The U.S. Supreme Court’s May 22, 2017 ruling in TC Heartland v. Kraft Foods held that personal jurisdiction alone does not convey venue for patent cases under the patent venue statute. Previously, the Court of Appeals for the Federal Circuit and the United States district courts had interpreted the patent venue statute, 28 U.S.C. §1400(b), to allow plaintiffs to bring a patent infringement case against a domestic corporation in any district court where there is personal jurisdiction over that corporate defendant. Specifically, the patent venue statute provides that “[a]ny civil action for patent infringement may be brought in either 1) the judicial district where the defendant resides” or 2) “where the defendant has committed acts of infringement and has a regular and established place of business.” But, TC Heartland, held that a domestic corporation resides only in its state of incorporation for purposes of the patent venue statute, and not just anywhere it is subject to personal jurisdiction as had previously been the case.
However, TC Heartland did not address the second prong of § 1400(b), which makes venue proper in any judicial district where: (1) the defendant has a regular and established place of business, and (2) has committed acts of infringement. Post TC Heartland, a number of district courts and the Federal Circuit have weighed in on what constitutes a regular and established place of business under the second prong of § 1400(b). But, few courts have considered what is required to satisfy the second requirement, namely committing acts of infringement sufficient to establish venue.
Thus, it is notable that the U.S. District Court for the Eastern District of Texas, in Snyders Heart Valve LLC v. St. Jude Medical SC, Inc. et al, 4-16-cv-00812 (TXED March 7, 2018, Order), recently had to determine whether, under the second prong of § 1400(b), sufficient infringement occurred in the District to establish venue. The specific issue in the case turned on whether all sales of the accused products in the District were subject to the safe harbor provided in 35 USC § 271(e)(1). The safe harbor provided by § 271(e)(1) extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the Federal Food, Drug, and Cosmetic Act of 1938. In other words, if all of Defendants’ challenged activities in the District are covered by the safe harbor, there can be no acts of infringement in the District, and venue is thus improper.
The Plaintiff argued that the safe harbor under § 271(e)(1) is irrelevant for purposes of determining whether venue is proper, and that its allegations of infringing activity in the District—as required under §1400(b)—are sufficient. Plaintiff also argued that because the clinical trial safe harbor is all or nothing, Defendants’ commercial activity outside this District effectively revokes the safe harbor protection for activities inside the District.
The District Court first considered Plaintiff’s argument that the safe harbor defense is irrelevant to venue under § 1400(b). Plaintiff argued its mere allegation of infringing acts in the District make venue proper under § 1400(b). The Court rejected this argument, reasoning both the venue statute and the safe harbor statute speak of “acts of infringement,” not acts of “alleged” infringement. The Court continued, “if Plaintiff were right, any venue limitation could be overcome by simply making infringement accusations in the forum of the plaintiff’s choice, regardless of the defendant’s actual activities in that particular forum. This is contrary to law. Once the defendant comes forward with evidence that venue is improper, the plaintiff cannot rely on mere venue allegations in its complaint to maintain its chosen venue.” The Court then found the Plaintiff has not alleged any facts showing activities in this District other than those statutorily exempted from infringement by safe harbor under § 271(e)(1).
Next, the Plaintiff argued the safe harbor defense is “all or nothing” and to the extent Defendants make and sell accused products elsewhere in the United States for commercial purposes, such uses are not “solely for uses reasonably related” to seeking FDA approval and Defendants are not entitled to any exemption at all under § 271(e)(1). The Court also rejected this argument, reasoning the Federal Circuit has made clear that for purposes of the safe harbor, each accused activity must be analyzed separately. The Court noted a two-part test under the safe-harbor analysis: “(1) whether the activity at issue is a potentially infringing one; and (2) whether the exemption applies to that activity.” Therefore, some of the accused products could fall within the safe harbor, while some of could not, even though the accused products were all of the same group. Thus, the Court found all acts of infringement in the Eastern District of Texas are solely clinical, and therefore, the § 271(e)(1) safe harbor applies despite purported nonexempt activity in Minnesota. The Court concluded that since there are no material factual questions on challenged activities remaining, summary judgment on the safe harbor issue is proper, and this renders venue in the District deficient.
Although this case concerned a specific statutory exemption to infringement, namely the safe harbor under § 271(e)(1), its reasoning could have broader implications in the on-going evolution of venue in patent litigation cases post TC Heartland. In addition to challenging whether it has a regular and established place of business in the District, defendants may also begin challenging a plaintiff’s bare-bones allegations that the defendant has committed acts of infringement in the District. And, District Courts may begin to require plaintiffs to show actual acts of infringement in the District by Defendant in order to maintain venue.