In recent years, pharmaceutical patent laws have been subjected to significant legislative reforms, controversial amendments to FDA regulations, numerous investigations into pharmaceutical industry practices by antitrust enforcement authorities, judicial precedent from the Supreme Court, and far-reaching pronouncements from the World Trade Organization. Not only have few legal disciplines observed such a rapid pace of change, but the number and diversity of decision makers that govern this area is of particular consequence. Pharmaceutical Patent Law takes on the complicated task of tracking legal developments within the PTO, FDA, Congress, the courts, the FTC, the Department of Justice, and the WTO; examining how these agencies and organizations interact with each other; and determining how they impact strategies within a practitioner’s core area of expertise.
Pharmaceutical Patent Law provides practitioners with a more complete understanding of how pharmaceutical patenting operates in the context of three interlocking disciplines—the relationship between drug innovation and the patenting process; the interplay between patents and the FDA approval process for both innovators and generic drug companies; and how both the patenting process and the FDA approval process together play out in the arena of Hatch-Waxman litigation.
This comprehensive treatise is the only reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and the food and drug laws. In scrupulous detail, it explains how both food and drug and intellectual property attorneys should coordinate their client’s patent filings and FDA strategies. Whether you are weighing which patent is most appropriate for term extension under the Hatch-Waxman Act, drafting and selecting patents for inclusion in the Orange Book under the FDA’s new regulations, or weighing the consequences of the different patent certifications associated with an Abbreviated New Drug Application (ANDA) Process for Generic Drugs, no other treatise on the market provides such detailed analysis of the critical relationship between the FDA and the PTO regarding pharmaceutical patents.
Pharmaceutical Patent Law provides a practical and unbiased analysis of the field in clear language. Its approach is to present the basics of pharmaceutical patent law to practitioners, then give specific analysis of the pitfalls—and how to avoid them. Providing up-to-date analyses of the latest statutory, administrative, and judicial developments pertaining to the Hatch-Waxman Act and related legislation, the book focuses on patent acquisition and enforcement, FDA marketing procedures for innovative and generic drugs, and the complex statutes and regulations that tie these topics together. Pharmaceutical Patent Law also provides complete coverage of advanced topics, including the antitrust implications of patent settlements, the experimental use privilege, and international aspects of the field. Core topics covered in Pharmaceutical Patent Law include:
--the substance and procedure of pharmaceutical patent acquisition --FDA marketing approval procedures for innovative and generic drugs --the FDA’s Orange Book --patent term extension standards --FDA marketing exclusivities --the scope of patent rights --patent infringement procedures under the Hatch-Waxman Act --defenses to patent infringement --remedies for patent infringement --the experimental use privilege --antitrust treatment of pharmaceutical patent settlements --international aspects of pharmaceutical patent practice
Other important topics discussed in Pharmaceutical Patent Law include:
--the parallel importation of patented pharmaceuticals --the experimental use privilege after Merck v. Integra --authorized generics --latest judicial developments on "reverse payment" patent settlements --patent strategy in light of Federal Circuit case law on inherent anticipation --current congressional legislative reform efforts --new FDA Orange Book listing requirements --the new rules on generic marketing exclusivity --the availability of jury trials in Hatch-Waxman cases --implications of recent free trade agreements --latest case law on declaratory judgments under the Hatch-Waxman Act --strategies for patent term extension --the remedial implications of generic market entry prior to patent expiration The treatise contains an index, case table, and appendix for easy reference.
Pharmaceutical Patent Law not only reviews current issues of importance, but identifies topics—such as parallel importation and authorized generics—that are likely to be of growing significance in the future. Pharmaceutical Patent Law will prove invaluable to the busy practitioner who is determined to keep on track in this evolving area of the law.
