Patent Law Weblog

recent posts

about

  • John Marshall Law School 60th Annual IP Law Conference

    JMLSThe John Marshall Law School Center for Intellectual Property Law will be holding its 60th Annual Intellectual Property Law Conference on February 26, 2016 in Chicago, IL.  The conference will consist of the following sessions:

    • Recent Developments in Intellectual Property Law
    • Keynote speaker — Probir Mehta, Acting Assistant U.S. Trade Representative for Intellectual Property & Innovation

    The conference's afternoon patent track will consist of sessions on:

    • Patent Office Perspectives — Christal Sheppard, Ph.D., Director, Midwest Regional USPTO
    • Judges Panel on ADR and Patent Litigation Issues
    • Lexmark and Patent Exhaustion in the Federal Circuit
    • Drafting and Prosecuting Patents in the Present Challenging Patenting Environment
    • Thwarting Challenges to Patents in IPRs

    Additional information about the conference, including an agenda and complete list of speakers, can be found here.  Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).

  • Webinar on Patent Law Year in Review

    Clear Law InstituteClear Law Institute will be offering a webinar entitled "Patent Law Year in Review — 2015 and a Look Ahead to 2016" on February 24, 2016 from 3:00 – 4:15 pm (ET).  Andrew R. Sommer of Winston & Strawn LLP will review key Supreme Court and Federal Circuit decisions from 2015 and important decisions that will be handed down in 2016.

    The registration fee for the program is $199.  Those interested in registering for the program, can do so here.

  • Driessen v. Sony Music Entertainment (Fed. Cir. 2016)

    By Joseph Herndon —

    Federal Circuit SealOn February 10, 2016, the Federal Circuit issued a nonprecedential opinion in a case captioned Driessen v. Sony Music Entertainment, Best Buy Stores, Fye, & Target Corp. addressing issues related to means-plus-function claims and written description.  While the decision is nonprecedential, it serves as a reminder to provide detailed descriptions of claim terms and to use means-plus-function terms sparingly.

    James L. Driessen is the named inventor on U.S. Patent Nos. 7,003,500 ("the '500 patent"), 7,636,695 ("the '695 patent"), and 7,742,993 ("the '993 patent").  Mr. Driessen and his wife sued Sony Music Entertainment, Best Buy Stores, FYE, and Target (collectively "Sony"), alleging infringement of these patents in the U.S. District Court for the District of Utah.  The District Court granted Sony's motions for summary judgment, finding some of the asserted claims of the '500 patent invalid as indefinite, and some of the asserted claims of the '500 patent, all claims of the '695 patent, and all claims of the '993 patent invalid for lack of written description.

    All three patents have virtually the same specification and relate to systems and methods of purchasing downloadable content from the Internet.  Rather than purchasing the content directly through the Internet, the buyer goes to a retail store to pay for the item in person.  At the retail store, the buyer obtains a ticket or other "physical medium" proof of sale containing a web address specific to the item sold and a unique password that will enable its download.  The buyer can then anonymously download the media content from any computer with Internet access by going to the web address and inputting the unique password provided.

    Indefinite Claims

    Claim 1 of the '500 patent, which contains several means-plus-function elements, provides,

    1.  A payment system for itemized Internet merchandise or itemized downloadable media material objects, comprising:
        a retail point of sale establishment;
        a customer access point at said retail point of sale establishment;
        URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
        means for accepting payment through an in person transaction with a customer wherein said payment is designated for purchase of said itemized Internet merchandise or itemized downloadable media material objects;
        means for storing and retrieving a record on or in a physical medium corresponding to said URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
        means for transfer of said physical medium from said retail point of sale establishment to said customer; and
        means for Internet transaction authorization on, in, or actuated from said physical medium wherein ownership rights in said itemized Internet merchandise or itemized downloadable media material objects are preselected and transferred to said customer through said transfer of said physical medium.

    Primarily at issue in the case is the "means for storing and retrieving a record on or in a physical medium" limitation.  This claim element was construed pursuant to 35 U.S.C. § 112(f), in which the function is identified and then the specification is analyzed to determine what is described as performing the identified function.  The District Court found that the function of this element is "storing and retrieving a record on or in a physical medium".  Specific terms of this element were then construed in which "storing" was construed to mean "both putting into storage and holding in storage," "retrieving" was construed to mean "taking out of storage for the purpose of presenting authentication to prove purchase," "record" was construed to mean a "unique URL corresponding to specific web merchandise or content," and "on or in a physical medium" was construed to mean the location where "the record is stored and from where it may be retrieved."

    A means-plus-function claim is indefinite unless structure to perform the function is identified in the specification.  Here, the District Court rejected the Driessens' contention that Figure 5 (a portion of which is reproduced below) — which depicts an "Admit One" ticket and a floppy disk — provides the necessary structure to correspond with the above function.

    The District Court explained that while Figure 5 perhaps discloses examples of "physical media," it does not disclose a structure that "stor[es] and retriev[es] a record on or in a physical medium."  The disk lacks structure for retrieving any record.  Thus, because the specification failed to disclose any such associated structure for "storing" and "receiving" the record in a physical medium, the claims were held invalid as indefinite.

    The Federal Circuit agreed with the District Court, and noted that in the context of storing "a record on or in a physical medium," it is apparent that "store" implies not only maintaining the record in a physical medium, but also getting it there to begin with.  The fact that necessary structures for performing a "means for storing and retrieving a record on or in physical medium" were known in the art does not save the claims.  For means-plus-function claim terms, the inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure.  Accordingly, a bare statement that known techniques or methods can be used does not disclose structure.

    Lack of Written Description

    A portion of claim 10 of the '500 patent provides:

    10.  A method of merchandise transfer on a computer network comprising at least one buyer computer on a network for operation by a user desiring to buy at least one product and at least one selling computer on said network operating for a purpose to sell said product, the method comprising the steps of: . . .
        sending a payment message as a response to said in person transaction either directly or through other computers on said network to said selling computer on said network;
        causing an authorization message to be created on said selling computer in or as a result of said payment message that comprises at least said specification of said product and authentication based on cryptographic key(s), said selling computer being programmed to receive said authorization message for verification of said authentication; . . .

    The three terms "selling computer," "payment message," and authorization message," which first appeared when Mr. Driessen added new claims by amendment more than four years after filing the original application that became the '500 patent, also appear in all asserted claims of the '695 and '993 patents.

    The District Court found that no written description for "selling computer," "payment message," or "authorization message" is provided anywhere in the specification or original application.  The Driessens argued that the terms were implicitly present in the original application, but the District Court held that the asserted description of "secure web transactions" and "public key infrastructure" in these patents did not necessarily provide for "payment messages" or "authorization messages," let alone require such messages to be sent to or from "selling computers."

    The Federal Circuit agreed with the District Court and cautioned that when a patent applicant adds new claims after the original filing date, the new claims must find support in the original specification.  The question becomes whether one of ordinary skill in the art would consider the added claim terms to be supported by the specification as originally filed.

    Here, the terms added by amendment of "selling computer," "payment message," and "authorization message" are not present anywhere in the specification or original provisional application.  The fact that the words "payment," "message," "authorization," and "computer" appear individually numerous times in the specification does not provide adequate written description for the terms "selling computer," "payment message," and "authorization message" as defined in the claims.  The Federal Circuit cited LizardTech and noted that the mere presence of these words in isolation does not suffice to show that the "patentee had possession of" the "selling computer," "payment message," and "authorization message" elements of the claimed invention at the time of the application, as 35 U.S.C. § 112(a) requires.

    Thus, the Federal Circuit affirmed the District Court's conclusion that such claims are invalid for lack of written description.

    This case serves as a lesson for using means-plus-function terms sparingly and carefully, and for having clear support in the specification for all amendments entered during prosecution.  From a point of personal experience, recently, it feels like U.S. patent examiners seemingly have been told to have a heightened scrutiny with respect to section 112 issues requiring very specific support in the specification for all claim terms.  While the requirements in the U.S. Patent Office are not as strict as seen in foreign jurisdictions (e.g., the EPO requires near verbatim or one-to-one use of terminology in the claims as seen in the specification), it does appear that the standards at the U.S. Patent Office have been raised somewhat.

    Driessen v. Sony Music Entertainment (Fed. Cir. 2016)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Mayer, and Hughes
    Opinion per curiam

  • Celltrion’s Proposed REMICADE® Biosimilar Recommended for Approval

    By Andrew Williams —

    CelltrionEarlier today, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody.  According to a press release from Celltrion, the committee voted 21-3 to recommend approval for all sought indications, including treatment of a variety of autoimmune diseases such as Crohn's disease, ulcerative colitis, and rheumatoid arthritis.  This would be the second biosimilar ever approved in the United States (U.S.) pursuant to the Biologics Price Competition and Innovation Act (BPCIA), and the first biosimilar therapeutic monoclonal antibody.  If the experience with Sandoz's ZarxioTM biosimilar is any indication, the FDA should be expected to approve the application in the next couple of months.  Marketing of the drug may be delayed, however, pending the outcome of Janssen's motion for partial summary judgment and a preliminary and permanent injunction.  A key consideration of that case is the Federal Circuit's Amgen v. Sandoz decision and its interpretation, which may delay marketing for an additional six months because the Notice of Commercial Marketing cannot be effective until approval by the FDA.

    FDALast week, in advance of today's meetings, staff at the FDA released a briefing document in which they reported that the data submitted by Celltrion showed "that CT-P13 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between CT-P13 and US-licensed Remicade in terms of the safety, purity, and potency of the product."  Importantly, much like Sandoz's experience with Zarxio, Celltrion benefited from the fact that CT-P13 has already been approved outside the U.S. for similar indications.  For example, in the EU, South Korea, Japan, and India, Celltrion's biosimilar has been approved for all US-approved indications under the trade names Inflectra and Remsima (although no name has yet been assigned to the U.S. version of the drug).  In Canada, however, the same drug has been approved for all indications except ulcerative colitis and Crohn's Disease.  Because the development of CT-P13 occurred entirely outside of the U.S., Celltrion had to provide additional comparative data — in order to "scientifically justify the relevance of that data by establishing an adequate scientific bridge between EU-approved Remicade, the US-licensed reference product and CT-P13."  The FDA explained that this bridging data should always include results from analytical studies, such as structural and functional data that directly compares all products, and should also include bridging PK and/or PD clinical data.

    The FDA's briefing document also said that Celltrion had "provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use and potential licensure of CT-P13 for each of the seven indications for which US-licensed Remicade is currently licensed and for which CT-P13 is eligible for licensure."  Celltrion is seeking to market CT-P13 for the following indications: (1) Crohn's Disease (CD), (2) Pediatric CD, (3) Ulcerative Colitis (UC), (4) Rheumatoid Arthritis, (5) Ankylosing Spondylitis, (6) Psoriatic Arthritis, and (7) Plaque Psoriasis.  In addition, Celltrion is seeking approval for Pediatric CD, but according to the briefing, this indication is protected by orphan drug exclusivity until September 23, 2018.  Unlike in Canada, the committee recommended approval for all sought-after indications in the U.S.

    Once the FDA accepts the committee's recommendation and approves Celltrion's application, it may still be at least six months before the biosimilar drug can be marketed.  Unlike Sandoz in the case of Zarxio, Celltrion provided Janssen with its aBLA after it was accepted by the FDA.  Nevertheless, according to the Complaint filed by Janssen in the U.S. District Court for the District of Massachusetts, Celltrion refused to provide the requisite "other information" required by the BPCIA, which would describe the manufacturing process.  Moreover, Celltrion served a notice of commercial marketing on February 5, 2015, indicating that it would begin selling the product as early as August 4, 2015.  Of course, even though this notice occurred after Celltrion's application was accepted, it was significantly before actual approved (especially considering the biosimilar is not yet approved).  Celltrion has responded to Janssen's injunction motions by alleging that the Notice-of-Commercial-Marketing provision of the BPCIA is not a stand-alone provision and that because it took part in the "Patent Dance," it is not required to give such notice.  While Janssen's motion is pending, the Federal Circuit will be considering the almost identical issue in the Amgen v. Apotex case, which we will preview in an upcoming post.

    Nevertheless, the committee's vote today is especially significant considering the intense interest focused on biosimilar therapeutic antibodies.  Going into this meeting, there was a lot of uncertainty about just how much information the FDA would require in order for a biosimilar applicant to establish "no clinically meaningful differences" between its biosimilar drug and the reference product.  Of course, Celltrion benefited from extensive data that it had already generated outside of the U.S.  It therefore remains to be seen just how much data the FDA will require for biosimilar therapeutic antibodies that do not have such a history.

  • Avid Technology, Inc. v. Harmonic, Inc. (Fed. Cir. 2016)

    Lesson for Defendant-Appellee's: Provide Responsive Arguments on Appeal

    By Joseph Herndon —

    Federal Circuit SealOn January 29, 2016, the Federal Circuit issued an Opinion in Avid Technology, Inc. v. Harmonic, Inc. in which the judgment of the District Court was vacated, and the case was remanded for a new trial on infringement.  Avid asserted two patents against Harmonic, U.S. Patent No. 6,760,808 and No. 7,487,309.  Both patents concern data storage systems that allow users to store and retrieve large files, such as movies.  The main focus of the error in the District Court's judgment, as found by the Federal Circuit, was reliance on prosecution history statements for a disclaimer of claim scope.  The Federal Circuit thus remanded for a new trial based on a different claim construction.  More importantly, however, due to defendant Harmonic's failure to make certain arguments on appeal, Harmonic effectively has lost the opportunity to argue for non-infringement during the new trial.

    Turning to the asserted patents, in the system described by Avid's patents, when a client wishes to store ("write") a file, such as a movie, the system splits the file into "segments."  The segments are distributed among various storage units and stored in duplicate at different units (one primary unit and one backup).  The system creates and updates segment tables listing file segments and their storage-unit locations.  The segment tables may be stored together, as a catalog, and the catalogs may be stored on a catalog manager, at individual clients, at a central database, or may be distributed among several databases or clients.  When a client wishes to retrieve ("read") a file, the client determines which storage units have the needed segments, and sends a request for a given segment to a storage unit, which transmits it to the client.

    Claim 1 of the '808 patent is illustrative of the claims:

    1.  A distributed data storage system for allowing one or more client systems to access data, comprising:
        a plurality of independent storage units for storing the data;
        wherein the data is stored on the plurality of storage units in files, wherein each file includes segments of data and redundancy information for each segment, wherein each segment has an identifier, and wherein, for each file, the segments and the redundancy information for each segment are distributed among the plurality of storage units;
        wherein each storage unit comprises: means for maintaining information associating the identifier of each segment stored on the storage unit with the location of each segment on the storage unit; means for receiving a request from one of the client systems for a segment of a file, wherein a request includes the identifier of the segment of the file; and
        means, operative in response to a request from one of the client systems for a segment of a file, for retrieving the requested segment of the file from the storage unit using the information associating the identifier of each segment stored on the storage unit with the location of each segment on the storage unit; and
        means for sending the requested segment to the client system.

    The italicized phrases are the focus of this case.  The District Court gave the jury a claim construction of the "independent storage unit" claim element, basing that construction on statements Avid made in the prosecution history.

    The second italicized claim element at issue went to the jury without a clarifying construction, over neither party's objection.  The jury rejected Harmonic's validity challenge to Avid's patents, but found that Harmonic did not infringe.  Avid challenged the non-infringement judgment by post-trial motions and argued that the District Court's claim construction regarding the "independent storage unit" element was incorrect and that, under a correct claim construction, that claim element is clearly met.  Avid appealed the non-infringement judgment.

    Prosecution History Estoppel – Disclaimer?

    The District Court ruled that, during prosecution, Avid had disclaimed a system in which the central controller tells the client which storage unit the client should deal with during read and write operations.  On that basis, the District Court instructed the jury that "independent storage units" means "storage units which are not centrally controlled and whose memory addresses are not globally allocated" and that "systems with independent storage units cannot use a central controller to access data, and, in particular, cannot use a central controller that identifies the storage unit on which data is stored in response to client requests."

    The Federal Circuit found that the District Court erred with this claim construction because the standard for finding a disclaimer was not met.  The Federal Circuit noted that "for prosecution disclaimer to attach, our precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable."  But, where the alleged disavowal is ambiguous, or even "amenable to multiple reasonable interpretations," the Federal Circuit has declined to find prosecution disclaimer.

    The District Court relied on two passages from an Avid submission during the prosecution history including:

    [T]he claimed system, by virtue of the independent storage units, avoids using a central controller to access data.  In particular, storage units "receiv[e] . . . request[s] from one of the client systems for a segment of a file."  Clients do not issue requests to a central controller that in turn identifies storage units that store the data and issues requests to storage units.

    The Federal Circuit found that the District Court misread this passage.  In the Federal Circuit's opinion, the first portion does not itself say what exactly "access[ing] data" entails; it is the second portion that identifies what Avid means.  What that portion says, by its terms, is that a central controller is excluded if it performs both of two functions:  it "identifies storage units that store the data and issues requests to storage units."  The language on its face does not exclude a central controller that performs only one or the other of the two stated functions — which would have been the meaning if the phrase had used "or" rather than "and."  In any event, it does not do so clearly, as would be required to find a disclaimer of a central controller that merely identifies the storage units.

    In short, the Federal Circuit found no clear and unmistakable disclaimer of central controllers that provide storage-unit location information for retrieving segments.  The jury instruction limiting "independent storage units" in that way was incorrect.

    Vacate Judgment, New Trial, Judgment of Infringement?

    Now that the Federal Circuit found such an error, what action is necessary?  The error, undisputedly preserved for review, concerned the legal standard (claim construction) for evaluating a central element of the infringement dispute.  The error requires at least vacatur of the verdict and a remand for a new trial unless the Federal Circuit can conclude that the error was not prejudicial, i.e., was harmless.

    Because there was no separate jury determination of non-infringement on a distinct ground, the error in the instruction governing this central dispute at trial would be harmless only if a reasonable jury would have been required by the evidence to find non-infringement even without the error.

    But Harmonic did not even argue for that conclusion.  The Federal Circuit noted that nowhere in its brief did Harmonic argue that the jury was required to find non-infringement — on any ground — even if the "independent storage units" element permits a central component that supplies storage-unit-location information to a client wishing to retrieve data from storage units.  In particular, Harmonic did not argue that the evidence required a non-infringement finding based on the other claim element in dispute; its only argument regarding the second at-issue element was that the jury could reasonably find that element not to be met by the infringing product.  That is not enough, because the Federal Circuit cannot infer that the jury did so find.  Similarly as to the "independent storage units" element itself:  Harmonic nowhere argued that, even if the construction given to the jury was wrong, the evidence still required a finding that the infringing product lacks the required independent storage units.

    In short, the Federal Circuit found that Harmonic made no argument under the proper legal standard to answer Avid's argument that the instructional error was prejudicial, requiring a new trial.  Thus, the Federal Circuit was at least required to remand for a new trial.

    Avid actually took its argument one step further to contend that, once the legally erroneous narrowing of the claim construction is reversed, the evidence not only permits but requires a finding that Harmonic's system meets the "independent storage units" claim element.  And, Harmonic still presented no argument to the contrary!!

    Given that, in response to Avid's argument, Harmonic has simply not suggested an alternative claim construction on this point, or argued that any such alternative claim construction could be found not to reach the alleged product, satisfaction of this claim requirement is now settled.  The Federal Circuit thus stated that infringement as a whole is to be retried, but Harmonic's assertion of non-infringement based on this claim element is not, thus narrowing the scope of issues for the new trial on remand.

    Thus, because Harmonic did not properly present arguments for non-infringement in the alternative using the suggested claim construction, or even provide responsive arguments to Avid's position of infringement in view of their proposed claim construction, Harmonic effectively waived the opportunity to do so at the new trial.  Thus, the error on this central trial issue required setting aside the non-infringement verdicts, which were general verdicts as to each patent, but because Harmonic did not argue that the evidence compels a finding of non-infringement independently of the construction error, satisfaction of this particular claim element is now settled.

    With respect to the second claim term at issue, the Federal Circuit rejected the contention that the evidence allows a reasonable finding of infringement.  The case went to the jury without a construction of the key claim language, and Avid did not meet its burden of showing that it has the only reasonable view of the claim element as long as it is un-construed.  As a result, the Federal Circuit stated that Avid has not shown entitlement to more than a new trial, and thus, no entry of a judgment of infringement was made by the Federal Circuit.  But, Avid received a vacatur of the judgment and a new trial in which infringement of a central claim element is satisfied providing for a second opportunity to convince another jury that Harmonic infringes.

    Avid Technology, Inc. v. Harmonic, Inc. (Fed. Cir. 2016)
    Panel: Circuit Judges Reyna, Taranto, and Stoll
    Opinion by Circuit Judge Taranto

  • Court Report

            By Sherri Oslick —

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

    Astellas Pharma Inc. et al. v. Apotex Inc. et al.
    1:15-cv-00857; filed September 22, 2015 in the District Court of Delaware

    • Plaintiffs:  Astellas Pharma Inc.; Astellas US LLC; Astellas Pharma US, Inc.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 6,107,458 ("Cyclic Hexapeptides Having Antibiotic Activity," issued August 22, 2000) and 6,774,104 ("Stabilized Pharmaceutical Composition in Lyophilized Form," issued August 10, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Astellas' Mycamine® (micafungin sodium, used for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; esophageal candidiasis; and prophylaxis of Candida infections in hematopoietic stem cell transplant recipients).  View the complaint here.


    Taro Pharmaceuticals U.S.A., Inc. et al. v. Perrigo UK FINCO Limited Partnership
    1:15-cv-00859; filed September 22, 2015 in the District Court of Delaware

    • Plaintiffs:  Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceuticals North America, Inc.
    • Defendant:  Perrigo UK FINCO Limited Partnership

    Infringement of U.S. Patent Nos. 8,277,780 ("Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity" issued October 2, 2012) and 8,715,624 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Taro's Topicort® (desoximetasone topical spray, used for the treatment of plaque psoriasis).  View the complaint here.


    AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al.
    1:15-cv-07009; filed September 21, 2015 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; Astrazeneca UK Limited; AstraZeneca AB
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.

    Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  View the complaint here.


    Bayer Pharma AG et al. v. Alembic Pharmaceuticals Limited et al.
    1:15-cv-00832; filed September 18, 2015 in the District Court of Delaware

    • Plaintiffs:  Bayer Pharma AG; Bayer Intellectual Property GMBH; Bayer HealthCare Pharmaceuticals Inc.
    • Defendants:  Alembic Pharmaceuticals Limited; Alembic Global Holding SA; Alembic Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 8,613,950 ("Pharmaceutical Forms With Improved Pharmacokinetic Properties," issued December 4, 2013) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Bayer's Staxyn® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.


    Amgen Inc. et al. v. Hospira, Inc.
    1:15-cv-00839; filed September 18, 2015 in the District Court of Delaware

    • Plaintiffs:  Amgen Inc.; Amgen Manufacturing, Ltd.
    • Defendant:  Hospira, Inc.

    Infringement of U.S. Patent Nos. 5,856,298 ("Erythropoietin Isoforms," issued January 5, 1999) and 5,756,349 ("Production of Erythropoietin," issued May 26, 1998) based on Hospira's filing of a BLA to market a biosimilar version of Amgen's Epogen® (erythropoietin, used to treat anemia).  View the complaint here.


    Vivus, Inc. v. Teva Pharmaceuticals USA, Inc. et al.
    2:15-cv-06957; filed September 18, 2015 in the District Court of New Jersey

    • Plaintiff:  Vivus, Inc.
    • Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

    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 Teva's 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.

  • Conference & CLE Calendar

    CalendarFebruary 8-9, 2016 - Naples Patent Experts Conference (University of Akron School of Law) – Naples, FL

    February 9, 2016 - Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    February 9, 2016 – "Caught in a web — how the court in Kimble v. Marvel ruled on whether payment of royalties for an expired patent in unlawful per se" (American Intellectual Property Law Association) – 12:30 – 1:30 pm (Eastern)

    February 10, 2016 – "Putting the Fun in Functional Claiming: §112(f) and Related Indefiniteness Considerations after Williamson v. Citrix and Nautilus v. BioSig" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    February 11, 2016 – "Overcoming 101 Rejections for Computer and Electronics Related Patents — Leveraging USPTO Guidance and Recent Decisions to Meet 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

    February 17, 2016 – "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EST)

    February 24, 2016 – "Patentable Subject Matter after Alice: Best Practices for Addressing 35 U.S.C. § 101" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    March 10-11, 2016 - Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

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

  • USPTO Patent Quality Chat Webinar Series

    USPTO SealThe U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series on February 9, 2016 from 12:00 to 1:00 pm (ET).  The latest webinar, which will be hosted by Kathleen Fonda of the Office of Patent Legal Administration (OPLA), and Tom Hughes of the Office of Patent Quality Assurance (OPQA), will address First Inventor to File (FITF) Patent Prosecution.  The presenters will share some FITF statistics about filings and prosecution since FITF went into effect nearly three years ago, and present some helpful tips concerning identifying the America Invents Act (AIA) status of your application, invoking prior art exceptions during prosecution, and getting more help with application-specific questions.  The presenters look forward to hearing your ideas on ways to help applicants with the prosecution of their FITF applications.

    Instructions for viewing the webinar can be found here.  Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.

  • Webinar on Functional Claiming

    AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar entitled "Putting the Fun in Functional Claiming: §112(f) and Related Indefiniteness Considerations after Williamson v. Citrix and Nautilus v. BioSig" on February 10, 2016 from 12:30 – 2:00 pm (Eastern).  Nicholas Mattingly of Mattingly & Malur, PC and Bryan Wheelock of Harness Dickey & Pierce will review functional claiming and § 112(f), and help practitioners identify when a claim will and won't be found to invoke 35 U.S.C. § 112(f) (or § 112, sixth paragraph, for pre-AIA applications).  The webinar will also address the disclosure needed to support functional claiming under §112(f), with a focus on adequately disclosing the algorithms to support computer-implemented inventions.

    The registration fee for the program is $95 (AIPLA member rate) or $150 (non-member rate).  Those interested in registering for the program, can do so here.

  • Webinar on Enablement and Written Description

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" on February 17, 2016 from 1:00 to 2:30 pm (EST).  Dr. Li Feng, Thomas L. Irving, and Dr. Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner, and Donna M. Meuth, Associate General Counsel of Eisai will provide guidance to patent counsel on leveraging decisions by the Court of Customs and Patent Appeals (CCPA) and the Federal Circuit regarding application of § 112 written description, examine lessons learned through CCPA and early Federal Circuit decisions, and offer strategies to overcome the challenges of § 112.

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.