the transitional period has ended, this will be the only system in Europe for litigation of European Patents.  Whatever your view as to whether the new Court achieves its aims or not, the new Court is coming, and you can't afford to ignore it.

    Liz Cohen is a Patent litigation Partner with Bristows LLP

    This article was reprinted with permission from Bristows.

  • Court Report

            By Sherri Oslick —

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

    Vivus, Inc. v. Actavis Laboratories FL, Inc.
    2:15-cv-06256; filed August 17, 2015 in the District Court of New Jersey

    • Plaintiff:  Vivus, Inc.
    • Defendant:  Actavis Laboratories FL, Inc.; Actavis, Inc.; Allergan PLC

    Infringement of U.S. Patent Nos. 9,011,905 ("Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof," issued April 21, 2015) and 9,011,906 ("Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity" issued April 21, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Vivus' Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management).  View the complaint here.


    Noven Therapeutics, LLC v. Actavis Laboratories FL, Inc. et al.
    2:15-cv-06225; filed August 14, 2015 in the District Court of New Jersey

    • Plaintiff:  Noven Therapeutics, LLC
    • Defendant:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Andrx Corp; Actavis, Inc.

    Infringement of U.S. Patent No. 8,946,251 ("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 3, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Brisdelle® (paroxetine mesylate, used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause).  View the complaint here.


    Millennium Pharmaceuticals Inc. v. Pharmascience Inc. et al.
    1:15-cv-00702; filed August 13, 2015 in the District Court of Delaware

    • Plaintiff:  Millennium Pharmaceuticals Inc.
    • Defendants:  Pharmascience Inc.; Pharmascience Laboratories Inc.

    Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Pharmascience's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.


    Hospira Inc. v. Amneal Pharmaceuticals LLC
    1:15-cv-00697; filed August 11, 2015 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 8,242,158 ("Dexmedetomidine Premix Formulation," issued August 14, 2012), 8,338,470 (same title, issued December 25, 2012), 8,455,527 ("Methods of Treatment Using a Dexmedetomidine Premix Formulation," issued June 4, 2013), and 8,648,106 ("Dexmedetomidine Premix Formulation," issued February 11, 2014) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Hospira's Precedex® (dexmedetomidine hydrochloride injection, used for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting).  View the complaint here.


    Par Pharmaceutical, Inc. et al. v. TWi Pharmaceuticals, Inc. et al.
    1:15-cv-00698; filed August 11, 2015 in the District Court of Delaware

    • Plaintiffs:  Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd.
    • Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

    Infringement of U.S. Patent No. 9,101,540 ("Nonoparticulate Megestrol Formulations," issued August 11, 2015) and 9,101,549 (same title, issued August 11, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients).  View the complaint here.


    Boehringer Ingelheim Pharmaceuticals, Inc. et al. V. Intas Pharmaceuticals, Ltd., et al.
    1:15-cv-00664; filed August 11, 2015 in the Middle District of North Carolina

    • Plaintiffs:  Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim Corp.
    • Defendants:  Intas Pharmaceuticals, Ltd.; Accord Healthcare, Inc.

    Infringement of U.S. Patent Nos. 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014) and 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014) following a Paragraph IV certification as part of Intas' filing of an ANDA to manufacture a generic version of Boehringer's Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products.  View the complaint here.  [NB: The complaint was later voluntarily dismissed.]


    Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT, Inc. et al.
    1:15-cv-06131; filed August 11, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
    • Defendants:  Actavis Laboratories UT, Inc.; Actavis, Inc.; Allergan PLC

    Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
    1:15-cv-06132; filed August 11, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
    • Defendant:  Amneal Pharmaceuticals LLC

    Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
    1:15-cv-06134; filed August 11, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
    • Defendant:  IGI Laboratories, Inc.

    Horizon Pharma Ireland Ltd. et al. v.Taro Pharmaceuticals USA, Inc. et al.
    1:15-cv-06135; filed August 11, 2015 in the District Court of New Jersey

    • Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
    • Defendants:  Taro Pharmaceuticals USA, Inc.; Taro Pharmaceuticals Industries, Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,101,591 ("Diclofenac Topical Formulation," issued August 11, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the Actavis complaint here.


    Eli Lilly and Company v. Emcure Pharmaceuticals Ltd. et al.
    1:15-cv-01244; filed August 7, 2015 in the Southern District of Indiana

    • Plaintiff:  Eli Lilly and Company
    • Defendants:  Emcure Pharmaceuticals Ltd.; Heritage Pharma Labs Inc.; Heritage Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Emcure's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.


    AstraZeneca AB et al. v. Lupin Ltd. et al.
    3:15-cv-06092; filed August 7, 2015 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR®  (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

  • Conference & CLE Calendar

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

    November 17, 2015 - Efficient patent prosecution (U.S. Patent and Trademark Office's Silicon Valley Office) – San Jose, CA

    November 19, 2015 – "Demonstrating Jurisdiction in Hatch-Waxman Litigation After Daimler — Navigating the New Standard and Leveraging Lessons From Recent Court Treatment" (Strafford) – 1:00 to 2:30 pm (EST)

    November 19, 2015 – "USPTO's After Final Consideration Pilot: Tips to Reach Allowance" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    November 20, 2015 - 2015 Friedman Memorial Lecture on Excellence in Appellate Advocacy (Federal Circuit Bar Association) – Washington, DC

    December 2, 2015 – "USPTO's Subject Matter Eligibility: An Update" (Knowledge Group) – 3:00 to 5:00 pm (ET)

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

  • Webcast on Subject Matter Eligibility

    The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "USPTO's Subject Matter Eligibility: An Update" on December 2, 2015 from 3:00 to 5:00 pm (ET).  Michael D. Van Loy, PhD of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., and Robert R. Sachs of Fenwick & West LLP will examine the USPTO's July 2015 Interim Guidance, highlight the implications of the Guidance on patent eligibility, and provide practical advice and best strategies for drafting claims and writing applications under this latest Guidance.  The panel will cover the following issues:

    • Subject Matter Eligibility: An Overview
    • 2014 Interim Patent Eligibility Guidance
    • July 2015 New Guidance: Practical Implications and Best Practices
    • Prima Facie Case
    • Recent Decisions
    • Alice Corp v. CLS Bank
    • Mayo v. Prometheus
    •     Patent Eligibility: Best Practices for Handling Uncertainties
    • Possible Outcomes and Changes

    The registration fee for the webcast is $299 to $349 (regular rate) or $149 (government/nonprofit rate).  Those registering by November 22, 2015 will receive a $100 early bird discount.  Those interested in registering for the webinar can do so here.

  • USPTO Program on Efficient Patent Prosecution

    USPTO SealThe U.S. Patent and Trademark Office's Silicon Valley Office will be hosting a program on efficient patent prosecution on November 17, 2015 from 3:30 to 4:45 pm (PT) at the Silicon Valley USPTO, 26 S. Fourth Street, San Jose, CA.  The program will will showcase: (1) virtual interviewing capabilities and tips for conducting a successful examiner interview from San Jose; (2) searching for prior art using the search tools available in the Regional Office; and (3) utilizing the Patent Ombudsman to resolve procedural prosecution issues.

    The event is free and open to the public.  However, because space is limited, those wishing to attend must RSVP by contacting the the Silicon Valley USPTO at siliconvalley@uspto.gov.

  • IPO Webinar on After Final Consideration Pilot

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "USPTO's After Final Consideration Pilot: Tips to Reach Allowance" on November 19, 2015 from 2:00 to 3:00 pm (ET).  Tariq Hafiz of the U.S. Patent and Trademark Office; David Longo of Oblon, McClelland, Maier & Neustadt, L.L.P.; and Eli Loots of Knobbe, Martens, Olson & Bear, LLP will discuss which cases are best suited to the After Final Consideration Pilot (AFCP) and which are not, giving real-life examples of successful cases that passed through the program and others that failed. The panel will also discuss another recently-extended USPTO program aimed at the later stages of prosecution, the Quick Path Information Disclosure Statement (QPIDS) program, which can let an applicant file an IDS after the issue fee is paid without paying for reopening prosecution through an RCE.

    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.

  • Prometheus Labs., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2015)

    By Kevin E. Noonan —

    Prometheus LaboratoriesThe Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane.  In doing so, the Court might also have given an indication of the types of claims for "personalized medicine" (in the form of methods for determining treatment of subsets of individuals suffering from a particular disease)  that it would consider patentable (from one of the least patent friendly judges on the Court).

    The case involved ANDA litigation over alosetron, marketed by Prometheus as Lotronex®; this drug is used for treating irritable bowel syndrome (IBS).  The patent-in-suit was U.S. Patent No. 6,284,770 for treating a particular form of IBS (the diarrheal form, or IBS-D) with alosetron.  This patent was found obvious by the District Court over expired U.S. Patent No. 5,360,800, also owned by Prometheus; this patent claimed methods for treating IBS generically with IBS, i.e., treating both IBS-D and its alternative forms, IBS-C (for constipation) and rarer forms (IBS-M and IBS-A).  The drug is believed to work by antagonizing 5-HT3 receptors in the colon.

    The '770 patent had been the subject of reexamination, and Prometheus asserted reexamined claims 5, 10, and 13 (and dependent claims) against Roxane:

    1. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising:
          assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months; and
                administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.
    2. The method for treating according to claim 5, further comprising assessing whether said female IBS patient has experienced at least moderate pain prior to administration of alosetron.
    3. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising:
          assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months;
          assessing whether said nonconstipated female IBS patient experiences at least moderate base- line pain from IBS; and
          administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months and who experiences at least moderate baseline pain from IBS, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.

    (where underlined portions of the claims indicate amendments made during ex parte reexamination, and italicized portions indicate claim terms at issue before the Court.)

    Roxane LaboratoriesThe opinion notes as relevant background that administering alosetron carries sufficient risk that the FDA has placed a "black box" warning on the drug, and that patients having the IBS-C form of the disease should not take it.  These population limitations are in the claims, specifically that the drug should be administered to patient with the IBS-D form of the disease, who have had chronic symptoms for at least six months.  Importantly for both the District Court and the Federal Circuit, limiting the patient population did not reduce the rate at which adverse effects occurred (but did reduce the number of adverse events, since fewer patients were taking the drug).  Even then the District Court found that this reduction in adverse event rate was due to other changes in how the drug was prescribed and not due to any limitations recited in the claims.

    The District Court in the ANDA litigation below found that the asserted claims of the '770 patent were obvious even when considered in light of the secondary considerations (long-felt need, expected results, commercial success) raised by Prometheus.  Instead, the District Court found that the claims merely recited elements present in the prior art for which the skilled worker would have had a reasonable expectation of success.  The District Court based its conclusion on the near identity of the prior art to the claimed invention, and also because what difference there was between the art and the claims was "insubstantial."  (In the alternative, the Court found that the claims were also invalid over the '800 patent under the judicially created obviousness-type double patenting (OTDP) doctrine, but the Federal Circuit did not reach the correctness of this determination.)

    The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judges Taranto and Hughes.  The panel appreciated that the '800 patent was the principle prior art reference applied by the District Court against the '770 patent claims in deciding the obviousness question, but that the Court also relied upon scientific references related to IBS and methods for treating the disease.  Like the parties and the District Court, the Federal Circuit considered the relationship between the '800 patent claims and the asserted claims of the patent-in-suit to be between an earlier disclosed genus and a later claimed species, wherein the '800 patent claimed treating IBS sufferers with alosetron and the '770 patent claimed treating only a subset of these patients.  Specifically, the opinion defines this subset as being "(1) [] women (2) with IBS-D (3) who have experienced symptoms for at least six months and (4) who have had moderate pain."  The opinion recognizes that in some cases a species can be patentable over a prior art genus, citing  AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1372 (Fed. Cir. 2014) (in the context of OTDP), and Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270 (Fed. Cir. 2003) (with regard to statutory obviousness).

    The opinion then addressed and rebuts the distinctions raised by Prometheus for the '770 patent claims and the prior art.  The first is that the claims asserted here are limited to women with IBS-D, but the Court cites prior art research papers that disclosed that 75-80% of IBS-D sufferers are women, and in particular that there was evidence in the art that female IBS-D sufferers treated with alosetron had higher concentrations in their blood than men, suggesting that the drug would be more effective ("[t]his could reasonably suggest that women would have a greater response to the drug than men," citing a study by Hysu from 1995, two years prior to the earliest priority date to which the '770 patent was entitled).  Next was the limitation that alosetron only be administered to women with IBS-D.  The Federal Circuit noted that the District Court had based its rejection of this limitation as distinguishing over the '800 patent on prior art scientific articles teaching that the 5-HT3 inhibitors (like alosetron) "slowed colonic transit" (although alosetron itself was not tested) and that the skilled worker (a gastroenterologist with three years of experience) would have recognized that this action would benefit IBS-D sufferers and potentially harm patient with IBS-C.  Extrapolating results obtained using healthy volunteers rather than IBS-D sufferers made no difference to the panel because it was supported by expert testimony that the District Court was entitled to rely upon.

    With regard to the limitation concerning duration of IBS-D symptoms ("at least six months), the Federal Circuit held that this was common practice, noting that there was ample support in the prior art for this practice and that even Prometheus' own expert had conceded as much.  Similarly the District Court found and the Federal Circuit agreed that assessing pain was one of the criteria for diagnosing IBS.  In addition, the opinion states that conservative medical treatment was consistent with limiting the patient population administered alosetron to those patients in at least moderate pain in view of the known risks associated with this treatment.

    [The opinion also cites the decision in the AbbVie case, another case where Judge Dyk wrote the opinion, as being analogous to the situation here.]

    Turning to the secondary considerations (or objective indicia of non-obviousness), the opinion one again illustrates the importance of establishing a nexus between the asserted secondary consideration and the non-obviousness of the claimed invention.  For commercial success, the panel opines that the evidence supported the District Court's conclusion that Prometheus had not rebutted Roxane's prima facie case of obviousness based on commercial success because it had not shown sufficient nexus between that success and the limitations in the claims.  Indeed it was worse than this, because the panel believed that there was only weak evidence of increased commercial sales of alosetron after the '770 came out from reexamination.  The District Court concluded that it was marketing, not patenting, that was responsible for whatever success Prometheus could assert and the panel found no reason to second guess that decision.

    [In this regard the opinion takes the opportunity to consider the differences between the burden of proof, which never shifts from the accused infringer to the patentee, and the burden of production:  ""once a challenger has presented a prima facie case of invalidity, the patentee has the burden of going forward with rebuttal evidence.  But, all that means is that even though a patentee never must submit evidence to support a conclusion by a judge or jury that a patent remains valid, once a challenger introduces evidence that might lead to a conclusion of invalidity — what we call a prima facie case — the patentee would be well advised to introduce evidence sufficient to rebut that of the challenger," citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1360 (Fed. Cir. 2007).]

    Finally, the opinion rejects Prometheus' challenge to the District Court's decision with regard to unexpected results and long-felt but unmet need, saying that the need was met by "the drug itself, which is covered by the '800 patent" and that the supposed unexpected results were caused by "the new safety precautions, heightened awareness, and warnings issued after Lotronex's reintroduction."

    One interesting portion of the opinion is this:

    The genus-species distinction may have particular relevance in the field of personalized medicine, where, for example, a particular treatment may be effective with respect to one subset of patients and ineffective (and even harmful) to another subset of patients.  See, e.g., Margaret A. Hamburg & Francis S. Collins, The Path to Personalized Medicine, 363 New Eng. J. Med. 301, 301 (2010).  Singling out a particular subset of patients for treatment (for example, patients with a particular gene) may reflect a new and useful invention that is patent eligible despite the existence of prior art or a prior art patent disclosing the treatment method to patients generally.  An obviousness rejection likely would not be appropriate where the new patient subset displayed unexpected results.  But that is not the situation here.

    While admittedly dicta, this passage suggests a willingness by this panel to consider the appreciation of specific patient populations for whom it is desirable (or not) to be administered a particular treatment for a particular disease.  Much of the current discussion on this topic has focused on patent eligibility and rightfully so in view of the recent spate of Supreme Court decisions.  But insofar as those decisions blend concepts of patent eligibility with traditional (Supreme Court) ideas regarding "inventiveness" and "invention," it is certainly noteworthy that this panel seems to indicate that these types of claims, in this context, may recite the ineluctable "something more" that has so far eluded courts and patentees from defining or deciding whether such claims can be obtained or enforced.  It is only a glimmer but perhaps it is a start.

    Prometheus Labs., Inc. v. Roxane  Labs., Inc. (Fed. Cir. 2015)
    Panel: Circuit Judges Dyk, Taranto, and Hughes
    Opinion by Circuit Judge Dyk

  • Ex parte Jung (PTAB 2015)

    Computer-Readable Medium Claims vs. Printed Matter

    By Joseph Herndon —

    USPTO SealMost software or computer-related patent applications today include a number of different types of claims, such as method claims, device claims, and computer-readable medium (CRM) claims.  Such CRM claims are usually directed to an article of manufacture, for example, a computer-readable medium, on which are encoded, typically, instructions for carrying out a method.  This type of claim is often referred to as a Beauregard or a CRM claim, named after the decision In re Beauregard 53 F.3d 1583 (1995), in which the Federal Circuit noted that computer programs embodied in a tangible medium, such as floppy diskettes, are patentable subject matter under 35 U.S.C. § 101.  Prior to this decision, claims to pure computer instructions were generally considered not patentable because they were viewed as "printed matter," that is, a set of instructions written down on paper as noted in an old U.S. Court of Customs and Patent Appeals case In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) ("printed matter by itself is not patentable subject matter, because [it is] non-statutory . . .").

    A recent decision by the Patent Trial and Appeal Board (PTAB) at the U.S. Patent Office again considered a CRM claim type not patentable because it was viewed as "printed matter."

    On September 28, 2015, the Patent Trial and Appeal Board (PTAB) at the U.S. Patent Office issued a decision captioned Ex parte Edward K.Y. Jung, Royce A. Levien, Robert W. Lord, Mark A. Malamud, and John D. Rinaldo (Appeal 2013-003143; Application 12/799,367; Technology Center 2600).  A number of issues were appealed, and only the appeal of rejections of claims under 35 U.S.C. § 101 is discussed here.

    In particular, claim 95 was rejected under 35 U.S.C. § 101 because the claimed subject matter was found to be nonfunctional descriptive material.  Claim 95 is reproduced below:

    95.  One or more non-transitory media bearing one or more instructions for facilitating operations comprising:
        obtaining at least one image representation from at least one image capture device;
        identifying one or more entities authorized to receive the at least one image representation obtained from the at least one image capture device based on at least one indication of at least one subset list of one or more individuals selected from at least one larger list; and
        transmitting at least one portion of the at least one image representation obtained from the at least one image capture device to at least some of the one or more entities identified as being authorized to receive the at least one image representation obtained from the at least one image capture device.

    During prosecution, the Examiner had concluded that claim 95 encompasses non-functional descriptive matter because it recites instructions on non-transitory media without reciting that the non-transitory media is used or usable with a computer or machine.  The Examiner explained that "the scope of the presently claimed non-transitory media can range from paper on which the program is written, to a program simply contemplated and memorized by a person."

    The Appellants contended that the Examiner erred because the Examiner improperly applied the machine or transformation test to reject the claim under § 101.

    However, the PTAB was not persuaded by the Appellants.  The PTAB stated that Claim 95 is not a claim to a process, but rather it is a claim to media bearing instructions for a process.  The PTAB stated that the Examiner has found, and the Board agreed, that claim 95 does not preclude embodiments that are merely printed instructions on paper, which is a non-transitory medium.  The Board stated that claim 95 did not recite any new and unobvious relationship of the instructions with its substrate.  The Board held that because of the finding of claim 95 encompassing printed matter by itself, the rejection of claim 95 under § 101 was affirmed.

    Here, although claim 95 appears to recite functions performed by devices within the claim limitations (e.g., "obtaining at least one image representation from at least one image capture device…"), the preamble of the claim sets forth the statutory category by which the claim is judged.  The preamble here in claim 95 is somewhat different from other traditional forms of CRM claims because the preamble only recites "One or more non-transitory media bearing one or more instructions for facilitating operations comprising".  The preamble itself recites that the non-transitory media bears instructions, but no further details of the media are given.  Thus, using a broadest reasonable interpretation of non-transitory media, the Patent Office is able to consider such media as anything on which the instructions are provided and last for more than a short period of time, such as secondary or persistent long term computer storage like read only memory (ROM), optical or magnetic disks, compact-disc read only memory (CD-ROM), for example, or more generically, such media here can include paper.  Thus, this preamble in claim 95 can really cover any and all types of non-transitory "media".

    Consequently, given the broadest reasonable interpretation of the term "media", the Examiner found that in claim 95, "media" can include paper on which the instructions are written, and thus, the printed matter rejection was issued and affirmed on appeal.

    This may be a subtle or over-looked issue with respect to CRM claims, in that, although the claim is directed to the "non-transitory media", it is best practice to recite in the preamble that the media is used or usable with a computer or machine.  Another common preamble that satisfies this requirement would include "A non-transitory computer readable medium, having stored thereon, instructions that when executed by a computing device, cause the computing device to perform operations comprising…".  Of course, other variations of this preamble are possible, but when reciting that the instructions are stored on the medium and executed by a computing device, this is more likely to be interpreted by the U.S. Patent Office outside of the realm of printed matter.

    Also, today most Examiners require the term "non-transitory" to be included in the preamble of CRM claims.  Sometimes, Applicants try to avoid this term by reciting the preamble as "An article of manufacture including…" or other language specifically stating a physical/tangible storage device that stores the instructions.  But, due to a memo titled "Subject Matter Eligibility of Computer Readable Media" issued by the U.S. Patent Office on January 26, 2010, Examiners usually quote the memo and require that the claim recite the media as "non-transitory" media.  This memo indicated that the broadest reasonable interpretation of a claim drawn to a computer readable medium typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent.  The USPTO noted that when the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter based on the decision In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007).  The USPTO recognized that to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggested that such CRM claims that cover both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim.  And it is this language of the memo that is often quoted by Examiners within a rejection under 35 U.S.C. § 101 of any CRM claims that lack the terminology "non-transitory".

    Generally, it is not much of an issue to draft CRM claims to recite "non-transitory" and to recite that the media is used or usable with a computer or machine because the invention is not realistically limited in any narrower way by doing so.  In any event, Applicants may not have much of a choice due to the lessons learned here from the PTAB.

    Ex parte Jung (PTAB 2015)
    Before Administrative Patent Judges Thomas, Winsor, and Trock
    Decision on Appeal by Administrative Patent Judge Winsor