This Perspective takes the position that the generation of whole genome sequence testing information needs to be treated differently than the tests and results associated with more traditional diagnostic assays. Part I considers the current regulatory environment and efforts to reform the oversight of genetic tests, in particular, the solution to the question of whether consumers should be permitted to order whole genome sequence tests without the guidance of a health-care professional. Part II discusses how whole genome sequence tests differ from conventional genetic tests both in the vastly greater amount of information that is generated and in the ways the information can be interpreted and reinterpreted for different purposes at different times. Part III suggests that rather than using the current regulatory approach of concentrating on technical attributes of the whole genome sequence testing process, regulatory approaches should be directed to the tools needed to analyze and apply deoxyribonucleic acid (DNA) sequence information. Such efforts will safeguard patients from adverse outcomes associated with unreliable disease-risk prediction, while improving access to the perceived benefits of whole genome sequence testing.

In the American Inventors Protection Act of 1999 (AIPA), Congress gave patent applicants provisional rights in their published patent applications under 35 U.S.C. § 154(d). Prior to the passage of the AIPA in 1999, the Court of Appeals for the Federal Circuit, affirming its earlier decisions, had held that a patentee “may of course obtain damages only for acts of infringement after the issuance of the . . . patent.” However, the AIPA provided damages for infringement in the period before a patent applicant is granted a patent. Provisional rights, also known as pre-issuance royalties, provide a patentee with the prospect of obtaining a reasonable royalty from a third party that infringes a published application claim. This right is provided only if the third party has actual notice of the application and a patent issues from the application with a substantially identical claim.

The Federal Circuit has not had the opportunity to interpret the “substantially identical” and “actual notice” requirements under § 154(d), but several district courts have done so. At first glance, the district court rulings appear to be conflicting. However, this Comment explains how the rulings are actually consistent, with each one adding a slightly different layer to the interpretation of § 154(d). Currently, the various rulings addressing the actual notice requirement have not only ruled out constructive notice but also indicate that direct notification action by the patentee is not a necessary condition. It is sufficient if the alleged infringer knew about the patent application through other channels. Other rulings indicate that when patentees do take direct actions to notify, they cannot conceal the notification among other documents, although they do not have to point out the infringement of specific claims.

The cases addressing the substantially identical requirement emphasize that each claim amendment should be evaluated carefully to see if it changes the scope of the claim and that not all claim amendments preclude a finding that claims are substantially identical, even those that are in response to USPTO rejections. These cases suggest that narrowing amendments can preclude a finding that claims are substantially identical, and such an interpretation, when considered in combination with an earlier Federal Circuit decision that arguably expands the definition of narrowing amendments, could severely limit the application of § 154(d). This Comment first explores the different rulings, reconciles them, and suggests that the Federal Circuit should consolidate the rulings from the district courts into one binding decision that will provide greater certainty to litigants. This Comment also explores the potential implications of the suggested decision.

Although the few district courts that have addressed these issues so far have produced reasonable results, their rulings are not binding. This Comment recommends that the Federal Circuit, when given the chance to review a case where § 154(d) provisional rights are disputed, provide a decision consolidating the reasonable interpretations applied by the various district court rulings up to this point. Otherwise, there is a risk that other district courts may produce undesirable interpretations. Forum shopping is very common in patent cases and infringers might find courts that take the interpretation in a direction that weakens the protection promised to inventors. Such uncertainty about the application of § 154(d) could conflict with Congress’s intent to provide protection for inventors and could increase overall litigation costs.