The opinion of the court was delivered by: LEE
Presently before the Court is Zeneca Limited's ("Zeneca") Motion To Retransfer This Action To The District Of Maryland And Certify To The U.S. Court of Appeals For The Federal Circuit (Document No. 31).
After considering the parties' memoranda and examining the applicable law the Court will grant Zeneca's Motion to Retransfer and will certify for interlocutory appeal the question of the effect of 35 U.S.C. § 271(e)(2) on personal jurisdiction over Defendant Mylan Pharmaceuticals, Inc. ("Mylan") in the United States District Court for the District of Maryland ("Maryland Court") in light of the "government contacts" exception.
Zeneca is the patent owner for the pharmaceutical tamoxifen, U.S. Patent No. 4,536,516 ("516 patent"). Mylan submitted an Abbreviated New Drug Application ("ANDA") to the Food and Drug Administration (FDA), located in Rockville, Maryland, seeking approval to market the 516 patent before the patent expires. Mylan also submitted a certification, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii), stating that the 516 patent is invalid and/or unenforceable. Mylan's submission of the ANDA and its filing of the accompanying relevant certification is a statutory act of patent infringement.
After receiving notification of the filing of the ANDA and certification from Mylan, Zeneca filed this patent infringement action against Mylan in the United States District Court for the Western District of Pennsylvania on February 22, 1996.
Zeneca subsequently filed a motion to transfer the case to the Maryland Court. This Court granted Zeneca's motion to transfer on May 31, 1996, pursuant to 28 U.S.C. § 1404(a). In granting the motion the Court based its ruling on, inter alia, the fact that several other cases were pending involving the same patent and same plaintiff before the same Judge in the Maryland Court; that a savings in time, cost and convenience would result from potential consolidation of the cases, which would serve the interests of justice; and that jurisdiction is proper in the District of Maryland. Zeneca v. Mylan Pharmaceuticals, Inc., 968 F. Supp. 268, 1997 U.S. Dist. LEXIS 9017, *4, Civil Action No. 96-333 (W.D. Pa. May 13, 1997).
On January 3, 1997, the Maryland Court, Honorable Frederic N. Smalkin, issued an Order transferring this action back to the Western District of Pennsylvania for want of personal jurisdiction pursuant to 28 U.S.C. § 1631. Zeneca Ltd. v. Mylan Pharmaceuticals, Inc., 1996 U.S. Dist. LEXIS 12377, Civil Action No. S 96-1763, slip op. (D.Md. January 3, 1997). Judge Smalkin found that Mylan was not subject to either general or specific personal jurisdiction in Maryland. Particularly relevant to the instant motion, Judge Smalkin found that Mylan's act of submitting an ANDA to the FDA in Maryland falls under the "government contacts" exception and therefore cannot be relied upon as a basis for asserting personal jurisdiction over Mylan.
Zeneca filed the instant Motion in the Western District of Pennsylvania on January 31, 1997.
In support of its Motion, Zeneca asserts that the Maryland Court erred as a matter of law in finding that Mylan was not subject to personal jurisdiction in Maryland. Specifically, Zeneca argues that the government contacts exception, applied by the Maryland Court, is inapplicable to Mylan's intentional act of infringing Zeneca's patent. Finally, in addition to its request for an order retransferring the action to the Maryland Court, Zeneca requests that this Court certify for appeal the question of personal jurisdiction over Mylan in the Maryland Court.
Mylan, however, contends that this Court is barred by the law of the case from reviewing the Maryland Court's transfer Order. Alternatively, Mylan asserts that the Maryland Court's decision correctly applied the government contacts exception resulting in a determination that the Maryland Court lacked personal jurisdiction over Mylan. Finally, Mylan opposes Zeneca's motion to certify the personal jurisdiction question for appeal.
Law of The Case Does Not Bar Review of the Maryland Court's Transfer Order
Mylan argues that the Maryland Court's January 3, 1997 Order transferring this action to the Western District of Pennsylvania is the law of the case and as such "that decision should continue to govern the same issues in subsequent stages in the same case." Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 816, 108 S. Ct. 2166, 2178, 100 L. Ed. 2d 811 (1988). Mylan thus claims that the Maryland Court transfer Order is not subject to review in this Court absent extraordinary circumstances. Id. 486 at 817, 108 S. Ct. at 2178.
Mylan misapplies the Christianson rationale to the factual procedure of the instant case. The procedural history of Christianson parallels the transfer history in this case (although Christianson concerned transfer orders between coordinate Courts of Appeal, rather than sister District Courts). In Christianson, summary judgment was entered against the defendant, Colt Industries, by the District Court for the Southern District of Illinois. Colt appealed that decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit Court determined it lacked jurisdiction over the appeal and transferred the action to the United States Court of Appeals for the Seventh Circuit. The Seventh Circuit Court of Appeals retransferred the case to the Federal Circuit. The Federal Circuit again determined it lacked jurisdiction, but chose to decide the case on the merits.
The Supreme Court, after reviewing the doctrine of the law of the case, explained that the Federal Circuit properly reviewed the Seventh Circuit's retransfer. First, the law of the Christianson case was initially decided by the Federal Circuit when it transferred the action to the Seventh Circuit. Thus, "it was the Seventh Circuit, not the Federal Circuit, that departed from the law of the case". Id. 486 U.S. at 817, 108 S. Ct. at 2178. Second, "[a] court has the power to revisit prior decisions of its own or of a coordinate court in any circumstance, although as a rule courts should be loathe to do so in the absence of extraordinary circumstances such as where the initial decision was clearly erroneous and would work a manifest injustice." Id. (citation omitted). Therefore, the Federal Circuit Court of Appeals had the power to review the Seventh Circuit's decision with regard to jurisdiction even if the Seventh Circuit's decision was the law of the case. Id.
Following the rationale of the Christianson Court, it is apparent that this Court's initial Order dated May 31, 1996, transferring the case to Maryland is the law of the case. The relevant jurisdictional decision made by this Court is that Mylan's filing of an ANDA, "is a statutory act of patent infringement, 35 U.S.C. § 271(e) and provides for jurisdiction for suit in Maryland."
Zeneca v. Mylan Pharmaceuticals, Inc., 968 F. Supp. 268, 1997 U.S. Dist. LEXIS 9017, *9, Civil Action No. 96-333 (W.D. Pa. May 13, 1997) (citing Glaxo Inc. v. Genpharm Pharmaceuticals, Inc., 796 F. Supp. 872, 876 n.9 (E.D.N.C. 1992). The Maryland Court disagreed with this decision and found that the Maryland Court lacked personal jurisdiction. Although the Maryland Court did not make a specific finding, the necessary implication of the Maryland Court's opinion is that this Court's May 31, 1996 jurisdictional finding was clearly erroneous.
The Court now revisits its initial jurisdictional decision and finds that jurisdiction over Mylan in Maryland is proper and thus, the action will be retransferred. However, pursuant to 28 U.S.C. § 1292(a) and (b), the retransfer Order will be stayed and the jurisdictional question will be certified for appeal to the Federal Circuit Court of Appeals.
Jurisdiction Over Mylan in Maryland is Proper based on Mylan's submitting an ANDA and filing a Paragraph IV Certification
The Court will first determine whether personal jurisdiction over Mylan is proper before considering the government contacts exception. See U.S. v. Wilfred American Education Corp., 1987 WL 10501, at *3 (D.D.C. 1987) (jurisdiction upheld where defendant's "petition" to Department of Education to benefit from federal student aid programs was found not to implicate first amendment and government contacts exception was not applicable). Important to an understanding of the personal jurisdiction question is an understanding of the relevant background of section 271(e).
The relevant portions of 35 U.S.C. § 271(e)(2)(A) state:
(e)(2) It shall be an act of infringement to submit-
(A) an application . . . for a drug claimed in a patent or the use of which is claimed in a patent . . . .
if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
Essentially, section 35 U.S.C. § 271(e)(2) "gives a drug patent owner the right to bring an action for infringement upon the filing of a paragraph IV certification." Bristol-Myers Squibb Co. v. Royce Laboratories, Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995). Here, there is no dispute that Mylan has submitted an ANDA and filed a paragraph IV ...