[author: Donald Zuhn]
In February, the U.S. Patent and Trademark Office announced the establishment of the Thomas Alva Edison Visiting Professionals Program, which is designed to tap into the expertise of distinguished IP professionals and academics who are able to devote up to six months of service to the Office on a full time basis. The Office also announced that the first Edison Professional will be Georgetown Law Professor John R. Thomas. The Office noted that since 1999, Prof. Thomas has served as a Visiting Scholar with the Congressional Research Service (CRS), where he assisted members of Congress and their staff during the enactment of both the American Inventors Protection Act (AIPA) and Leahy-Smith America Invents Act (AIA). Prof. Thomas also clerked for Chief Judge Helen Nies of the Court of Appeals for the Federal Circuit.
As a Visiting Scholar with the CRS, Prof. Thomas (at left) recently prepared a report for Congress entitled "Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues." In that report, Prof. Thomas notes that "[r]eflecting its compromise nature, the [Hatch-Waxman Act] both provides an exemption for patent infringement (for FDA regulatory compliance activities) and creates a new infringing act (the filing of certain ANDAs by generic firms)." In particular, the Act contains one provision (35 U.S.C. § 271(e)(1)) that creates a statutory "safe harbor" exempting someone from a patent infringement claim based on acts reasonably related to seeking marketing approval from the FDA, and a second provision (35 U.S.C. § 271(e)(2)) that creates a "somewhat artificial" act of infringement allowing a brand-name company to enforce its patent against a generic competitor that has filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification.
The report indicates that recent judicial developments have involved both provisions. With respect to § 271(e)(1), the report notes that in Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit concluded that § 271(e)(1) is "directed to premarketing approval of generic counterparts before patent expiration." The report concludes that "[i]n view of this holding, activities not associated with the preparation of an NDA or ANDA are not shielded by the safe harbor, even though they lead to information that must be reported to the FDA." However, "[b]ecause 35 U.S.C. §271(e)(1) does not expressly restrict its scope to premarketing approval efforts," the report notes that the holding in Classen "has been the subject of considerable discussion." In addition, as Judge Moore noted in her dissent in Classen, the Supreme Court has consistently construed the safe harbor in an expansive manner. The report, however, acknowledges that "[i]f 35 U.S.C. §271(e)(1) were to apply to post-approval activities, then a potentially broad swath of activity could be conducted free of the patent system."
With respect to § 271(e)(2), the report indicates that while this section does not expressly state that brand-name companies must explicitly identify patents to the FDA prior to asserting those patents under § 271(e)(2), "the Supreme Court has suggested that such identification is a predicate for litigation." Nevertheless, the report points out that "[t]he courts have yet to rule definitively on this point." Noting that "[w]hether a cause of action under 35 U.S.C. §271(e)(2) is predicated upon a paragraph IV certification or not holds notable consequences for the Hatch-Waxman system," the report suggests that if such a certification is not required, then the filing of an ANDA could lead to a claim of infringement for a patents that is not listed in the Orange Book. The report notes that the issue was most recently acknowledged (but left unresolved) by the Federal Circuit in Abraxis Bioscience Inc. v. Navinta LLC, 625 F.3d 1359 (Fed. Cir. 2010). However, the report suggests that "[t]his issue may yet be placed before the courts in the future."
The report concludes that should Congress decide that it needs to intervene and revise the two provisions, it "could stipulate whether 35 U.S.C. §271(e)(1) applies to acts that occur following the award of FDA marketing approval or not," and "also explicitly state whether 35 U.S.C. §271(e)(2) establishes a cause of action for infringement of patents that have not been listed in the Orange Book and therefore were not the subject of a paragraph IV certification."
Hat tip to Greg Aharonian for making the CRS report available via his e-mail newsletter.