Medtronic: Patent Enforcement will Kill Patients

By Dennis Crouch

[Update - In an order released only hours after Medtronic's emergency motion, the Federal Circuit has asked for immediate briefing on whether to grant a stay of preliminary relief - a decision is expected by the expiry of the district court's seven business day temporary reprieve.]

Edwards Life Science v. CoreValve and Medtronic (Fed. Cir. 2014)

In an emergency motion, Medtronic has asked the Federal Circuit to stay a preliminary injunction blocking sale of the Medtronic’s CoreValve aortic heart valve replacement system. Delaware district court Chief Judge Gregory Sleet ordered the preliminary injunction and would enforce the injunction pending outcome of the appeal did grant a seven–business-day stay to allow for an emergency appeal.

Medtronic writes:

A stay should be entered and this appeal expedited because, if the injunction were permitted to go into effect, treatable patients may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights. The injunction bans the sale of Medronic’s life-saving CoreValve system (“MCS”) and precludes the training of additional hospitals and other medical care facilities to use MCS. MCS is a unique and revolutionary minimally invasive aortic heart valve replacement system that is fundamentally different than the only similar product in the U.S. market, which is the Sapien product line of Plaintiffs-Appellees Edwards Lifesciences AG and Edwards Lifesciences LLC’s (collectively, “Edwards”). The MCS replaces diseased aortic heart valves in dying patients who may not survive traditional surgery.

There are basically two arguments here: (1) that the public interest weighs in favor of denying injunctive relief and (2) that the patent is not enforceable because it has expired (infringement has already been determined).

The district court agreed that some lives may be lost and attempted to mitigate that damage by ordering the parties to find some resolution so that “patients who cannot be helped by Edwards’ devices” can receive the CoreValve system since it is “a safer device and … patients in whom it is implanted have better outcomes with a lower risk of death.” Medtronic argues that the order is not enough to save lives.

Wall-street analysts are not known for their humanity, but in their note on the case, even the JP Morgan Analysts questioned: “How does a judge take a product off the market that has shown an ability to reduce mortality?”  Of course, Medtronic has not been giving these away but instead sells the valves for $30,000 each.

The enforceability question is interesting the patent expired in May 2012, but the FDA has granted an interim extension of patent rights under 35 U.S.C. § 156 (for delays in FDA approval). One limitation of a patent term extension is that ordinarily, the extension does extend the term of the entire patent, but instead is “limited to any use approved for the product.” In Merck v. Kessler (Fed. Cir. 1996), the court interpreted this as extending only to “the product on which the extension was based.” Here, Medtronic argues that its product – although perhaps covered by the original patent – is different from Edwards approved product (Sapien) and therefore is not covered by the term extension.

The district court considered these issues and decided that the clear language of Section 156(b) was limited approved uses not approved products. And, since the accused infringing product has the same use (valve transplant), then the patent covers it as well.

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The case highlights an important strategic concern for injunctive relief, although district court judges have the power to stay injunctive relief pending appeal, there is no right to such a stay and courts regularly refuse to grant stays pending appeal.

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61 thoughts on “Medtronic: Patent Enforcement will Kill Patients

  1. I find it surprising that so many are surprised by this preliminary injunction. It was a long time coming, but the Edwards patent was found valid and infringed and those findings were affirmed. I believe Medtronic paid an out-sized damages amount to Edwards in the course of this litigation, the damages relating to an earlier generation valve that was implanted in clinical trials. Apparently Medtronic (or CoreValve prior to its acquisition) forgot that it could have invoked 35 USC 271(e)(1) to avoid liability.

    Anyone watch this litigation could see the injunction coming. Despite that very real threat, Medtronic paid big bucks to acquire CoreValve. And Medtronic ‘s new CEO keeps making bold announcements to the financial community about the looming sales and financial gains Medtronic will enjoy from its CoreValve sales. When will the shareholder suits start flying?

    I am a former Medtronic patent attorney responsible for a number of defensive and offensive patent lawsuits since the mid 70s that resulted in injunctions including the injunction Lilly obtained in Lilly v. Medtronic that persisted until it was rendered moot by the SCOTUS ruling of no infringement due to the 271(e)(1) exemption. The losing side always cries out for relief presumably for patients denied access to life saving technology as Medtronic did to no avail in the Lilly case. Lilly v. Medtronic finally settled with a cross-license of Medtronic pacing and Lilly-Mirowski ICD patent portfolios. Note that Medtronic just recently lost an appeal to SCOTUS re its obligation to pay a royalty on one of the last Mirowski patents in that portfolio.

    In this case, does Medtronic have anything to cross-license? It claims superior results, so there must be some technology that can be cross-licensed. Or maybe not.

    1. Joe, I am not familiar with the Supreme Court case you cite regarding the 271(e)(1) exemption. Can you give us a citation?

      1. You can Google Eli Lilly v. Medtronic or go here to find the CAFC and SCOTUS opinions:

        link to scholar.google.com

        The ruling wiped out a $26M reasonable royalty (before trebling) District Court judgment based on sales of less than $250K in alleged infringing Medtronic implantable cardioverters that were in a clinical trial that was halted due to poor results. If you can find the PA District Court opinions they make fascinating reading re this damages judgment and other issues including a contempt finding based on violating the preliminary injunction due to Medtronic continuing to talk about the ongoing European development and the district court reading the Mirowski claim on the prior art and then adding the word “implantable” to the claim to make it different from the prior art even though the USPTO had expressly rejected adding that word to the claim in a reexam I initiated because Mirowski had not invented an implantable defibrillator and the word was not supported by the specification.

        I should write a book on this litigation.

        1. Joe, that case was in 1990, and concerns the text of 271(e)(1) then present. The current text is changed and would not arguably support a conclusion that medical devices are covered by the exemption:

          “(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The notes say “subsection (e) amended March 23, 2010.”

          There were quite a few prior amendments to (e) as well. I suspect that Medtronic can no longer seek protection of (e).

          Do you have any idea why the exemption was essentially devastated?

          1. I do not understand your point Ned. Which part was amended? If it is the addition of the ((double)) parenthetical expression relating to recombinant DNA, that has no relation to other drugs or medical devices as far as I can tell. The exemption for medical devices in clinical evaluation still stands as far as I can tell.

            1. Joe, on further reading of the statute, I missed the last parentheses.

              For the reader, this is the way to statute used to read and what the issue was at the Supreme Court:

              “The issue in this case concerns the proper interpretation of a portion of § 202 of the 1984 Act, codified at 35 U. S. C. § 271(e)(1). That paragraph, as originally enacted, provided:

              “It shall not be an act of infringement to make, use, or sell a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913)) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” 35 U. S. C. § 271(e)(1) (1982 ed., Supp. II).[1]

              The parties dispute whether this provision exempts from infringement the use of patented inventions to develop and submit information for marketing approval of medical devices under the FDCA.
              The phrase “patented invention” in § 271(e)(1) is defined to include all inventions, not drug-related inventions alone. See 35 U. S. C. § 100(a) (“When used in this title unless the context otherwise indicates . . . [t]he term `invention’ means invention or discovery”). ” Medtronic , 496 US 661, at 665.

  2. I would not be surprised if Edwards would offer a limited license to Medtronic where a Doctor made a specific request for Medtronic’s product affirming that Edwards product was insufficient.

    1. The tort lawyer and the doctor arrive that the scene of the car crash at the same time. The lawyer hands the bleeding victim his card and says, “I am here to protect you.” The doctor leaves.

  3. As a reminder, here is the Sup. Ct. requirement for an injunction for patent infringement:
    As stated by the Supreme Court:
    “[a] plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.” eBay Inc. v. MercExchange, L.L.C., 126 S. Ct. 1837 (2006)

    1. Paul, as to (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury;

      The patentee has had its exclusive rights injured by the infringer’s infringement, how can anything other than cessation of that infringement repair that injury?

      1. The patentee has had its exclusive rights injured by the infringer’s infringement, how can anything other than cessation of that infringement repair that injury?

        That would have been a hilariously bad argument even without a recent Supreme Court precedent saying the exact opposite, which Paul quoted in the post you replied to.

        1. Only made even more hilarious by the comically bad interpretation of the eBay Court decision.

          (hint: it did not say the exact opposite)

        1. Money can be and often is a remedy that approximates the repair to the injury.

          But it is a hoary notion that “injunction” should be considered a “heavy response” – nay, too heavy a response in the normal treatment of equitable remedies without first looking at the right transgressed to which any remedy is to be geared.

          A baseline view of any remedy is to approximate as close as possible the conditions for which remedy is sought. In many contexts, the remedy of ‘making whole’ is simply not a possibility. One cannot un-injure another in a typical tort settings.

          The plain (and often overlooked) fact of the matter is that patents are different in this regard. It is perhaps a singular nature of the patent right that the equitable remedy of injunction is by far the best and most closely way of ‘making whole,’ and it is only in the hoary clutching of “injunction is too severe” that this ready tool of making whole is apparently denigrated without any deep thinking.

          1. this ready tool of making whole is apparently denigrated without any deep thinking.

            Is this the same “deep thinking” that leads you to write stuff like “the hoary clutching of ‘injunction is too severe’ “?

            If so, I’m pretty sure we can all live without it.

        2. Ask the corporate shareholders — they are looking for money.

          Or ask all the pre-eBay plaintiffs who couldn’t trade a court-ordered injunction for money fast enough.

        3. Dennis, assuming you are right, the amount of money becomes an issue, and if the Corporate patentee cannot effectively forbid use of his invention unless his price is met, the corporation won’t get as much money, to those shareholders’ chagrin.

          The FTC derides this analysis as “hold-up,” but it is the essence of the property right. If I want to spend the week at the Plaza Hotel, and they say it is $400 a night to stay there, I have to pay their price or be kept out, under the protection of the law. I don’t get to say, I think they are charging too much and go sleep in one of their rooms. The law will back up the Plaza in having me evicted, to give effect to the Plaza’s right to exclude. When courts don’t make injunctions routine in patent infringement cases they are doing the same as letting squatters stay at the Plaza.

          Yes, one of you antiteabaggers will say that that patents are not like hotel rooms… if that is so, I sure hope you don’t carry on the pretense of calling yourself an intellectual “property” lawyer.

          1. AC, what’s so galling is that the rich and powerful seem to think they can flout the law and get away with M*rder, having of course seen the OJ trial. They not only take $400 room, but the entire hotel and say to the owner, sue me. The owner soon goes bankrupt, and his contingency lawyer has to go through hel* and high water, visiting even the Supreme Court, before he sees verdict on liability. At the end of the day, can the owner expect only to see the back and future rent for the hotel rooms at $400 a day with the high and mighty continuing to occupy the hotel?

            The people who say that a legal remedy is sufficient even where the patent owner provides all comers with a reasonable royalty where the arrogant and powerful seek to crush the patent owner under the weight of litigation and expense are just a bit — well, let us say, unsympathetic.

            These folks would have championed the cause of Marquis during the French Revolution.

          2. “Yes, one of you antiteabaggers will say that that patents are not like hotel rooms… if that is so, I sure hope you don’t carry on the pretense of calling yourself an intellectual “property” lawyer.”

            Is there no way for patents to not simply be a different type of property than real property is in your mind AC?

            1. 6, “Says?”

              The Supreme Court of the United States of Frickin’ America, that’s who.

              McCormick Harvesting Machine Co. v. Aultman, 169 U.S. 606, 18 S. Ct. 443, 42 L. Ed. 875 (1898).

              “It has been settled by repeated decisions of this court that when a patent has received the signature of the Secretary of the Interior, countersigned by the Commissioner of Patents, and has had affixed to it the seal of the Patent Office, it has passed beyond the control and jurisdiction of that office, and is not subject to be revoked or cancelled by the President, or any other officer of the Government. United States v. Schurz, 102 U.S. 378; United States v. Am. Bell Telephone Co., 128 609*609 U.S. 315, 363. It has become the property of the patentee, and as such is entitled to the same legal protection as other property. Seymour v. Osborne, 11 Wall. 516; Cammeyer v. Newton, 94 U.S. 225; United States v. Palmer, 128 U.S. 262, 271, citing James v. Campbell, 104 U.S. 356.

              The only authority competent to set a patent aside, or to annul it, or to correct it for any reason whatever, is vested in the courts of the United States, and not in the department which issued the patent. Moore v. Robbins, 96 U.S. 530, 533; United States v. Am. Bell Telephone Co., 128 U.S. 315, 364; Michigan Land and Lumber Co. v. Rust, 168 U.S. 589, 593. And in this respect a patent for an invention stands in the same position and is subject to the same limitations as a patent for a grant of lands. The power to issue either one of these patents comes from Congress and is vested in the same department. In the case of a patent for lands it has been held that when one has obtained a patent from the Government he cannot be called upon to answer in regard to that patent before the officers of the Land Department, and that the only way his title can be impeached is by suit. United States v. Stone, 2 Wall. 525, 535; Iron Silver Mining Co. v. Campbell, 135 U.S. 286; Noble v. Union River Logging Railroad, 147 U.S. 165. But a suit may be maintained by the United States to set aside a patent for lands improperly issued by reason of mistake, or fraud; but only in the case where the Government has a direct interest, or is under obligation respecting the relief invoked. United States v. Missouri, Kansas & Texas Railway, 141 U.S. 358.” Id., at 608-609.

            2. “(1898)”

              That was under the lawl of 1898 Ned. Likely not even statutory lawl either at the time.

              “The only authority competent to set a patent aside, or to annul it, or to correct it for any reason whatever, is vested in the courts of the United States, and not in the department which issued the patent.”

              As a result of the statutes or caselaw of the time.

              You’re no doubt aware of the recent change in the statute.

              Either way there seems to be some kind of a misunderstanding of what the courts were pronouncing there in your mind ned. The courts were not pronouncing that “property” in and of itself is some sort of immutable concept or thing that requires xyz. Property is a thing created by statutes/law of a government or, in the old times, caselaw filling the gaps more than it does today. Nothing more, nothing less. Check their citations if you’d like.

              Particularly you may find of interest:

              “2. If there be any lawful reason why the patent should be cancelled or rescinded, the appropriate remedy is by a bill in chancery, brought by the United States, but no executive officer is authorized to reconsider the facts on which it was issued and to recall or rescind it or to issue one to another party for the same tract.”

              Note the part about “authorized”. Then see the new statutes authorizing such.

              Obviously utility patents issued today are a different kind of property than the land patents of old. Just like they are a different kind of property than real property. And AC just can’t abide that. He wants all the protections of other kinds of property to necessarily have to apply to patents because in his view they are property currently by statute. Well ok. If that view be correct then we’ll simply have to repeal that statute and then pass the controls on patents. Of course, if that view is mistaken then we may pass controls on patents np.

              A little gem from one of the cited decisions:

              “Letters patent are not to be regarded as monopolies, created by the executive authority at the expense and to the prejudice of all the community except the persons therein named as patentees, but as public franchises granted to the inventors of new and useful improvements for the purpose of securing to them, as such inventors, for the limited term therein mentioned, the exclusive right and liberty to make and use and vend to others to be used their own inventions, as tending to promote the progress of science and the useful arts, and as matter of compensation to the inventors for their labor, toil, and expense in making the inventions and reducing the same to practice for the public benefit, as contemplated”

              Look at that carefully:

              “public franchises granted to the inventors … for the purpose of securing to them … for the limited term therein mentioned, the exclusive right and liberty to make and use and vend to others to be used their own inventions”

              Lol. So funny. If only.

              In either event, I should make you aware that I’m willing to concede the entire discussion to you guys in favor of simply repealing patents being property at all and simply making them franchises issued under an entitlement program just so everyone is clear. Patent attorneys only practicing patent law will no longer call themselves IP attorneys. Works for me. I couldn’t care less either way.

            3. 6, except that the Supreme Court rested its holding on the constitution. The executive could seek cancellation — in court.

              The doctrine that vested rights in property can only be cancelled in court is an aspect of judicial power. The doctrine is still recognized. Stern v. Marshall, 131 S. Ct. 2594, 564 U.S. 2, 180 L. Ed. 2d 475 (2011). Not surprisingly, the Federal Circuit did not follow the Supreme Court, believing that Art. III exclusive venue doctrine was limited to “common law rights” as opposed to rights litigated in the common law courts of England prior to 1789, which included patent validity. Patlex Corp. v. Mossinghoff, 758 F.2d 594 (Fed. Cir. 1985) (Newman). Thus in Newman’s view, any right that was Federal could be entirely withdrawn from Art. III courts because by definition, Federal Rights are not common law rights.

              There is no support for Newman’s point of view in the Supreme Court’s jurisprudence, and the Supreme Court has already suggested in dicta, of course, that patent infringement enjoins a right to a trial by jury. See, Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996). As such, the exclusive power to adjudge patent infringement is in the courts and cannot be withdrawn from them as a matter of Constitutional Law.

              Since Newman’s opinion, the Federal Circuit has held that patent validity also enjoys a right to a trial by jury. Thus, patent validity cannot be withdrawn from the exclusive province of the courts.

              We can go on, but Justice Story, in ex parte Wood & Brundage, 22 U.S. 603, 6 L. Ed. 171, 32 S. Ct. 589 (1824), held there to be a right to a trial by jury for a cancellation proceeding based on patent validity.

              No matter how one cuts it, reexaminations and IPRs are plainly and utterly unconstitutional. At some point, the Supreme Court is going to take the case and decide the issue. The fact that Judge Rader is appalled by the new IPRs is telling. The proverbial Sh & T is about to hit the fan, believe me.

            4. “The executive could seek cancellation — in court.”

              Yes of course. Way back in the day. Now we’ve moved beyond that.

              Why is that so hard for you to understand?

              “The doctrine that vested rights in property can only be cancelled in court is an aspect of judicial power.”

              Yeah well that “doctrine” has been overruled in some situations by statute of late.

              “Stern v. Marshall, 131 S. Ct. 2594, 564 U.S. 2, 180 L. Ed. 2d 475 (2011).”

              Yeah they held in that case that Congress cannot constitutionally authorize non-Article III bankruptcy judges to enter a final judgment on a state law counterclaim that is not resolved in the process of ruling on a creditor’s proof of claim. That has dick to do with whether or not congress can constitutionally authorize non-article III judges to enter a final judgement on a federal law action or claim that is resolved in the process of ruling on an issue of patent lawl. They nearly surely can. And I wish you gl with your argument. You’re going to need more than what ya got.

              “Thus in Newman’s view, any right that was Federal could be entirely withdrawn from Art. III courts because by definition, Federal Rights are not common law rights.”

              Well I might not be completely in camp Newman so to speak but meh, I can go along with that.

              “There is no support for Newman’s point of view in the Supreme Court’s jurisprudence, and the Supreme Court has already suggested in dicta, of course, that patent infringement enjoins a right to a trial by jury. See, Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S. Ct. 1384, 134 L. Ed. 2d 577 (1996). As such, the exclusive power to adjudge patent infringement is in the courts and cannot be withdrawn from them as a matter of Constitutional Law.”

              That is retarded Ned. Better keep that to yourself.

              ‘Since Newman’s opinion, the Federal Circuit has held that patent validity also enjoys a right to a trial by jury. Thus, patent validity cannot be withdrawn from the exclusive province of the courts.”

              Yeah you better ask the Fed. Circ. about that. Patent validity enjoying a right to trial by jury doesn’t magically make congress not able to send the whole issue to a body outside Art. 3.

              “We can go on, but Justice Story, in ex parte Wood & Brundage, 22 U.S. 603, 6 L. Ed. 171, 32 S. Ct. 589 (1824), held there to be a right to a trial by jury for a cancellation proceeding based on patent validity.”

              Sure, if we’re talking a court case. In patents we’re talking about an administrative procedure that was just implemented.

              “No matter how one cuts it, reexaminations and IPRs are plainly and utterly unconstitutional. ”

              I knew you were going to try to arrive at that at some point.

              /facepalm.

              Good luck with your endeavors to have them torn down. Really.

              “The proverbial Sh & T is about to hit the fan, believe me.”

              If the USSC tears them down no biggie. Congress will simply nix more patents other ways. Harsher ways. Again, I wish you good luck. I even hope you prevail. I want congress to take note of patents and the protections they gain from having the protections of being “property” or “property like”. And then work around them in harsher ways to ensure that they are more suited to those things they wish to hand out entitlements for.

            5. ensure that they are more suited to those things they wish to hand out entitlements for

              LOL – predictably absent of understanding, 6.

              Quid.
              Pro.
              Quo.

            6. 6, but you will have to accept that Supreme Court in the cases relied on by Stern v. Marshall has already held that if there is a right to a trial by jury for a particular matter, it cannot be a public right, and the executive cannot finally decide such issues. Stern the Marshall is not as limited as you suggest, but the culmination of a long series of cases that go back to the 1850s and define the relative jurisdictions between the executive and judicial. Essentially, if a matter was adjudicated in the courts of England prior to 1789, it is a matter that is within the exclusive jurisdiction of the courts. Exclusive jurisdiction!

            7. Ned, you might also want to remind 6 that the notion of scire facias was explicit in patent law – and explicitly removed.

              One cannot then “assume” this back into the statutes.

      2. The patentee has had its exclusive rights injured by the infringer’s infringement, how can anything other than cessation of that infringement repair that injury?

        First, it’s just a preliminary injunction pending appeal. The Federal Circuit might reverse the district court.

        Second, you can’t “injure” exclusive rights. Those rights are abstractions. They don’t bleed. They don’t even get headaches.

        To the extent that the plaintiff is here is “injured” by the infringement, it’s “injuries” can be compensated for with money after the appeal is decided. What else does this corporation need besides money? Is the corporation going to have a nervous breakdown or something?

        The people that die because they can’t get this stent unless someone violates this judge’s order are going to be dead forever. All because of some silly patent lawsuit.

        Maybe think about this from the larger perspective: do you patent teabagger types really want some people to die so you can make your point about the super awesomeness of patent injunctions? Think about it.

        1. Second, you can’t “injure” exclusive rights. Those rights are abstractions. They don’t bleed. They don’t even get headaches.

          Oh, the inanity of it all…

    2. I seem to recall that an injunction is an equitable remedy, and that the US statute gives the court discretion whether or not to grant an injunction. That would be wholly consistent with the position here in the UK.

      There can be few recent cases where grounds for withholding an injunction are stronger. A patient wants the best possible device for treating his or her condition and the concept that proprietary rights should interfere with that is wholly repugnant.

      In this case the arguments for confining the remedy to monetary damages are compelling (2) and the public interest would plainly be disserved by an injunction of any kind.

      The equities would be different if the devices were equivalent, but apparently they are not.

      1. A patient wants the best possible device for treating his or her condition and the concept that proprietary rights should interfere with that is wholly repugnant.

        You are walking upon a very treacherous and slippery slope, Paul. Does the moral ‘want’ automatically make the “very best” something that a de facto compulsory license must be granted for?

        What is the proper starting point for any calculus? The world as might exist without the invention?

        (note: it should be understood that I am not advocating a position that equity has no dog in this fight)

        1. it should be understood that I am not advocating a position that equity has no dog in this fight

          Right. You just want to cut the dog’s legs and tail off and put a muzzle on its snout.

          Tell everyone exactly what position you are advocating for. It gets tiresome trying to figure that out for you.

        2. I joined this profession to do my best for inventors and the organizations employing them. But I did NOT join this profession to deny anyone the most appropriate medical treatment EVER or in ANY CIRCUMSTANCES. I hope that most readers in our profession will feel the same.

          If there are any issues, money payment must sort it out, not limitations on the availability of medically necessary equipment.

          1. Did you see Dallas Buyer’s Club where the FDA came down hard on unapproved remedies imported into the US by a group of desperate aids victims in Dallas?

            Well the FDA is behind this fiasco as well.

          2. You are walking upon a very treacherous and slippery slope, Paul. Does the moral ‘want’ automatically make the “very best” something that a de facto compulsory license must be granted for?

            What is the proper starting point for any calculus?

            The world as might exist without the invention?

            (note: it should be understood that I am not advocating a position that equity has no dog in this fight)

    3. The Federal Circuit was already applying this equitable test prior to ebay in the context of preliminary injunctive relief, with the exception that steps (1) and (2) are merged and with an added requirement that the movant show a likelihood of success on the merits.

  4. If ever there was a case for denying an injunction against infringement, this may well be it. For most cases of patent infringement, though, an injunction must issue if the statutory “right to exclude” means a thing.

  5. All Medtronic has to do is pay Edward’s demands and their patients can get their lifesaving product. If Medtronic loses settlement will come immediately.

    1. All Medtronic has to do is pay Edward’s demands and their patients can get their lifesaving product.

      Indeed. In fact, Edwards could pay their own demands on Medtronic’s behalf and that would also work. That’d be a totally selfless act. They’d be heroes for doing that.

  6. What I find puzzling is why the Fed. Cir. has not, apparently [not yet as far as I am aware?] clearly required D.C. pre-trial preliminary injunctions to meet all of the specific Sup. Ct. eBay decision requirements for a permanent injunction? Especially since the former is logically and practically more difficult to obtain than the latter (where the patent owner has already fully overcome all invalidity and non-infringement defenses).
    Was this a case in which the same patent had been held not proven invalid in a prior trial against another infringer? [Those have been more commonly sustained preliminary injunction cases.]

    1. Paul, full trial, jury award of damages and lost profits, remand for consideration of a permanent injunction….

      Then Medtronic introduces a new product that also infringes….

  7. well, the sky’s the limit for dollars in medicine (I’m a family doc, and see this garbage every day).
    first, comment on a financial station, about investing in stocks; the one place to make money is in consumables, thus cigarette companies were good, because the POOR people, with less discretionary income, would buy more smokes first (ok for investors to use that as rationale) as income rose

    then, new company making drug for hepatitis C, investors feel it is OK to charge the patients in United States $50,000.00 or so for the curative drug, while about 1% of that to third world patients (how nice of the investors; meanwhile, american consumers bear the brunt of this cost)

    now, patent dispute; a better product being restricted by a company with an allegedly inferior product; again, dollars speak; let it go to appeals; thus a few more can die, while companies fight it out.

    anyway, healthcare at its finest

      1. Ha. I’m a med student reading this blog and find it fascinating. I constantly struggle with the legal jargon, but the issues discussed are very interesting and informative.

  8. It does seem to me that the case depends upon the proper construction of §156 and whether it extends the patent to approved uses or to specific products approved by the FDA. The Medtronic motion cites federal circuit cases for the proposition that the extension is only with respect to particular products, not uses. If so, the patent has expired for all but specific products approved and a preliminary injunction is improper except for products virtually the same as those approved. Medtronic argues that its product is radically different.

    I haven’t read the cases relied upon by Medtronic to form an independent judgment as to whether Medtronic is correct in citation. I simply assume that they correctly cite cases.

    1. Medtronic argues that its product is radically different.

      Everyone seems to agree it’s an improvement. It also appears to fall within the scope of the claims of the “extended” patent … that term extension being granted on the basis of FDA delays, where the FDA was busy evaluating the patentee’s inferior product.

      Doesn’t seem like the right result.

  9. The district court agreed that some lives may be lost and attempted to mitigate that damage by ordering the parties to find some resolution

    So the judge with the power to save lives — lives that he admits are at risk — decides that he’s not going to use that power. Instead, he’s going to put the burden on the companies who came to him with their dispute in the first place to figure something out.

    Fascinating experiment. Good thing it’s only human life that’s at stake.

    1. No kidding. If saving lives in service of the public interest doesn’t outweigh the laughable thought that money might not remedy the injuries suffered by an infringed patentee, I don’t know what possibly could.

      1. Isn’t that very balancing of interests part of the 4-factors balancing of equities that the Sup. Ct. eBay decision already told the Fed. Cir. and the D.C.’s to apply to patent suit injunctions but which has apparently not been clearly applied by them to preliminary injunctions?

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