Attitudes to patents vary over time and with changing economic circumstances. When the Court of Appeals for the Federal Circuit was created in 1982 to have appellate jurisdiction throughout the United States over all patent matters irrespective of whether the lower decision was in respect of an ex parte matter starting in the Patent and Trademark Office, an interference proceeding being appealed from the Patent and Trademark Office, a district court decision relating to a dispute involving patent law or a decision of the International Trade Commission relating to the possible exclusion of goods produced abroad on the ground that they infringed a U.S. patent, a major change in the environment occurred. Since then, the Court of Appeals for the Federal Circuit has, with some intervention from the United States Supreme Court and Congress, rewritten large swathes of patent law and much of this rewriting has been in the field of biotechnology and pharmaceutical inventions. Nevertheless, there have been several different phases in the development of the law even since 1982. In its early years, the new court seemed to have seen one of its primary roles as reestablishing the credibility of the patent system by reversing a trend in which large numbers of the patents brought before the courts were being held to be invalid. It did this by reasserting the requirement of the patent statute that patents carry with them a presumption of validity. [2] Since then, however, the court has taken care to ensure that the protection afforded to patentees is confined to what it believes they have really invented by focusing on the problems that arise when claims are construed too broadly or when the claims as written are broader than the invention actually made and described.

Legislative changes have also occurred over this period. The most significant affecting the biotechnology and pharmaceutical industries include:

Paralleling these changes in the attitude of the courts and Congress there have also been changes in approach within the United States Patent and Trademark Office (USPTO) over the past decade, particularly in the field of inventions relating to biotechnology. In the early 1990's the USPTO was reluctant to accept that there was utility in almost any biotechnology application and frequently demanded clinical data to show that an invention worked. This presented enormous problems for what were then still relatively small start-up companies pursuing research in this area. They were confronted with what was effectively a “Catch 22” situation. In order to obtain a patent they were required to show clinical data. Obtaining clinical data was very expensive. Investors would only provide money for generation of such data if they were sure that a patent would be granted. However, the USPTO would not grant the patent without the data. A series of public hearings in 1994 severely criticized the USPTO position on this issue. This resulted in a policy change so that in assessing the utility of inventions in this field, the USPTO focused on whether there was a specific and credible utility disclosed in the application and the burden was placed on the examiner to provide reasons for doubting the credibility of what was asserted. The result of this change was a perception that the U.S.P.T.O was now making it too easy for applicants to secure protection, particularly for short chains of DNA or for proteins having no known physiological role since a utility for the former could be asserted as a probe and the latter for, for example as dog food. In 1999 interim rules were adopted which became final in 2001 adding a requirement that an asserted utility must not only be specific and credible but also substantial. The objective was to avoid granting patents for new pieces of DNA or protein when no significant use for them was disclosed.

We will see a number of examples of these trends in reviewing recent developments in the biotechnology and pharmaceutical areas.