CHAPTER § 3.03 Litigation Practices and Liability

JurisdictionUnited States

§ 3.03 Litigation Practices and Liability

[1] Patent Litigation Practices

Very early in a lawsuit, patent litigants and their counsel must be attentive to the scope and meaning of the patent claims that are asserted in the case. Plaintiff's counsel must reasonably inquire into the law and facts associated with any infringement claim.204 This necessarily requires that a patent attorney identify and assert the relevant patents and claims. The patent attorney must then develop arguments for a construction of those claims broad enough to allow the claims to capture the potentially infringing act but narrow enough to avoid the prior art.205 Similarly, to position itself favorably during discovery, an accused infringer must sort out the claim terms likely to be disputed, and the information potentially relevant to construction of those terms. Often, a court's construction of essential claim terms will lead to the entry of a final judgment as to invalidity or infringement.

[a] Personal Jurisdiction and Venue in Hatch-Waxman Litigation

Courts have considered how to assess issues of personal jurisdiction and venue in view of the unique features of Hatch-Waxman patent litigation, including the "artificial" nature of the act of infringement in Hatch-Waxman cases before generic launch.

There are generally two categories of personal jurisdiction: specific (i.e., conduct-linked) personal jurisdiction and general (i.e., all-purpose) personal jurisdiction. A court has specific personal jurisdiction over a defendant when the suit "arises out of or relates to the defendant's contacts with the forum."206 A court has general personal jurisdiction over a defendant "only when the [defendant] corporation's affiliations with the State in which suit is brought are so constant and pervasive 'as to render it essentially at home in the forum State.'"207 A company is typically subject to general personal jurisdiction in the state in which it is organized (e.g., incorporated) and the state in which it has its principal place of business.208

In Hatch-Waxman actions there is an added complexity in assessing where the infringing acts occurred for purposes of determining specific personal jurisdiction, because no actual infringement has yet occurred (i.e., it is the filing of the application to market the generic product that serves as an "artificial" act of infringement). The Federal Circuit addressed these issues in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., which found that Mylan—a company incorporated and headquartered in West Virginia—was nonetheless subject to specific personal jurisdiction in Delaware, one of many states in which Mylan intended to sell its generic product following ANDA approval.209 In Acorda, the Federal Circuit reasoned that "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."210 Further, the Federal Circuit noted that "it suffices for Delaware to meet the minimum-contacts requirement . . . 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."211 Thus, the Federal Circuit held that an ANDA filer is subject to specific personal jurisdiction in any state in which it intends to market its future drug.

Venue in patent cases, including those under the Hatch-Waxman Act, is governed by 28 U.S.C. § 1400(b), which states: "[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business." In TC Heartland LLC v. Kraft Foods Grp. Brands LLC, the U.S. Supreme Court confirmed that, under § 1400(b), "a domestic corporation 'resides' only in its State of incorporation."212 Accordingly, to satisfy the patent infringement venue statute for defendants sued outside their state of incorporation, a patentee must show that (1) the defendant has "committed acts of infringement" in the district, and (2) the defendant has a "regular and established place of business" in the district.213

The application of TC Heartland to venue disputes in Hatch-Waxman cases is still developing through district-court litigation. In one recent district-court case where Mylan, a West Virginia corporation, was sued for Hatch-Waxman infringement in Delaware, the district court found that Mylan's ANDA filing constituted an "act of infringement" under Section 1400(b) in Delaware—a state where Mylan would sell its generic product if approved—and allowed for BMS to take "venue-related discovery" regarding whether Mylan maintained a "regular and established place of business" in Delaware under the second prong of Section 1400(b).214 In the end, the plaintiff contended that it received insufficient discovery to address the second prong of Section 1400(b), and argued that Mylan "resides" in Delaware through the Delaware incorporation of one of its subsidiaries.215 That argument failed, and the district court dismissed the Delaware action, leaving the parties to litigate the same patent-infringement issues in a co-pending suit filed against Mylan in the Western District of West Virginia.216

TC Heartland and the uncertainty of its application to Hatch-Waxman cases further emphasizes the importance of innovators filing a "protective suit" in the state of incorporation for domestic Hatch-Waxman defendants within the 45-day window following receipt of a Paragraph IV Notice Letter from such defendants. Doing so preserves the 30-month stay of ANDA approval in case a suit brought by the innovator in their favored jurisdiction is dismissed for lack of venue or personal jurisdiction. Notably, the impact of TC Heartland has been to greatly increase the patent-infringement case load of jurisdictions where many parties tend to be incorporated, and in particular, the District of Delaware.217

[b] Claim Construction

As the Federal Circuit explained in its en banc decision Phillips v. AWH Corp., claim terms "are generally given their ordinary and customary meaning," that is, "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application."218 "Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification."219 "[T]he specification 'is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.'"220

The Federal Circuit in Phillips further explained that "[w]hen the specification describes a single embodiment to enable the invention, this court will not limit broader claim language to that single application unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction."221 "By the same token, the claims cannot enlarge what is patented beyond what the inventor has described as the invention."222

Moreover, "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs."223 "Even when guidance is not provided in explicit definitional format, the specification may define claim terms by implication such that the meaning may be found in or ascertained by a reading of the patent documents."224

"In other cases, the specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor. In that instance as well, the inventor has dictated the correct claim scope, and the inventor's intention, as expressed in the specification, is regarded as dispositive."225 "[W]hen the scope of the invention is clearly stated in the specification, and is described as the advantage and distinction of the invention, it is not necessary to disavow explicitly a different scope."226

A court can consider the patent's prosecution history if it is in evidence.227 The court may also consult "[e]xtrinsic evidence, which 'consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries and learned treatises."228 Ultimately, claim construction is an issue of law that the Federal Circuit reviews de novo, while any subsidiary factual findings supporting the construction are reviewed for clear error.229

[c] Experts

Patent cases under the Hatch-Waxman Act or the BPCIA almost always employ expert witnesses, typically including technical experts in the underlying technology of the patents-in-suit and the medical conditions addressed by the drugs at issue; and economics experts who can address issues regarding "commercial success" of the patented inventions and, if they arise, remedy issues such as damages or "irreparable harm" to support an injunction. Technical experts who are usually scientists with academic or job-related experience in the relevant art are used to define technical terms and industry jargon, and to explain the design, operation, and use of the patented inventions and infringing products. They can assist counsel confidentially in assessing strategic options and technical arguments, and submit expert reports and provide trial testimony to help the court understand the parties' competing positions on complex scientific issues. A qualified and well-prepared technical expert with excellent communication skill can make a patent attorney more agile and effective. Courts hearing Hatch-Waxman or BPCIA litigations also regularly rely upon the testimony of technical experts to guide...

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