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  • Conference & CLE Calendar

    CalendarApril 7, 2015 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – 11:00 am to 5:00 pm (EDT)

    April 9, 2015 – "Conducting and Analyzing Patent Searches — Strategies for Validity, Patentability, Infringement, FTO and State-of-the-Art Searches" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 9, 2015 – "Issue Preclusion: Impact of B&B Hardware v. Hargis on Patent Law" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 15-17, 2015 – 2015 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – St. Louis, MO

    April 16, 2015 – "Patent Subject Matter Eligibility: Navigating the New USPTO Guidance — Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 21, 2015 – U.S. Biosimilars (American Conference Institute) – Munich, Germany

    April 23, 2015 – "Key Trade Secret Developments in 2015" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    April 24, 2015 – Ethics in the Practice of Intellectual Property Law (The John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – Chicago, IL

    April 27-29, 2015 – M&A and Strategic Alliances in the Life Sciences Industries*** (American Conference Institute) – New York, NY

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

  • Program on Ethics in the Practice of Intellectual Property Law

    JMLSThe John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be holding its 7th Annual Program on Ethics in the Practice of Intellectual Property Law on April 24, 2015 in Chicago, IL.  The conference will consist of the following sessions:

    • What IP Lawyers Should Know About ARDC Proceedings and Client Complaints
    • Malpractice Issues in Patent Cases
    • Insights on Judicial Ethics — The Hon. Virginia Kendall, U.S. District Court for the Northern District of Illinois
    • Conflicts of Interest in the Practice of IP Law
    • Harmonization of USPTO Ethical Standards in the Post-AIA Era — to be presented by Patent Docs author Andrew Williams, McDonnell Boehnen Hulbert & Berghoff LLP
    • Ethical Issues Facing In-House IP Counsel

    Additional information about the program can be found here.  Those interested in registering for the conference online can do so here; the registration fee is $195 (general registration); JMLS Students, Faculty, Staff, and IP Advisory Board Members can register for free.

  • Webinar on Key Trade Secret Developments

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on "Key Trade Secret Developments in 2015" on April 23, 2015 from 10:00 am to 11:15 am (CT).  In this presentation, Patent Docs contributor and MBHB attorney Joshua R. Rich will cover recent developments in the attempts to mitigate theft of U.S. trade secrets.  Topics to be addressed during the webinar include:

    • Recent Implementation of the "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets"
    • Proposed legislative measures for the prevention of trade secret misappropriation
    • Recent case law on trade secret misappropriation

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO Webinar on Issue Preclusion

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Issue Preclusion: Impact of B&B Hardware v. Hargis on Patent Law" on April 9, 2015 beginning at 2:00 pm (ET).  Erika Arner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Andrew Pincus, Mayer Brown LLP; and Thomas Saunders, Wilmer Cutler Pickering Hale and Dorr, LLP will address the impact on patent law of the U.S. Supreme Court's decision in B&B Hardware v. Hargis, which involves a trademark opposition running in parallel with a trademark infringement lawsuit and where the Court held that a final decision by the USPTO’s Trademark Trial and Appeal Board (TTAB) can serve as issue preclusion to collaterally estop a court from rejudging already-decided issues.

    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.

  • Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

    By Andrew Williams —

    Apotex #1Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent?  Of course, the Federal Circuit explained this week in the Apotex Inc. v. Daiichi Sankyo, Inc. case, at least if you are in the wild world of the Hatch-Waxman statute.  In this case, Apotex was a second ANDA filer seeking to market a generic version of Daiichi's Benicar® drug product for treating hypertension.  The first filer, Mylan Pharmaceuticals, Inc. (or Matrix Laboratories, which is now Mylan) was unable to invalidate one of the Orange Book listed patents during its ANDA litigation with Daiichi, so a judgment of infringement was entered against it.  However, Daiichi disclaimed the only other listed patent — one which would have been expired later.  Nevertheless, despite requests for delisting, both patents were still found in the Orange Book.  Thus, Apotex included a Paragraph III certification for the patent that had already been litigated, but was forced to include a Paragraph IV certification for the disclaimed patent.  Not only did Daiichi not sue Apotex after receiving notification of the certifications, but it filed a motion to dismiss for a lack of case or controversy which the U.S. District Court for the Northern District of Illinois granted.  Mylan also moved to intervene, but this was dismissed as moot.  The Federal Circuit reversed, in part, because even though the patent was essentially non-existent, "Apotex has a concrete, potentially high-value stake in obtaining the judgment it seeks," and therefore a substantial controversy existed to warrant the issuance of a declaratory judgment.

    This case is specific to Hatch Waxman litigation.  Most of the analysis focused on the statute and the Congressional purpose in passing both the original statute, as well as the changes related to forfeiture of the 180-day generic exclusivity included in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("the MMA").  However, case-or-controversy analysis is universal.  The Court highlighted four considerations for this case: (1) whether the parties lack a concrete stake in the outcome of the declaratory judgment action in view of the patent disclaimer; (2) whether the alleged harm is traceable to Daiichi; (3) whether Apotex' failure to obtain tentative approval caused the case to be too contingent on future events; and (4) whether Apotex's alleged harm can even be redressed in view of the statutory scheme surrounding Mylan's generic exclusivity period.

    Patent Disclaimer

    The Federal Circuit quickly rejected the District Court's conclusion that the statutory disclaimer of the Orange-Book listed patent means there is no adversity between the parties.  In this case, it is the listing of the patent that creates the "adverse concrete interests" in the outcome for all three parties (including Mylan).  In other words, "by any common-sense measure, the parties have substantial, concreate stakes in whether Apotex secures the non-infringement judgment it seeks" to allow entry into the market.  This stems in large part from the substantial revenue that Apotex stands to gain if it can obtain early approval, as well as the commensurate revenue that both Daiichi and Mylan stand to lose.

    Traceable Harm

    The Court also rejected Daiichi's argument that the harm is not traceable to it because the delayed entry of Apotex's generic drug product does not rest solely with Mylan and its period of generic exclusivity.  Again, it is the listing that gave rise to the harm.  If Daiichi's disclaimed patent, U.S. Patent No. 6,878,703 ("the '703 patent") were not listed in the Orange Book, Mylan would have only been left with a Paragraph III certification for U.S. Patent No. 5,616,599 ("the '599 patent") after losing at the district court.  Without the '703 patent, Mylan would have been forced to forfeit its eligibility for the 180 days of generic exclusivity.  Therefore, it was the patent that was as-of-then improperly listed in the Orange Book that was supporting Mylan's exclusivity period.  It was this barrier that was caused by the "listing" that Apotex was seeking to eliminate through a declaratory judgment.  The Court did clarify, though, that the propriety of the original patent listing was not important.  Instead, "as long as it is 'likely, as opposed to merely speculative,' that the consequence would be the concreate one of advancing the date of approval by the FDA and market entry by Apotex."

    Uncertainity Based on Lack of Tentative Approval

    The Court next considered whether the relief sought by Apotex would be too uncertain prior to its receiving tentative approval for its ANDA to support a declaratory judgment action.  After all, the ultimate relief would depend on the action of a third party — the FDA.  However, the Federal Circuit noted that the "congressional judgment" found in the Hatch Waxman statute "makes clear that tentative approval for [the ANDA filer] is not a precondition to adjudicating the patent issue."

    The filing of the ANDA is an "artificial act of infringement" that allows litigation to take place prior to FDA approval.  In fact, nowhere in the statute is it suggested that approval is required — rather it is the filing of the ANDA that is the act of infringement.  To find otherwise, the Court continued, would be nonsensical.  The ANDA applicant must include the certification in its ANDA, it must give prompt notice to the NDA holder, and the NDA holder has only 45 days in which to bring suit to obtain the statutory 30-month delay.  It is unrealistic to think that approval (or tentative approval) will occur in these 45 days.  "Accordingly," the Court concluded, "tentative approval of an ANDA is generally not a precondition to the existence of a case or controversy concerning patents listed in the Orange Book."

    Redress of Harm

    Finally, the Court looked to whether the declaratory judgment action could actually redress the harm faced by Apotex, specifically whether a judgment of non-infringement would trigger the forfeiture of Mylan's 180-day exclusivity.  The cases before the MMA amendments are not necessarily applicable because many of the changes introduced by that statute were meant to address the problems resulting from the period of generic exclusivity.  For example, before the MMA amendments, the first ANDA filer could essential "park" its exclusivity, thereby preventing any follow-on applicant from reaching market before the Orange Book listed patents expired.  The MMA introduced various "forfeiture" provisions to make it possible for secondary ANDA filers to break through this roadblock.

    One of these "forfeiture" events is a final, non-appeal decision that a patent is invalid or not infringed.  Specially, the first filer has 75 days from the date that the first applicant or another applicant with "tentative approval" brings "an infringement action . . . against that applicant with respect to the patent or in a declaratory judgment action brought by the applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that that patent is invalid or not infringed."  There are two conditions that must be met — (1) there must be tentative approval and (2) there must be a finding of non-infringement.  Apotex can therefore "trigger forfeiture in this case by obtaining the judgment it seeks here and by obtaining tentative approval . . . ."  The Court rejected Mylan's assertion that the "tentative approval" must precede the initiation of a DJ action of non-infringement for a lot of the same reasons expressed above.

    Because the Federal Circuit found that a case or controversy existed, it reversed the judgment of the District court.  In addition, the Court reversed the denial of Mylan's motion to intervene.  Mylan has a direct and immediate interest, and it stands to either gain or lose because of the "direct legal operation and effect of the judgment."

    Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)
    Panel: Circuit Judges Taranto, Mayer, and Clevenger
    Opinion by Circuit Judge Taranto

  • Patent Offices Issue Warnings Regarding Fraudulent Requests for Fees

    By Donald Zuhn —

    EPOSeveral patent offices, including the European Patent Office (EPO), United Kingdom Intellectual Property Office (UK IPO), World Intellectual Property Organization (WIPO), and Israel Patent Office (ILPO), have recently issued warnings to applicants and practitioners regarding invitations or requests to pay fees that do not come from those patent offices and that are unrelated to the processing of applications at those patent offices.  The fraudulent notices purport to offer registration or publication services that are not connected to those patent offices or to any of the official publications distributed by those offices.  In its warning, the EPO notes that the firms distributing such notices use names, abbreviations, and logos that are designed to make it appear that the notice has been issued by an official source, and that frequently, the notices bear a confusing similarity to documents that are actually issued by the EPO or WIPO in order to give the impression that the firms distributing the notices are acting on the behalf of the EPO or WIPO.  The EPO warning advises applicants and practitioners that (emphasis in original):

    Despite the misleading official look of such invoices, the services offered by these firms are unrelated to the processing of European patent applications and PCT applications by the EPO and WIPO.  There is therefore no obligation to pay any invoice issued by these firms for the processing of your patent application by the EPO and WIPO.  Moreover, any payment made to these firms will have no legal effect whatsoever in proceedings under the EPC and the PCT.

    The EPO warning also provides 26 examples of notices that have been issued by the following firms or organizations requesting payment of "fees":

    • E.C.R.-Euro Central Reg.

    • EOOD Patent und Markendienst

    • EPTR – European Patent and Trademark Register

    • Euro IP Register

    • European Patent Portal

    • European Register of Brands and Patents

    • Federated Organization for Intellectual Property (F.O.I.P.)

    • F.O.I.P.

    • IBIP – International Bureau for Intellectual Property

    • International Patent and Trademark Service

    • International Trademark and Patent Registration

    • IP Data

    • IPTG International Patent and Trademark Guide

    • IPTR International Patent and Trademark Register

    • Novislink Limited

    • Patent Trademark Register

    • PMS Patent und Markenservice AG

    • Registration of International Patent

    • RCE – Registre Central Européen

    • RPT Servis

    • TPS Trademark and Patent Service

    • UPTS

    • WDTP Worldwide Database of Trademarks and Patents

    • WIPP – World Intellectual Property Publisher

    • World Patent and Trademark Index

    The warning from UKIPO includes an example of a notice from OHIM-Organization for Harmonizing in the Intern. Market.

    The warning from WIPO includes a list of 91 notices requesting payment of "fees".

    (We have also collected copies of notices requesting "fees" that were sent by Comm Ctr Ind Trade, CPTD – Central Patent & Trademark Database, IP Data, Patent Trademark Register, USTMS – United States Trademark Maintenance Service, UPTS, WDTP, and WIPT.)

    The EPO warning concludes by noting that "[o]nly the EPO can publish and register European patent applications and patents with legal effect, and it does so automatically," and "[s]imilarly, the International Bureau of WIPO alone is responsible for the international publication of PCT applications."  The EPO advises applicants and practitioners "to read carefully the content of any invitation to make payments in relation to your patent applications and patents."

    Hat tip to the Reinhold Cohn Group for alerting the patent community to the warnings issued by the EPO, WIPO, UKIPO, and ILPO.

  • Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)

    By Kevin E. Noonan —

    Senju PharmaceuticalEarlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju Pharmaceutical Co., Ltd. v. Lupin Ltd.  The case involved patentee Senju Pharmaceutical's (joined by Kyorin Pharmaceutical Co. and Allergan, Inc.) suit against Lupin Ltd., Lupin Pharmaceuticals, and Hi-Tech Pharmacal in response to a Paragraph IV certification against Senju's patented ocular antimicrobial agent containing the drug gatifloxacin as claimed in re-examined U.S. Patent No. 6,333,045 and marketed under the brand name Zymar®.  The patent claimed an ophthalmic formulation of the drug containing 0.01% (w/v) disodium edetate (EDTA) that improved delivery of the drug across the cornea of the eye.

    In earlier litigation against Apotex (before the same U.S. District Court judge on the same patent), the generic formulation was found to infringe but the asserted claims were found invalid for obviousness.  Thereafter, the patentee submitted a request for ex parte reexamination containing all of the art cited at trial.  This resulted in cancellation of all but one of the claims asserted against Apotex and a reexamination certificate containing additional claims having limitations that overcame the grounds of obviousness found by the District Court.

    LupinSenju and co-plaintiffs filed the lawsuit that is the subject of this appeal against Lupin, asserting the re-examined claims against generic formulations comprising 0.5% w/v gatifloxacin and 0/3% w/v gatifloxacin.  The District Court, keeping in mind its earlier obviousness determination (according to Senju) again invalidated the re-examined claims as being obvious while finding that if valid Lupin's generic formulation would infringe the re-examined claims.

    The Federal Circuit affirmed, in an opinion by Judge Plager joined by Judge Moore, with Judge Newman dissenting.  The opinion exhaustively set forth the arguments from both sides, the Court setting forth these arguments but little regarding the District Court's grounds for finding the claims obvious; claims 6 and 12 are as follows:

    6.  A method for raising corneal permeability of an aqueous pharmaceutical Gatifloxacin eye drop solution comprising Gatifloxacin or its salt, having a pH of from about 5 to about 6 containing from about 0.3 to about 0.8 w/v% Gatifloxacin or its salt, which comprises incorporating about 0.01 w/v% disodium edetate into [eye drops containing Gatifloxacin or its salt] said Gatifloxacin eye drop solution.

    12.  An aqueous liquid pharmaceutical eye drop solution which comprises from about 0.3 to about 0.8 w/v% Gatifloxacin or its salt, about 0.01 w/v% disodium edetate, and wherein the aqueous liquid pharmaceutical solution has a pH of from about pH 5 to pH 6.

    (following the convention that the italicized portions of the claims were added during reexamination and the bracketed portions deleted).

    The majority found Senju's arguments to be unavailing, specifically that the District Court had improperly included her earlier judgment concerning obviousness and thus lowered Lupin's burden for satisfying the clear and convincing evidence standard for invalidating the claims, and further not considering the limiting amendments made during reexamination.  The opinion identified two primary arguments on the merits put forth by Senju: (1) the District Court erred by finding that the prior art taught using 0.01 w/v% EDTA in an ophthalmic formulation would work to increase corneal permeability; and (2) the District Court erred by finding appellants' proffer of evidence of unexpected results unavailing.  Regarding the first argument, the Court considered the four prior art references asserted by Lupin (which were the same asserted by Apotex in the earlier litigation): "U.S. Patent Nos. 4,551,456 ("the '456 patent"), 4,780,465 ("the '465 patent"), and 4,980,470 ("the '470 patent"), and Grass 1985 [Effects of Calcium Chelating Agents on Corneal Permeability, 26 Investigative Ophthalmology & Visual Science 110 (1985)]."  These references taught other examples of topical administration of quinolones (including norfloxacin and lomefloxacin) for treating bacterial infections in the eye, in formulations containing EDTA as a "conventional excipient" at 0.01 w/v% concentrations.  One of the references, the '470 patent, taught that gatifloxacin was "an improvement over the prior art quinolones in that it exhibits a broader antibacterial activity, higher selective toxicity and safe oral and parenteral administration."  And the Grace reference taught using EDTA to improve corneal permeability, albeit at concentrations much (~50-fold) higher than the 0.01 w/v% specified in the '045 patent's claims.  However, the lower concentration (and its efficacy with regard to increased corneal permeability) was disclosed in additional references not earlier considered (including two additional Glass references, which showed concentrations of 0.1, 0.05, and 0.01 w/v% EDTA in quinolone formulations, and the Rojanasakul reference which showed enhanced corneal permeability even at EDTA concentrations of 0.00037 w/v%).

    The Federal Circuit, like the District Court, also rejected Senju's argument that two additional references, the Mitra reference and the Kompella reference, supported their non-obviousness argument by teaching away from the combination of other references.  The opinion further rejected Senju's argument that, because the references were published "at least eight years" prior to their earliest filing date their claims should not be considered obvious over these references (apparently taking the position that if their invention was obvious at its filing date the references would have motivated the skilled worker to combine them prior to that date).  (The Court held that this argument had been waived for not being timely advanced by Senju at trial.)  The Court also held that the enhanced corneal permeability limitation was not affirmatively recited in the composition of matter claims (claims 12-16) and thus any evidence of this property was "not relevant" to the asserted non-obviousness of these claims.  And absent this limitation inclusion of EDTA was merely one of several "conventional ingredients" the inclusion of which in the claimed formulations was not sufficient to render them non-obvious.

    Similarly, the Federal Circuit affirmed the obviousness of claim 6, the sole method claim on the basis that the Mitra and Kompella references did not teach away from the combination of references and this combination (of all the other references of record) supported the District Court's obviousness determination.  Curiously the opinion states that "[w]hile both references find success at higher EDTA concentrations, they do not provide any indication that lower EDTA concentrations would not also work," which seems to put the evidentiary shoe on the wrong foot, particularly because Senju argued that the District Court did not properly consider these references.  (In her dissent, Judge Newman states in this regard: "[a] reference need not foresee a later-discovered invention and warn against it, to teach away from the discovery," citing Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011).)  The opinion also discredits Senju's argument that the art did not show that EDTA was effective at concentrations of 0.01 w/v% based on teachings in the art of concentrations of this component of the claimed formulation that were 30-50-fold higher.  The opinion cites with approval disclosure in the cited art that any amount of EDTA increased corneal permeability, even amounts showing no statistically significant increase over control.  Finally, the opinion appears to defer to the District Court's crediting of Lupin's witnesses over Senju's (not heretofore mentioned in the opinion) to support its decision affirming the obviousness determination below.

    The Federal Circuit approved of the District Court's disregard for evidence of unexpected results put forward by Senju, on the grounds that the results were "a product of routine optimization that would have been obvious to one of skill in the art," again deferring to the credibility determinations of the District Court (and despite the same evidence having been considered sufficient to overcome an obviousness rejection during the re-examination, i.e., under a much lower evidentiary burden).  In view of the higher burden at trial, the following statement in the opinion seems somewhat baffling:

    We further conclude that the district court properly applied a presumption of validity, considering both the evidence of obviousness and the evidence of unexpected results, to find that appellees set forth clear and convincing evidence of invalidity in this case.  See Sciele Pharma Inc., 684 F.3d at 1260.  We agree that it was not clear error for the district court to conclude that the unexpected results evidence that Senju relied upon during reexamination, [] did not withstand scrutiny by Lupin's experts and the district court.  Ultimately, the district court properly concluded that the theories presented during reexamination proved too weak when challenged in a judicial forum to rise to the level of unexpected results sufficient to rebut a strong case of obviousness.  See Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009).

    Judge Newman dissented, based on her perception that neither the District Court nor the panel majority showed proper deference to the presumption of validity for the re-examined claims and her belief that both judicial bodies misinterpreted the teachings of the cited art.

    She states her understanding of the law of obviousness:  "[o]bviousness is a matter of foresight, not hindsight.  A determination of obviousness requires some reason or suggestion, in the prior art or in common sense, that the claimed subject matter is likely to be effective for its intended purpose," citing KSR Int'l Corp. v. Teleflex Inc., 550 U.S. 398, 420–22 (2007), and that here the evidence of record was that the art taught away from the method claimed in claim 6 as issued in the reexamination certificate.  She also cites Daubert v. Merrell Dow Pharm., Inc., for the proposition that a court must not give unsupported expert testimony greater weight than the experimental data set forth in the cited art.  509 U.S. 579, 589 (1993).  She asserts that "[t]he published contemporaneous statements of scientists interpreting their experiments warrant more weight than unsupported opinions appearing for the first time in litigation" and that the District Court improperly dismissed Senju's expert's testimony because he did not use "statistical analysis" to show the significance of the data supporting non-obviousness in the '045 patent specification.  This failure was not enough for either the District Court or the panel majority to disregard this expert's opinion, according to Judge Newman, because  "[w]ith the exception of Lupin's expert witnesses, those skilled in the art interpreted Senju's experiments as demonstrating unexpected results."

    Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)
    Panel: Circuit Judges Newman, Plager, and Moore
    Opinion by Circuit Judge Plager; dissenting opinion by Circuit Judge Newman

  • USPTO Director Announces “Quick-Fix” and Anticipated Changes to PTAB Practice

    By Grantland Drutchas and Andrew Williams —

    USPTO SealOn Friday, March 27, U.S. Patent and Trademark Office Director Michelle Lee issued a statement on the PTO Blog indicating several "quick-fix" and proposed rule changes.  The "quick-fix" rules package will apply to all newly filed petitions before the Board, and will be implemented in pending cases by APJs through scheduling orders effective immediately.  The second proposed-rules package will likely be released this summer and the community will be given an opportunity to provide feedback before the rules are finalized.  These new rules packages stem from 37 written comments that the Office received when it requested feedback at the end of last year.  See "Deputy Directory Lee Announces the Request for Written Comments to Help Improve PTAB Proceedings"; "PTAB Update — A Review of the First Round of Comments (Part 1)"; "PTAB Update — A Review of the First Round of Comments — Part 2".  In fact, the authors of this post, along with Alison Baldwin and Lisa Schoedel, submitted one of these comments advocating that the Board adopt the same standard for construing claim terms as used by federal courts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).  See "PTAB Update — Is "Broadest Reasonable Interpretation" the Appropriate Standard?"

    According to Director Lee, immediate changes include nearly doubling the number of pages for a motion to amend to up to 25 pages, along with the addition of a claims appendix.  Opposition briefing and reply briefing will get a commensurate amount of additional pages.  Judges will begin implementing these changes through scheduling orders effective immediately.

    The increase in the number of pages allowed for a motion to amend is up from the current 15 pages, which must include the listing of the claims (unless indicated otherwise in a scheduling order).  As a result, we are likely to see an increase in the number of motions being granted.  Of course, it is hard to imagine any less (considering only two sets of motions have been granted in the past 2 ½ years).  The patent owner was already at a huge disadvantage because of the high hurdle required to establish it was entitled to amend a claim, but the 15-page limit made it practically impossible.  It is really no surprise that so few motions have been granted.

    The other "quick fix" rule change will also be significant, especially as it relates to a petitioner's reply brief responding to a patent owner response.  The current page limit is 15 pages, which puts the petitioner at a disadvantage in responding to the assertions made by the patent owner in response to the petition (which can be up to 60 pages for an IPR petition).  Even though the petitioner initially received a commensurate number of pages when it filed its original petition, it is very difficult to anticipate every argument that the Patent Owner will raise.  This is especially true with regard to secondary indicia of non-obviousness, for which the patent owner bears the burden of establishing.  The page increase will relieve some of the pressure on the petitioner to anticipate every argument in the petition.

    The upcoming anticipated rule changes (second rule changes) include:

    • Modifying the motion to amend process;

    • Adjustments to the evidence a patent owner can provide in a preliminary response; and

    • Clarification of the claim construction standard as applied to expired patents in AIA proceedings.

    This last noted change is somewhat disheartening, because it suggests that the Patent Office is not entertaining the possibility of changing the claim construction standard for unexpired patents.  The final remaining hope of a "plain and ordinary meaning" standard may rest with Congress, which is a distinct possibility, considering such a standard has been proposed in almost every piece of legislation.

    The other rule changes under consideration mentioned by Director Lee include:

    • Adjustments to the scope of additional discovery;

    • How to handle multiple proceedings before the Office involving the same patent;

    • Use of live testimony at oral hearings;

    • Whether the parties should be required to make a certification with their filings similar to a Rule 11 certification in district court litigation;

    • For motions to amend, emphasizing that a motion for a substitutionary amendment will always be allowed to come before the Board for consideration (i.e., be "entered");

    • For amendments to result in the issuance ("patenting") of amended claims, a patent owner will not be required to make a prior art representation as to the patentability of the narrowed amended claims beyond the art of record before the Office;

    • Changes to the Trial Practice Guide to clarify usage of live testimony and to emphasize the importance of real-party-in-interest discovery; and

    • A single-judge pilot program where the single judge would make the decision on whether to institute a trial.

    Director Lee's full blog posting is available here.

    For those interested in following the events at the PTAB, the authors are proud to announce the launch of the PTAB TRIALS group on LinkedIn, which provides up-to-date information on IPR, PGR and CBM Info.  That group will continue to cover the roll-out of the new AIA post-issuance proceeding rule packages.  And, of course, we will continue to cover any significant updates here on Patent Docs.

  • Court Report

            By Sherri Oslick —

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

    Purdue Pharma L.P. et al. v. Collegium Pharmaceutical, Inc.
    1:15-cv-11294; filed March 26, 2015 in the District Court of Massachusetts

    • Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendant:  Collegium Pharmaceutical, Inc.

    Purdue Pharma LP et al. v. Collegium Pharmaceutical Inc.
    1:15-cv-00260; filed March 24, 2015 in the District Court of Delaware

    • Plaintiffs:  Purdue Pharma LP; P.F. Laboratories Inc.; Purdue Pharmaceuticals LP; Rhodes Technologies
    • Defendant:  Collegium Pharmaceutical Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Extampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).   Also, infringement of U.S. Patent No. 8,652,497 ("Pharmaceutical Formulation Containing Irritant," issued February 18, 2014) based on Collegium's filing of its Extampza ER NDA.  View the Delaware complaint here.

    Helsinn Healthcare S.A. et al. v. Hospira Inc.
    1:15-cv-00264; filed March 25, 2015 in the District Court of Delaware

    • Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
    • Defendant:  Hospira, Inc.

    Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies Inc. et al.
    1:15-cv-00265; filed March 25, 2015 in the District Court of Delaware

    • Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
    • Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

    Helsinn Healthcare S.A. et al. v. Hospira, Inc.
    3:15-cv-02077; filed March 23, 2015 in the District Court of New Jersey

    • Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
    • Defendant:  Hospira, Inc.

    Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies, Inc. et al.
    3:15-cv-02078; filed March 23, 2015 in the District Court of New Jersey

    • Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
    • Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the Hospira New Jersey complaint here.

    Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC
    1:15-cv-00250; filed March 20, 2015 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  View the complaint here.

    Noven Pharmaceuticals Inc. v. Actavis Laboratories UT Inc.
    1:15-cv-00249; filed March 20, 2015 in the District Court of Delaware

    Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis).  View the complaint here.

    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Breckenridge Pharmaceutical, Inc.
    9:15-cv-80377; filed March 20, 2015 in the Southern District of Florida

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendant:  Breckenridge Pharmaceutical, Inc.

    Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation).  View the complaint here.

    Horizon Pharma Ireland Ltd. et al. v. Taro Pharmaceuticals USA, Inc. et al.
    1:15-cv-02046; filed March 13, 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 Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Taro's 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 complaint here.

  • Conference & CLE Calendar

    CalendarMarch 30-31, 2015 – Post-Grant Patent Challenges at the PTAB*** (Momentum) – San Jose, CA

    March 31, 2015 – "Overcoming Sect. 101 Rejections Post-Alice Corp. — Leveraging USPTO Guidance and Recent Decisions to Meet Sect. 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 31, 2015 – "Trade Secret or Patent Protection? Making the Right Choice for Your University’s Innovations" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    April 1, 2015 – "PCT Filing and International Patent Prosecution" (American Intellectual Property Law Association)

    April 2, 2015 – "IP5 Global Dossier: A New Era in Global Patent Prosecution?" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 7, 2015 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – 11:00 am to 5:00 pm (EDT)

    April 9, 2015 – "Conducting and Analyzing Patent Searches — Strategies for Validity, Patentability, Infringement, FTO and State-of-the-Art Searches" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 15-17, 2015 – 2015 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – St. Louis, MO

    April 16, 2015 – "Patent Subject Matter Eligibility: Navigating the New USPTO Guidance — Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 21, 2015 – U.S. Biosimilars (American Conference Institute) – Munich, Germany

    April 27-29, 2015 – M&A and Strategic Alliances in the Life Sciences Industries*** (American Conference Institute) – New York, NY

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