• House IP Subcommittee holds yet another one-sided hearing on bad patents and patent trolls

    House IP subcommittee chair Rep. Darrell Issa (R-CA) led off the hearing by discussing the large number of interests who are often on Capitol Hill to discuss their issues with “patent trolls,” including the “genius ones” which have only been developed in recent years. Despite the intent of the America Invents Act (AIA) of 2011 to weed bad patents out of the system, “patent trolls” remain active. Issa felt there were a few reasons for this, including the fact that such entities make money and…

    Continue Reading ...
  • USPTO/Federal Circuit Webinar on SEPs in China

    The ChinaIPR Blog this morning posted a notice of a free conference/webinar hosted by the USPTO and the Federal Circuit Bar Association, titled “Recent Developments in Standard-essential Patents in China.”  The event takes place next Tuesday, July 25, from 9:00 to 11:30 a.m. Eastern Time.  This looks really interesting, with a terrific list of speakers.  Here is a link to the registration page, and here is the description:
    The United States Patent and Trademark Office (USPTO) and the Federal Circuit Bar Association (CFBA) are co-hosting this meeting and webinar to discuss updates on the treatment of standard-essential patents (SEPs) in China, with a focus on prosecution and injunctions. This free event will offer an unparalleled opportunity to gather information from leading academics and experts on this topic from the United States, China, and Switzerland. 

    Speakers Include:

    • Mark Cohen, senior counsel, USPTO
    • David Kappos, partner, Cravath, Swaine & Moore LLP
    • Koren Wong, director, Global Antitrust Institute, Adjunct Professor of Law, Antonin Scalia Law School, George Mason University
    • Li ZHU, judge, Supreme People’s Court of China
    • Gaétan De Rassenfosse, holder of the chair of innovation and IP policy, College of Management of Technology, Switzerland
    • Yuan HAO, researcher, IP Research Center, Tsinghua Law School, Tsinghua University
    • Yijun Jill GE, IP managing associate, Allen & Overy, Shanghai Office

    Registration:

    The meeting is open to members of the public to attend on a first-come, first-served basis. Registration is free. Registration can be done online in advance of the meeting at the link below, and may also be available on site one half hour on the day of the meeting, space permitting. Register to attend here (link is external). 

    Webcast:

    The meeting will be available for viewing via live webcast (link is external)

    • Event number: 310 682 179
    • Event password: Ey94PWAX
    • Dial-in number (audio only):  +1 (571) 270-7000

    Agenda:

    The agenda will be published no later than one week prior to the event.

    Additional information:

    The registration website (link is external) provides additional information about directions and accommodation. For non-press inquiries, please contact Kelly Sheng (link sends e-mail) at the USPTO’s Office of Policy and International Affairs, telephone (571) 272-2227; or Nadine Herbert (link sends e-mail), telephone (571) 272-6094.
    Continue Reading ...
  • Copyright Preemption in the Smart Phone Society: The Ninth Circuit Clouds the Picture in T3Media

    There is no question that smart phones have transformed the social and economic structure of society, and the integration of increasingly effective cameras has helped spark the revolution.  It is now the norm for people to document their lives through images of themselves and those around them, and to share those images through social media, where others then copy, edit, and reuse them within the blink of an eye.  Just imagine all the ways that photos are now taken, posted and virally spread…

    Continue Reading ...
  • Report shows drug patents fare better in IPR proceedings at PTAB

    While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners, to put it mildly, the PTAB has not been inhospitable to pharma patent owners according to a report issued in mid-June by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges…

    Continue Reading ...
  • Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

    I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same Humira patent, four of which are pending and awaiting institution decisions. Coherus’s aggressive use of PTAB proceedings to challenge Humira patents shows that biosimilar applicants…… Continue reading this entry

    Continue Reading ...
  • Oral Argument of the Day

    The oral argument of the day is from INTEGRATED CLAIMS SYSTEMS, LLC v. TRAVELERS LLOYDS OF TEXAS INSURANCE COMPANY, No. 2016-2163 (Fed. Cir. Apr. 11, 2017).  The oral argument primarily concerns application of the court’s SECURE AXCESS, LLC, v. PNC BANK NAT. ASSOCIATION decision from earlier this year with respect to how to determine whether a […]

    Continue Reading ...
  • CHOSEN TO BE

                            目次はこちら

    CHOSEN TO BE

    $$ The exponent is chosen to be of width 4 and the mantissa to be of width 6. (USP6691301)

    $$ The counter 30 is chosen to be a modulo-3125 …

    Continue Reading ...
  • When is an the inherent, but unexpected result obvious?

    Millennium Pharma v. Sandoz (Federal Circuit 2017) As part of a brand-generic pharma battle, the district court invalidated a set of Millennium’s patent claims covering its Velcade drug used to treat multiple myeloma.[1]  The district court held that the claims (covering the chemical compound active ingredient) were obvious as the inherent result of an obvious […]

    Continue Reading ...
  • Autonomous vehicle development keeps creeping forward to a self-driving future

    Autonomous, or self-driving, vehicles are coming, even if it’s going to take some time for the technology to become fully operational on U.S. highways. When the technology catches up with the commercial demand, however, there’s little doubt that the market for autonomous vehicles will be huge. News reports from last June indicate that market research firm IHS Automotive published a report forecasting that almost 21 million driverless cars will be driven on roads across the world by the year…

    Continue Reading ...
  • Chemical Compound Invention, Even if the Inherent Result of a Well-Known Process, is not Obvious if there is no Teaching or Suggestion to Make the Compound in the Prior Art

    Millennium Pharmaceuticals v. Sandoz Inc., No. 2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762 (Fed. Cir. July 17, 2017). Before Circuit Judges Newman, Mayer and O’Malley. Takeaway: An invention, albeit the inherent result of a well-known process, is not itself obvious if the prior art references contain no teaching or …

    The post Chemical Compound Invention, Even if the Inherent Result of a Well-Known Process, is not Obvious if there is no Teaching or Suggestion to Make the Compound in the Prior Art appeared first on CAFC Blog.

    Continue Reading ...
  • Federal Circuit Remands For Further Consideration of Proper Irreparable Harm Test for Permanent Injunction

    Author: Alexander E. Harding* Editor: Kara A. Specht In Genband US v. Metaswitch Networks, No 2017-1148 (Fed. Cir. July 10, 2017), the Federal Circuit clarified that a patentee only need show “some connection” between the patent and sales of infringing products to meet the irreparable harm requirement for a permanent injunction. The Eastern District of […]

    Continue Reading ...
  • MILLENNIUM PHARMACEUTICALS scores win at CAFC in ‘446 (Velcade® ) case; Judge Newman explicates obviousness

    The case pertains to the chemical compound D-mannitol
    N-(2-pyrazine)carbonyl-L-phenylalanine-Lleucine
    boronate, described in the text


    The mannitol
    ester of bortezomib acts as a “prodrug,” a compound that
    converts to or releases the active pharmaceutical ingredient
    upon administration to a patient. This discovery is
    described and claimed in the ’446 Patent.
    The ensuing drug product (Velcade®) became “a cancer
    treatment that changed the decades-old standard of
    care for multiple myeloma and has saved thousands of
    lives.

    The outcome of the CAFC decision:


    On review of the record and the applicable law, we
    conclude that the district court erred in the Sandoz litigation
    and that invalidity was not established. We reverse
    and enter judgment in favor of Millennium in the Sandoz
    litigation. We also vacate the district court’s judgment in
    the action between Millennium, Teva, and Apotex based
    on our decision in the Sandoz litigation and remand that
    action for further proceedings.

    There is a Kansas connection:

    The inventor of the ’446 Patent was associated with
    the National Cancer Institute and the University of
    Kansas, and was consulted by Dr. Adams after years of
    unsuccessful attempts to solve formulation and stability
    problems with bortezomib. Despite preparing approximately
    twenty-five different liquid formulations, these
    efforts encountered the same stability and solubility
    problems as had other researchers attempting to solve
    this problem.
    After failing to develop a viable liquid formulation, researchers
    began work on a lyophilized formulation for
    injection. The process of lyophilization (freeze-drying) is
    not intended to change the chemical structure of the
    active pharmaceutical ingredient. After experimenting
    with multiple variables that affect the lyophilization
    process, including solvents and bulking agents, researchers
    produced a promising lyophilized formulation using
    mannitol, a known bulking agent. It was discovered that
    the reason for the dramatic improvement in dissolution
    and stability for this formulation was the formation of a
    new chemical compound during lyophilization: the
    claimed ester of bortezomib and mannitol. The mannitol
    ester of bortezomib acts as a “prodrug,” a compound that
    converts to or releases the active pharmaceutical ingredient
    upon administration to a patient. This discovery is
    described and claimed in the ’446 Patent.

    District court reasoning:


    The district court held that the claims were obvious
    because they were the inherent result of an allegedly
    obvious process, viz., lyophilizing bortezomib in the presence
    of the bulking agent mannitol. Millennium argued
    that a person of ordinary skill would avoid lyophilization
    in developing a formulation involving bortezomib because
    “bortezomib was known to be unstable even in the dry
    state as a freestanding solid compound.” Dist. Ct. Op. *6.
    The court was not persuaded by this argument and instead
    relied on the testimony of Sandoz’s witness, Dr.
    Repta, to find that, as of the ’446 Patent’s priority date,
    lyophilization “was well-known in the field of formulation”
    and that it was considered an obvious alternative “when a
    liquid formulation provided limited success.” Id.
    The district court did not find that the prior art
    taught or suggested that the claimed new compound
    would be formed, or taught or suggested making the
    claimed new compound by any method, or taught or
    suggested that this new compound would have the properties
    of stability, solubility, and dissociability that it
    exhibited. No reference taught or suggested reacting
    bortezomib with mannitol, and no reference hinted that
    such an esterification reaction might occur during lyophilization.
    No reference taught or suggested that the product
    of such lyophilization would be a new chemical
    compound that would solve the problems that had inhibited
    development of bortezomib in oncology. H

    (…)

    On the evidence of objective indicia of obviousness,
    the district court found that Millennium did not establish
    unexpected results because it did not compare the claimed
    invention to a glycerol ester of bortezomib. Id. at *9. The
    court also rejected long-felt need as objective evidence of
    non-obviousness, stating that “the lyophilized mannitol
    ester of bortezomib did not solve any problem having
    persisted over a long period of time without resolution by
    the prior art.” Id. at *10 (quoting Hitachi Koki Co. v.
    Doll, 620 F. Supp. 2d 4, 30 (D.D.C. 2009)).

    The CAFC said:

    Recognizing our obligation to give deference to a district
    court’s greater familiarity with the record and authority
    to reach factual conclusions therefrom, we
    conclude that the district court erred in its evaluation of
    obviousness. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.
    398, 419-20 (2007) (the question of law is whether the
    prior art rendered the invention obvious). In the case at
    bar, the question is whether a person of ordinary skill,
    seeking to remedy the known instability and insolubility
    and to produce an efficacious formulation of bortezomib,
    would obviously produce the D-mannitol ester of bortezomib,
    a previously unknown compound.
    The prior art contains no teaching or suggestion of
    this new compound, or that it would form during lyophilization.
    Sandoz identifies no reference or combination of
    references that shows or suggests a reason to make the
    claimed compound. No reference teaches or suggests that
    such a new compound would have the long-sought properties
    of stability and solubility, and sufficiently dissociate
    to release bortezomib at an effective rate in the bloodstream,
    all critical to effective use for treating multiple
    myeloma.
    The D-mannitol ester of bortezomib is a new compound
    with distinct chemical properties. We consider
    whether the prior art “would have supplied one of ordinary
    skill in the art with a reason or motivation to modify
    a lead compound to make the claimed compound with a
    reasonable expectation of success.” Otsuka Pharm. Co.,
    Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012);
    see also Bristol-Myers Squibb Co. v. Teva Pharm. USA,
    Inc., 752 F.3d 967, 973 (Fed. Cir. 2014) (“To establish
    obviousness in cases involving new chemical compounds,
    the accused infringer must identify some reason that
    would have led a chemist to modify a known compound.”);
    In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511,

    518 (Fed. Cir. 2012) (affirming district court conclusion
    that “the Defendants did not demonstrate the required
    motivation for selecting Sandoz Compound 1b as a lead
    compound”). The parties agree that bortezomib is the
    proper lead compound for this analysis. It is not disputed
    that the Velcade® compound provided unexpected properties,
    solving the problems that accompanied bortezomib.
    The district court clearly erred in its obviousness
    analysis. There is no teaching or suggestion in the references
    to produce the claimed mannitol ester. No reference
    shows or suggests ester formation at freeze-drying conditions,
    or that any such ester might solve the problems of
    instability and insolubility of the free acid while dissociating
    rapidly in the bloodstream. No reference provides a
    reason to make the mannitol ester of bortezomib.

    (…)

    Although mannitol was a known
    bulking agent, and lyophilization was a known method of
    drug formulation, nothing on the record teaches or suggests
    that a person of ordinary skill should have used
    mannitol as part of a synthetic reaction to make an ester
    through lyophilization. A result is obvious when it is “the
    natural result flowing from the operation as taught,” or a
    “property that is necessarily present” when applying a
    process disclosed in the prior art. Par Pharm., Inc. v. TWI
    Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (emphasis
    omitted) (first quoting In re Oelrich, 666 F.2d 578,
    581 (CCPA 1981); then quoting Alcon Research, Ltd. v.
    Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012), and In
    re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009)). Sandoz
    failed to show that it was obvious to use mannitol to make
    an ester during lyophilization, or that the ester would
    solve the problems experienced with bortezomib.

    Nobel laureate H.C. Brown appears in a footnote:


    Herbert C. Brown and J.V.N. Vara Prasad, Chiral
    Synthesis via Organoboranes. 9. Crystalline “Chelates”
    from Borinic and Boronic Esters. A Simple Procedure for
    Upgrading Borinates and Boronates to Materials Approaching
    100% Optical Purity, 51 J. ORGANIC CHEMISTRY
    4526 (1986)

    Yes, the CAFC discussed inherency:


    The district court also clearly erred in its consideration
    of inherency. “A party must . . . meet a high standard
    in order to rely on inherency to establish the existence of
    a claim limitation in the prior art in an obviousness
    analysis.” Par Pharm., 773 F.3d at 1195–96. “The mere
    fact that a certain thing may result from a given set of
    circumstances is not sufficient” to render the result inherent.
    In re Oelrich, 666 F.2d at 581 (quoting Hansgirg v.
    Kemmer, 102 F.2d 212, 214 (CCPA 1939)).
    The district court stated that Millennium “conceded
    as a matter of law that the ester is the ‘natural result’ of
    freeze-drying bortezomib with mannitol.” Dist. Ct. Op. *8.
    However, “[t]he inventor’s own path itself never leads to a
    conclusion of obviousness; that is hindsight. What matters
    is the path that the person of ordinary skill in the art
    would have followed, as evidenced by the pertinent prior
    art.” Otsuka, 678 F.3d at 1296. This oft-cited principle is
    explained in, for example, In re Kratz, 592 F.2d 1169,
    1175 (CCPA 1979):
    However, making weight of the method appellant
    used in finding the invention is beside the point.
    The last sentence of 35 U.S.C. § 103, with great
    clarity, excludes such methodology in stating that
    “(p)atentability shall not be negatived by the
    manner in which the invention was made.”
    See also, e.g., Life Techs., Inc. v. Clontech Labs., Inc., 224
    F.3d 1320, 1325 (Fed. Cir. 2000) (“[T]he path that leads
    an inventor to the invention is expressly made irrelevant
    to patentability by statute.”).

    Sandoz argues that although lyophilization in the
    presence of mannitol produced an unexpected result, the
    result was “inevitable” and thus “inherent,” and thus not
    “inventive.” Sandoz Br. at 1, 12-17. However, invention
    is not a matter of what the inventor intended when the
    experiment was performed; obviousness is measured
    objectively in light of the prior art, as viewed by a person
    of ordinary skill in the field of the invention. “Those
    charged with determining compliance with 35 U.S.C.
    § 103 are required to place themselves in the minds of
    those of ordinary skill in the relevant art at the time the
    invention was made, to determine whether that which is
    now plainly at hand would have been obvious at such
    earlier time.” Interconnect Planning Corp. v. Feil, 774
    F.2d 1132, 1138 (Fed. Cir. 1985). No expert testified that
    they foresaw, or expected, or would have intended, the
    reaction between bortezomib and mannitol, or that the
    resulting ester would have the long-sought properties and
    advantages.

    And of secondary considerations:


    We conclude finally that the district court clearly
    erred in its examination of the objective indicia of unexpected
    results and long-felt need. All of the Graham
    factors must be considered, including the objective indicia
    when present, before any conclusion regarding obviousness
    is reached. In re Cyclobenzaprine, 676 F.3d at 1075–
    76 (citation omitted); Gambro Lundia AB v. Baxter
    Healthcare Corp., 110 F.3d 1573, 1579 (Fed. Cir. 1997);
    see Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520
    F.3d 1358, 1365 (Fed. Cir. 2008) (stating that objective
    indicia are “not just a cumulative or confirmatory part of
    the obviousness calculus but constitute[] independent
    evidence of nonobviousness”).
    Evidence of objective indicia “can be the most probative
    evidence of nonobviousness in the record,” and objective
    indicia enable “the court to avert the trap of
    hindsight.” Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d
    1346, 1358 (Fed. Cir. 2013) (quoting Crocs, Inc. v. Int’l
    Trade Comm’n, 598 F.3d 1294, 1310 (Fed. Cir. 2010)).
    These indicia cannot be set aside in the analysis of obviousness.

    The outcome:


    The district
    court’s judgment of invalidity is reversed, and judgment is
    entered in favor of Millennium as to the Sandoz defendants.
    We remand for any appropriate further proceedings
    in that action.
    The judgment between Millennium and Apotex and
    Teva is vacated, and remanded for further proceedings in
    those actions.

    link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2066.Opinion.7-13-2017.1.PDF

    **Separately, from blawgsearch on 17 July 17:

    Continue Reading ...
  • German Court Affirms Preliminary Grant of Compulsory License for HIV Drug

    As readers of this blog probably are aware, a few decades ago it wasn’t all that uncommon for countries either to exclude pharmaceuticals from the scope of patent protection altogether, or to require drug patent owners to submit to the compulsory licensing of those patents.  Following implementation of the TRIPs Agreement, just about everybody now issues drug patents, and while TRIPs permits countries to engage in compulsory licensing subject to various conditions, compulsory licensing isn’t all that common any more, particularly among developed countries.  (These days, when governments do invoke or threaten to invoke their power to compel patent licensing, it’s more often developing countries such as Brazil or Thailand or India that are involved.)  So when Germany’s Federal Supreme Court (the Bundesgerichtshof, or BGH) recently affirmed a ruling of the Federal Patent Court  (Bundespatentgericht) awarding Merck a preliminary injunction to continue selling the HIV drug raltegravir (trade name Isentress), it’s big news.  The story has already been covered in other sources including a recent post by Mark Schweizer on IPKat (which also links to this press release, in German, from the BGH, which hasn’t yet published its judgment); and discussion of the August 31, 2016 decision of the Federal Patent Court can be found in this post on Kluwer Patent Blog from this past March and this post from Mayer Brown’s “All About IP” from this past November.  There’s also a summary of the Federal Patent Court decision by Dr. Uwe Friedrich in the May 2017 issue of Mitteilungen der deutschen Patentanwälten.  But I thought I should add a few observations of my own as well. 
    First off, before anyone starts jumping to the conclusion that the BGH’s recent decision heralds a new era of compulsory licensing in Germany, it’s important to note that the underlying facts–as far as I’ve been able to piece them together so far, albeit without having invested a lot of time into researching the matter–appear to be rather unusual.  The Japanese firm Shionogi & Co. applied for a European patent back in August 2002 (with priority dates going back to August 2001), but the patent (EP 1,422,218, “Antiviral Agent”) didn’t issue until 2012.  (The Japanese patent appears to have issued in 2005.)  Meanwhile, Merck obtained marketing approval for the drug in the U.S. in 2007 (see here) and in Germany in 2008 (and for all I know, lots of other places too).  The FDA’s Orange Book lists several U.S. patents under the heading “raltegravir potassium,” the earliest of which appear to have been filed by an Italian inventive entity in October 2002, with priority dates going back to October 2001.  
    Anyway, I haven’t yet reviewed the patents very carefully, or looked into whether there are any European Patents corresponding to these U.S. patents–so if anyone has any relevant information on these issues that you’d be willing to share with me, or can point to any errors in my reconstruction of the facts, I’d appreciate it–but based on what I have read I gather that Merck (not Shionogi) has marketed the drug in question Europe since 2008.  (I think that Shionogi has been involved in the marketing of other related integrase inhibitor drugs, but not this specific one.)  In 2014, Merck and Shionogi entered into negotiations for Merck to take a worldwide license, but that didn’t get anywhere, so Shionogi sued Merck for infringement in Germany in 2015.  That litigation was stayed pending a German invalidity proceeding which is still ongoing (though the patent survived an opposition proceeding before the EPC).  Merck then applied to the German Patent Court for a compulsory license, and moved for a preliminary injunction to allow it to continue marketing the drug, which the court granted–the first time the court has ever granted a preliminary injunction for this purpose.  Earlier this month, the BGH affirmed the grant.  As discussed in the IPKat post:
    § 24(1) Patent Act allows the grant of a compulsory license if (i) the infringer tried to obtain a license on reasonable terms, and (ii) there is a public interest in the grant of the license. In its Polyferon decision, the BGH had further specified the requirements for a compulsory license in the public interest for medicaments (BGH GRUR 1996, 190 – Interferon-gamma/Polyferon). The BGH ruled that in order for a medicament to fulfill the requirement of public interest, it (a) must treat a serious disease that (b) cannot be treated by a comparable product or (c) can only so with considerable side effects.
    Applying the Polyferon criteria, the Federal Patent Court held that HIV-infections were both infectious and lethal, thus a “serious disease”. While there might have indeed been alternative compounds like Dolutegravir on the market the Court appointed experts confirmed that the replacement of Isentress with another drug was not acceptable given potential life-long side effects and  disadvantageous drug interaction due to the exchange.

    Further, the expert also stated that Raltegravir showed particular advantages in the post-exposure prophylaxis and in the treatment of certain patient groups (e.g. babies, infants, pregnant women and long-term patients). In consequence, as the other pre-requisites of § 24(1) Patent Act were fulfilled, the public interest outweighed Shionogi’s interest in the exclusive exploitation of the patent at issue.

    Judging from the media release – the grounds of the decision are not available yet – the Federal Court of Justice fully followed this reasoning, preliminarily permitting Merck to distribute Isentress for the treatment of specific patient groups that could not be treated with other drugs without serious side effects.

    Again, I’d like to know more about the underlying facts, which seem quite unusual to me.  I am fairly sure, however, that the fact that the allegedly infringing product was on the market for a long time before Shionogi’s European patent issued and before the parties entered into negotiations would have strongly weighed against granting Shionogi a preliminary injunction in its infringement lawsuit, had it sought one.  In the U.S., delay in filing suit can be a factor weighing against granting a permanent injunction as well, both under the eBay factors and the equitable doctrine of laches.  On the other hand, to my knowledge delay in enforcing one’s rights wouldn’t normally preclude the entry of a permanent injunction in Germany, as long as the action was brought within the relevant statute of limitations; but perhaps in cases like this one the availability of the compulsory licensing option serves much the same purpose as the eBay or laches rules in the U.S.  At some point, in other words, even if you think that patents generally should be protected by property rules (injunctions), perhaps the reliance interests of implementers and their customers must take precedence over the interests of a patent owner that has been slow to assert its rights. 
    Finally, if I understand correctly the amount of the compulsory licensing fee is yet to be determined.  I also would assume that, if the preliminary injunction ultimately were to be vacated, Merck would have to reimburse Shionogi for having been wrongly denied the ability to enforce its patents in the interim.
    Continue Reading ...