• CalendarNovember 24, 2014 – "The Role of Patents in Pharmaceutical Innovation: Lessons to Be Learned" (American University Washington College of Law Program on Information Justice and Intellectual Property) – 4:30 to 6:00 pm (Eastern)

    December 4, 2014 – "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)

    December 8, 2014 – "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinions" (Strafford) – 1:00 to 2:30 pm (EST)

    December 10, 2014 – European Patent Reform Forum (Managing Intellectual Property) – San Jose, CA

    December 11, 2014 – "IP Due Diligence in M&A Transactions — Conducting IP Investigations and Leveraging Results During Deal Negotiations" (Strafford) – 1:00 to 2:30 pm (EST)

    December 12, 2014 – European Patent Reform Forum (Managing Intellectual Property) – New York, NY

    December 16, 2014 – "Inter-Partes and Post-Grant Reviews: How to Protect Your University IP" (Technology Transfer Tactics) – 1:00 to 2:00 pm (ET)

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

  • Washington College of LawThe American University Washington College of Law Program on Information Justice and Intellectual Property is hosting a program entitled "The Role of Patents in Pharmaceutical Innovation: Lessons to Be Learned" from 4:30 to 6:00 pm (Eastern) on November 24, 2014 at the American University Washington College of Law in Washington, DC.  Public Citizen Global Access to Medicines Attorney Burcu Kilic will discuss her new book Boosting Pharmaceutical Innovation In The Post-TRIPS Era: Real-Life Lessons for the Developing World, which investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation.  Drawing on extensive country and company case studies, the book identifies the key issues relevant to the revival of local pharmaceutical industries.  The program will also include a panel including Sean Flynn of the American University Washington College of Law and Walter Park of the American University Department of Economics.

    Additional information about the program, including registration information and an agenda, can be found here.

  • By Andrew Williams

    Federal Circuit SealThe Federal Circuit made it clear earlier today that district courts should freely grant stays in view of Covered Business Method ("CBM") patent reviews instituted by the Patent Trial and Appeal Board ("PTAB").  In Versata Software, Inc. v. Callidus Software, Inc., the Court reversed and remanded a United States District Court for the District of Delaware's denial of a motion to stay.  The Court determined that an analysis of the factors outlined in § 18(b) of the America Invents Act ("AIA") "strongly favor[ed]" the stay.  In fact, the Federal Circuit appeared to stop just short of mandating stays in such cases.  And, even though the AIA provides that the Federal Circuit may review such district court's decision de novo in order to "ensure consistent application and established precedent," (AIA § 18(b)(2)), the Court indicated that the outcome would have been the same if analyzed under the traditional abuse-of-discretion standard.  As a result, this case may have implications for district court stays in other post-issuance proceedings, such as Inter Partes Review ("IPR"), because despite not having the same articulated factors in the statute, the factors commonly used by district courts for analyzing such motions are similar.       

    To provide a brief context, the present case stems from a July 19, 2012 action in which Versata sued Callidus in the Delaware district court alleging infringement of three patents related to the "management and tracking of sales information by a financial services company."  Callidus tried to both dismiss the case on the pleadings and transfer it to the Northern District of California.  Both motions were denied.  Callidus subsequently answered and counterclaimed, asserting its own patents.  Callidus also filed a first set of CBM petitions which challenged all of the claims of one of the patents, but only selected claims of the other two patents.  When the PTAB instituted CBM review of this first set, Delaware Judge Robinson stayed the proceedings with respect to the one patent, but denied the stay with respect to the other two.  Callidus filed an interlocutory appeal pursuant to § 18(b)(2) of the AIA.  While the appeal was pending, a second set of CBM petitions were acted upon by the PTAB, resulting in trial initiation for the remaining claims.

    For those not aware, the AIA contained a section on requesting a stay of a civil action in the CBM portion of statute.  This section provides for which factors must be considered, and allows for immediate interlocutory appeal.  Specifically, the Court must look at:

    (A) whether a stay, or the denial thereof, will simplify the issues in question and streamline the trial;

    (B) whether discovery is complete and whether a trial date has been set;

    (C) whether a stay, or the denial thereof, would unduly prejudice the nonmoving party or present a clear tactical advantage for the moving party; and

    (D) whether a stay, or the denial thereof, will reduce the burden of litigation on the parties and on the court.

    AIA, §18(b)(1).  Of course, this is not significantly different than the factors used by district courts in general in determining whether to grant a stay.  For example, Judge Robinson recently articulated the factors to consider in the IPR context in another case:  "(a) whether the granting of a stay would cause the non-moving party to suffer undue prejudice from any delay or allow the moving party to gain a clear tactical advantage over the non-moving party; (b) whether a stay will simplify the issues for trial; and (3) whether discovery is complete and a trial date is set."  Peschke Map Tech., LLC v. J.J. Gumberg Co., Civ. No. 12-1525-SLR (D. Del. April 24, 2014).

    In the present case, Judge Robinson acknowledged "the presence of Congress' thumb on the scales of justice," but still concluded that a complete stay would "not simplify the issues or reduce the burdens of litigation."  The Federal Circuit disagreed, but in view of different facts than what the lower court was considering.  With regard to the first issue — whether a stay would simplify the issues or streamline the trial — Judge Robinson noted that Callidus did not include all of the claims in the CBM petition.  Therefore, with regard to the patents that only had a subset of patents being reviewed, she denied the motion.  The Federal Circuit turned this into "a categorical rule" on her part ("if any asserted claims are not also challenged in the CBM proceeding, this factor disfavors a stay"), and deemed the rule inappropriate.  But Judge Robinson never articulated such a rule, and any such extrapolation from her decision is impossible because the sample size is too small to be meaningful.  Moreover, the Federal Circuit took judicial notice of the fact that all of the patent claims are now involved in an instituted CBM review.  Using the "categorical rule," because every claim has now been instituted by the PTAB, there is "little doubt that issues will be simplified."  Nevertheless, the important take-away from the Federal Circuit regarding this factor is that a stay can be warranted even if the CBM proceedings will not simplify all of the invalidity issues at trial (whether all of the claims, or all of the invalidity defenses).

    With regard to the second factor, Judge Robinson did little more than highlight that discovery was not complete, and that the trial date was within months of when the CBMs were expected to be concluded.  The Federal Circuit took issue with this, criticizing her failure to explain why the seven month difference between the anticipated conclusion of CBM review and the start of trial counseled against a stay.  The Court was also clear that the date from which this factor must be analyzed is the day the motion is filed, not the date it is considered.  A problem occurs, however, when the motion to stay is filed at the same time as the CBM petitions.  Courts are rarely going to grant stay for proceedings that may never materialize.  Therefore, instead of denying the motion outright, Judge Robinson postponed the decision until after review was instituted.  In the interim, discovery progressed.  It seems illogical to pretend that the intervening time did not occur.  This problem could be solved by encouraging lower courts to deny stay motions without prejudice, or providing leave to refile on institution of the CBM.

    The factor that the lower court spent the most time highlighting was Callidus' tactical advantage in filing the stay.  Judge Robinson was influenced by the fact that Callidus asserted its own patents.  The implication was that the Callidus was using the "stay card" as a sword and a shield.  If granted, only Versata would now be at risk.  The Federal Circuit's responded by pointing out Callidus intended to stay the entire case.  However, no such indication appears in Judge Robinson's opinion.  It is possible that such a position was only adopted during appeal.   Judge Robinson does make a point of noting that Callidus is defending itself "aggressively," by filing motions to dismiss, and motions to transfer, the case.  The Appeals Court responded noted that Judge Robinson never explains why the use of such motions was "improper."  In fact, apparently Versata never alleged that they were improper either.  Without some such indication, this factor strongly favors a stay, according to the Court.

    Finally, with regard to the last fact, Judge Robinson noted that "Callidus' tactics have actually increased the burdens of litigation, rather than reduced them."  The problem is that this is a retrospective analysis, but it is the prospective impact that is important.  When reviewed properly, according to the Federal Circuit, it becomes clear that a stay will reduce future burdens.  Altogether, the Court found that the factors strongly favored a stay.

    The outcome of this case was similar to that in VirtualAgility Inc. v. Salesforce.com, Inc., 759 F.2d 1307, 1312-12 (Fed. Cir. 2014).  In that case, the panel majority also reversed and remanded.  The one distinction was that in VirtualAgility Inc., Judge Newman dissented.  She believed a trial judge's decision to stay an infringement action should be consigned to the judge's discretion.

    An important question is whether this case will have any impact on stays in cases with corresponding IPRs, and other such proceedings before the PTAB.  On the one hand, the IPR-section of the AIA does not articulate factors, and it contains a less deferential standard of review.  On the other hand, the factors are common, and the lower courts will likely look to this case and VirtualAgility for guidance.  Even if it will be more difficult to reverse and remand a denial of stay in the IPR context, the application of the factors from these cases could be persuasive to the lower courts.  As such, the outcome of CBM decisions becomes more relevant to those that have little to no experience with the practice.  Therefore, it would behoove all patent attorneys practicing before the PTAB to pay attention to these CBM decisions, and how the Federal Circuit is interpreting the statute.

    Versata Software, Inc. v. Callidus Software, Inc. (Fed. Cir. 2014)
    Panel: Circuit Judges Chen, Mayer, and Linn
    Opinion by Circuit Judge Chen

  • By Donald Zuhn

    Prioritized Examination Interim Rule Adopted As Final

    USPTO SealLast March, we reported on an interim rule implemented by the U.S. Patent and Trademark Office that expanded the time periods for meeting certain requirements for filing a request for Track I prioritized examination (see "USPTO to Permit Delay in Meeting Certain Prioritized Examination Requirements").  Under the interim rule, the requirements for which the time periods were expanded included: the submission, upon filing, of an inventor's oath or declaration and all required fees, as well as an application containing no more than four independent claims, thirty total claims, and no multiple dependent claims.  In particular, the rules changes (1) postponed the requirement to file an inventor's oath or declaration if an application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is present upon filing, (2) provided a non-extendable one-month period (following notification of noncompliance from the Office) to file an amendment to cancel any independent claims in excess of four, any total claims in excess of thirty, or any multiple dependent claim, and (3) no longer required the payment of excess claims fees or the application size fee upon filing.

    In a final rule published in the Federal Register last week (79 Fed. Reg. 68124), the Office noted that it had received no comments from the public regarding the interim rule, and therefore adopted as final the amendments to the rules of practice set forth in the interim rule.  The final rule took effect as of November 14, 2014, and applies to applications filed under 35 U.S.C. § 111(a) on or after September 16, 2012, in which a first action has not been mailed.


    USPTO Extends Quick Path Information Disclosure Statement Pilot Program

    The U.S. Patent and Trademark Office recently noted on its website that the Quick Path Information Disclosure Statement (QPIDS) pilot program has been extended to September 30, 2015.  The QPIDS pilot program, which was implemented by the Office in May of 2012, allows applicants to have an Information Disclosure Statement (IDS) considered after the issue fee has been paid and without having to file a Request for Continued Examination (RCE) (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program").

    Under the QPIDS pilot program, an examiner will consider IDS submissions made after the issue fee has been paid (and provided that the conditions below are met) to determine whether prosecution should be reopened.  Where the examiner determines that no item of information in the IDS necessitates reopening prosecution, the Office will issue a corrected notice of allowability and the application will pass to issue, thereby eliminating the delays and costs associated with RCE practice.  To be eligible to participate in the pilot program, an application must be an allowed utility or reissue application for which the issue fee has been paid and the patent has not yet issued, and a QPIDS submission must be made electronically via the EFS-Web.  The QPIDS submission must include the following:

    • A transmittal form that designates the submission as a QPIDS submission (e.g., form PTO/SB/09);
    • An IDS accompanied by a timeliness statement set forth in 37 CFR 1.97(e), with the IDS fee set forth in 37 CFR 1.17(p) — note: the QPIDS pilot program does not eliminate the requirements that an IDS be accompanied by the statement of 37 C.F.R. § 1.97(e)(1) or (2) and the fee set forth in 37 C.F.R. § 1.17(p)).
    • A Web-based ePetition to withdraw from issue under 37 CFR 1.313(c)(2), with the petition fee set forth in 37 CFR 1.17(h); and
    • An RCE, which will be treated as a "conditional" RCE, with the RCE fee under 37 C.F.R. 1.17(e) — note: the IDS fee under 37 C.F.R. § 1.17(p) will be automatically returned if the examiner decides to reopen prosecution, necessitating that the RCE be processed, and the RCE fee will be automatically returned if the examiner determines that prosecution need not be reopened.

    Additional information regarding the QPIDS pilot program can be found on the Office's QPIDS webpage.


    USPTO Extends After Final Consideration Pilot 2.0 Program

    The U.S. Patent and Trademark Office also recently noted on its website that the After Final Consideration Pilot 2.0 (AFCP 2.0) program has been extended to September 30, 2015.  The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program") and then modified in May 2013 (see "USPTO News Briefs"), provides examiners with a limited amount of non-production time — three hours for utility and reissue applications — to consider responses filed following a final rejection.

    In implementing the original AFCP, the Office described six limited situations in which further amendments or arguments may be considered under the AFCP:

    1.  The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action.
    2.  The amendment places the application in condition for allowance by rewriting objected-to claims in independent form.
    3.  The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search.
    4.  The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims.
    5.  The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search.
    6.  The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]

    When the Office implemented the AFCP 2.0 program, it described three main differences between the original AFCP and the AFCP 2.0:  (1) an applicant must file a request to participate in the AFCP 2.0; (2) a response after final rejection under the AFCP 2.0 must include an amendment to at least one independent claim; and (3) when a response does not result in a determination that all pending claims are in condition for allowance, the examiner will request an interview with the applicant to discuss the response.  The requirements for participating in the AFCP 2.0 are as follows:

    (1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
    (2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
    (3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the notice, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
    (4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
    (5) the required papers must be filed via the EFS-Web.

    In extending the AFCP 2.0 program, the Office notes that applicants submitting AFCP 2.0 requests will begin receiving a specialized form (PTO-2323) in response to requests.  The new form will communicate the status of the submission, and if applicable, also accompany an interview summary.  According to the Office, the new form is designed to more clearly indicate how the AFCP submission was treated by the examiner.  Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.

  • By Andrew Williams

    Antares PharmaWhen can a sufficient disclosure for patentability purposes nevertheless fail to adequately "describe" the claims of a patent?  According to the Federal Circuit in a case issued this week, when the claims are added in a broadening reissue application.  In Antares Pharma Inc. v. Medac Pharma Inc., the Court had the opportunity to expound on the "original patent" requirement of 35 U.S.C. § 251 for reissue claims.  Writing for the 3-judge panel, Judge Dyk explained that prior Federal Circuit case law defined this requirement as "analogous to the written description requirement . . . ."  Of course, this is distinct from a "new matter"-type "written description" requirement, because § 251 has one of those requirements also.  Instead, the Antares case can be understood in the context of the line of written description cases like Gentry Gallery v. Berkline Corp. and Tronzo v. Biomet, where patent specifications that only include one embodiment, or tout a particular embodiment, can only support claims drawn to that embodiment.  Similarly, as in this case, a patent specification that only appears to envision "jet"-type automatic injection devices for the self-administration of pharmaceuticals cannot support reissue claims that cover non-jet-type injectors.

    The problem in this case stems from the Court's reliance on a 1942 Supreme Court case, U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942).  The strict adherence to the language in this case forced the Federal Circuit to contort reissue jurisprudence to such a degree that it appeared to demand a heightened disclosure requirement.  This stems, in part, from the Court elevating a line from Industrial Chemicals that suggested that to satisfy the "same invention" requirement "it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification."  Id. at 676.  As such, the Federal Circuit was forced to conclude that the "original patent" requirement was somehow more exacting than the original requirements for patentability, necessitating the conclusion that "the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention." (emphasis added).

    The patent at issue in this case was U.S. Reissue Patent No. RE44,846, entitled "Needle Assisted Jet Injector."  When it had previously issued as U.S. Patent No. 7,776,015, it had the same title and all claims were drawn to jet injection devices.  The specification explained that that the disclosed system for injecting pharmaceuticals utilized a needle to puncture the skin, instead of the typical jet injectors in which the medicant itself ruptured the skin.  In fact, the entire specification was drawn to only jet injectors, and during prosecution, the applicants focused on the "jet injectors" limitations to distinguish the prior art.  Nevertheless, within two years of issuance, the applicants filed reissue claims drawn to particular combinations of safety features for injectors, although without being limited to jet injectors.  Each particular limitation may have found support in the specification, but it was only with respect to jet injectors (and not injector devices more generally).

    Medac PharmaThe case posture before the Federal Circuit was an appeal of the denial of a preliminary injunction.  Medac Pharma had filed a 505(b)(2) NDA application for pre-filled methotrexate syringes.  Because Medac was seeking approval to sell a product that would allegedly infringe the '846 patent, Antares filed suit pursuant to the Hatch-Waxman cause of action — 35 U.S.C § 271(e)(2)(A).  Antares soon moved for a preliminary injunction, which was denied because the District Court believed that the reissued claims were vulnerable under the "recapture rule."  When appealing such a denial, generally the case turns on whether the lower court had abused its discretion.  This often results in just an affirmance.  However, this Court took the additional step of determining that the claims were "invalid for failure to satisfy the original patent requirement of 35 U.S.C. § 251."  Because it was unnecessary to reach the recapture conclusion, the Court did not address it.

    The relevant statute, section 251, reads:

    Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent.  No new matter shall be introduced into the application for reissue

    (emphasis added).  The original patent requirement stems from a different requirement that existed before the current statute — the "same-invention" requirement.  Prior 35 U.S.C. § 64 read in pertinent part:  "Whenever any patent is wholly or partly inoperative or invalid . . . the commissioner shall . . . cause a patent for the same invention . . . to be reissued to the patentee . . . ." (emphasis added).  On its face, these requirements appear distinct.  However, the Federal Circuit pointed out that P.J. Federico (co-architect of the 1952 statute) believed there was no indication that the requirement had been changed.  The Court also cited several cases in supporting the proposition that the two standards were the same.  This exercise in tracing the history of the statute was done in order to make the 1942 Industrial Chemicals case mentioned above relevant for the present discussion.

    As suggested above, the Industrial Chemicals case matches nicely with the Tronzo v. Biomet written description case.  The applicants had developed a process for the production of a chemical compound (ethylene oxide), which the applicants believed required the presence of water.  Even though the specification did not provide any disclosure of the process without water, the patentees obtained a reissue patent because the specification read in one place: "Water can be admitted in the reaction vessel . . . ."  (emphasis added).  Despite this suggestion, the Industrial Chemicals Court invalidated the reissue claims because they did not cover the same invention.  In doing so, the Court rejected the use of experts that said the invention could work without water, because it was clear on its face that the original patent required the presence of water.

    This analysis would probably have been sufficient for the present case.  However, because the Federal Circuit was reading Supreme Court case law from before the 1952 statute, the language was not going to sync up nicely.  Moreover, patent drafting in the 1930s differed significantly from the practices employed today.  For example, reissue application No. 20,370, at issue in Industrial Chemicals, had a specification that stretched only one and a half columns.  Most introductions today are longer.  Therefore, it is understandable that not all of the idiosyncrasies found in this 1942 case will translate well to today's practice.  Nevertheless, this is what the present Court did.  In an effort to make all of the square pegs fit into the round holes, Judge Dyk was required to contort the language and reasoning of intervening case law.  The resulting conclusion was that the "original patent" requirement for reissue patents was somehow more exacting than the written description requirement for original applications (despite an earlier acknowledgement that they were basically the same).  This is unfortunate because the case appears to fit squarely within current written-description jurisprudence.  Nevertheless, moving forward, reissue applicants, accused infringers, and district courts are all going to need to figure out what it means to satisfy the "clear and unequivocal" disclosure test when it comes to reissue patents.

    Antares Pharma, Inc. v. Medac Pharma Inc. (Fed. Cir. 2014)
    Panel: Circuit Judges Dyk, Reyna, and Taranto
    Opinion by Circuit Judge Dyk

  •         By Sherri Oslick

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

    AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al.
    1:14-cv-07105; filed November 3, 2014 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
    • Defendants:  Pharmadax USA, Inc.; Pharmadax Inc.; Pharmadax (Guangzhou) Inc.

    Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Pharmadax's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

    Endo Pharmaceuticals Inc. et al. v. Actavis Inc., et al.
    1:14-cv-01381; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Actavis Inc.; Actavis South Atlantic LLC

    Endo Pharmaceuticals Inc. et al. v. Amneal Pharmaceuticals LLC, et al.
    1:14-cv-01382; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC

    Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
    1:14-cv-01383; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendant:  Impax Laboratories Inc.

    Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc. et al.
    1:14-cv-01384; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Impax Laboratories Inc.; ThoRx Laboratories Inc.

    Endo Pharmaceuticals Inc. et al. v. Par Pharmaceutical Companies Inc. et al.
    1:14-cv-01385; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

    Endo Pharmaceuticals Inc. et al. v Ranbaxy Laboratories Ltd. et al.
    1:14-cv-01386; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.

    Endo Pharmaceuticals Inc. et al. v. Roxane Laboratories Inc.
    1:14-cv-01387; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendant:  Roxane Laboratories Inc.

    Endo Pharmaceuticals Inc. et al. v. Sandoz Inc.
    1:14-cv-01388; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendant:  Sandoz Inc.

    Endo Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
    1:14-cv-01389; filed November 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Endo Pharmaceuticals Inc.; Mallinckrodt LLC
    • Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.; Barr Laboratories Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,808,737 ("Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment," issued August 19, 2014) and 8,871,779 ("Process for Preparing Morphinan-6-One Products with Low Levels of α,β-Unsaturated Ketone Compounds," issued October 28, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Endo's Opana® ER CRF (oxymorphone hydrochloride, crush-resistant formulation, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the Actavis complaint here.

    Otsuka Pharmaceutical Co., Ltd. v. Lupin Ltd. et al.
    1:14-cv-07105; filed November 3, 2014 in the District Court of New Jersey

    • Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
    • Defendants:  Lupin Ltd.; Atlantic Holding SA; Lupin Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

  • By Michael Borella

    UltramercialUltramercial sued Hulu, YouTube, and WildTangent for infringement of U.S. Patent No. 7,346,545.  Hulu and YouTube were eventually dismissed from the case.  On a 12(b)(6) motion, and without construing the claims, the District Court held that the '545 patent does not claim patent-eligible subject matter under 35 U.S.C. § 101.  On appeal, the Federal Circuit reversed and remanded.  However, that decision was vacated by the Supreme Court.  Back in the Federal Circuit again, a unanimous panel of Chief Judge Rader, Judge O'Malley, and Judge Lourie once again reversed the District Court, finding that the claims did indeed address patent-eligible subject matter.

    WildTangent petitioned for Supreme Court review.  On June 30th of this year, the Court granted the petition, vacated the Federal Circuit's judgment, and remanded the case back to the Federal Circuit for further consideration in view of the Alice Corp. v. CLS Bank decision.  Since Chief Judge Rader had stepped down in the interim, Judge Mayer was appointed to take his place.

    Since the remand, this opinion has been widely anticipated by patentees and patent practitioners.  Many were hoping that the Federal Circuit would provide some clarity to the two-part patent-eligibility test handed down in Alice.  Arguably, some extent of clarity has been provided, even as the Court has closed the door even further on the patentability of computer-implemented inventions.

    Claim 1 of the '545 patent recites:

    A method for distribution of products over the Internet via a facilitator, said method comprising the steps of:
        a first step of receiving, from a content provider, media products that are covered by intellectual property rights protection and are available for purchase, wherein each said media product being comprised of at least one of text data, music data, and video data;
        a second step of selecting a sponsor message to be associated with the media product, said sponsor message being selected from a plurality of sponsor messages, said second step including accessing an activity log to verify that the total number of times which the sponsor message has been previously presented is less than the number of transaction cycles contracted by the sponsor of the sponsor message;
        a third step of providing the media product for sale at an Internet website;
        a fourth step of restricting general public access to said media product;
        a fifth step of offering to a consumer access to the media product without charge to the consumer on the precondition that the consumer views the sponsor message;
        a sixth step of receiving from the consumer a request to view the sponsor message, wherein the consumer submits said request in response to being offered access to the media product;
        a seventh step of, in response to receiving the request from the consumer, facilitating the display of a sponsor message to the consumer;
        an eighth step of, if the sponsor message is not an interactive message, allowing said consumer access to said media product after said step of facilitating the display of said sponsor message;
        a ninth step of, if the sponsor message is an interactive message, presenting at least one query to the consumer and allowing said consumer access to said media product after receiving a response to said at least one query;
        a tenth step of recording the transaction event to the activity log, said tenth step including updating the total number of times the sponsor message has been presented; and
        an eleventh step of receiving payment from the sponsor of the sponsor message displayed.

    In simpler terms, the Court characterized the invention as "a method for distributing copyrighted media products over the Internet where the consumer receives a copyrighted media product at no cost in exchange for viewing an advertisement, and the advertiser pays for the copyrighted content."

    Beginning its substantive analysis, the Court recited the two-prong subject-matter eligibility test from Alice.  The first prong is to determine whether the claims are directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea.  If so, the second prong is to determine whether any additional claim elements transform the claim into a patent-eligible application that amounts to significantly more than the ineligible concept itself.

    Ultramercial, of course, argued that its claims were not directed to a patent-ineligible exception to § 101.  Unlike the claims in Alice that were ultimately found to be abstract because they attempted to capture a "routine," "long prevalent," and "conventional" idea, Ultramercial posited that the claims at issue are "directed to a specific method of advertising and content distribution that was previously unknown and never employed on the Internet before."  Further, Ultramercial contended that even if its claims do encompass an abstract idea, "the claims require users to select advertisements, which was a change from existing methods of passive advertising and involves more than merely implementing an abstract idea."

    WildTangent's position was that the claims are "directed to the abstract idea of offering free media in exchange for watching advertisements and that the mere implementation of that idea on a computer does not change that fact."  WildTangent further contended that "the claims do no more than break the abstract idea into basic steps and add token extra-solution activity, [and thus] add no meaningful limitations to convert the abstract idea into patent-eligible subject matter."

    The Court agreed with WildTangent.  In particular, the Court found that claim 1 recited an "ordered combination of steps recit[ing] an abstraction — an idea, having no particular concrete or tangible form."  The Court wrote, moreover, that "[t]he process of receiving copyrighted media, selecting an ad, offering the media in exchange for watching the selected ad, displaying the ad, allowing the consumer access to the media, and receiving payment from the sponsor of the ad all describe an abstract idea, devoid of a concrete or tangible application."  While the Court did find that "certain additional limitations, such as consulting an activity log, add a degree of particularity," these limitations were apparently insufficient to render the claim as a whole anything more than abstract.

    Further, the Court noted that even though some steps of the claim "were not previously employed in this art [that] is not enough — standing alone — to confer patent eligibility upon the claims at issue."  As a result, patentees and applicants now find themselves in an odd position — their claims can be deemed abstract if the claims incorporate fundamental, long-standing procedures.  But they may not be able to rebut this notion by attempting to establish that some of these procedures (or the claim as a whole) were novel at the time of the invention.

    Turning to the second prong of the test, the Court concluded that "[a]dding routine additional steps such as updating an activity log, requiring a request from the consumer to view the ad, restrictions on public access, and use of the Internet does not transform an otherwise abstract idea into patent-eligible subject matter."  Instead the Court found that the claim included only "conventional steps, specified at a high level of generality."  Even though the claim required use of the Internet, which is arguably a concrete, tangible system, the Court reiterated its reasoning from CyberSource Corp. v. Retail Decisions, Inc., and stated that "use of the Internet is not sufficient to save otherwise abstract claims from ineligibility under § 101."

    Finally, to drive a nail in the coffin of Ultramercial's claims, the Court held that they failed both prongs of the machine-or-transformation test.  The only machine recited in the claims was the Internet, which is a "ubiquitous information-transmitting medium, not a novel machine."  As for any sort of transformation elicited by the many steps of claim 1, the Court wrote that "manipulations of public or private legal obligations or relationships, business risks, or other such abstractions" are not transformations "because they are not physical objects or substances, and they are not representative of physical objects or substances."

    Consequently, all of Ultramercial's claims were invalidated, on the 12(b)(6) motion, as failing to meet the requirements of 35 U.S.C. § 101.  The Court did not address the procedural requirements of granting such a motion, such as making all reasonable inferences in the light most favorable to non-movant.  However, it did throw a bone of sorts, writing that "we do not purport to state that all claims in all software-based patents will necessarily be directed to an abstract idea."

    In 2014, with innovations in information technologies driving the world's economy, it is hard to understand why non-physicality has become such a barrier to invention.  And when patentees add physical limitations to their claims, these limitations are often ignored because they are alleged to be routine, conventional, or general-purpose.  It seems as if the courts believe that most or all computer-based inventions should involve design of a new physical device, or at least some improvement thereof.

    But hidden behind this 19th-century thinking is an undercurrent — the abstract idea prong of Alice is becoming a sniff test for claim breadth.  The Court referred to Ultramercial's claimed invention as being high-level, general, and lacking tangibility.  While the Court may not be saying as much in this opinion, such reasoning allows one to read a claim and conclude, with little or no supporting evidence, that it is "too broad" to be patentable.

    As many commentators have articulated since 2012's Mayo Collaborative Servs. v. Prometheus Labs., Inc. case, determining whether the breadth of a claim is appropriate is better served by conducting the well understood and more objective analyses of §§ 102, 103, and 112.  Despite the lack of any suggestion from Congress that  § 101 is to be used for these purposes, the Supreme Court, now followed by the Federal Circuit, have made patentable subject matter a perverse weapon for the unsupported rejection and invalidation of claims.

    Which bring us to Judge Mayer's concurrence.

    Judge Mayer wrote separately to make three distinct points: (1) "whether claims meet the demands of 35 U.S.C. § 101 is a threshold question, one that must be addressed at the outset of litigation," (2) that "no presumption of eligibility attends the section 101 inquiry," and (3) that Alice "set out a technological arts test for patent eligibility."

    We addressed the third point in a discussion of Judge Mayer's dissent in the I/P Engine, Inc. v. AOL Inc. case.  Herein, we will focus on the first and second points.

    Judge Mayer believes that "the section 101 determination bears some of the hallmarks of a jurisdictional inquiry" and therefore it should be addressed early in litigation.  Despite citing a number of Supreme Court and Federal Circuit cases for support of this notion, none of those cases actually go as far as stating that § 101 determinations must be made early in litigation (e.g., at the pleading stage or prior to discovery).  While many of these cases suggest the § 101 inquiry should take place before §§ 102 and 103 examination, they do not imply that the patentable subject matter determination is to be made so far ahead of these other determinations.

    Judge Mayer argued that allowing early § 101 challenges will "conserve scarce judicial resources" and provide "a bulwark against vexatious infringement suits."  Yet, he does not address how, under Alice, it could be used by infringers to rapidly dismiss valid lawsuits by making nebulous "the claims are too broad" arguments.  Judge Mayer's own reasoning suggests how § 101 can be misused in this fashion, when he wrote that "[s]ubject matter eligibility challenges provide the most efficient and effective tool for clearing the patent thicket."

    Turning to his second point, Judge Mayer stated that "[t]he rationale for the presumption of validity is that [the PTO] in its expertise, has approved the claim, [but this] rationale, however, is much diminished in situations in which the PTO has not properly considered an issue."  He continued, arguing that because "the PTO has for many years applied an insufficiently rigorous subject matter eligibility standard, no presumption of eligibility should attach when assessing whether claims meet the demands of section 101."  (Emphasis added.)

    But Congress has spoken on this issue.  35 U.S.C. § 282 plainly states that "[a] patent shall be presumed valid."  Even though the validity of a patent is more open for assault when an attacker can, for instance, cite relevant prior art that the PTO did not consider, the Supreme Court has never stated that 35 U.S.C. § 282 should not apply to the § 101 inquiry.  And even if it did, such a ruling would be in clear violation of the statute.

    So what is an applicant to do?  If the Alice test is to be decided on vague notions of whether a claim is "too abstract" or "too broad," what patenting strategy should be adopted?  In the past, software inventions were often claimed broadly at first go, with this breadth being defined by what the applicant reasonably believed to be the scope of the invention to which it was entitled.  If the claims had to be narrowed during prosecution, so be it.

    Today, an alternative strategy may prove more viable — one in which the applicant divides its invention (if the invention can be so divided) into several narrower, clearly-defined embodiments to submit as separate patent applications.  These applications may then be filed in a parallel fashion (all at once) or serial fashion (a string of continuations).  While outcomes cannot be guaranteed, such an approach may sadly be necessary in light of this ruling and Alice.

    Ultramercial Inc. v. Hulu LLC (Fed. Cir. 2014)
    Panel: Circuit Judges Lourie, Mayer*, and O'Malley
    Opinion by Circuit Judge Lourie, concurring opinion by Circuit Judge Mayer
    • Circuit Judge Mayer was designated to replace Randall R. Rader, now retired, on
    this panel.

  • CalendarNovember 19, 2014 – "Navigating the Shoals between the PTAB and District Court" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    November 20, 2014 – "PTAB Invalidity Proceedings — Lessons Learned in the First Two Years" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    December 4, 2014 – "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)

    December 8, 2014 – "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinions" (Strafford) – 1:00 to 2:30 pm (EST)

    December 10, 2014 – European Patent Reform Forum (Managing Intellectual Property) – San Jose, CA

    December 11, 2014 – "IP Due Diligence in M&A Transactions — Conducting IP Investigations and Leveraging Results During Deal Negotiations" (Strafford) – 1:00 to 2:30 pm (EST)

    December 12, 2014 – European Patent Reform Forum (Managing Intellectual Property) – New York, NY

    December 16, 2014 – "Inter-Partes and Post-Grant Reviews: How to Protect Your University IP" (Technology Transfer Tactics) – 1:00 to 2:00 pm (ET)

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinions" on December 8, 2014 from 1:00 to 2:30 pm (EST).  Michael L. Kiklis and Stephen G. Kunin of Oblon Spivak McClelland Maier & Neustadt will examine recent decisions applying the Supreme Court's decision in Alice Corp. v. CLS Bank on patent eligibility, discuss the guidance from these opinions, and offer best practices for addressing patent eligibility issues.  The webinar will review the following questions:

    • How are the courts applying the framework for patent eligibility created in Alice Corp.?
    • How can patent litigation defendants take advantage of the guidance for Section 101 challenges?
    • What are best practices for patent counsel to demonstrate patent eligibility?

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

  • Technology Transfer Tactics
    Technology Transfer Tactics will be offering a webinar entitled "Inter-Partes and Post-Grant Reviews: How to Protect Your University IP" on December 16, 2014 from 1:00 to 2:00 pm (ET).  Shawn Ambwani, Chief Operating Officer of Unified Patents, Dipanjan "DJ" Nag, CEO and President of IP Shakti LLC, and B. Scott Eidson of Armstrong Teasdale will address the following topics:

    • A solid understanding of the mechanics IPR (inter partes review) and PGR (post-grant review)
    • Due diligence best practices to help avoid patent challenges
    • How IPR is being used as a license negotiation tactic
    • What technologies in your patent portfolio are most likely to be targeted
    • Numbers and trends: Filings in 2014 and forecast for 2015
    • A review of the universities that have lost patents due to IPR – and how they could have prevented the
    challenges
    • Strategies to reduce the effects of IPR and PRG on early stage technologies and start-ups
    • How to keep your TTO's legal and patent budget in check in light of potential challenges
    • Understand how the 11th Amendment immunity clause may work for state schools

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.