Imagine a scenario where a branded pharmaceutical company holds U.S. patents claiming a process for making an active pharmaceutical ingredient, intermediates of the API, or the finished branded drug product. The process patents were not listed in the U.S. Food and Drug Administration's Orange Book. The branded pharmaceutical company did not prevail in the abbreviated new drug application litigation over the patents that were listed in the Orange Book. The generic challenger together with foreign manufacturers have plans for the sale of imported batches of the API, intermediates of the API, or finished generic drug products made by your company's patented process. This article examines whether a branded pharmaceutical company can (or should) use the U.S. International Trade Commission as a forum to block the importation of API, any intermediates of the API, or finished generic drug products in the context of Hatch-Waxman litigation.

The ITC as a Forum Option In Hatch-Waxman Matters

In light of the 30-month stay provision, innovators enforce their patent rights in federal district courts under the Hatch-Waxman Act rather than file a complaint at the ITC, since an ITC action will not trigger the 30-month stay. The ITC cannot replace the litigation scheme set up by the Hatch-Waxman Act for asserting Orange Book patents. However, non-Orange Book patents do not have the advantages provided by the Hatch-Waxman Act. The ITC can be an alternative forum by which innovator drug companies can protect products covered by non-Orange Book patents following the 30-month stay in Hatch-Waxman litigation.[1] A successful ITC action can result in an exclusion order that blocks importation of the product made by the allegedly infringing process.

Asserting Process Patents to Extend Brand Protection

Process patents are not asserted during ANDA litigation because they cannot be listed in the Orange Book and, thus, are not subject to a Paragraph IV certification under the Hatch-Waxman Act. After a branded pharmaceutical company has gone through the statutory litigation process outlined under the Hatch-Waxman Act and generics companies are not subject to the 30-month stay of the FDA's approval that branded pharmaceutical company is in the same position as any other patent litigant.

Asserting pharmaceutical process patents can be effective in extending the market value of a branded drug product. Foreign generic manufacturers often import into the U.S. pharmaceutical APIs, intermediates used to manufacture the API, and finished drug products. Where at least one generic company is offering for sale imported APIs or generic drug products made by an allegedly infringing process, an ITC exclusion order provides injunctive relief for the patent owner, which is usually the innovator drug company. To utilize the ITC, the innovator must establish (1) an unfair act or unfair method of competition (i.e., patent infringement); (2) an importation, sale for importation, or sale after importation of accused product made by the infringing process; and (3) a "domestic industry" related to the asserted process patents.

An innovator does not have to wait until the generic products are imported and distributed into the U.S. before initiating an ITC action. Section 337 of the Tariff Act declares unlawful the importation into the U.S., the sale for importation, or the sale within the U.S. after importation by the owner, importer, or consignee, of articles that are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable U.S.s patent.[2] The ITC has jurisdiction to prevent imminent irreparable damages to a patent owner. It is well established that the commission's jurisdiction is broad, and that Section 337 is a remedial statute, which authorizes the commission to prevent unfair acts in their incipiency.[3] In Certain Steel Rod Treating Apparatus and Components Thereof, Inv. No. 337-TA-97, the commission indicated that jurisdiction would lie where the imported article is either present in the U.S. or constructively present by virtue of its sale and imminent importation, and where the unfair acts related to the imported article are the subject-matter of an investigation. The relief given is prospective rather than retrospective.[4] Therefore, an innovator can initiate an exclusion action at the ITC to block the importation of an API, an intermediate used to manufacture the API, or the finished generic drug product upon establishing an intended sale for the importation of an infringing product in the U.S. by a foreign generic company.

When the process patent is found enforceable and infringed the ITC will issue exclusionary orders blocking the importation of all APIs, intermediates or finished generic drug product that are made by the infringing process. As a result, the innovator maintains protection of its branded drug product, which is particularly valuable when the innovator drug company does not prevail at the ANDA trial or in situations where the Orange Book listed patent may not be infringed or otherwise unenforceable.

Pharmaceutical companies are no strangers to the ITC. For example, in Certain Gemcitabine and Products Containing Same, before filing an ITC action, Eli Lilly went through the ANDA litigation process involving Orange Book-listed patents, but did not prevail in the district court action.[5] In an attempt to preserve its market share, Eli Lilly filed a complaint under Section 337 against the generic ANDA filer and other respondents, which included the foreign generic manufacturer and importers. Similarly, Merck filed an ITC action against 20 respondents to block importation of generic indomethacin alleging that the respondents' importation of indomethacin into the U.S. infringed on its process patent for making indole aliphatic acid derivates, which includes indomethacin.[6] And Marion Merrell Dow brought an ITC action against nine respondents alleging that the respondents' importation and sale of diltiazem hydrochloride and its preparations infringed its process patent on preparing benzothiazepine derivatives.[7]

The ITC vs. District Court

Jurisdiction and Discovery at the ITC

The ITC has jurisdiction over products imported by or on behalf of respondents. As a result, respondents can be subject to discovery, regardless of whether the respondents would be subject to personal jurisdiction in federal district court. The ITC provides advantages to parties seeking to obtain discovery from foreign API manufacturers and importers. The ITC allows complainants to obtain more than just documents from foreign manufacturers that are named as respondents. For example, the ITC can grant requests for plant inspections at foreign facilities in the course of ITC investigations, particularly when process patents are at issue.[8]

Defendant's Defenses Under 271(g) Are Not Available at the ITC

An importer of products made outside of the U.S. by a process that is patented in the U.S. may be liable for infringement, under 35 U.S.C. §271(g), which is adjudicated in federal district court. Allegations of violations of the trade statute of § 1337(a)(1)(B)(ii) are adjudicated before the ITC. A patent holder, therefore, may file a patent infringement suit for a product by process claims in either forum. However, there are defenses available, under § 271(g), in federal district courts that are not available in ITC actions under Section 337, which makes the ITC an attractive forum for patent owners.

With respect to district court actions, an imported product that is made by a patented process does not infringe if the imported product is (1) materially changed by subsequent processes or (2) becomes a trivial and nonessential component of another product. 25 U.S.C. § 271(g)(1)-(2). It is well settled, that the § 271(g)(1)-(2) defenses do not apply to ITC actions.[9] In the Process Patent Amendments of 1988, Congress made clear that the defenses set forth in §271(g)(1)-(2) would not apply to Section 337 investigations, which was confirmed by the Federal Circuit in Kinik Co. v. ITC, 362 F.3d 1359 (Fed. Cir. 2004).

Process Patent Exemption Under 271(g) For District Court Actions

For district court actions, Section 287(b) imposes limitations on remedies available against entities accused of infringement under § 271(g), such as the sellers or importers of an API or a finished drug product made by a patented process outside the U.S.[10] Section 287(b) requires the innovator drug company to identify all process patents owned or licensed as of the time of the request that the company reasonably believes could be asserted to be infringed under §271(g) if that drug product was imported into, sold or used in the U.S. by an unauthorized person. For district court actions, there are consequences for failing to comply, such as no liability for products already imported or in transit at the time of filing suit.[11] To avoid any forfeiture of remedies, process patents should be included in the marking of an innovator's drug products, which will also safeguard the innovator from having to comply with letter inquiries under § 287(b)(5). But Section 287 is applicable in ITC actions where remedy is an exclusion order and not monetary damages.

Asserting Method of Use Patents Under Suprema

The ITC can also be an alternative form in situations involving method patents allegedly infringed in a "carve-out" situation by an ANDA or 505(b)(2) challenger. Under Suprema v. ITC, the ITC's jurisdiction may extend to infringement that occurs after importation due to inducement on the part of the importer or the foreign manufacturer. The Federal Circuit held that articles that do not directly infringe until after they have been imported into the U.S. may nonetheless qualify as "article[s] ... that infringe," which can be excluded from entry by the ITC pursuant to 19 U.S.C. § 1337. Therefore, an innovative drug product that is protected by a method of treatment patent and that is faced with launched-at-risk by a generic challenger (or 505(b)(2) applicant) may be adjudicated before the ITC in cases where the generic drug is imported into the U.S and then prescribed by doctors or administered to patients post-importation. It should be recognized that alleging infringing acts of inducement might be harder to substantiate prior to product launch to support an ITC complaint, which typically may require documentary support to show the likelihood of infringement by the potential respondent(s).

Strategic Considerations

Timing is a key strategic consideration when contemplating the ITC as a forum in the context of Hatch-Waxman litigation. The pace of litigation at the ITC is faster than the pace of most district court actions. After an initial determination by the administrative law judge and a final determination by the commission, an ITC case is usually complete in 18 months. In most cases, it may be more advantageous to bring an ITC action towards the end of (or after) the 30-month stay, assuming the district court ANDA litigation is not moving in a favorable direction. Alternatively, an ITC action could be strategically employed after an unfavorable ruling by the district court in the related ANDA litigation.

Another strategic consideration is to bring an ITC action against foreign parties involved in allegedly infringing acts who are not parties in the related district court ANDA litigation. The ITC has no restrictions on naming unrelated defendants, which provides a potential forum for innovator drug companies interested in stopping infringement by other parties (e.g., an API manufacturer or drug master filer holder).

Strategic considerations should also include an assessment of non-Orange Book listed patents claiming a process for making an API, intermediates of the API, or the finished branded drug product and various crystalline forms of the API as well as methods of use patent that may be susceptible to a "carveout."
With high research and development costs and a restricted window of market exclusivity, innovator drug companies should consider the enforceability of non-Orange Book patents as a way to maximize market share of branded drug products. Enforcing process patents and other non-Orange Book patents via an ITC action creates an opportunity for the innovator drug company to maximize brand protection. In addition, this strategy may generate royalties from the imported sales of generic APIs or drug products through favorable settlement agreements with foreign generic API manufacturers and importers.

[1] The Hatch-Waxman Act allows branded drug companies to sue ANDA filers for patent infringement in federal district courts over any Orange Book patent that is the subject of a Paragraph IV certification, is before the generic markets or sells the accused drug product. 21 U.S.C. § 355(j)(5)(B)(iii); 35 U.S.C. § 271(e)(2)(A). The filing of a suit within the statutory timeframe triggers a mandatory 30-month stay of final approval by the FDA of the accused ANDA, thereby preserving the branded drug product's exclusivity during the pendency of the lawsuit.

[2] See 19 U.S.C. § 1337(a)(1)(B)(ii).

[3] See Certain Low-Nitrosamine Trifluralin Herbicides, Inv. No. 337-TA-245, Order No. 23, 1986 WL 379441, *2 (Sept. 4, 1986); see also Certain Apparatus for the Continuous Production of Copper Rod., Inv. No. 337-TA-89, 214 U.S.P.Q. 892, 895 (1980).

[4] See Certain Low-Nitrosamine Trifluralin Herbicides, Order No. 23, Sept. 4, 1986 (citing Certain Steel Rod Treating Apparatus and Components Thereof, Inv. No. 337-TA-97.

[5] See Certain Gemcitabine and Products Containing Same, Inv. No. 337-TA-766 (filed Jan. 20, 2011).

[6] See Certain Indomethacin, 337-TA-183 (filed July 21, 1983).

[7] See Certain Diltiazem Hydrochloride and Diltiazem Preparations, 337-TA-349 (filed, Feb. 27, 1995).

[8] See 19 C.F.R. § 210.30.

[9] See Kinik Co. v. ITC, 362 F.3d 1359 (Fed. Cir. 2004); see also, Certain Sucralose, Sweeteners Containing Sucralose, and Related Intermediate Compounds Thereof, Inv. No. 337-TA-604.

[10] In part, 35 U.S.C. § 287(b)(4), states: a "request for disclosure" means a written request made to a person then engaged in the manufacture of a product to identify all process patents owned by or licensed to that person, as of the time of the request, that the person then reasonably believes could be asserted to be infringed under section 271(g) if that product were imported into, or sold, offered for sale, or used in, the U.S. by an unauthorized person.

[11] Section 287(b)(2) states: No remedies for infringement under section 271(g) shall be available with respect to any product in the possession of, or in transit to, the person subject to liability under such section before that person had notice of infringement with respect to that product.

Reprinted with permission from Law360(c) 2017 Portfolio Media. Further duplication without permission is prohibited. All rights reserved.