The Drug Price Competition and Patent Term Restoration Act of 1984, [202] amended the law relating to patent infringement to overrule the decision of the Court of Appeals for the Federal Circuit in Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc. [203] In that case, the court had held that clinical testing of a copy drug prior to the expiration of the patent on the active ingredient so as to expedite FDA approval of the copy drug after the patent expired was an infringement of the patent. The Act represented a compromise between the ethical and generic drug manufacturers. In return for permitting generic drug manufacturers a simplified procedure for securing FDA approval for generic drugs by filing an Abbreviated New Drug Application which did not require repetition of all of the testing carried out by the original introducer of the drug, certain amendments were made to the Patent Act. [204]

35 USC § 271(e) now excludes from patent infringement any activity in relation to a product (other than a new animal drug or a veterinary biological product) which is solely or reasonably related to the development and submission of information required for federal approval of the manufacture, use or sale of a drug. [205] It is, however, made a patent infringement to submit an IND or an application for marketing approval in respect of a drug which is subject to patent protection if the purpose of the submission is to obtain approval under the Food, Drug and Cosmetic Act to engage in the commercial manufacture, use or sale of a patented drug (or certain other biotechnology products) before the patent on it expires. [206]

The Food Drug and Cosmetic Act requires that applicants for New Drug Applications for pioneer drugs must file information about patents for their drugs with the FDA (these are collected in Approved Drug Products with Therapeutic Equivalence Evaluations, the so-called "Orange Book" and make any appropriate amendments when the drug is approved for sale). [207] Third parties have no rights to challenge the propriety of an Orange Book listing. [208] As a result of the Hatch-Waxman Act, applications for permission to market generic versions of drugs, filed as Abbreviated New Drug Applications, must include a certification as to one of the following: (I) that no patent information was filed by the original innovator of the drug; (II) that the patent has expired; (III) the date on which the patent expires; or (IV) that the patent is invalid or will not be infringed. Applicants for an ANDA must up-date their certifications if additional relevant patents are added to the Orange Book, unless the patentee delays more than thirty days after the issue of the patent to enter it in the Orange Book. [209] If the certification is of type (IV), the ANDA applicant must give the patentee notice and advise the patentee why it believes the patent is invalid, unenforceable or not infringed. [210] If within 45 days of giving this notice, the patentee institutes a suit for patent infringement, the FDA must delay grant of marketing approval until a court holds that there is no infringement or 30 months have elapsed, whichever is the sooner. (The thirty month term may be subject to extension, for example if the defendant failed to cooperate in expediting trial of the action.) [211]

The ability of the ANDA applicant to challenge the validity of pioneer pharmaceutical patents has led to significant litigation in which the ANDA applicant is effectively protected from serious damage since the statute provides that damages can be awarded against such an applicant at this stage only if it has actually undertaken commercial manufacture, which is unlikely. A further bonus for the ANDA applicant is that if its challenge to the validity of the pioneer patent is successful or if it is held that the product in question is not an infringement, the challenger will be guaranteed a lead time of at least 180 days over any other ANDA applicant for the same drug. [212] A first instance decision of invalidity or non-infringement suffices to start the 180 day period, even if the decision in question is appealed. [213] Various ploys by the pioneer drug producers and the generic manufacturers to use the 180 day lead time in interesting ways have come under scrutiny from the FTC as being possible violations of the antitrust laws. [214]

The courts have extended the exception to cover testing of new medical devices. [215]

8.4.2 Limitation of Remedies for Surgical Method Patents

Most recent changes in patent law have favored the patentee. In 1996, however, Congress took steps to limit the rights of owners of certain types of patents relating to medical uses. This was done by an amendment that deprived a patentee of its infringement remedies (to civil trial, injunction, damages and attorney’s fees) where a medical practitioner or a related healthcare entity performs a patented medical activity. The statute defines medical activity as:

In essence therefore the limitation is confined to surgical techniques relating to humans using instruments that are not themselves patented.

A related healthcare entity is an entity such as a hospital, health maintenance organization or nursing home with which the medical practitioner has a professional affiliation. The term "body" has been defined as a human body, organ, or cadaver or a non-human animal used in medical research or instruction directly relating to the treatment of humans. The term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method. [216]