Source: https://www.schwabe.com/newsroom-publications-14560
Timestamp: 2019-04-26 08:13:31+00:00

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Last week in Halo, the Circuit reversed the dismissal of a case against a Canadian company based on forum non conveniens since there was no showing that Canada would even hear the case. An anticipation ruling by the PTAB was reversed in Dell because the anticipation argument was made for the first time in oral argument before the Board. In the Acorda case, perhaps the most interesting ruling of the week, the Circuit affirmed that personal jurisdiction exists based largely on a defendant's future plans to market product in the forum state.
Halo – Halo (a Hong Kong based company) sued Comptoir (a Canada based company) in the Northern District of Illinois for infringing its intellectual property (including design patents, copyrights and non-registered trademark rights) and for violating Illinois consumer fraud and deceptive business practices statutes. The district court dismissed the case on forum non conveniens grounds, but the Circuit reverses the case and remands to the Northern District to resolve the infringement claims. Specifically, the Circuit finds that Canada was not the best forum for enforcing U.S. intellectual property rights in this case because the alleged infringement occurred elsewhere (in the United States) and the case has little or no connection to the Canadian forum. While the Circuit does not foreclose the possibility of a forum non conveniens motion being granted in the future in IP cases, it does illustrate the importance of the movant demonstrating the adequacy of an alternate foreign jurisdiction.
Dell – The Circuit rules for Acceleron in an appeal of an IPR relating to an Acceleron patent directed to a computer-network appliance having several hardware modules that can be removed and replaced without turning off the appliance. The PTO instituted the IPR in response to Dell's petition, ruling in its final written decision that some of the claims were invalid based upon anticipation or obviousness and confirming the validity of other claims. On appeal, the panel affirms the determination of validity but finds that the Board improperly read a limitation out of other claims that were determined to be invalid, so the panel vacates and remands that determination.
The panel also vacates and remands the Board's ruling as to the anticipation of other claims because Dell raised this anticipation argument for the first time at oral argument before the Board. Citing PTO rules, the panel holds that Acceleron was not given an adequate opportunity to respond to Dell's argument.
Acorda – The Circuit affirms that personal jurisdiction exists as to actions filed against generic drug manufacturer Mylan because it planned to sell its drugs in Delaware, the forum state. Two related appeals involve the issue of whether personal jurisdiction exists over Mylan in two infringement actions filed by brand name drug manufacturers Acorda, Alkermes and AstraZeneca following ANDA filings by Mylan. What the panel found to be of "particular importance" was that Mylan intended to direct sales of its drugs into Delaware once it has the requested FDA approval. A majority of the panel did not reach the issue of general jurisdiction, but the entire panel agreed that specific jurisdiction exists. The majority holds that specific jurisdiction exists because Mylan's ANDA conduct is "suit-related" that has a "substantial connection" with Delaware because the ANDA filings are tightly tied to the deliberate making of sales in Delaware, and that the suit is about whether that in-state activity will infringe valid patents.
The majority notes that if a defendant has minimum suit-related contacts with a state, the defendant may still defeat specific personal jurisdiction by demonstrating that other considerations render personal jurisdiction unreasonable, such as the burden on the defendant, the forum state's interest in adjudicating the dispute, the plaintiff's interest in obtaining convenient and effective relief, and the interstate judicial system's interest in obtaining the most efficient resolution of controversies. But the majority holds that Mylan cannot show that those due-process factors weigh against litigating the present cases in Delaware.
In a separate opinion, Judge O'Malley concurs that specific jurisdiction is appropriate, but not on the majority's reliance on expressions of future intent but instead on the ground that by seeking approval to market generic versions of plaintiffs' drugs, Mylan's acts were "calculated and directed to cause harm to the intellectual property rights of a known party with a known location." Judge O'Malley also feels that the requirements of general jurisdiction are met so she would not even reach the issue of specific jurisdiction.
Halo owns two U.S. design patents, thirteen U.S. copyrights, and one U.S. common law trademark relating to twenty-five of its furniture designs. Halo's common law trademark, ODEON, is used in association with at least four of its designs. Halo is located in Hong Kong but sells its furniture in the U.S. Halo sued Comptoir, a Canadian company, and its CEO, David Ouaknine, a Canadian resident (collectively, "appellees"), in the Northern District of Illinois. Halo asserted that appellees infringed its intellectual property and violated Illinois consumer fraud and deceptive business practices statutes. Appellee Comptoir designs and markets high-end furniture. Comptoir's furniture products are produced by manufacturers in China, Vietnam, and India. Comptoir's furniture products are imported into the United States, where Comptoir offers its products for sale to consumers directly at various furniture shows and through distributors, including in the Northern District of Illinois.
Appellees moved to dismiss on forum non conveniens grounds, contending that the Federal Court of Canada would be a superior forum. The district court granted the motion and dismissed the case. Under Seventh Circuit law, we review a district court's grant of a motion to dismiss on forum non conveniens grounds for abuse of discretion.
Although transfer between federal courts was codified in 28 U.S.C. § 1404(a), forum non conveniens concerning foreign and state venues has always been a common-law doctrine. In 1947, the Supreme Court recognized that the doctrine applies to suits in federal district court in Gulf Oil Corp. v. Gilbert, 330 U.S. 501 (1947), and Koster v. (American) Lumbermens Mutual Casualty Co., 330 U.S. 518 (1947). Forum non conveniens, the Court explained, allows a federal district court to dismiss a suit over which it would normally have jurisdiction if trial in a foreign forum would "best serve the convenience of the parties and the ends of justice." Id. Whether dismissal would promote convenience and justice should be determined by weighing various private and public interest factors.
In Piper Aircraft Co. v. Reyno, 454 U.S. 235 (1981), the Supreme Court established that every forum non conveniens inquiry must begin with a determination of whether there exists an alternative forum that is both adequate and available to hear the case. If such an alternative forum exists, district courts must proceed to balance the private and public interest factors described in Gilbert to determine whether dismissal is warranted. The moving party bears the burden of persuasion as to the adequacy of the alternative forum. Appellees fail to meet that burden here.
Halo's complaint seeks redress for alleged infringement of its U.S. intellectual property rights that occurred in the U.S. It cannot be assumed that a foreign court would adjudicate an intellectual property dispute where the alleged infringement occurred elsewhere, and the case otherwise has little or no connection to the chosen forum. The copyright and patent laws of the United States certainly reflect such territoriality. U.S. copyright law, for example, generally admits of no remedy for extraterritorial infringement unless a predicate act of infringement was first committed within the U.S. Appellee has provided no evidence that Canadian copyright law operates any differently. To the contrary, a leading Canadian copyright treatise notes that "a Canadian court would not have jurisdiction to entertain in an action brought by an author of a work in respect of acts being committed outside Canada, even if the defendant was within Canada." Canadian Law of Copyright and Industrial Designs 591 (3d ed. 2000).
The only evidence appellees submitted to the district court was a printout of the Federal Court of Canada webpage site, showing that the Federal Court of Canada has jurisdiction to adjudicate intellectual property rights, including copyright, industrial design patents and trademarks. This evidence demonstrates nothing more than the unremarkable proposition that the Federal Court of Canada has jurisdiction over Canadian intellectual property disputes. For the first time on appeal, appellees also cite certain provisions of the Canadian Copyright Act. But neither the cited provisions nor any other in the Canadian Copyright Act provides a remedy for extraterritorial infringement.
There is also no evidence in the record that any act of alleged infringement occurred in Canada. There is no evidence that appellees' furniture is designed in Canada, or that the allegedly infringing furniture was shipped through Canada to the U.S. after manufacture in Asia. The only evidence of any connection to Canada in the record is that appellees have their principal place of business there. But this fact alone cannot suffice. The question is whether the Federal Court of Canada could provide some potential avenue for redress for the subject matter of Halo's dispute. There is no evidence of any predicate act of infringement that occurred in Canada let alone evidence that such a predicate act, if found, would enable the Federal Court of Canada under Canadian law to redress subsequent infringing acts in the U.S.
It appears that the only intellectual property law the Federal Court of Canada would apply is its own. There is isolated support in the U.S. cases that U.S. courts can sometimes redress infringement occurring abroad by applying foreign law or that foreign courts could redress U.S. infringement by applying U.S. law. But these are cases in which at least a predicate infringing act occurred in the forum jurisdiction. Even in cases where predicate infringing acts occurred in the U.S., the application of foreign copyright law has remained an anomaly. In the present case, there is no evidence that any predicate act occurred in Canada, and no authority that Canada would provide a remedy for U.S. infringement or apply U.S. law under such circumstances. Thus, based on the evidence in the record, the Federal Court of Canada would not provide any "potential avenue for redress for the subject matter" of Halo's dispute, even with regard to Halo's claims of copyright infringement. The district court abused its discretion in concluding otherwise.
Because we hold that the district court abused its discretion and therefore that dismissal on forum non conveniens grounds was improper, we need not address Halo's remaining arguments regarding whether the district court abused its discretion by focusing solely on Halo's copyright claims when two of the accused products were allegedly covered only by design patents, whether Canadian copyright law would even protect the furniture designs at issue, or whether the district court erred in allocating the burden of proof or balancing the private and public interest factors.
Comment: This case does not deviate from the majority of district courts, which have routinely denied motions to dismiss on forum non conveniens grounds when U.S. intellectual property rights form the crux of the dispute. In turn, this case highlights the importance of a forum non conveniens movant demonstrating the adequacy of an alternative forum when the dispute implicates the enforcement of intellectual property rights, because if a domestic forum to adjudicate the rights they convey was denied without a sufficient showing of the adequacy of the alternative foreign jurisdiction, the policies underlying U.S. copyright, patent, and trademark laws would be defeated.
Acceleron's patent is directed to a computer-network appliance containing hardware modules that can be removed and replaced without turning the appliance off. After instituting the IPR, the Board confirmed the validity of claims 14-17 and 34-36. Dell appeals those rulings, primarily challenging the Board's finding that the key prior art reference fails to disclose a particular claim element. Acceleron appeals the Board's cancellation of claims 3 and 20 as anticipated. As to claim 20, Acceleron challenges the Board's claim construction, and as to claim 3, Acceleron challenges the Board's reliance on a basis first raised during the oral argument before the Board.
The patent discloses a computer-network appliance containing a number of hot-swappable components, meaning that those components can be removed and replaced without turning off or resetting the computer system as a whole. The hot-swappable components include CPU modules, a power module, a microcontroller module, and an ethernet switch module. Each of those modules is connected to a common backplane board. A chassis encloses the board and collection of modules. The chassis may also contain caddies that hold the modules while providing air flow from the front to the rear of the chassis.
Following institution of the IPR, Acceleron submitted its post-institution patent owner response, arguing for the validity of the claims at issue. Dell submitted a reply, arguing that the caddies required by claim 3 are found not only in Hipp's articulating door (previously argued) but also in Hipp's power-supply mounting mechanisms (newly argued). Acceleron requested a conference with the Board to address invalidity arguments newly raised in Dell's reply and to seek authorization to move to strike those arguments or, in the alternative, permission to file a sur-reply. The Board refused to hold a conference and denied Acceleron authorization to move to strike.
At oral argument Dell continued to rely on Hipp's articulating door and power supply mounting mechanisms as caddies, but it also added a new argument. For the first time, it contended that Hipp shows "slides" located below the power supplies and that such slides also constitute caddies. Acceleron disagreed and objected on the ground that Dell had never before identified the alleged slides as caddies.
In its final written decision, the Board determined that claims 14-17 survived Dell's anticipation challenge and claims 34-36 survived Dell's obviousness challenge, but that claims 3 and 20 were anticipated by Hipp. The Board concluded that claim 20 does not require the microcontroller module to be programmed for remote polling, but requires only that the claimed dedicated ethernet path would allow remote polling if the microcontroller module were so programmed. Under that construction, the Board found that Hipp meets the claim element involving polling because Hipp's disclosed bus could be used for polling.
The Board found that claim 3 is anticipated by Hipp, relying on Acceleron's agreement with Dell's contention that Hipp Figure 12 shows "slides"—the Board used a plural—that are caddies as required by claim 3. It concluded that Dell had pointed to that structure in Figure 12 in its reply and therefore rejected Acceleron's argument that Dell's contention was improperly presented for the first time at oral argument and therefore should be disregarded.
The Board accepted Dell's contention that Hipp discloses (a) a CPU module ("web server processing card") that includes a BIOS, can run on different operating systems, and can boot from a local area network and (b) a server that "provides network attached storage (NAS)" among the devices on the network. But the Board had ample evidence to find those facts not to be enough to meet the key claim 14 requirement at issue. We therefore affirm the Board's finding that Hipp does not anticipate claim 14. The Board determined that Hipp does not anticipate claims 15-17 and does not render obvious claims 34-36 for essentially the same reasons, and we affirm that determination.
Claim 20 requires "a microcontroller module and a dedicated ethernet path, wherein the dedicated ethernet path is separate from a switched fast ethernet connection and provides the microcontroller module with a connection to remotely poll the CPU module, the power module and the ethernet switch module." As Dell and Acceleron agree, the dedicated ethernet path itself is merely a conduit: it does not remotely poll but instead provides a connection for the microcontroller module to remotely poll. Acceleron contends that claim 20 can only be reasonably construed to require that the microcontroller module actually be configured for remote polling. Dell contends, and the Board concluded, that it is enough that there be an ethernet path that would provide a connection for polling if the microcontroller were configured for, and engaged in, remote polling of the three identified modules.
We agree with Acceleron. The Board's construction runs counter to the claim construction principle that meaning should be given to all of a claim's terms. As Dell has conceded, the Board's reading of claim 20 denies any substantial meaning to "remotely poll." The claim calls out one specific kind of communication. It is unreasonable to deny effect to the "remotely poll" language, which naturally indicates that the microcontroller module is actually configured to communicate in that way. The specification supports giving "remotely poll" effect as we read the claim. Because the Board did not find that Hipp anticipates claim 20 under the correct construction, we vacate the Board's cancellation of claim 20 and remand for reconsideration under that construction.
The Board found claim 3 to be anticipated by Hipp. For the required "caddies" element, the Board relied exclusively on what it found to be "slides" shown in Figure 12 of Hipp as lying beneath the power supplies. That structure was first identified as meeting the "caddies" claim limitation during the oral argument before the Board. We vacate the Board's ruling, holding that the Board denied Acceleron notice and a fair opportunity to respond to this basis of cancellation.
A patent owner in Acceleron's position is undoubtedly entitled to notice of and a fair opportunity to meet the grounds of rejection. For a formal adjudication like the inter partes review considered here, the APA imposes particular requirements on the PTO. The agency must "timely inform 1:1" the patent owner of"the matters of fact and law asserted," 5 U.S.C. § 554(b)(3), must provide "all interested parties opportunity for the submission and consideration of facts and arguments and hearing and decision on notice," and must allow "a party to submit rebuttal evidence as may be required for a full and true disclosure of the facts." Reflecting those fundamental requirements, the PTO has advised participants in its Board proceedings that, at oral argument, "a party may only present arguments relied upon in the papers previously submitted. No new evidence or arguments may be presented at the oral argument." Office Patent Trial Practice Guide.
In this case, the Board denied Acceleron its procedural rights by relying in its decision on a factual assertion introduced into the proceeding only at oral argument, after Acceleron could meaningfully respond. In its petition, Dell argued that the articulating door in Hipp's Figure 12 performs the same function as claim 3's caddies. In its post-institution reply, Dell added that the mounting mechanisms in Hipp's Figure 12 constitute a caddy. It was only at oral argument before the Board that Dell pointed to the structure on which power supplies rest in Hipp's Figure 12 as meeting the "caddies" requirement of claim 3. We need not address under what circumstances a cancellation may rely on a key factual assertion made for the first time in a petitioner's reply. In this case, contrary to the Board's conclusion, the key factual assertion was not in fact made in Dell's reply, but only at oral argument. Because Dell has not shown in this court that there can be no genuine factual dispute on that issue, we vacate the Board's cancellation of claim 3 and remand for further proceedings on anticipation of claim 3.
These appeals involve two actions brought in the District of Delaware against generic drug manufacturer Mylan. One, assigned to Chief Judge Stark, was brought by brand-name drug manufacturers Acorda Therapeutics and Alkermes Pharma Ireland; the other, assigned to Judge Sleet, was brought by brand-name drug manufacturer AstraZeneca. The plaintiffs brought the actions under 35 U.S.C. § 271(e)(2), alleging that their patents cover drugs that Mylan has sought permission from the FDA to manufacture and market. Mylan moved to dismiss on the ground that Delaware could not exercise personal jurisdiction—either general or specific personal jurisdiction—over Mylan in these cases. Chief Judge Stark and Judge Sleet denied the motions, concluding that Delaware could exercise specific personal jurisdiction, based on Mylan's suit-related contacts with Delaware. On interlocutory appeal, the panel affirms, holding that Mylan is subject to specific personal jurisdiction in these cases. The majority does not address the issue of general personal jurisdiction.
Under the authority of the FDA's approval of its New Drug Application (NDA), Acorda markets Ampyra® to help individuals with multiple sclerosis walk, identifying five patents for listing in the FDA's "Orange Book." In January 2014, Mylan filed an ANDA with the FDA, seeking approval to market generic versions of Ampyra®. In its filing, Mylan certified that Acorda's Orange Book patents for Ampyra® are invalid or would not be infringed by Mylan's marketing of its proposed drug. Acorda and Alkermes then sued Mylan in the District of Delaware for patent infringement, invoking 35 U.S.C. § 271(e)(2)(A), which provides that the submission of such a certification constitutes an act of infringement.
AstraZeneca markets FDA-approved Onglyza® and KombiglyzeTM to help individuals with type II diabetes, owning three patents for those drugs. Mylan filed two ANDAs seeking approval to market generic versions of the two drugs and certified that AstraZeneca's three patents are invalid or would not be infringed by Mylan's proposed drugs. AstraZeneca then sued Mylan for infringement in Delaware.
Mylan filed motions to dismiss under Fed. R. Civ. P. 12(b)(2) on the ground that Delaware could not—and therefore, derivatively, the federal district court in Delaware may not—exercise personal jurisdiction over Mylan in these matters under the Due Process Clause. The parties have debated both specific and general personal jurisdiction. The debate over the latter issue focuses on Mylan's registration to do business in Delaware as giving consent to the exercise of general personal jurisdiction.
The motions were decided on facts that are not in material dispute. Mylan is incorporated in West Virginia and has its principal place of business there. Mylan submitted its ANDAs to the FDA in Maryland, and it prepared its ANDA filings in West Virginia. Regarding the notices of its ANDA filings, Mylan sent notices to Acorda in New York and Alkermes in Ireland (for the Acorda matter), and it sent notices to AstraZeneca's subsidiary in Delaware and AstraZeneca in Sweden. Mylan has registered to do business and appointed an agent to accept service in Delaware. And, of particular importance, Mylan intends to direct sales of its drugs into Delaware, among other places, once it has the requested FDA approval. The plaintiffs also have connections with Delaware: Acorda is incorporated in Delaware, AstraZeneca's U.S. subsidiary has its principal place of business in Delaware, and both Acorda and AstraZeneca have sued other generic manufacturers for infringement of the same patents in Delaware.
Chief Judge Stark (in the Acorda case) and Judge Sleet (in the AstraZeneca case) denied the motions to dismiss. Both judges concluded that Delaware had sufficient contacts related to the subject of these cases that it could exercise specific personal jurisdiction over Mylan. In each case the district court certified its decision for interlocutory review, and we granted permission to appeal.
Under Fed. R. Civ. P. 4(k)(1)(A), the district court has personal jurisdiction over Mylan if Mylan would be subject to the jurisdiction of a court of general jurisdiction in the state where the district court is located, here Delaware. And there is no dispute that Mylan would be subject to Delaware courts' jurisdiction under Delaware's long-arm statute, as long as Delaware's exercise of personal jurisdiction over Mylan would be consistent with the Fourteenth Amendment's Due Process Clause. The jurisdictional dispute therefore turns on the constitutional question, and Mylan makes no argument against jurisdiction other than one based on due-process standards. We decide the question de novo, applying Federal Circuit law.
A court may exercise specific personal jurisdiction without violating the Due Process Clause when the defendant "has certain minimum contacts with the forum such that the maintenance of the suit does not offend 'traditional notions of fair play and substantial justice.'" Int'l Shoe Co. v. Washington, 326 U.S. 310 (1945). The minimum contacts requirement focuses on whether the defendant's suit-related conduct creates a substantial connection with the forum state. What conduct is suit-related depends on the relationship among the defendant, the forum, and the litigation, including specifically the nature of the claim asserted. In a formulation worded to address suits for retrospective relief based on past acts, the Supreme Court has said that the minimum-contacts requirement is met when the defendant "purposefully directed" activities at the forum, "and the litigation results from alleged injuries that 'arise out of or relate to' those activities." Burger King Corp. v. Rudzewicz, 471 U.S. 462 (1985).
Here, Mylan has taken the costly, significant step of applying to the FDA for approval to engage in future activities—including the marketing of its generic drugs that will be purposefully directed at Delaware and elsewhere. If Mylan had already begun its deliberate marketing of these drugs in Delaware, there is no doubt it could be sued for infringement in Delaware. But in our view, the minimum contacts standard is satisfied by the particular actions Mylan has already taken—its ANDA filings—for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware.
The Hatch–Waxman Act recognizes the close connection between an ANDA filing and the real world acts that approval of the ANDA will allow and that will harm patent-owning brand name manufacturers. In 35 U.S.C. § 271(e)(2), Congress declared the ANDA filing to be what has been called an "artificial act of infringement," allowing the brand-name manufacturer to sue the ANDA filer to litigate patent validity and coverage. In so doing, Congress stressed the ANDA filer's "purpose . . . to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such patent," 35 U.S.C. § 271(e)(2)(A)— concrete, non-artificial acts of infringement. The relief available in such a suit, moreover, is focused on preventing or remedying the distinctly non-artificial infringing activities that threaten commercial harm: an order to delay the ANDA approval that is a precondition to marketing; an injunction to prevent commercial manufacture, sale, importation, etc.; and monetary relief for such commercial activities in the past.
Likewise, an ANDA filer's certification regarding patents addresses the real-world actions for which approval is sought—specifically, whether those actions would infringe. This court has long recognized that the infringement inquiry called for by § 271(e)(2) is "whether, if a particular drug were put on the market, it would infringe the relevant patent" in the usual, non-artificial sense.
Those activities will unquestionably take place in Delaware (at least). The subject of the cases before us is whether those activities will infringe valid patents and should be stopped under the remedial provisions of the Hatch–Waxman Act. Mylan's ANDA filings, including its certifications regarding the patents at issue here, are thus suit-related, and they have a substantial connection with Delaware because they reliably, non-speculatively predict Delaware activities by Mylan.
For those reasons, it suffices for Delaware to meet the minimum-contacts requirement in the present cases that Mylan's ANDA filings and its distribution channels establish that Mylan plans to market its proposed drugs in Delaware and the lawsuit is about patent constraints on such in-state marketing. The parties consistently stated in their briefs that the only contact with the forum at issue was the act of making the ANDA filing (at the FDA's office in Maryland). That limit on the issue before this court was reflected in the question certified for interlocutory appeal.
One point remains. A finding of minimum contacts does not end the due-process inquiry—let alone any nonconstitutional venue inquiries—into whether a case properly remains in a forum. Even if a defendant has minimum suit-related contacts with a state, the defendant may defeat specific personal jurisdiction by sufficiently demonstrating that other considerations render jurisdiction unreasonable. The Supreme Court has identified a number of factors to consider, including the burden on the defendant, the forum state's interest in adjudicating the dispute, the plaintiff's interest in obtaining convenient and effective relief, and the interstate judicial system's interest in obtaining the most efficient resolution of controversies. But Mylan cannot show that those due process factors weigh against litigating the present cases in Delaware.
I agree that the district judges in these appeals have jurisdiction to hear the cases before them. I write separately because I believe we should reach the question of general jurisdiction, which the parties raise and the district judges decided. The specific jurisdiction issue, which the majority exclusively decides, is a more difficult question to resolve than the question of the continuing precedential effect of the line of Supreme Court authority articulated most clearly in Pennsylvania Fire Insurance Co. of Philadelphia v. Gold Issue Mining & Milling Co., 243 U.S. 93 (1917). The parties dispute a host of factual questions regarding the specific jurisdiction issue, including whether and to what extent Mylan ultimately may be authorized to—or decide to—market generic drugs in Delaware.
I would find specific jurisdiction over Mylan in these cases under a different legal theory than employed by the majority. I would find that, as in Calder v. Jones, 465 U.S. 783 (1984), the acts were calculated and directed to cause harm to the intellectual property rights of a known party with a known location. It is an act which—even before a single sale of product in the State of Delaware—called into question the validity and value of property rights protecting the marketing of profitable products by Acorda and AstraZeneca. In so doing, it called into question the very value of their respective businesses. By virtue of the provisions of the Hatch–Waxman Act requiring that they do so, the certification also triggered an obligation to quickly file an expensive infringement action in an effort to lift the cloud placed on the appellees' business interests.

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