Court Opinion

ID: 9492081
Source: CourtListenerOpinion
Date Created: 2023-08-05 14:31:30.086396+00
Date Added: 2024-06-11T17:55:05.749344
License: Public Domain

RADER, Circuit Judge,
concurring.
I, too, would end this jurisdictional ping-pong match by reversing the order of the Pennsylvania district court transferring this patent infringement suit to the Maryland district court, but without recourse to the so-called “government contacts exception” to personal jurisdiction. This court need not adopt this exception, which the courts of the District of Columbia created (and only those courts have applied) to finesse jurisdictional questions unique to that forum. Moreover, application of that exception in this case sidesteps the traditional Due Process analysis mandated by the Supreme Court. In my view, the traditional analysis precludes personal jurisdiction over Mylan. Therefore, by applying standard personal jurisdiction rules, I concur.
Personal jurisdiction over an out-of-state defendant involves two inquiries: first, whether the forum state’s long-arm statute confers jurisdiction and, second, whether the assertion of personal jurisdiction comports with Constitutional requirements for *835due process. See Genetic Implant Sys., Inc. v. Core-Vent Corp., 123 F.3d 1455, 1458, 43 USPQ2d 1786, 1788 (Fed.Cir.1997) (citing Burger King Corp. v. Rudzewicz, 471 U.S. 462, 471-76, 105 S.Ct. 2174, 85 L.Ed.2d 528 (1985)). Maryland courts have already interpreted that state’s long-arm statute, Md.Code Ann., Cts. & Jud. Proc. § 6-103 (1998), to provide jurisdiction to the full extent permitted under the Constitution. See Talegen Corp. v. Signet Leasing and Fin. Corp., 104 Md.App. 663, 657 A.2d 406, 410 (1995). Thus, the two inquiries collapse into one. See Genetic Implant Sys., 123 F.3d at 1458; Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355, 1358 (Fed.Cir.1998).
Under the due process clause of the Constitution, Maryland has personal jurisdiction over Mylan if Mylan has sufficient contacts with Maryland to give it “fair warning” that it might be haled into court there. See Burger King, 471 U.S. at 472, 474, 105 S.Ct. 2174; World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 297, 100 S.Ct. 559, 62 L.Ed.2d 490 (1980). Mylan has received fair warning if it purposefully availed itself of the benefits and protections of Maryland’s laws or purposefully directed its activities at residents of the forum, and if the litigation results from injuries arising out of its activities. See Burger King, 471 U.S. at 471-76, 105 S.Ct. 2174; Hanson v. Denckla, 357 U.S. 235, 253, 78 S.Ct. 1228, 2 L.Ed.2d 1283 (1958). “Once it has been decided that a defendant purposefully established minimum contacts within the forum State, these contacts may be considered in light of other factors to determine whether the assertion of personal jurisdiction would comport with ‘fair play and substantial justice.’ ” Burger King, 471 U.S. at 476, 105 S.Ct. 2174 (quoting International Shoe Co. v. Washington, 326 U.S. 310, 320, 66 S.Ct. 154, 90 L.Ed. 95 (1945)). Mylan’s contacts with Maryland do not suffice to satisfy these Constitutional requirements.
At the outset, Mylan’s contacts are not actually with the state of Maryland at all. Rather Mylan’s contacts involve the federal government whose office for receipt of ANDAs happens to be within that state. In the same sense, Mylan has not purposefully availed itself of the benefits of the laws of Maryland or purposefully directed its activities at Maryland residents. My-lan seeks benefits only from the federal government through the FDA. Therefore, Mylan has directed its activities at the FDA, not at the state of Maryland or its residents.
This reasoning applies even though My-lan’s filing of the ANDA itself constituted the tort of patent infringement under 35 U.S.C. § 271(e)(2) (1994). Section 271(e) was part of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. 98-417, 99 Stat. 1585, designed inter alia to compensate for distortions in the patent term resulting from lengthy regulatory approval processes. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669-71, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). Section 271(e)(1) benefits competitors of the patent holder by freeing them from liability for development work reasonably related to securing regulatory approval. By enabling testing to comply with regulatory processes before patent expiration, this section allows competitors to enter the market more quickly after the patent expires, thus limiting what would otherwise amount to an extension of the patent term. See Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562, 1568, 42 USPQ2d 1257, 1262 (Fed.Cir.1997). Section 271(e)(2), on the other hand, balances the effects of 271(e)(1) to a degree by making it an act of infringement for competitors to file an ANDA if the purpose of the submission is to obtain approval and “engage in the commercial manufacture, use, or sale” of the drug before the expiration of the patent. See Glaxo, 110 F.3d at 1568-69. At that point, the patent holder can seek to prevent approval of the ANDA by bringing a patent infringement suit. Such a suit can have the effect of barring *836ANDA approval for two and a half years. See Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1132, 36 USPQ2d 1641, 1643 (Fed.Cir.1995).
This statutory framework evinces, as'the Supreme Court has recognized, that the act of infringement created by section 271(e)(2) is “highly artificial” with a “limited and technical purpose.” Eli Lilly & Co., 496 U.S. at 678, 110 S.Ct. 2683. In sumi section 271(e)(2) employs the legal fiction of a defined act of infringement to create case or controversy jurisdiction, thereby enabling a court to promptly resolve any dispute concerning infringement and validity of the subject patent. See Glaxo, 110 F.3d at 1569. Section 271(e)(4)(C) recognizes the artificial nature of the filing of an ANDA by limiting monetary relief to unauthorized commercial manufacture, use, offer for sale, or sale of the patented invention.
Manufacture, use, offers for sale, and sales, unlike the filing of an ANDA, are real acts with actual consequences. Such acts fall within our traditional understanding of patent infringement, see 35 U.S.C. § 271(a), and subject a defendant to full liability under the law. Commercial manufacture, use, offers for sale, and sales are not legal fictions, but rather are genuine economic acts that, unlike the filing of an ANDA, operate under the commercial laws of a forum state or target its markets and residents. Thus, if Mylan engaged in such acts in Maryland, it might reasonably haye foreseen the possibility of being haled into Maryland courts to defend against the consequences of those acts.
The “highly artificial” act of filing an ANDA neither takes' advantage of Maryland’s commercial laws and legal structures nor targets Maryland’s markets and residents. Indeed, the mere filing of an ANDA does not at that point even cause a tangible injury to the patent holder. Accordingly, I believe that Mylan’s filing of an ANDA did not fairly warn of the possibility of implicit submission to Maryland courts. Mylan’s contacts with Maryland, then, are insufficient to establish personal jurisdiction.
Finally, although the above suffices to end' the Constitutional inquiry, I note further that the exercise of personal jurisdiction over Mylan also would not comport with “traditional notions of fair play and substantial justice.” Mylan’s filing of papers with a federal agency that happens to reside in Maryland does not qualify as significant contacts with that state at all. This situation is one in which “the plaintiffs interest and the state’s interest in adjudicating the dispute in the forum are so attenuated that they are clearly outweighed by the burden of subjecting the defendant to litigation within the forum.” Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558, 1568, 30 USPQ2d 1001, 1009 (Fed.Cir.1994)., Maryland has no interest in hearing this case. It has none of its laws to protect, enforce, interpret, or apply. The only laws at issue are federal laws. Nor does Zeneca have any compelling interest. Zeneca is incorporated under the laws of England with its principal place of business in England. It has identified no additional burden it would encounter by litigating in Pennsylvania, where Mylan’s parent has a place of business, rather than in Maryland.
In sum, because Mylan’s contacts with Maryland are Constitutionally deficient, Maryland cannot exercise personal jurisdiction over Mylan. I therefore agree that this- court should reverse the transfer order of the Pennsylvania district court and remand. Because this court can reach that conclusion under a traditional due process analysis, I believe it need not adopt the “government contacts exception” as the law of this circuit.