10.13 Selected topics
10.13.1 Standard-essential patents and FRAND licensing enforcement
As a way of aiding the development, adoption, and advancement of a growing range of network technologies, standard-setting organizations (SSOs) bring together engineers from multiple enterprises and universities to develop industry-wide technical standards. Participants in the standard-setting processes commit to making their patented technologies available to others on FRAND terms. Such projects are commonly pursued in the digital technology industries, where they have facilitated joint innovation and product development. For antitrust and other business reasons, these consortia rarely establish licensing rates. In addition, they do not always specify which patents are covered. The emergence of standard-essential patents (SEPs) and related contractual commitments to license such patents on FRAND terms over the past decade has spawned a complex set of patent-related cases with distinctive case management aspects.
10.13.1.1 FRAND rate-setting litigation
Standards implementers who have not been able to work out a licensing agreement with SEP owners can file declaratory judgment breach of contract actions asserting that the SEP owners have breached their FRAND obligations by not offering the implementers FRAND licensing rates.376 The implementers have standing to bring such actions as third-party beneficiaries of the SEP consortium. The SEP owner will typically counterclaim for patent infringement. The counterclaim brings the litigation within the appellate purview of the Federal Circuit, although it is obliged to apply regional circuit contract law. If no patent counterclaim is asserted, the contract-based cause of action is reviewable in the regional circuit court covering the district court handling the litigation.
10.13.1.2 Anti-suit injunction litigation
Global battles over SEPs and FRAND rate-setting have international forum shopping. Companies have sought to establish global FRAND rates by seeking so-called anti-suit injunctions barring a defendant from commencing or requiring that they cease to pursue parallel litigation regarding the FRAND dispute.
Thus far, U.S. courts have resisted efforts to impose such restraints on U.S. litigation. Several months after Microsoft filed a declaratory relief action against Motorola seeking to set a worldwide FRAND rate for two SEPs, Motorola filed an action in Germany alleging that Microsoft infringed German patents covered by the same contractual FRAND commitments at issue in the U.S. case. After the German court issued an injunction prohibiting Microsoft from infringing Motorola’s German patents, the U.S. district court prohibited Motorola from enforcing that injunction.377 The district court reasoned that the FRAND commitment required Motorola to license its SEPs on a “worldwide basis.” Since the U.S. court was charged with determining the parties’ worldwide rights, it was also responsible for deciding whether injunctive relief was allowed under the FRAND agreement. The court concluded that enforcing the German injunction would frustrate the district court’s ability to adjudicate the issues properly before it.
In another controversy, a U.S. court repelled an effort by a foreign court to enjoin U.S. patent enforcement and rate-setting.378 After negotiations between Samsung and Ericsson over the renewal of their global patent cross-licensing agreement broke down in 2020, Samsung filed a suit in China asking the court to determine the global licensing terms in accordance with the applicable FRAND agreement. Samsung neglected to provide notice to Ericsson of the Chinese action. Upon learning of the filing, Ericsson filed a parallel action in the Eastern District of Texas on December 11, 2020. Three days later, Samsung requested the Chinese court to issue an anti-suit injunction, which the Chinese court granted on December 25, 2020. On December 28, 2020, Ericsson sought a TRO in the Eastern District of Texas prohibiting Samsung from enforcing the anti-suit injunction issued by the Chinese court. Concluding that the anti-suit injunction would be vexatious or oppressive, the Eastern District of Texas granted Ericsson’s request for an anti-anti-suit (or anti-interference) injunction to prevent Samsung from attempting to enforce the Chinese anti-suit injunction and thereby interfering with the Eastern District of Texas’s exercise of its own jurisdiction.379
10.13.2 Pharmaceutical patent case management
The interplay of the regulation of pharmaceutical products by the FDA and litigation related to those products creates a distinctive patent case management regime for pharmaceutical patent cases. The differences arise primarily from the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (known as the Hatch-Waxman Act). In the Hatch-Waxman Act, Congress sought to streamline two related processes: (1) FDA marketing approval of generic small molecule pharmaceutical products, and (2) competition between generic drug manufacturers and pioneering drug manufacturers over the marketed small molecule drugs.
The Hatch-Waxman Act covers drug products with small molecule active ingredients. In 2010, Congress supplemented this legislation with the BPCIA to provide a similar litigation scheme to expedite the entry of generic versions of larger molecule, “biologic” drug products (called “biosimilars”).
10.13.2.1 Hatch-Waxman Act (ANDA) litigation
To understand pharmaceutical patent case management, it is important to begin with a description of the Hatch-Waxman statutory framework. We will then explore how this regime structures patent infringement litigation, the distinctive patent case management elements, and the unique competition issues that arise from settlement of such cases.
10.13.2.1.1 The Hatch-Waxman Act’s statutory framework
Prior to the passage of the Hatch-Waxman Act, a generic drug manufacturer had to obtain FDA marketing approval for its generic product before challenging patents encompassing a pioneering drug product. Obtaining this marketing approval required generic companies to generate data and complete clinical trials on their generic products, but there was little incentive for these companies to do so because, typically, they could not obtain patent protection for their products. The FDA approval process extended the effective term of patents encompassing a pioneering drug product for several years after the expiration of the patents, as generic companies had to manufacture or sell their generic drug products to create the basis for federal jurisdiction to adjudicate the validity, enforceability, and scope of the patents covering the pioneering drug.
The Hatch-Waxman Act established a framework to coordinate both FDA approval and adjudication of patent rights for generic versions of pioneering drugs covered by patents.380 In particular, the Hatch-Waxman Act provides a route for expediting litigation of patent validity and infringement issues related to generic drugs, thereby aiding generic drug manufacturers in marketing their noninfringing drug products sooner (and aiding consumers in obtaining cheaper drug products where patent protection does not block such marketing).
Table 10.5 shows the key dates and steps for Hatch-Waxman litigation.
|The FDA accepts generic’s ANDA for review||Trigger litigation||The generic company’s ANDA must be accepted for review before litigation can commence.|
|Within 20 days||Paragraph IV notice letter||Generic provides NDA holder with notice that it has filed a Paragraph IV certification, detailed statement(s).1|
|Within 45 days||Filing of complaint||NDA holder must file complaint within 45 days of receipt of Paragraph IV notice letter to receive an automatic 30-month stay of FDA approval for the generic product.2|
|30 months after filing of complaint||30-month stay of FDA approval of ANDA expires||30-month stay of FDA approval expires if stay has not already been lifted due to completion of litigation.3 If litigation is still pending, once ANDA is approved, generic can launch its product at risk.|
|After FDA approval of first filer’s ANDA||180-day marketing exclusivity||If patent challenge succeeds, first ANDA filer enjoys 180 days of marketing exclusivity.|
Note: FDA = Food and Drug Administration; ANDA = Abbreviated New Drug Application; NDA = New Drug Application.
1 21 U.S.C. § 355(j)(2)(B)(iv)(II); see 21 C.F.R. 314.95(c)(6).
2 21 U.S.C. § 355(j)(5)(B)(iii).
3 21 U.S.C. § 355(j)(5)(B)(iv).
10.13.2.1.2 Submission of NDAs (pioneering) and ANDAs (generic) to the FDA
Prior to marketing a new drug, a pioneering pharmaceutical company must submit a new drug application (NDA) to the FDA. The NDA must demonstrate the safety and efficacy of the proposed drug, usually through extensive testing data from a series of human clinical trials.381
One of the key features of the Hatch-Waxman Act is that generic drug companies can enter the market at the earliest possible time through a potentially shortened and cheaper regulatory approval process for generic drugs. The ANDA applicant (i.e., the generic competitor) is not required to conduct independent human clinical trials or other testing to establish the safety and efficacy of its product; instead, it must demonstrate that its product is “bioequivalent” to the pioneering drug.382 The testing required to demonstrate bioequivalence is usually significantly less onerous and expensive than that required to demonstrate safety and efficacy of a new drug.
10.13.2.1.3 Obtaining patent certainty: ANDAs and Paragraph IV certifications
Before the FDA will approve an ANDA, the ANDA filer must demonstrate that its generic drug will not infringe valid patents covering the equivalent pioneering drug. To facilitate this, the Hatch-Waxman Act requires that a pioneering drug company’s NDA must disclose all patents that cover the drug or a method of using the drug in a manner encompassed by the NDA.383
Under the Hatch-Waxman Act, ANDA filers are required to make particular certifications with respect to each patent listed in the Orange Book that covers a pioneering drug product. Specifically, the ANDA filer must certify one of the following for each Orange Book–listed patent:
- (i) that the [NDA-required] patent information has not been filed;
- (ii) that such patent has expired;
- (iii) the date on which such patent will expire; or
- (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the [ANDA] is submitted.384
The final certification listed above, that an Orange Book–listed patent is invalid or not infringed, is commonly known as a “Paragraph IV certification.” To support a Paragraph IV certification, the ANDA filer must provide to the NDA holder “a detailed statement of the factual and legal basis for the opinion of the applicant that the patent is invalid or will not be infringed” or is unenforceable to both the patent owner and the NDA holder.385 A Paragraph IV certification is the only mechanism by which an ANDA filer can obtain FDA approval to market a generic version of a listed drug for a patented use prior to expiration or invalidation of an Orange Book–listed patent.386
10.13.2.1.4 Patent infringement suits under the Hatch-Waxman Act
One of the most important and innovative features of the Hatch-Waxman Act is the way that it facilitates resolution over patent rights of drug patents.
10.13.2.1.4.1 Filing of an ANDA that challenges an NDA holder’s patent rights is a statutorily-created act of infringement conferring jurisdiction to sue
The Hatch-Waxman Act provides for the resolution of pioneering drug patent rights by treating the act of filing an ANDA that challenges an NDA holder’s patent rights as a statutorily-created act of infringement that “enables the judicial adjudication” of claims for infringement and patent invalidity even though the generic company has not actually marketed its generic product.387 Filing of an ANDA with a Paragraph IV certification thus allows the NDA holder to initiate an infringement suit before the generic manufacturer sells its drug product.388
The filing of an ANDA establishes jurisdiction in district court for a patent litigation under 35 U.S.C. § 271(e), but the act of filing the ANDA itself does not mean that the generic product described in the ANDA will actually infringe one or more of the listed patents once sold. The NDA holder bears the burden to establish actual infringement of the patent claims at issue.389 In some cases, the drug described in the ANDA will meet every claim limitation at issue but, where the ANDA’s description does not establish infringement, the Federal Circuit has endorsed the use of evidence such as testing of the final generic product that complies with the description in the ANDA (in Ferring, tests submitted to the FDA).390
10.13.2.1.4.2 Timing considerations for litigation and stays
Hatch-Waxman litigation differs from the other types of patent litigation previously discussed in that an action of the defendant to the suit – the filing of an ANDA by the generic drug company – triggers the litigation and dictates the timing of the lawsuit. To trigger this process, the ANDA filer is required to notify the NDA holder that it has filed a Paragraph IV certification within 20 days after the FDA accepts the ANDA for review. Typically, this notice takes the form of a letter (a Paragraph IV notice letter) in which the ANDA filer sets forth the detailed statement of the generic company’s basis for believing that the Orange Book–listed patents are invalid or not infringed. The NDA holder’s receipt of the Paragraph IV notice letter begins a 45-day period in which the NDA holder evaluates the claims and decides whether to file suit against the ANDA filer. If the NDA holder files an infringement action within this 45-day period, then the FDA may not grant final approval of the generic company’s ANDA for 30 months, or until the case is finally resolved. The FDA may grant “tentative” approval of an ANDA during this 30-month stay period, but such approval does not become “final” (and thus allow for actual marketing of the generic drug) unless, prior to the end of the 30-month period, all relevant patents expire, the ANDA filer receives a favorable district court or Federal Circuit judgment, or the parties settle the lawsuit and agree that the ANDA filer’s marketing of its generic drug product can begin.391
When litigation extends beyond the 30-month stay, the ANDA holder may elect to launch their competing generic product “at-risk,” even though it risks infringement of the drug patent(s). To prevent an at-risk launch, the NDA holder will often request a preliminary injunction. The prospect of launching at-risk changes the nature of an ANDA case, because post-launch damages will be available to the NDA holder, and the eventual trial could occur before a jury (as opposed to most ANDA cases, which are tried before a judge).
10.13.2.1.4.3 First ANDA filer’s 180-day exclusive marketing period
The Hatch-Waxman Act provides a significant incentive to generic drug manufacturers to challenge applicable patents held by the NDA holder: if the patent challenge succeeds, the first ANDA filer receives a 180-day market exclusivity period following FDA approval of the ANDA. During this period, only the first ANDA filer, the NDA holder, and companies licensed by the NDA holder may market their competitor drugs, and later-filed ANDAs cannot be finally approved until this exclusivity period has ended.392
For ANDAs filed after December 8, 2003, the first Paragraph IV ANDA filer’s marketing of its generic drug product is the only required trigger for the exclusivity period.393
10.13.2.1.4.4 Available remedies in ANDA litigation
Suits under the Hatch-Waxman Act usually do not involve damages.394 Thus, there is typically no right to a jury trial.395 Where an ANDA filer elects to launch at-risk after the 30-month stay has elapsed but before the litigation has concluded, damages may be available to the NDA holder (and the case can be tried before a jury).
In many circumstances, courts may only provide a declaratory judgment at the conclusion of a Hatch-Waxman litigation. Where the NDA holder wins and the patent is declared valid and infringed, the FDA will not grant final approval to the ANDA until the patent expires. If the district court judgment comes after the expiration of the 30-month stay and the ANDA filer has begun marketing its drug in an at-risk launch, the FDA will revoke its final approval, which precludes further sales. Although the FDA’s revocation of the ANDA’s final approval precludes the sale of the ANDA filer’s drug, some courts will also grant an injunction.396
Where the ANDA applicant wins the district court case, the remaining portion of the 30-month stay is terminated upon entry of the judgment and, typically, the FDA will convert its tentative approval of the ANDA to a final approval, allowing the drug to be marketed.397 Where the ANDA filer begins marketing after receiving FDA approval at the end of a 30-month stay before a district court judgment has been rendered, and the district court subsequently finds infringement of a valid patent, injunctive relief and damages apply. The same is true where the Federal Circuit reverses the district court judgment after the ANDA filer has begun marketing its drug.
10.13.2.1.5 Case management considerations for Hatch-Waxman litigation
Beyond the distinctive posture and structuring of ANDA patent litigation, courts deal with a variety of case management decisions ranging from personal jurisdiction and venue to scheduling and trial management.
10.13.2.1.5.1 Personal jurisdiction and venue in Hatch-Waxman cases
The relevant personal jurisdiction and venue considerations in Hatch-Waxman cases differ from those present in other types of patent litigation, as the act of infringement that triggers the jurisdictional and venue question are tied to the planned future acts of the generic filer, not already-committed acts of infringement.
On personal jurisdiction, the Federal Circuit has ruled that submission of an ANDA with the intention to direct sales of a generic drug into a particular state provides sufficient minimum contacts to give rise to specific personal jurisdiction.398 Under this ruling, a generic drug manufacturer is subject to specific personal jurisdiction in any state in which it intends to market its generic drug.
The significance of this holding was restricted significantly in light of the Supreme Court’s ruling in TC Heartland LLC v. Kraft Foods Group Brands LLC399 and later decisions from the Federal Circuit on venue in ANDA cases. TC Heartland reaffirmed that 28 U.S.C. § 1400(b) is the sole provision controlling venue in patent infringement actions. Thus, venue is proper for a generic drug manufacturer sued for patent infringement in two sets of judicial districts: (1) districts in the state of the generic manufacturer’s incorporation, and (2) districts in which (a) the corporation has a regular and established place of business and (b) an act of infringement has occurred (see Section 10.6.3).
As the “act of infringement” in ANDA cases is the submission of the ANDA, which occurs before marketing or sale of the generic drug, the Federal Circuit has clarified that venue in ANDA cases “must be predicated on past acts of infringement – i.e., acts that occurred before the action alleging infringement was filed [… I]t is the submission of the ANDA, and only the submission, that constitutes an act of infringement in this context.”400 The Federal Circuit functionally limited the personal jurisdiction holding of Acorda by limiting the number of venues in which the suit could be brought under the venue analysis, making clear that venue does not extend to districts solely where the future marketing of the generic product described in the ANDA may be intended, which was permissible from a jurisdiction perspective under the earlier Acorda decision.401 Valeant did not foreclose establishing venue at the generic filer’s place of incorporation, nor did this decision disturb precedent as to establishing venue where a generic filer has its principal place of business.402
Historically, the majority of ANDA cases have been filed in New Jersey or Delaware, as a large number of generic manufacturers are incorporated in Delaware or have a regular and established place of business in New Jersey. Plaintiffs in multi-defendant ANDA cases often seek to consolidate the various cases into a single jurisdiction, largely for efficiency, the convenience of parties and witnesses, and judicial economy purposes. Plaintiffs often will file protective suits in multiple jurisdictions while attempting to consolidate the litigation. Plaintiffs may seek consolidation through several potential mechanisms, including where defendants consent to jurisdiction and venue in a district, and through the Judicial Panel on Multidistrict Litigation, which consolidates two or more cases for pre-trial proceedings where there are common questions of fact. Foreign ANDA filers may be sued in any judicial district.403
10.13.2.1.5.2 Scheduling considerations and timing of judgment
The parties to a Hatch-Waxman litigation usually have more information available to them at the start of a case than is typical in a patent suit because of the ANDA filer’s required disclosures in the Paragraph IV certification, which enumerate the factual and legal basis for its invalidity, unenforceability, and/or noninfringement opinions.404 Further, NDA holders have had notice of the ANDA holder’s contentions, usually for 45 days before filing suit. Given these early disclosures and notice, courts can encourage quicker resolution of cases and issues by setting expedited case schedules and by requiring the early exchange of invalidity and noninfringement positions. This is important from a case management perspective because NDA holders have strong motivation to delay resolution until after the 30-month stay expires, to delay market entry of the first ANDA filer (as well as subsequent ANDA filers) and extend the NDA holder’s monopoly. First ANDA filers may not oppose this delay in some situations, as the ANDA filer will want to delay the start of any exclusivity period it enjoys until it is prepared to market its drug. Subsequent ANDA filers, conversely, nearly always want a speedy resolution of litigation, so that they can enter the market more quickly. In a litigation between an NDA holder and the first ANDA filer, both parties may be uninterested in early resolution, and the court will need to manage the litigation accordingly.
Courts can also directly combat attempts by the parties to delay litigation. The Hatch-Waxman Act explicitly grants courts the discretion to adjust the 30-month stay period based on the parties’ conduct during litigation, although this is uncommon.405
10.13.2.1.5.3 Order of case presentation at trial
Although the patent owner typically is the plaintiff in an ANDA case, the generic drug company defendant will often bear the burden of proof because ANDA cases typically focus on the invalidity or unenforceability of the patent owner’s patents rather than the generic company’s noninfringement of the patents in suit. As noted above, the ANDA applicant’s generic drug and associated label must be identical to the NDA holder’s drug and label and, thus, a patent that covers the NDA holder’s drug likely also covers the ANDA drug product. In cases where invalidity, unenforceability, or both are the sole issues in a suit, courts typically reverse the order of proof at trial.
10.13.2.1.5.4 Local patent rules and scheduling orders in ANDA cases
As discussed in Section 10.6.6.1, numerous district courts with significant patent dockets have developed specialized local rules (i.e., PLRs) to facilitate early case management of patent cases. Several courts have adopted PLRs specific to Hatch-Waxman litigation.406 Generally, these rules recognize that Hatch-Waxman litigants possess different levels of knowledge early in the case, and therefore reverse the typical order and timing for the disclosure of infringement and invalidity contentions. The plaintiff in a Hatch-Waxman action may have very little knowledge about the defendant’s generic drug, beyond what must be included in the Paragraph IV certification (the generic is bioequivalent, has the same dosage, and uses the same route of administration). Conversely, the defendant in a Hatch-Waxman case has controlled the timing and scope of litigation through its ANDA filing and has already prepared a “detailed statement of the factual and legal basis for the opinion of the applicant that the patent is invalid or will not be infringed” or is unenforceable, as part of its Paragraph IV certification.407 As such, ANDA local patent rules typically require the defendant to provide its invalidity contentions first.408The local patent rules in New Jersey require the ANDA defendant to provide any noninfringement contentions at the same time as disclosure of the invalidity contentions;409 the plaintiff is required to provide its infringement contentions 45 days later.410 In addition, New Jersey Local Patent Rule 3.6(j) amends the disclosure requirements for Hatch-Waxman cases. Parties with pending ANDAs that form the basis for a litigation must notify the FDA of motions for injunctive relief no later than three business days after filing the motion. These parties must also provide a copy of correspondence between the FDA and any party regarding the ANDA to each party bringing an infringement claim, or they must “set forth the basis of any claim of privilege” for the correspondence, no later than seven days after receiving or sending correspondence. This rule is intended to aid in the coordination of FDA proceedings and district court litigation, and to avoid discovery issues about the production of FDA correspondence during litigation proceedings.
Apart from these changes in the disclosure order and times, ANDA cases are subject to the remaining local patent rules in New Jersey. The ANDA rules, for example, are silent with regard to the order of proof at trial.
The District of Delaware has not adopted district-wide local patent rules; instead, each judge has developed specific practices to manage patent cases, although some judges have ANDA-specific scheduling orders. Generally, in Delaware, plaintiffs file infringement contentions, while defendants file invalidity contentions. Responses to these contentions are issued through interrogatories. Summary judgment motions are generally not permitted in ANDA cases in Delaware absent agreement between the parties or leave from the court.
10.13.2.1.6 Settlement of Hatch-Waxman lawsuits: antitrust constraints
The relative risk assessment for parties engaged in Hatch-Waxman litigation differs significantly from that in other patent cases. Although the NDA holder benefits from the 30-month stay on FDA approval of the ANDA through litigation, the NDA holder faces the risk of having its patents invalidated in litigation, yet it usually cannot seek damages because the generic company has not sold a competing drug product. ANDA holders, conversely, can benefit greatly from litigation if they can enter the market before the expiration of the Orange Book–listed patents with a period of market exclusivity and, even in the worst-case scenario, are no worse off than they were before litigation (except for the cost of the litigation itself).
In addition, both NDA filers and first ANDA filers have economic incentives to settle litigation in ways that may delay consumer access to cheaper generic drugs. NDA filers may seek to avoid the first ANDA filer’s market entry, both to delay market entry by all later-filing generics (by delaying the start of the first filer’s 180-day exclusivity period) and to avoid the risk of a finding of patent invalidation or noninfringement in litigation. And, if a first ANDA filer is not prepared to market its proposed product, it may also favor delay of market entry so that it can take advantage of the full 180-day exclusivity period.
In light of these incentives, in the 1990s, NDA holders and first ANDA filers began entering into “reverse payment” or “pay for delay” settlements – in these settlements, the NDA filer makes a payment of cash or other incentives to the first ANDA filer, in exchange for the ANDA filer’s promise to not enter the market for a negotiated period of time. Reverse payment settlements allow the NDA holder to guarantee market exclusivity for a period of time, regardless of the merits of the patents-in-suit. And, the first ANDA filer also wins, as it receives payment to delay its entry onto the market yet still retains the 180-day exclusivity period once it enters the market. Entry of later-filed ANDA holders onto the market is also delayed by these settlements, which in effect extend the period of exclusivity for the NDA holder.
In 2013, the Supreme Court found that reverse payment settlements were not always presumptively unlawful but may be anticompetitive in some circumstances.411 The Court ordered lower courts to apply a modified “rule-of-reason” antitrust analysis to determine whether specific settlements were, in fact, anticompetitive, where the plaintiff must show that the reverse payment settlement is intended to restrain or harm competition, that an actual injury to competition has occurred, and that the restraint or harm from the agreement is “unreasonable.”412
Since Actavis, both plaintiffs’ groups and the U.S. Federal Trade Commission have actively challenged various reverse payment settlements as anticompetitive in the lower courts. In addition, the antitrust law of U.S. states can also be applied to analyze reverse payment settlements. California has been active in this space, passing Assembly Bill 824 in 2019, a law which explicitly prohibits reverse payment settlements. In December 2021, the Eastern District of California preliminarily enjoined the enforcement of Assembly Bill 824 on the ground that the legislation discriminates against or excessively burdens interstate commerce.413
10.13.2.2 BPCIA litigation
The Hatch-Waxman Act governs the regulation and patent litigation related to small molecule drugs, typically synthesized from chemicals in a laboratory. Many drugs sold on the market today, however, are instead produced by living cells that have been genetically engineered to manufacture the drug or extracted from those cells. These drugs are called “biological products” or biologic drugs, and “generic” versions of these products are called “biosimilars.”414 A “biosimilar” is a biological product that is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and for which “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”415 A biosimilar product exists only in relation to a “reference product” (manufactured by a “reference product sponsor” [RPS]), an already-approved biological product against which the biosimilar is evaluated by the FDA.416
The development of biosimilar products requires the investment of significantly more resources than the development of small molecule generic drug products. Biosimilar applicants typically must provide data from large clinical trials to compare the efficacy of the biosimilar product to the reference product. These trials typically cost orders of magnitude more to conduct than the bioequivalence trials required for ANDA applicants. In addition, the cost and technical difficulty associated with manufacturing biological drug products (and their biosimilar competitors) are also substantially greater than those for generic small molecule drugs.
Until 2010 and the passage of the BPCIA, there was no mechanism for the FDA to approve biosimilar drug products seeking to compete with reference products. The BPCIA provides “processes both for obtaining FDA approval of biosimilars and for resolving patent disputes between manufacturers of licensed biologics and manufacturers of biosimilars.”417 The Supreme Court has recognized that this statutory scheme creating these regulatory and litigation processes is “complex.”418
The expense and other technical challenges in developing biosimilar products shape U.S. biosimilar litigation in several ways. In particular, the costs involved in biosimilar development have meant that there are no “small” biosimilar cases – typically, only products that generate billions of dollars in sales are the subject of litigation. Given these stakes, the parties are heavily motivated to dispute all potential issues in the case, which heavily burdens the court’s resources.
10.13.2.2.1 Food and Drug Administration application pathway and exclusivities for biosimilars
As with regulatory approvals under the Hatch-Waxman Act, the regulatory pathway for approval of biosimilar applications under the BPCIA has a significant impact on the course of patent litigation that occur under the statute. To obtain marketing approval for a biologic drug product, a pioneering company submits a biologic license application (BLA) with the FDA, analogous to the filing of an NDA in the Hatch-Waxman context. The BLA typically contains extensive data demonstrating that the proposed product is “safe, pure, and potent,” among other requirements.419 After approval of the pioneering company’s BLA, the approved drug is referred to as the “reference product” for purposes of subsequent biosimilar filings.
The BPCIA outlines an abbreviated route for FDA approval of biosimilar products. Under this route, the biosimilar manufacturer files an abbreviated biologic license application (aBLA) with the FDA. Applicants for aBLAs are permitted to rely on the approval of the reference product’s BLA (and the clinical trial data therein, demonstrating safety, purity, and potency), so long as the biosimilar manufacturer demonstrates that its product is “highly similar” to the reference product and that there are no “clinically meaningful differences” between the two in terms of safety, purity, and potency.420 Biosimilar manufacturers with products approved as “biosimilar” are not entitled to exclusivity as against other biosimilar manufacturers under the BPCIA.
10.13.2.2.2 Overview of BPCIA litigation procedures
RPSs typically hold multiple patents covering the biologic drug itself, use of that drug for medical treatment, and the drug’s manufacturing processes. The BPCIA provides a framework for patent litigation related to these patents prior to the biosimilar’s FDA approval, even if the biosimilar applicant has not yet taken an action that would traditionally constitute patent infringement, by making the submission of the aBLA an act of infringement.421
The BPCIA statute outlines several stages of pre-litigation exchanges (often called the “patent dance”), intended to force the parties to develop and test their contentions early, and to identify critical issues prior to litigation. First, the biosimilar applicant provides its application and information on its manufacturing process to the RPS (subject to default statutory confidentiality provisions). The parties then engage in detailed exchanges related to patents that may cover the biosimilar product, identifying the parties’ contentions as to the infringement, validity, and enforceability of these patents. The parties then identify a set of patents for a first phase of litigation – any remaining patents may be litigated in a second phase of litigation. These exchanges dictate the timing of the litigation and, as explained further below, the remedies that the RPS may seek.
The Federal Circuit has held that the BPCIA’s prelitigation procedures are not mandatory, however.422 Therefore, the biosimilar applicant can decline to participate in these exchanges. If the biosimilar applicant declines to participate, however, the RPS may immediately bring an infringement suit against the biosimilar applicant.423
|The FDA||The FDA accepts the biosimilar’s aBLA for review.|
|Within 20 days||Biosimilar applicant||The biosimilar applicant provides the aBLA and manufacturing information to the RPS.1|
|Within 60 days||RPS||The RPS discloses a list of patents that it may assert in litigation to the biosimilar applicant and identifies which patents it is willing to license to the applicant.2|
|Within 60 days||Biosimilar applicant||The biosimilar applicant discloses a list of other patents it believes should be included in litigation to the RPS, and identifies which patents it is willing to license. For each listed patent, the biosimilar applicant must provide a detailed statement or indicate it does not intend to market the biosimilar before expiration.3|
|Within 60 days||RPS||The RPS responds to the biosimilar applicant’s detailed statement(s).4|
|Both the RPS and the biosimilar applicant||Parties begin negotiation on a list of patents for immediate infringement action.5|
Note: FDA = Food and Drug Administration; aBLA = abbreviated biologic license application; RPS = reference product sponsor. Timeline is from the date the aBLA is accepted for review.
1 42 U.S.C. § 262(l)(2).
2 42 U.S.C. § 262(l)(3)(A). Throughout this process, the reference product sponsor shall supplement its patent list with any later-issued or licensed patents no later than 30 days from the issuance or licensing, or it may not assert those patents in the litigation proceeding. 42 U.S.C. § 262(l)(7).
3 42 U.S.C. § 262(l)(3)(B).
4 42 U.S.C. § 262(l)(3)(C).
5 42 U.S.C. § 262(l)(4).
|Within 15 days from the start of negotiation||Both the RPS and the biosimilar applicant||
||If the parties reach agreement after 15 days of negotiation, the RPS must file complaint within 30 days.1 First phase of patent litigation commences.|
|Within 5 days||Both the RPS and biosimilar applicant||Parties simultaneously exchange patent lists.3 The RPS may not list more patents than the biosimilar applicant.|
|Within 30 days||RPS||The first phase of patent litigation commences upon filing of complaint against the biosimilar applicant, on patents listed by both parties.4|
Note: RPS = reference product sponsor.
1 42 U.S.C. § 262(l)(6).
2 42 U.S.C. § 262(l)(5).
3 42 U.S.C. § 262(l)(5)(a).
4 42 U.S.C. § 262(l)(6).
|The FDA||The FDA approves the abbreviated biologic license application (if RPS market exclusivity has expired).|
|At least 180 days before beginning marketing of the biosimilar drug product||Biosimilar applicant||The biosimilar applicant provides notice to the RPS no later than 180 days before the date of first commercial marketing.1 The biosimilar applicant does not need to wait until the FDA approves the biosimilar before providing notice.2|
|Immediately (or within 6 months)||RPS||After receiving notice of commercial marketing, the RPS may seek a preliminary injunction on any patent listed on its initial § 262 (l)(3) list exchanged during the patent dance (or any patent under § 262(l)(7) later) that was not included in the first phase of litigation.3|
Note: FDA = Food and Drug Administration; RPS = reference product sponsor.
1 42 U.S.C. § 262(l)(8)(A).
2 Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1677 (2017).
3 42 U.S.C. § 262(l)(8)(B).
10.13.2.2.2.1 Remedies available in BPCIA litigation
Injunctive relief is available where a patent was included on any of the lists prepared to identify patents for the first stage of litigation, and the RPS filed suit on the patent within 30 days of the production of the lists. It is mandatory where there has been a final court decision on infringement and validity, and the exclusivity period for the reference product has not yet expired. If the patent owner fails to bring suit within 30 days on a patent included in the separate or agreed lists for litigation, the patent owner may only seek a reasonable royalty as to those patents, and injunctive relief is not available.424 Likewise, only a reasonable royalty may be recovered if an action on such patents was dismissed without prejudice or was not prosecuted in good faith.425 Where a biosimilar applicant has launched its biosimilar product at-risk prior to the conclusion of litigation, damages or other monetary relief may be available.426
To encourage the parties to a BPCIA dispute to comply with the statutorily-outlined exchanges and framework, the BPCIA includes consequences for each of the parties if they fail to engage with the procedural requirements. As discussed above, if the RPS fails to include a patent in its initial list, suit by the patent owner on that patent is barred.427 In addition, suit is barred on a later-issued or later-licensed patent if it is not added within 30 days.428 Where a biosimilar applicant fails to provide its aBLA and manufacturing information to the RPS, the parties do not engage in the exchanges outlined above. The RPS (but not the applicant) may immediately bring a declaratory judgment action, directed to infringement, validity, and/or enforceability of any patent that claims the biological product or a use of the product.429 And, where the biosimilar applicant provides its aBLA and manufacturing information but fails to complete a later exchange in the process, the RPS may bring a declaratory judgment action with respect to any patent listed on the RPS’s initial list (and later-issued and later-acquired patents).430