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  • Top Stories of 2014: #15 to #18

    By Donald Zuhn —

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories.  For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  Today, we count down stories #18 to #15, and then over the next few days, we will work our way towards the top stories of 2014.  As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

    18.  White House Begins to Implement Initiatives to "Foster innovation"

    In June of 2013, the White House released a Fact Sheet on the Administration's task force on high-tech patent issues providing seven different legislative recommendations and five executive actions (see "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues").  In 2014, the White House took the first steps toward implementing the executive actions.  The step that attracted the most attention was the U.S. Patent and Trademark Office's publication of a notice of proposed rulemaking in which the Office proposed changes to the rules of practice that it claimed would "facilitate the examination of patent applications and . . . provide greater transparency concerning the ownership of patent applications and patents."  The proposed changes to the rules would require that the "attributable owner" be identified at the time an application is filed (or shortly thereafter), during the pendency of an application when there is a change in the attributable owner (within three months of such change), at the time the issue fee is paid, when maintenance fee payments are made, and if a patent becomes involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board.  In February, the White House provided an update on the five executive actions, "announcing major progress" on the initiatives that the Administration declared would help combat so-called "patent trolls."  One of the initiatives involved the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements."  With respect to the White House's initiative to promote transparency concerning patent ownership, Hal Wegner stated in his e-mail newsletter in February that while "attempts to minimize comment [on the proposed rulemaking regarding attributable owner identification] have involved suppression of existing comments as if this will perhaps lead to the public falling asleep at the comment switch," "the leadership of the Patent Office has been sheltered from questioning by the public, while the Administration’s lobbyist group, 'Business Forward', continues to have access to PTO leadership" (emphasis in original).

    For information regarding this and other related topics, please see:

    • "White House Seeks to Promote Transparency Concerning Patent Ownership," February 24, 2014
    • "The White House Releases Update on "Protecting American Inventors and Innovators"," February 20, 2014
    • "USPTO Proposes Rules Changes to Require Identification in Applications and Patents of Attributable Owners," January 28, 2014


    17.  Federal Circuit Dismisses Consumer Watchdog Appeal for Lack of Standing

    In June, the Federal Circuit dismissed an appeal by Consumer Watchdog from a decision of the Patent Trial and Appeal Board affirming the patentability of claims 1-4 of the Wisconsin Alumni Research Foundation's U.S. Patent No. 7,029,913, which is directed to a replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo.  In dismissing the appeal, the Federal Circuit determined that Consumer Watchdog had failed to establish an injury in fact sufficient to confer Article III standing because it had failed to identify any alleged injury aside from the Board denying Consumer Watchdog the particular outcome it desired in the reexamination of the '913 patent.  Given that Consumer Watchdog had been seeking to invalidate the patent as being invalid for encompassing ineligible subject matter, but for the dismissal for lack of standing, the appeal might have helped elucidate how the Federal Circuit viewed the patent eligibility of subject matter other than nucleic acids after The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.

    For information regarding this and other related topics, please see:

    • "Consumer Watchdog v. Wisconsin Alumni Research Foundation (Fed. Cir. 2014)," June 5, 2014
    • "Consumer Watchdog Replies to United States Brief on Standing Issue," February 11, 2014
    • "United States Argues That Consumer Watchdog Lacks Standing to Appeal Board Decision on WARF Patent," February 6, 2014


    16.  Federal Circuit Decisions in Terminal Disclaimer Cases Serve as Reminder of Traps for the Unwary

    Two decisions by the Federal Circuit in June and December served as a reminder to applicants and practitioners that patent law remains "full of traps for the unwary."  In Dinsmore, the Court affirmed a final rejection by the U.S. Patent and Trademark Office, which had refused to accept a reissue declaration in which the patentee indicated that the "error" in the patent that made it defective was the inadvertent filing of a terminal disclaimer.  In Japanese Foundation for Cancer Research, the Federal Circuit reversed a District Court determination ordering the U.S. Patent and Trademark Office to withdraw an improperly filed terminal disclaimer.  In distinguishing the facts of the instant case from the Court's earlier decision in Carnegie Mellon Univ. v. Schwartz, the Court indicated that Carnegie Mellon had intended to file a terminal disclaimer but had erred in identifying the correct patent serial number, whereas here the issue was whether the Office could withdraw a disclaimer that was intentionally filed (in the correct patent), i.e. where there was not the kind of error in Carnegie Mellon that justified the contrary results.

    For information regarding this and other related topics, please see:

    • "Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014)," December 11, 2014
    • "In re Dinsmore (Fed. Cir. 2014)," June 10, 2014


    15.  Federal Circuit Hears Oral Argument in Ariosa v. Sequenom

    In the context of the controversy caused by the U.S. Patent and Trademark Office's Myriad/Mayo guidance, the Ariosa Diagnostics v. Sequenom case worked its way through the appeal process with oral argument before the Federal Circuit taking place in November.  A little more than a year earlier, the Northern District of California had granted summary judgment for declaratory judgment plaintiff Ariosa Disgnostocs, finding that Sequenom's claimed method for detecting a paternally inherited nucleic acid of fetal origin was not patent eligible.  Among the controversial aspects of the case, was the District Court's determination that Sequenom's argument that there were alternative methods of detecting cffDNA available was unpersuasive because "Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable" (emphasis added).  Regardless of where the Federal Circuit comes down on this case, it will likely make a return visit to next year's list of top stories and likely impact future iterations of the USPTO's guidance on subject matter eligibility.

    For information regarding this and other related topics, please see:

    • "Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings (D. Del. 2014)," November 24, 2014
    • "Ariosa v. Sequenom — Ariosa's Responsive Brief," November 11, 2014
    • "PTAB Decides Inter Partes Review of Patent at Issue in Ariosa v. Sequenom," September 15, 2014
    • "Amicus Briefs Urging Reversal Filed in Ariosa Inc v. Sequenom, Inc.," March 6, 2014
    • "Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds," January 30, 2014

  • Hatch-Waxman Watch: Personal Jurisdiction Edition

    By Andrew Williams —

    Mylan #1Is the ability to obtain personal jurisdiction against an ANDA filer for a Hatch-Waxman-type litigation going to become exceedingly more difficult?  In the past, jurisdiction against such a defendant was often predicated on general jurisdiction, analyzing whether the party's contacts with the forum "are so continuous and systematic as to render it essentially at home in the forum State."  Daimler AG v. Bauman, 134 S. Ct. 746, 761 (2014).  The Supreme Court in the Daimler case made the finding of general jurisdiction for a foreign entity more difficult.  Consistent with that holding, Judge Sleet in the AstraZeneca AB v. Mylan Pharmaceuticals, Inc. case found that an ANDA filer's contacts with Delaware were insufficient to confer general jurisdiction — contacts that might have been sufficient previously.  Nevertheless, Judge Sleet did find that the act of sending the paragraph IV notification to AstraZeneca in Delaware provided sufficient minimum contact for the Delaware court to exercise specific jurisdiction.  Because this result is allegedly inconsistent with an outcome from a North Carolina District Court, Mylan sought certification for interlocutory appeal, which Judge Sleet granted on December 17, 2014 (Certification Order).  In so deciding, the judge noted the huge volume of Hatch-Waxman cases pending in Delaware, and that therefore "immediate appeal may indeed advance the termination of this and other ligitation."  Certification Order at FN 1.  Needless to say, if the Federal Circuit disagrees with Judge Sleet's determination, this could have an immediate and sufficient impact on Hatch-Waxman cases in the state of Delaware, and potentially elsewhere.

    AstraZeneca_smallThe present case stems from Mylan's filing of two ANDAs to seek approval to market generic versions of AstraZeneca's ONGLYZA® and KOMBIGLYZETM drug products.  The first of these is for saxagliptin hydrochloride tablets, and the latter is for saxagliptin hydrochloride and metformin hydrochloride extended release-release tablets.  AstraZeneca filed suit in Delaware, alleging that the District Court had jurisdiction because Mylan "purposefully availed itself of the rights and benefits of Delaware law by engaging in systematic and continuous contacts with Delaware."  Nevertheless, AstraZeneca failed to allege in its complaint that Mylan engaged in any specific activities in Delaware related to the present action, other than a generic statement that "this action arises from actions of Mylan directed toward Delaware."  Instead, as in many similar cases, AstraZeneca pointed to the "regular[] and continuous[]" business transactions within the state, which included the selling of pharmaceutical products.  Because Mylan derived substantial revenue from the sale of such products, it was alleged, Mylan had "availed itself of the privilege of conducting business within the State of Delaware."  Moreover, Mylan had been previously sued in Delaware without objecting to personal jurisdiction and even asserting counterclaims (thereby availing itself of the court).  This case was filed at about the same time as cases against several other ANDA filers, all of which were consolidated under the heading AstraZeneca AB v. Aurobindo Pharma., Ltd.

    As a refresher of first-year Civil Procedure jurisprudence, the U.S. Constitution's due process clause requires that a defendant not located within a state must "have certain minimum contacts with it such that maintenance of the suit does not offend traditional notions of fair play and substantial justice."  Int'l Shoe Co. v. State of Wash., Office of Unemployment Compensation & Placement, 326 U.S. 310, 316 (1945).  There are two ways to satisfy this requirement — the presence of specific or general jurisdiction.  As suggested above, general jurisdiction can exist even if the cause of action arises outside of the forum state, provided that the party's contacts with the state are "so continuous and systematic as to render it essentially at home in the forum State."  Last term, the Supreme Court in the Daimler case pointed out that being "at home" really only existed for a narrow set of circumstances, such as at the place of incorporation or the principal place of business.  This effectively reduced the instances in which general jurisdiction exists.  However, a court can still have specific jurisdiction over a case if "the litigation results from alleged injuries that 'arise out of or relate to'" activities that are purposefully directed to residents of the forum.  Burger King Corp. v. Rudzewicz, 471 U.S. 462, 472-73 (1985).  Therefore, for example, in the Hatch-Waxman contact, any previous contacts that an ANDA-filer may have had with a particular state are irrelevant to the determination of specific jurisdiction.  Instead, only contacts related to specifics of the case can be considered.

    In the present case, Mylan is a West Virginia corporation.  It prepared its two ANDAs in West Virginia and filed them in Maryland (where the FDA is located).  Mylan is registered to do business in Delaware, and has appointed a registered agent to accept service of process in Delaware, both of which were required by the state.  Otherwise, Mylan allegedly has no property or employees in Delaware.  Because of these limited contacts with the state, Mylan challenged personal jurisdiction via a Motion to Dismiss.  Departing from previous opinions, Judge Sleet determined that the common ways of finding general jurisdiction in the past were no longer viable in view of Daimler.  For example, the Court noted that obtaining substantial revenue from drug sales in the state was no longer sufficient.  If Delaware was able to assert general jurisdiction over Mylan, Judge Sleet explained, than that would permit the "exercise of general jurisdiction in every [s]tate," which was precluded by the Daimler case.  Moreover, the Court rejected AstraZeneca's argument that Mylan consented to general jurisdiction by registering to do business in the state, because Daimler still requires minimum contacts in such circumstances (which still did not exist).  Therefore, the Court found general jurisdiction did not exist.

    Nevertheless, Mylan's motion to dismiss was denied because of specific jurisdiction.  The only "specific" acts that the Court could point to were the filing of the ANDA and the sending of the notification letter into the state, but these were sufficient.  Of course, the ANDA was not filed in Delaware, but Judge Sleet noted that the consequences of this "real act" of filing was (or will be) suffered in Delaware.  This is partially because the Federal Circuit had already held that jurisdiction is not conferred in Maryland simply because the FDA is located there.  The sending of the notice letter was probably more significant because, according to Judge Sleet, the cause of action arose from the receipt of this correspondence, which trigged the 45-day window to file suit.  Moreover, the traditional notions of fair play and substantial justice weighed in favor of exercising specific jurisdiction because Mylan is no stranger to litigation in the state of Delaware.  To hold otherwise would force AstraZeneca to bring the lawsuit in Mylan's state of West Virginia (which the Court found contrary to the "balance" established by Congress in the statute).  Finally, the Court did consider that there were at least ten generic defendants, and resolution of each of these cases in a single district promoted judicial economy.

    All eyes will be in the Federal Circuit to see how it addresses this issue of personal jurisdiction.  Judge Sleet noted that he was not aware of any other judicial decisions regarding personal jurisdiction in Hatch-Waxman cases that considered the impact of the Daimler case.  Because it could impact not only the present case, but may other litigations, the Court found certification appropriate.  We will continue to monitor and report on the progress of the interlocutory appeal.

  • The Uncomfortable Intersection between the Practice of Medicine and Reality

    By Kevin E. Noonan —

    PfizerThe disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors working for the National Health Service in the UK and innovator drug company Pfizer over its patented Lyrica® drug (pregabilin).

    As reported on the Biospace GenePool website, the patent protecting the drug itself expired in July 2014, but Pfizer also has a patent on uses of the drug for neuropathic pain (the use most Americans would recognize based on countless viewings of televised commercial advertisements).  But it seems that Lyrica® was first approved for generalized anxiety disorder (GAD) and epilepsy and that the pain indication was disclosed and claimed in a later patent that does not expire until July 2017.

    Accordingly, generic versions of pregabilin have been approved only for the GAD and epilepsy indications, and treatment of neuropathic pain with generic pregabilin would be an "off-label" use that would be an act of patent infringement.  While drug companies rarely sue doctors, generic drug companies and others who promote such off-label uses can be sued for inducing or contributory infringement (or both) under U.S. law, and while this situation has arisen in Britain it appears that similar grounds of legal liability exist under UK law.

    Pfizer addressed these issues in a letter to "physicians" (but, it seems, directed to pharmacists and hospital administrators either in addition to or instead of physicians themselves), setting out what Pfizer characterized as "relatively unusual circumstances":

    Re. Lyrica® (pregabalin) pain patent

    I am writing to you to ensure you are informed about the relatively unusual issues surrounding the loss of exclusivity situation for the Pfizer product Lyrica (pregabalin) and so that you can take necessary action to prevent patent infringement by your organisation.

    An appendix is attached describing the factual aspects of the situation in detail to ensure that you have the full information available.  You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017.  Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication.  This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy.

    As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place.  Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics).  In other words, the generic pregabalin products are expected to carry so-called a so-called "skinny label" and will not be licensed for use in pain.  In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights.  This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.

    In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication.  Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act.  This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

    We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing and dispensing in your area.  We believe these powers must be exercised responsibly and with a view to avoiding the infringement of Pfizer's pain patent.

    In view of the above, Pfizer requests that you issue appropriate guidance to prescribing clinicians within your CCG to help to ensure that our pain patent is respected and that all prescribing clinicians are aware of the pain patent situation.  There are a number of ways in which this might be achieved, but the simplest solution, we believe, is for clinicians to be advised to prescribe Lyrica® by brand when prescribing pregabalin to treat neuropathic pain.  Pharmacists will then be able to dispense Lyrica® against such prescriptions and this will ensure that they do not infringe the pain patent.  In addition this will mean that patients with pain will be provided with a PIL that describes the use of pregabalin in pain.

    Your CCG may also consider reviewing patient records retrospectively (in advance of the availability of generic drugs) and use prescribing decision support mechanisms such as Scriptswitch to support appropriate ongoing prescribing.  We are willing to discuss, or assist CCGs with, the development of other solutions.

    We should also note that, in our view, (i) CCG guidance instructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act); and (ii) your CCG is under an obligation to address the risk of wide scale infringement of Pfizer's patent rights.  Pfizer therefore formally reserves all of its legal rights in this regard.  If you have any questions in relation to the above please contact Pfizer Ltd on 01304 616161.

    Yours sincerely

    Ruth Coles

    Legal Director

    APPENDIX

    Lyrica® (pregabalin) Pain Patent: Statement of Facts

    A. Background

    1. Regulatory data protection (data exclusivity) for Lyrica® expired in July 2014 across the European Union. Therefore, generic companies may now submit their applications for marketing authorisations for generic versions of pregabalin.

    2. The composition of matter (basic) patent for pregabalin has also expired and the Supplementary Protection Certificate (SPC) relating to this patent has lapsed. There may be inaccuracies in some publicly available records — but as far as we are concerned the basic patent and the SPC are no longer relevant.

    3. A patent protecting pregabalin's use in pain is in force for the product until July 2017. This patent (sometimes called a 'second medical use' patent) arises from further research and development on pregabalin leading to the invention of its use in pain, after the original invention of the compound for other uses.

    4. As you may be aware, Lyrica® is authorised for treating neuropathic pain, epilepsy, and generalised anxiety disorder. Pfizer's pain patent only provides patent protection in respect of the use of pregabalin to treat pain.

    B. Pain patent facts

    Broadly speaking, a 'second medical use' patent is one that relates to a new medical use for a known pharmaceutical or biological compound. The use in question may consist of a new condition that can be treated with the compound (i.e. a new indication). Provided the new use meets the usual tests for patentability (i.e. novelty, an inventive step, etc.) then a patent can be granted to protect it. In fact, the use in question does not have to be the second medical use, since it could be the third, fourth, etc, and the same rules would apply.

    This has been the case in Europe for many years. Second medical use patents are recognised in Art 54(5) of the European Patent Convention 2000, provided that the specific use is novel (i.e. not comprised in the state of the art). Art 54(5) of the European Patent Convention 2000 is implemented by primary legislation in the UK through section 4A of the Patents Act 1977 (as amended by the Patents Act 2004).

    Pfizer's Lyrica pain patent in Europe is number EP 0 934 061. Details can be found on the European Patent Office online register here:

    https://register.epo.org/application?number=EP97932617&tab=main

    Pfizer believes the patent is valid and that it prevents the sale of pregabalin for use in pain, which is the largest indication for which Lyrica is prescribed (pain comprises the majority of all prescriptions in the UK).

    Accordingly, Pfizer believes that appropriate safeguards should be put in place to ensure that the generic product is not dispensed in situations where pregabalin has been prescribed for pain. Pfizer has no issue with generic supply / dispensing of generic pregabalin for the non-pain indications. Both Generics (UK) Limited (trading as Mylan) and Actavis Group PTC ehf have sought to challenge the validity of the pain patent in the English Patents Court. The two sets of proceedings will be heard together at a trial commencing in June 2015. Pfizer believes the pain patent is valid and will be contesting the case vigorously.

    C. Generic pregabalin

    Whilst Pfizer's pain patent remains in effect, we expect that generic manufacturers will generally only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder, i.e. the two indications for which Pfizer has no patent protection. This would mean that generic pregabalin products will not have relevant information regarding neuropathic pain in the PIL (Patient Information Leaflets) and Summary of Product Characteristics. Pregabalin generics will contain the same active substance as the originator branded medicine, Lyrica® and (as mentioned above) are generally expected to obtain a licence which will only cover the epilepsy and generalised anxiety disorder indications, based on their ability to demonstrate bioequivalence with Lyrica®. There will be no clinical superiority of the originator branded medicine Lyrica® over generic pregabalin.

    Pfizer is not involved in the regulatory procedures of generic competitors. However, we have been notified by one generic company (Actavis Group PTC ehf) that it intends to launch generic pregabalin in the UK in December 2014 or January 2015, with an authorisation and label that will only cover the epilepsy and generalised anxiety disorder indications. Other generic companies may be operating to a similar — or even a faster – timeframe.

    On 8 December 2014, Pfizer issued infringement proceedings against Actavis Group PTC ehf, Actavis UK Limited, and Caduceus Pharma Limited concerning the proposed launch of their generic pregabalin product. Pfizer also issued an application for interim relief on this date, seeking appropriate precautions to minimise the risk of the Actavis generic pregabalin product being prescribed or dispensed for pain. The interim relief sought by Pfizer does not interfere with Actavis' ability to sell its generic pregabalin product for the epilepsy and generalised anxiety disorder indications for which it is authorised. Pfizer has no issue with Actavis selling its generic pregabalin product for non-patented indications. Indeed, Pfizer proposed to Actavis to engage in a collaborative effort to ensure that its generic pregabalin is not supplied or dispensed for pain and could accordingly be launched without the need for a court dispute.

    D. What it means

    The Lyrica® pain patent situation is a legal issue rather than a clinical one. Pfizer believes the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would be infringing Pfizer's patent protection and would constitute an unlawful act. The patent may also be infringed, even unwittingly, by pharmacists and others in the supply chain. This may occur if either the pain indication or the brand Lyrica is not stated on the prescription and generic pregabalin is dispensed and used to treat pain — as opposed to epilepsy or GAD. Without information, guidance and a practical solution, Pfizer believes that multiple stakeholders may contribute to IP infringement, an unlawful act, which also runs contrary to the established policy of rewarding additional research by the granting of a second medical use patent.

    The result, according to Biospace, has been "scorn" from UK physicians, while characterizing the notice as an "over-reaching legal decree."  Quoting Cory Doctorow from the Boing Boing weblog, the site complains that Pfizer wants doctors to prescribe Lyrica® for pain instead of generic pregabilin, "even though the two drugs are identical" and the branded version "costs much more."  Quoting additionally from Boing Boing:

    Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem.  The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'.  Doctors' duty is to science and health, not Pfizer's profit-margins.  Scientifically, there's no difference between the two compounds.  Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals.

    If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it.  But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

    Of course the reality is much different.  Pfizer doesn't have a problem, it has a presumptively valid patent on another, different use for its branded drug than the use for which pregabilin was initially approved.  While drug development itself is expensive, an additional, typically much greater expense is imposed by regulatory agencies, which require that the innovator drug company demonstrate that the drug is safe and effective.  While establishing safety is relatively straightforward, demonstrating effectiveness has the inherent requirement of being effective for what.  The second use in this case was likely to have been not self-evident; anxiety and epilepsy are not intrinsically associated with neuropathic pain, and Pfizer would have had to both recognize that use and establish efficacy in order to get regulatory approval for that use.  The reward for that effort and cost was patent protection for the use, which is what raises the possibility of patent infringement liability now.

    In addition, while the physicians themselves will (likely) not be sued, pharmacists and hospital administrations might be (and, frankly, even if Pfizer has no intention of suing either making them aware of the legal consequences is fair and responsible exercise of their patent and regulatory exclusivity).

    So why this tempest in this particular teapot?  As usual, it comes down to experience, and physicians will always want to treat as many patients as possible as effectively (and cheaply) as possible.  However, the physician's experience typically does not include any understanding regarding how medicines actually get developed, approved and marketed.  It is unfortunate that the politics of medical care provides an incentive for individuals providing care to oppose individuals providing the new drugs that improve our ability to treat and cure patients (which should be the goal for all of us).

    But acting on the incentive to demonize biotech and pharmaceutical companies is self-defeating.  Generic drug companies, for all their benefits, do not invest the time and resources to produce any new drugs; without innovator biotechnology and pharmaceutical companies, generic drug makers would have nothing to copy or sell.  It would be well for physicians to consider where novel therapies will come from without companies with experience in obtaining (and financing) regulatory approval of such drugs, protecting them with patents, and having the business resources to bring such drugs to market.  It is certainly the case that these companies are for-profit (it's capitalism, after all), but the costs of R&D and regulatory approval, as well as scale-up, production, and distribution are realities that cannot be ignored.

    That is where experience, specific experience with drug development, is invaluable.  Frankly, it is precisely because most physicians lack this experience that makes it easy to allude to corporate "greed" to explain outcomes they do not support.  (Similarly, in this way there are many (including apparently the Chief Justice) who attribute support of the patent system by patent attorneys as being self-serving, not realizing that efforts to complicate the system work only to our economic benefit.  Of course, that realization would prompt the thought that perhaps our motivations are not as self-serving as they may presume, leading to questions that might upset their comfortable presumptions.)

    Relying on assumptions, and believing that donning a white coat relieves you of the responsibility for actually knowing something before voicing an opinion, results in the kind of uninformed outrage expressed by the UK physicians.  Ultimately this is just a waste of time and a venting of spleen that may make these doctors feel superior but does nothing to help patients or patient care.  Which is presumably supposed to be the point.

  • Court Report

            By Sherri Oslick —

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

    Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc.
    1:14-cv-01494; filed December 18 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Par Pharmaceutical Inc.

    Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 7,297,703 ("Macrolides," issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected).  View the complaint here.

    Novartis AG et al. v. Actavis Inc. et al.
    1:14-cv-01487; filed December 16 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
    • Defendants:  Actavis Inc.; Actavis Elizabeth LLC

    Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis).  View the complaint here.

    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Teva Pharmaceuticals USA, Inc. et al.
    3:14-cv-07811; filed December 15, 2014 in the District Court of New Jersey

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendants:  Teva Pharmaceuticals USA, INC.; Teva Pharmaceutical Industries, Ltd.; Alkem Laboratories, Ltd.; Mylan Phamaceuticals 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 defendants' 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.

    AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA Inc. et al.
    1:14-cv-01478; filed December 12, 2014 in the District Court of Delaware

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca AB; Amylin Pharmaceuticals LLC
    • Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent Nos. 6,858,576 ("Methods for Regulating Gastrointestinal Motility," issued February 22, 2005), 6,872,700 ("Methods for Glucagon Suppression," issued March 29, 2005), 6,956,026 ("Use of Exendins for the Reduction of Food Intake," Issued October 8, 2005), 6,902,744 ("Exendin Agonist Formulations and Methods of Administration Thereof," issued June 7, 2005), and 7,521,423 ("Exendin Pharmaceutical Compositions," issued April 21, 2009) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of AstraZeneca's Byetta® (exenatide injection, used to improve blood sugar control in adults with Type II diabetes, when used with diet and exercise).  View the complaint here.

    Shire Development LLC et al. v. InvaGen Pharmaceuticals, Inc.
    2:14-cv-07263; filed December 12, 2014 in the Eastern District of New York

    • Plaintiffs:  Shire Development LLC; Shire Canada Inc.; Shire International Licensing B.V.
    • Defendant:   InvaGen Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999), 7,381,428 ("Stabilized Lanthanum Carbonate Compositions," issued June 3, 2008), and 7,465,465 ("Pharmaceutical Formulation Comprising Lanthanum Compounds," issued December 16, 2008) following a Paragraph IV certification as part of InvaGen's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease).  View the complaint here.

  • Conference & CLE Calendar

    CalendarJanuary 8, 2015 – "Proving and Avoiding Inequitable Conduct in Patent Prosecution and Litigation — Leveraging Court Treatment Post-Therasense and the AIA's Answer to Inequitable Conduct Issues" (Strafford) – 1:00 to 2:30 pm (EST)

    January 13-14, 2015 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

    January 15, 2015 – "Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" (Strafford) – 1:00 to 2:30 pm (EST)

    January 16, 2015 – 5th Annual Patent Law Conference (University of San Diego School of Law) – University of San Diego

    January 20, 2014 – "Top Patent Law Stories of 2014" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 22, 2015 – "Preparing for and Navigating PTAB Appeals Before the Federal Circuit — Conducting PTAB Trials With Eye to Appeal, Determining Errors for Appeal, Understanding PTO Practice and Federal Circuit Law" (Strafford) – 1:00 to 2:30 pm (EST)

    January 29, 2015 – "IPR Defense: An Overview of Strategic Considerations and Potential Pitfalls From the Patent Owner's Perspective" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    January 29, 2015 – "Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Post-Grant and Litigation — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

    March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

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

  • Webinar on IPR Defense

    ABAThe American Bar Association (ABA) Center for Professional Development and Section of Intellectual Property Law will be offering a live webinar entitled "IPR Defense: An Overview of Strategic Considerations and Potential Pitfalls From the Patent Owner's Perspective" on January 29, 2015 from 1:00 to 2:30 pm (ET).  Jonathan Rudolph Kominek Stroud will moderate a panel consisting of David L. Cavanaugh, Lora Marie Green, and Michael John Flibbert, which will take an in-depth look at patent owner defense inter partes review (IPR) challenges, including:

    • Motion to amend practice
    • Patent owner preliminary response
    • Secondary considerations

    The registration fee for the webcast is $150 for members and $195 for the general public.  Those interested in registering for the webinar, can do so here.

  • USD Patent Law Conference on Patent Invalidity after the America Invents Act

    University of San_DiegoThe University of San Diego School of Law will be hosting its 5th Annual Patent Law Conference on January 16, 2015 in the Manchester Conference Center Auditorium at the University of San Diego.  The conference, which is entitled "Patent Invalidity after the America Invents Act," will feature a lunch keynote by Hon. Raymond Chen, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit.

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

  • Webinar on Obviousness after The AIA

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" on January 15, 2015 from 1:00 to 2:30 pm (EST).  Barry J. Herman of Womble Carlyle Sandridge & Rice and Jon Schuchardt of Dilworth IP will provide patent counsel with guidance on the evolving obviousness standard.  The panel will discuss, in a post-AIA, post-KSR v. Teleflex world in which obviousness is at times confused with patent eligibility under Section 101, how the Federal Circuit's treatment of obviousness issues is changing?  The panel will also discuss how the Patent Trial and Appeal Board (PTAB) handles obviousness in the increasingly popular inter partes review (IPR) proceedings.  The webinar will review the following questions:

    • How have recent Federal Circuit decisions affected application of the obviousness standard?
    • What level of "unexpected results" is needed to demonstrate patentability in light of recent decisions?
    • Should a Section 101 argument be part of every patent challenger's arsenal?
    • What are the most effective strategies for both patentees and petitioners in prevailing on obviousness assertions in the relatively new inter partes review proceedings?

    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.

  • Chisum Patent Academy Patent Law Seminar

    The Chisum Patent Academy will be offering its next Advanced Patent Law Seminar on March 5-6, 2015 in Cincinnati, OH.  The seminar is co-taught by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Janice Mueller, who was a tenured full Professor at the University of Pittsburgh School of Law from 2004-2011.  The registration fee for the seminar is $1,400; a maximum of ten registrations will be accepted for the seminar.  Those interested in registering for the seminar can do so here.  Additional information regarding the seminar can be obtained here or by e-mailing info@chisum.com.

    Chisum Patent Academy

  • Season’s Greetings from Patent Docs

    Holiday StarsThe authors and contributors of Patent Docs wish their readers and families a Happy Holidays.  Publication of Patent Docs will resume on December 26th.