Source: https://www.keionline.org/us-injunction-medical
Timestamp: 2019-04-26 15:50:17+00:00

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Cases where a federal court in the United States determine there is infringement, but denies a permanent injunction.
Compulsory license granted to Cordis Corp. over U.S. patents 5,445,625, 6,083,213 and 6,475,195.
Patents 5,445,625, 6,083,213 and 6,475,195 claim an angioplasty guide catheter, a medical device, and methods of use. Jan K. Voda, holder of the these patents, filed a lawsuit against Cordis Corp. for the infringement of those patent. A jury held that the defendant infringed the plaintiff’s patents, and determined that plaintiff was entitled to a reasonable royalty of 7.5% of defendant’s gross sales of the infringing catheters. Following the jury verdict, Voda moved for a permanent injunction.
Plaintiff argues irreparable harm is presumed whenever validity and continuing infringement have been established. Brief in Support of Plaintiff’s Request for Permanent Injunction at 5 (Doc. No. 350). This argument, however, runs afoul of the court’s reasoning in eBay where the Court clearly held the right to exclude does not, standing alone, justify a general rule in favor of injunctive relief. eBay Inc., 126 S.Ct. at 1840. Moreover, other than the presumption of irreparable harm, plaintiff identifies no harm to himself; rather, he relies on alleged harm to a non-party, Scimed. See Brief in Support of Plaintiff’s Request for Permanent Injunction at 6-12. The court concurs with defendant that such harm is irrelevant because Scimed elected not to sue to enforce the patent rights. As patents have “the attributes of personal property”, the person seeking a permanent injunction must demonstrate harm from infringement of those rights that is personal as well.
The court also finds plaintiff has not established that monetary damages are inadequate to compensate him. Plaintiff argues he granted Scimed an exclusive license to his patented inventions and defendant’s continuing infringement will damage his relationship with Scimed. This argument, however, is simply the other side of the right-to-exclude coin and is not sufficient to justify granting injunctive relief. Plaintiff’s request for a permanent injunction is therefore denied.
Compulsory license granted to Invacare over U.S. patents 5,148,802, 5,433,193, 6,105,575, and 6,609,517.
Patents 5,148,802, 5,433,193, 6,105,575, and 6,609,517 claim a medical devices for sleep therapy. Respironics, holder of the four patents, filed a lawsuit against Invacare for the infringement of those patents. After a finding of infringement against the defendant Invacare, the plaintiff Respironics moved for a permanent injunction.
The Court denied the permanent injunction requested by Respironics and granted a compulsory license to Invacare based on the Ebay doctrine. To reach this decision the Court took into consideration the fact that Invacare was described as the industry leader in the field of sleep therapy, a fact that was not disputed in this case. Based on this, the Court did not find a new entrant in the market to be a serious threat to the plaintiff’s reputation for innovation.
As Respironics itself points out, the vast majority of Invacare’s sales is in its traditional product lines, such as wheelchairs, walkers and oxygen. Only a “small fraction” of Invacare’s sales come from “its recent foray into sleep products.” [doc. no. 313, p. 8]. On the other hand, Respironics consistently describes itself as the leader in the field of sleep therapy. The status of Respironics as the industry leader was not disputed in this case. Under these facts, we do not find a new entrant in the market, with what Respironics itself describes as a side business in the field of sleep therapy, to be a serious threat to the industry leader’s reputation for innovation.
Second, although it is true that the protection of patent rights generally fosters innovation, that, in itself, is insufficient to justify permanent injunctive relief. As the Supreme Court has cautioned us, we must consider the facts of each patent case on its own merits, and not grant permanent injunctive relief based on broad principles, and generalities, of patent law. Here, where the device found to be infringing is no longer on the market, has never been on the market, and was last displayed more than four years ago, general statements regarding innovation do not support entry of a permanent injunction.
Compulsory license granted to Abbott Labs over U.S. patent 5,846,704.
Patent 5,846,704 claims a method of genotyping HCV based on distinct genetic sequences that can be found in the 5 prime untranslated region (5′ UTR) of the HCV genome. Innogenetics, holder of the ‘704 patent, filed a lawsuit against Abbott for infringement of that patent. After a finding of infringement against the defendant Abbott, the plaintiff Innogenetics moved for a permanent injunction.
The Court of Appeal denied the permanent injunction requested by Innogenetics and granted a compulsory license to Abbott under the Ebay doctrine, and remanded to the District Court to determine the terms of a compulsory license. The Court focused on the fact that Innogenetics had been awarded damages including an upfront market entry fee of $5.8 million “as an amount paid in anticipation of Abbott’s long-term license to sell its products,” and noted that the request and receipt of compensation that contemplates or is based upon future sales in a long term market blunted an assertion of irreparable harm.
The reasonable royalties awarded to Innogenetics include an upfront entry fee that contemplates or is based upon future sales by Abbott in a long term market. When a patentee requests and receives such compensation, it cannot be heard to complain that it will be irreparably harmed by future sales. Moreover, this factor greatly outweighs the other eBay factors in this case. As a result, the district court’s grant of an injunction prohibiting future sales of Abbott’s genotyping assay kits was an abuse of discretion and must be vacated. While the market entry fee was based upon the projection that Abbott could sell its product through 2019, even Abbott acknowledges that such future sales would be subject to the running royalty, a compulsory license. We remand to the district court to delineate the terms of the compulsory license, such as conditioning the future sales of the infringing products on payment of the running royalty, the 5–10 Euros per genotyping assay kit.
Compulsory license granted to Medtronic Vascular over U.S. patents 5,514,154, 6,066,167, 6,066,168, and 6,432,133.
Patents 5,514,154, 6,066,167, 6,066,168, and 6,432,133 claim a second generation stent devices and methods for delivery and manufacture of several versions those devices. Advanced Cardiovascular Systems, holder of these patents, filed a motion for a permanent injunction after a trial for infringement returned a jury verdict in its favor.
The Court denied the permanent injunction requested by Advanced Cardiovascular Systems and granted a compulsory license to Medtronic Vascular under the Ebay doctrine. To reach this decision the Court noted that Advanced Cardiovascular Systems was willing to forego its patent rights for compensation, and concluded based on this that the plaintiff will not suffer irreparable harm absent an injunction. The Court suggested that permanent injunctions are typically granted in two-competitor situations where the patentee has demonstrated an unwillingness to part with the exclusive right. The Court also concluded that the public interest favors the denial of a permanent injunction in this case considering the strong public interest in maintaining diversity in the coronary stent market.
The court also notes that ACS’s willingness to forego its patent rights for compensation supports the court’s conclusion that ACS will not suffer irreparable harm absent an injunction. ACS has licensed the Lau patents to both Cordis (in April 2000) and BSC (in May 2000). ACS asserts that it has not licensed its patents simply for money—to do so would violate its “general policy”—but in exchange for cross-licenses and to settle litigations. (D.I. 805 at 7–8) The fact that ACS was selective regarding its licensing compensation—exchanging its technology only for other licenses to competing technology—does not rectify the fact that ACS was willing, ultimately, to forego its exclusive rights for some manner of compensation. Money damages are rarely inadequate in these circumstances; rather, permanent injunctions are typically granted in two-competitor situations where the patentee has demonstrated an unwillingness to part with the exclusive right. Compare Novozymes, 474 F.Supp.2d at 613 (D.Del.2007) (finding irreparable harm where patentee only licensed its patent to its subsidiary who competed head-to-head with the infringer) (granting permanent injunction), with Voda v. Cordis Corp., No. Civ. A. 03–1512, 2006 WL 2570614 at *6 (W.D.Okla. Sept. 5, 2006) (denying permanent injunction where plaintiff was a willing licensor, rejecting plaintiff’s argument that “ongoing infringement will damage his relationship with [plaintiff’s exclusive licensee]” as “simply the other side of the right-to-exclude coin”).
Finally, the court notes that the public interest favors the denial of a permanent injunction in this case. A strong public interest in maintaining diversity in the coronary stent market has been previously recognized by this court and the Federal Circuit. See Cordis Corp. v. Boston Sci. Corp., 99 Fed.Appx. 928, 935 (Fed.Cir.2004) (unpublished) (“[A] strong public interest supports a broad choice of drug-eluting stents, even though no published study proves the superiority of either Cordis’s Cypher of BSC’s Taxus stent.”); Cordis Corp. v. Boston Scientific Corp., Nos. Civ. A. 03–027, 03–283, 2003 WL 22843072, *2 (D.Del. Nov. 21, 2003) (noting the “obvious concern of depriving the public of the best and safest medical devices by limiting competition”).
Compulsory license granted to W.L. Gore over patent 6,436,135.
Patent 6,436,135 claims a prosthetic vascular graft, a medical device. Bard Peripheral filed a lawsuit against W.L. Gore for the infringement of that patent. After a finding of infringement against the defendant W.L. Gore, the plaintiff Bard Peripheral moved for a permanent injunction.
In 2012, the Bard decision was vacated in part by 682 F.3d 1003 (Fed. Cir. 2012) and 476 F. App’x 747 (Fed. Cir. 2012), but on aspects not related to the grant of a compulsory license.
Compulsory license granted to Globus Med over U.S. patents 6,530,929 and 7,008,422.
Patents 6,530,929 and 7,008,422 claim devices and methods used by spinal surgeons to stabilize bony structures. Warsaw Orthopedic, Inc, holder of these patents, and its licensee Medtronic filed a lawsuit against Globus Med for infringement of those patents. Following a finding of infringement, the parties stipulated to bench trial on issues of damages and injunctive relief.
The Court denied the injunction requested by Warsaw Orthopedic, Inc, and others, and granted a compulsory license to Globus Med under the Ebay doctrine. The Court determined that Warsaw did not provide evidence of potential loss of market share or good will absent the grant of a permanent injunction, therefore failed to demonstrate irreparable harm.
Medtronic USA presented evidence of “[irreparable] harms that defy monetary quantification and that controvert [Medtronic USA’s] long-term goals, including loss of access to surgeons, loss of the opportunity to sell other products for use in the same Sextant surgeries …, loss of the opportunity to use these flagship products to sell surgeons other products for use in non-Sextant surgeries, eroded market share, loss of goodwill, and injury to [Medtronic USA]’s reputation as an innovator in the area of minimally invasive surgeries.” Pls. Post–Trial Brief at 12. But Warsaw is a manufacturer of medical devices, not a distributor; it is unlikely that Warsaw suffers the same irreparable injuries as Medtronic USA. There is no evidence that Warsaw would have had access to surgeons or the opportunity to sell the Sextant System (or other products) to hospitals that purchase surgical equipment. Warsaw presented no evidence of its market share or the loss of good will. The evidence of record does not support entry of a permanent injunction. Warsaw failed to present evidence of irreparable harm, so the court cannot consider the balance of hardships between Warsaw and Globus. The parties presented evidence on whether issuance of an injunction would be contrary to the public interest, but since no injunction will issue for lack of evidence of irreparable harm to Warsaw, the only plaintiff with standing, the court need not decide the matter.
Compulsory license granted to Johnson & Johnson Vision Care over U.S. patents 849,811 and 6,951,894.
Patents 5,849,811 and 6,951,894 claim extended-wear contact lenses and related methods. Johnson & Johnson Vision Care brought action against CIBA Vision Corp., holder of those patents, seeking declaratory judgment staying that Johnson & Johnson Vision Care did not infringe those patents. CIBA Vision Corp counterclaimed alleging infringement of its patents by Johnson & Johnson Vision Care. After the Court determined that Johnson & Johnson Vision Care infringed these patents, CIBA Vision Corp moved for a permanent injunction.
The Court denied the injunction requested by CIBA Vision Corp and granted a compulsory license to Johnson & Johnson Vision Care under the Ebay doctrine. The Court determined that CIBA Vision Corp failed to prove that it will be irreparably harmed if a permanent injunction does not enter or that monetary damages are inadequate to compensate it for future injuries due to continued infringement. To reach this conclusion of lack of irreparable harm the Court took into consideration CIBA Vision Corp’s licensing behavior, whom either offered or actually entered into licensing agreements with its three major domestic competitors and also entered into licenses with two foreign manufacturers. The Court was also convinced that innocent contact lens wearers will suffer real adverse consequences if sale of this product was enjoined. An injunction would have created consequential medical, practical and economic issues for large numbers of these lenses.
Looking at CIBA’s licensing behavior and the specific facts of this case, the Court, as it did at the preliminary injunction stage (see Doc. 49 at 15), finds compelling that CIBA has been willing to share the Nicolson patents with so many of its competitors (again, including J & J itself). This conduct, taken in its totality, is inconsistent with CIBA’s assertion that only enforcement of its right to exclude J & J from using the Nicolson patents will redress the harm that CIBA will suffer in the future on account of J & J’s infringement. The Court finds that CIBA has failed to prove that it will be irreparably harmed if a permanent injunction does not enter or that monetary damages are inadequate to compensate CIBA for future injuries due to J & J’s continued infringement.6 See e.g. Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F.Supp.2d 554, 560 (D.Del.2008), appeal dismissed, 356 Fed.Appx. 389 (Fed.Cir.2009) (patent owner’s willingness to forego its patent rights for compensation supports the court’s conclusion that patent owner will not suffer irreparable harm absent an injunction; “[t]he fact that ACS [patent owner] was selective regarding its licensing compensation—exchanging its technology *1290 only for other licenses to competing technology—does not rectify the fact that ACS was willing, ultimately, to forego its exclusive rights for some manner of compensation”); see also MercExchange, 500 F.Supp.2d at 577 (“decisions subsequent to the Supreme Court’s opinion [in eBay ] have rejected the broad classification that direct competitors always suffer irreparable harm from infringement”); Praxair, Inc. v. ATMI, Inc., 479 F.Supp.2d 440, 444 (D.Del.2007) (permanent injunction denied despite infringer being patentee’s sole competitor).
This evidence convinces the Court that millions of innocent contact lens wearers will suffer real adverse consequences if sale of ACUVUE®OASYS is enjoined. These are not just issues of comfort or cosmetics, as CIBA argues, but rather deal with the more substantive concerns of proper vision and eye care. There will also be significant disruption, confusion and cost (estimated to be in the hundreds of millions of dollars) caused by ACUVUE®OASYS patients being abruptly told that the contact lens for which they have been fitted and with which they are satisfied, is no longer available. Choosing a new lens will at minimum require refitting and the new lens may not prove as efficacious as the ACUVUE®OASYS lens. Moreover, patients may have to be refitted more than once until an appropriate lens is found. An undefined number will not be able to be refitted appropriately at all. CIBA’s answer that “they can just wear glasses” is no answer, in this Court’s view.
The preponderance of the evidence convinces the Court that an injunction will create consequential medical, practical and economic issues for large numbers of ACUVUE®OASYS users. The deleterious effects of the injunction on the general public would simply be too great to permit. Thus, CIBA has failed to carry its burden of proving that the public interest would not disserved by the entry of a permanent injunction.
The Court understands that the product in Bard Peripheral involved “potentially life saving technologies.” Id. Here, the consequences of enjoining the ACUVUE®OASYS are not so grave; nevertheless, this Court, sitting in equity, finds those consequences to be sufficiently important and adverse to millions of ACUVUE®OASYS patients that the public interest would be disserved if an injunction were to be entered.
Compulsory license granted to CoreValve over U.S. patent 5,411,552.
Patent 5,411,552 claims a valve prosthesis that can be implanted in the body without the need for surgical intervention, but rather through use of a catheter. Edwards Lifesciences AG, holder of the patent, filed a lawsuit against CoreValve, Inc., for infringement of this patent. After a verdict of infringement against the defendant CoreValve the plaintiff Edwards Lifesciences AG moved for a permanent injunction.
The Court denied the injunction requested by Edwards Lifesciences AG and granted a compulsory license to CoreValve under the Ebay doctrine. The Court found that the harm alleged by Edwards Lifesciences AG would continue even if a permanent injunction was issued, because it stems from the CoreValve’s past conduct. Edwards Lifesciences AG failed to make allegations of prospective lost customers or harms that are truly irreparable unless the Court issues a permanent injunction. Since CoreValve is able to move its manufacturing operations from the United States to Mexico, it would remain in the market with little or no interruption even if the court were to enjoin its infringing manufacturing operations in the United States, and an injunction thus would not affect the alleged harm. The Court denied the motion for permanent injunction but granted Edwards Lifesciences AG’s request for an accounting of the number of relevant devices made, used, sold, offered for sale, imported or supplied in or from the United States by CoreValve, and corresponding revenue from March 16, 2010 through the date of the order accompanying this memorandum.
In this case, the irreparable harm factor weighs against granting a permanent injunction for several closely-related reasons. First, the “irreparable” component of the injury that Edwards alleges stems from CoreValve’s past conduct, and would continue even if a permanent injunction were issued. Edwards makes no allegations of prospective lost customers or harms that are truly irreparable unless the court issues a permanent injunction. On the contrary, the court concludes that with respect to the irreparable harms that Edwards alleges, Edwards would not benefit substantially from an injunction being issued at this stage, several years after CoreValve’s accused product entered the market.
Second, Edwards’ allegations of irreparable harm are undercut because CoreValve’s infringement stems not from sales of the accused product, all of which occurred outside the United States, but rather from the manufacturing of the accused product in the United States. Thus, Edwards must establish that CoreValve’s manufacturing operations in the United States are continuing and will continue to cause irreparable harm if not enjoined. Edwards, however, does not appear to dispute that CoreValve would be able to move its remaining manufacturing operations to Mexico almost immediately if the court enjoined it from continuing to manufacture its products in the United States. (See, e.g., D.I. 402 at 1 (“Even now, CoreValve admits that it has been moving off shore to Mexico since January 2010 and could immediately ramp up manufacturing there.”); id. at 7–8; D.I. 357 at 15.) Thus, CoreValve would remain in the market with little or no interruption even if the court were to enjoin its infringing manufacturing operations in the United States, and an injunction thus would not affect the alleged harm.
As it did in this case, Edwards can bring suit against CoreValve and seek damages if CoreValve continues its infringing manufacturing operations in spite of the judgment of infringement. Moreover, Edwards has licensed the ′ 552 Patent to a competitor, 3F Therapeutics, for a field of use that overlaps significantly with that of Edwards’ Sapien product. (See A116.) While not determinative, such licensing activity is further evidence that monetary damages would be adequate to compensate Edwards for any future infringing manufacturing operations by CoreValve.15 See, e.g., Telcordia, 592 F.Supp.2d at 748 n. 10.
The court will grant, however, Edwards’ request for an accounting of the number of CoreValve Revalving System devices made, used, sold, offered for sale, imported or supplied in or from the United States and corresponding revenue from March 16, 2010 through the date of the order accompanying this memorandum.
Compulsory license granted to Terumo Med. Corp over U.S. patent 7,264,613.
Patent 7,264,613 claims intravenous (IV) catheters, a medical device. B. Braun Melsungen AG, holder of the patent, filed a lawsuit against Terumo Med. Corp., for infringement of this patent. After a jury a jury verdict in his favor, B. Braun Melsungen AG filed for a motion seeking permanent injunction for the immediate, complete removal of defendant’s device from the United States market. Terumo Med. Corp. opposed to the scope of the injunction proposed by B. Braun Melsungen AG, and instead proposed a limited injunctive relief allowing defendant to continue to sell the device in the smaller (30%) alternative care market segment where it was already being sold, for a period of fifteen months.
The Court denied the injunction proposed by B. Braun Melsungen AG, and instead granted a limited injunctive relief as proposed by Terumo Med. The Court found that the public interest favors the limited injunction proposed by the defendant considering the public interest in access to competing alternatives to medical devices.
The Court concludes that the public interest likewise favors entry of the more limited injunctive relief proposed by Terumo, as opposed to the injunction sought by Braun. The Court reaches this conclusion largely for the reasons already described, primarily the impact of Braun’s requested relief on medical professionals currently using Terumo’s Surshield, Again, the Court does not minimize the importance of the competing considerations relied on by Braun—including, especially, the public interest in strong and consistent enforcement of patent rights. See Callaway, 585 F.Supp.2d at 622 (finding insufficient evidence “to counter the strong public policy favoring the enforcement of patent rights recognized by the courts.”) (internal quotation marks omitted). However, in the overall circumstances presented here, particularly the public interest in access to competing alternatives to safe medical devices, see, e.g., Cordis Corp. v. Boston Scientific Corp., 2003 WL 22843072, at *6 (D.Del. Nov. 21, 2003) (denying preliminary injunction in part due to “the obvious concern of depriving the public of the best and safest medical devices by limiting competition”), the public interest favors the more limited injunction proposed by Terumo.
Compulsory license granted to Hologic over U.S. patent 6,634,361.
Patent 6,634,361 claims an intrafallopian contraceptive, a medical devices. Conceptus, Inc, holder of the ‘361 patent, filed a lawsuit against Hologic for infringement of this patent. Following a jury verdict in his favor, Conceptus, Inc, moved for a permanent injunction.
The Court denied the permanent injunction requested by Conceptus, Inc, and granted a compulsory license to Hologic under the Ebay doctrine. The Court found that monetary award for ongoing infringement will adequately compensate for the harm suffered by Conceptus. The Court also considered that public health has benefited from having a choice of products for transcervical hysteroscopic sterilization. Taking this into consideration, the Court found that the public interest would undoubtedly be harmed by an injunction because it would leave only one product for transcervical hysteroscopic sterilization. Since the products commercialized by Conceptus and the defendant were different, removing Hologic’s product from the market would have eliminated an important alternative for patients.
Even though Hologic is a larger and more diversified company, it has identified substantial hardship that would occur if a permanent injunction is imposed. As discussed above, a monetary award for ongoing infringement will adequately compensate for Conceptus’s harm. This factor weighs against a permanent injunction.
Essure is the core of Conceptus’s business because it is the company’s sole product. Harm to the core of a patentee’s business also supports a finding of irreparable harm. See Bosch, 659 F.3d at 1152. This factor weighs in favor of a permanent injunction.
Conceptus would not have to re-litigate the entire action if it sought to collect damages for the period after the last damages period litigated. And Conceptus does not dispute that Hologic can pay the judgment and ongoing damages. Because Conceptus can be adequately compensated for its harm, this factor weighs against a permanent injunction.
The public interest would undoubtedly be harmed by an injunction. Enjoining the sale of Adiana would leave only one product for transcervical hysteroscopic sterilization. Public health has benefitted, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization. This is especially important because the products are different. Removing Adiana from the market would have eliminated an important alternative for patients.
Essure and Adiana are not interchangeable products and procedures. With Essure, there is a risk of perforations because of its long corkscrew-like tail. Evidence at trial also showed that some patients do not want Essure because it is metallic. For example, Essure is not available to patients who have nickel allergies. With Essure, there is a concern that the trailing coils could interfere with certain types of endometrial ablation procedures. There is also the possibility of pain after placement of Essure coils (TX 137 at 9976–78).
On the other hand, Adiana is not a metallic coil but is a small foam cylinder. It is not screwed into the fallopian tube. Instead, the fallopian tube is “burned” slightly by radiofrequency energy. As the tube heals, the healing tissue grows into the foam insert. The insert itself infringes nothing. The procedure for inserting it was found by the jury to infringe the method claims in suit. Nonetheless, the precise mechanism of action has important advantages over Essure, such as a non-metalic body, no risk of perforation, and use of radiofrequency energy.
In this action, the public benefit of having two products with different qualities in the transcervical hysteroscopic sterilization market militates strongly against an injunction.
The Court denied the injunction requested by Valeant International, considering it unnecessary.
Patents 7,569,610, 7,563,823, 7,649,019, 7,553,992 claim bupropion hydrobromide, a pharmaceutical drug used as antidepresan. Valeant International, holder of these patents, filed a lawsuit against Watson Pharm. for patent infringement. Following a final judgement in his favor, Valeant International filed a motion to amend the final judgement to permanently enjoin the defendant from the commercial manufacture or sale of its generic drug before the expiration of the patents in June 2026.
The Court denied the injunction requested by Valeant International, finding that it was unnecessary. This decision was based on the fact that the Court Second Amended Final Judgment prohibited Watson from marketing its bupropion hydrobromide products prior to the expiration of the plaintiff Orange Book patents, which prevents Watson from directly competing with Valeant International, or usurping any market share until the plaintiff patents’ expire. Moreover, the Court noted that generic competition does not, in itself, establish irreparable harm to Valeant International.
Even if the Court were to find that the evidence of competition establishes irreparable harm, Plaintiff Valeant still does not meet the eBay standard for injunctive relief. The Court agrees that its findings of fact, rulings, and declaratory judgment under 35 U.S.C. § 271 (e)(4)(A) render injunctive relief unnecessary in this case. The Court’s February 22, 2012 Second Amended Final Judgment prohibits Watson from marketing its proposed bupropion hydrobromide products prior to the expiration of Valeant’s Orange Book patents, which currently are set to expire on the same day as Valeant’s 992 patent, or June 27, 2026. This prevents Watson from directly competing with Valeant or usurping any market share from Valeant’s Aplenzin® products until Valeant’s patents expire. In the event there is a violation of the Court’s February 22, 2012 Declaratory Judgment, Valeant may file another case in the Southern District of Florida and note this related case.
By contrast, Plaintiff Valeant relies on a line of cases granting injunctive relief to patentees in Hatch-Waxman cases. See Eli Lilly & Co. v. Sicor Pharms., Inc., 705 F. Supp. 2d 971, 1011 (S.D. In. 2010), aff’d, 426 Fed. Appx. 892 (Fed. Cir. 2011); Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., No. 07-1000, 2010 WL 4596324, at *36 (D.N.J. Nov. 15, 2010). Plaintiff argues that all Hatch-Waxman cases involve a direct competitor attempting to take market share by selling a cheaper generic version of the patented drug product, which would create irreparable harm to the prevailing patentee were an injunction not to issue. While this may be true, given the procedural posture of this case, the Court agrees with the analysis of the Alcon, Inc. court. After the eBay decision, the Federal Circuit and district courts repeatedly have required that such evidence must be presented before an injunction may issue in cases, including pharmaceutical cases, involving generic competition. See, e.g., Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1347-48 (Fed. Cir. 2006) (vacating district court’s decision granting a preliminary injunction, stating that “[W]e do not doubt that generic competition will impact Abbott’s sales of Biaxin XL, but that alone does not establish that Abbott’s harm will be irreparable.”) Under Abbott, it is unclear that Plaintiffs showing of generic competition, without more, would establish irreparable harm.
Compulsory license granted to Ethicon Endo-Surgery over U.S. patents 6,063,050, 6,468,286, 6,682,544.
Patents 6,063,050, 6,468,286, 6,682,544 claim ultrasonic surgical devices employing ultrasonic energy to cut and coagulate vessels in surgery. Tyco Healthcare brought actions alleging infringement of these patents, and requested injunctive relief.
The Court denied the injunction requested by Tyco Healthcare and granted a compulsory license to Ethicon Endo-Surgery under the Ebay doctrine. The Court took into consideration the fact that, throughout trial, Tyco Healthcare emphatically sought monetary awards for lost profits and a certain royalty. According to the Court, this supported the position that monetary damages were fully adequate to compensate Tyco Healthcare. In its analysis of the public interest, the Court noted that a permanent injunction would pull many devices that are presently used in surgery off the market. For the purpose of royalty damages the Court took into account a licensing agreement previously conducted by Tyco Healthcare, the fact that Ethicon Endo-Surgery had its own ultrasonic technology, and the fact that the infringing products were far more successful than other products commercialized by Ethicon Endo-Surgery. The royalty damages were set at eight percent of the infringing sales from April 2004 and March 2012.
Most importantly, the Court finds that Plaintiff did not prove the first prong, as Philip Roy, the first witness who testified at trial, and who spoke on the subject of Tyco’s ultrasonic devices in relation to Ethicon’s, spoke of “irreparable harm” suffered by Tyco in terms of the damage to its reputation, but was unable to articulate why if Tyco has endured infringement and harm to its reputation since 2004, it never sought preliminary injunctive relief. (2012 Tr. at 209–210.) Throughout trial, Tyco has been emphatic as to its entitlement to lost profits and to a certain royalty rate, which further supports the position that “remedies available at law, such a monetary damages,” are fully adequate to compensate for Tyco’s injury.
The Court finds that the public interest prong cuts both ways, as there is certainly an interest in “protecting the rights of patent owners,” see Smith & Nephew, Inc. v. Synthes (U.S.A.), 466 F.Supp.2d 978, 985 (W.D.Tenn.2006), as well as an important consideration that a permanent injunction would pull many devices that are presently used in surgery off the market. See, e.g., Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc., CV–03–0597–PHX–MHM, 2009 WL 920300, at *9 (D.Ariz. Mar. 31, 2009) aff’d, 670 F.3d 1171, opinion vacated in part on reconsideration, 682 F.3d 1003 (Fed.Cir.2012) vacated in part on reh’g en banc, 476 Fed.Appx. 747 (Fed.Cir.2012)(“Given the utility of Gore’s infringing products, both Counterpart and Non–Counterpart, the important role that these products play in aiding vascular surgeons who perform life saving medical treatments, sound public policy does not favor removing Gore’s items from the market. The risk is too great. Placing Gore’s infringing products out of reach of the surgeons who rely on them would only work to deny many sick patients a full range of clinically effective and potentially life saving treatments. The Court finds that the strength of this factor alone precludes it from imposing a permanent injunction.”).
The Court has also considered the “balance of hardships” and concludes that a “remedy in equity” is not warranted. These parties, self-described as the Coke and Pepsi of the surgical tool market, are both giants in the industry, and the balance of hardships does not tip sufficiently in Plaintiff’s favor to warrant such an extreme remedy.
Compulsory license granted to OptumInsight over U.S. patent 7,739,126.
Patent 7,739,126 claims a method for measuring physician’s efficiency and patient’s health risk stratification. Cave Consulting Group, LLC, holder of this patent, brought a patent infringement action against OptumInsight, Inc. After a verdict in its favor, Cave Consulting moved for permanent injunction.
The Court denied the permanent injunction requested by Cave Consulting and granted a compulsory license to OptumInsight under the ebay doctrine. The Court considered that Cave Consulting had shown willingness to license the ‘126 patent to OptumInsight. This supported the conclusion that Cave Consulting would not be irreparably harmed absent a permanent injunction. Moreover, the took into consideration the facts harm alleged by Cave Consulting was quantifiable; and that Cave Consulting delayed nearly five years in seeking an injunction.
A patent holder’s “willingness to forego its patent rights for compensation supports the…conclusion that [the patent holder] will not suffer irreparable harm absent an injunction.” Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F. Supp. 2d 554, 560 (D. Del. 2008). “Money damages are rarely inadequate in these circumstances….” Id.
Therefore, evidence proves that CCGroup has given up exclusivity over its patent to other market participants and would have been willing to license the ‘126 patent to Optum. Advanced Cardiovascular Sys., 579 F. Supp. 2d at 560. Accordingly, this factor weighs against granting a permanent injunction.
To the contrary, CCGroup proved that its harm is quantifiable, both at trial and by seeking an ongoing royalty. See Conceptus, Inc. v. Hologic, Inc., No. 09-cv-02280, 2012 WL 44064, at *2 (N.D. Cal. Jan. 9, 2012) (concluding that harm was quantifiable, and that “it would be disingenuous” for patent holder to argue otherwise because patent holder’s expert argued for the reasonable royalty rate that the jury awarded). Lost customers or lowered prices, if proven to be true, are forms of quantifiable harm compensable by money damages. See ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1338 (Fed. Cir. 2012) (observing that, when infringer pays patent holder a monthly royalty, patent holder is adequately compensated).
CCGroup waited nearly five years to seek an injunction against Optum’s sale of Impact Intelligence. Dkt. No. 407-19 at 7. This significant delay suggests that CCGroup did not suffer irreparable harm. As such, although this factor is not as important as the others, it weighs against granting a permanent injunction.
CCGroup fails to meet its burden to prove irreparable harm because (1) CCGroup’s business has grown despite competition from Optum; (2) CCGroup has licensed to other competitors and been willing to license to Optum; (3) CCGroup’s alleged harm is quantifiable; and (4) CCGroup delayed nearly five years in seeking an injunction.
Court denied the request for a permanent injunction, considering it would be duplicative of the monetary relief.
CardiAQ Valve Technologies filed a lawsuit against Neovasc for misappropriating CardiAQ’s trade secrets related to CardiAQ’s transcatheter mitral valve device to develop its own competing device. After a verdict in its favor, CardiAQ moved for a permanent injunction.
The Court denied the injunction requested by CardiAQ, considering that a 18-month suspension of Neovasc’s TMVI program would be duplicative of the monetary relief already obtained by CardiAQ. The Court also determined that the public would be disserved by the injunction because it could potentially delay the progress of the TMVI device.
In 708 F. App’x 654, 657 (Fed. Cir. 2017) the U.S. Court of Appeals, Federal Circuit, affirmed the district court’s judgment in all respects, including the denial of the permanent injunction.
Having considered the four-factor test for a permanent injunction, the Court will not suspend Neovasc’s TMVI program for any amount of time. The $70 million already awarded by the jury, together with the enhanced damages granted in this Order, adequately compensate CardiAQ for its injury. The proposed 18-month suspension would be duplicative of the monetary relief, and is not warranted given the uncertainty in the TMVI market, the impact the injunction would have on Neovasc, and the public’s interest in having access to a potentially life-saving technology.
The public would also be disserved by the injunction. As evidenced at trial, Neovasc and CardiAQ’s prototypes now differ in several respects and it is unknown which one will be most effective at treating malfunctioning mitral valves. No TMVI device has received regulatory approval, and it is impossible to know which device(s) will or will not be approved. By imposing the 18-month injunction, the Court could potentially delay the progress of the one TMVI device that works, and thereby keep a lifesaving device off the market for an additional year-and-a-half. While there is a countervailing interest in protecting trade secrets and disincentivizing trade secret misappropriation, that interest is largely addressed by the damages Neovasc must pay, and is outweighed by the public’s interest in getting the most effective TMVI device to the market as fast as possible.
Court denied permanent injunction that sought to prevent Watson from engaging in pre-commercialization activities.
Patent 8,071,577 claims a combined oral contraceptive, a pharmaceutical drug. Bayer Pharma AG brought action against Watson Labs pursuant to the Hatch–Waxman Act. The Court found that the proposed product subject to a ANDA application filed by Watson would infringe the patent held by Bayer Pharma. Following this judgement, the parties agreed to reset the date of the ANDA procedure to a date not earlier than the date of the expiration of the patents. Nevertheless, Bayer Pharma moved for permanent injunctive relief to limit Watson solely to research activities regarding the patented product and prevent Watson from engaging in pre-commercialization activities that could precede a launch of a generic product.
The Court denied the injunction requested by Bayer Pharma. The Court found that Bayer Pharma failed to show irreparable harm or that the remedies available at law are inadequate, considering that if Watson launches a generic product during the life of the patent without the FDA approval Watson will risk civil and criminal sanctions. A prospective harm caused by the launch of products without FDA approval was an unfounded speculation, and the civil and criminal litigation that type of action would be subject to was quantifiable.
Effectively, the parties’ dispute seems to be whether to limit Defendant solely to research activities that are within the Hatch–Waxman Act’s “safe harbor,” 35 U.S.C. § 271(e)(1), or whether instead to allow Defendant to engage in all research and pre-commercialization activity that could precede a launch of a generic product. While there may be valid reasons to limit Defendant’s activities to the extent Plaintiffs request, here Plaintiffs have failed to create a record which would justify such relief.
It is true, as Bayer contends, that Watson seeks to be a direct competitor of Bayer in the market for Natazia® and has committed an “act of infringement” (albeit an “artificial” act) by filing an ANDA. (D.I. 162 at 1–2) But these facts alone are insufficient to establish irreparable harm in all ANDA cases. See generally Alcon, 2010 WL 3081327, at *2. Bayer presents little evidence to support its claim that it will be irreparably harmed in the absence of an injunction. As Watson correctly observes, “Bayer does not submit any data to explain the general magnitude of potential lost revenues or establish any harm to itself as a company.” (D.I. 161 at 4) Although Bayer suggests that it has already been harmed due to changing its marketing plans for Natazia®, Bayer has not proven that Watson’s ANDA filing caused those changes. See Apple Inc. v. Samsung Elecs. Co., 735 F.3d 1352, 1363 (Fed. Cir. 2013) (“[T]he purpose of the causal nexus requirement is to show that the patentee is irreparably harmed by the infringement.”). Indeed, the testimony Bayer relies on suggests that other factors, such as the timing of FDA approval of indications, played a significant role in Bayer’s marketing decisions. (See D.I. 160 Ex. A at 337) While Defendant’s launch of a generic product during the life of the patent is the type of activity that could result in irreparable harm to Bayer, Plaintiffs’ speculation that Defendant will risk criminal sanctions by launching its generic product into the market without FDA approval strikes the Court as entirely unfounded, and FDA approval will not happen until after the expiration of the patent. Moreover, the possible necessity of future litigation with Defendants is slight, and litigation costs cannot support a finding of irreparable harm. See ActiveVideo Networks, Inc. v. Verizon Comm., Inc., 694 F.3d 1312, 1337 (Fed. Cir. 2012) (“Reliance on litigation costs to support a determination of irreparable harm [is] legal error.”). Further support for the conclusion that Bayer has failed to prove irreparable harm is the evidence of the relatively small sales of Natazia®, and the drug’s seemingly close-to-inconsequential place in Bayer’s overall portfolio of corporate activities. (See generally id. at 1–2) (summarizing evidence) Generally, the record lacks evidence of irreparable harm.
Bayer has also failed to show that the remedies available to it at law are inadequate. The costs of litigation, including any future litigation, are quantifiable and can be compensated by money damages. As with the irreparable harm factor, Bayer hypothesizes there could be “a premature product launch,” by which Watson would “flood the market with lower priced generics” before FDA approval. (D.I. 160 at 3) However, as Bayer acknowledges, this would subject Watson “to significant penalties.” (Id. at 3 n.1) Watson contends, without contradiction, that such penalties would be both civil and criminal. (D.I. 161 at 3) It seems unlikely that if Watson—which is in the business of developing and marketing drug products in the United States, all of which require FDA approval—proves willing to risk its relationship with the FDA in order to prematurely and unlawfully launch its generic version of this one product, Natazia®, that an additional order from this Court would prove to be the dispositive deterrent to such unlawful conduct. Thus, Plaintiffs have not demonstrated that legal remedies are inadequate. See also Alcon, 2010 WL 3081327, at *3 (explaining that § 271(e)(4)(A) relief, delaying FDA approval of ANDA, “effectively precludes practice of the [patent-in-suit] outside the context of experimentation … until after the patent’s expiration,” supporting a finding that adequate legal remedies for harm to patentee do exist).
Bayer has succeeded in showing that the balance of hardships favors its requested additional injunctive relief. Bayer stands to lose some of the value of its patent if “infringing activity” is permitted to occur during the life of the patent. By contrast, there would be little, if any, harm to Watson were the Court to grant Bayer’s requested injunction. Watson suggests that the requested injunction would “prevent[ ] Watson from making or using or experimenting with its ANDA product,” which could “chill further experimentation on the product.” (D.I. 161 at 4–5) But Watson does not address whether some of these activities would fall within the safe harbor of § 271(e)(1). Also, the record contains no evidence as to how much more quickly, if at all, Watson could launch its proposed generic product (following FDA approval) without the injunction as compared to with the injunction in place. Thus, while there is little evidence of harm on either side of the balance, the Court concludes from the record that the balance of hardships slightly favors Bayer.
Finally, the public interest also appears, slightly, to favor Bayer. Here, the public has an interest in having what could be a somewhat earlier launch of a generic drug, which favors Watson, but the public also has an interest in protecting valid patents and encouraging investment in new pharmaceutical products. Neither side presented evidence on these points. However, given that the FDA already must delay approval of the product until after the expiration of the patent, the Court finds that the public interest would not be disserved by an additional injunction of equal duration being directed to Watson.
In sum, Bayer has failed to show irreparable harm or that the remedies available at law are inadequate, although Bayer has succeeded in showing that the balance of harms and the public interest do support the additional requested injunction. Weighing all of the pertinent considerations, the Court has determined that the most reasonable exercise of its discretion is to deny the requested permanent injunction.
Compulsory license granted to Ariosa Diagnostics, owned by Roche, over U.S. patent 7,955,794.
Patent 7,955,794 relates to methods for simultaneously detecting multiple target nucleic acids in a sample, which can be used for commercial diagnostic testing. Verinata Health and Illumina, holder of this patent, filed a infringement lawsuit against Ariosa Diagnostics, now owned by Roche. Following a verdict finding that the patent ‘794 was infringed by the non-invasive prenatal diagnostic test currently marketed by Ariosa/Roche as Harmony, Illumina moved for permanent injunction.
The Court denied the request for a permanent injunction requested by Illumina and granted a compulsory license to Ariosa under the Ebay doctrine. In the analysis of the public interest prong the Court determined that the public will not be served by the issuance of a permanent injunction in this case because the plaintiff Illumina does not currently practice the ’794 patent.
However, the Federal Circuit has noted that the public interest weighs in favor of the patentee “especially when the patentee practices his inventions.” Apple., 809 F.3d at 647. Here, the ’794 patent is not currently in practice. Its primary iteration was in the now discontinued GoldenGate product. See Trial Tr. (1/8/2018) 133:21-25; Ex. I (McGrath Depo.) at 119:17-19, 121:18-22).
This Court is persuaded that the public interest will not be served by the issuance of a permanent injunction. See Novozymes A/S v. Danisco A/S, No. 10-CV-251-BBC, 2010 WL 3783682 (W.D. Wis. Sept. 24, 2010). In Novozymes, the defendants did not practice its patent or license the patent to a third party. Id. at *10. The court held that it would not permit a preliminary injunction because it is “inconsistent for plaintiffs to be arguing on one hand that the ’723 patent represents an important new invention and then argue on the other hand that it should make no difference if no one is allowed to actually use it.” Id.
Here, much like the defendants in Novozymes who did not practice or license their patent, Illumina does not currently practice the ’794 patent. Consequently, this Court similarly holds that granting a permanent injunction could disserve the public interest or at the very most is neutral.

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