Search

The product of nature doctrine states that subject matter found in nature is not patentable. This doctrine has generally been ignored in the granting of biotechnology patents, but it should not have been. Its applicability to biotechnology patents is examined.

In the case of Eli Lilly & Co. v. Barr Labs, Inc., the US Court of Appeals for the Federal Circuit decided that Eli Lilly recieved double patents on the drug Prozac. However, the C ourt made errors in interpreting patent law regarding what test it should use to determine double patenting.

The author discusses caselaw regarding the statutory patent requirement for utility, the Patent and Trademark Office's utility examination guidelines in light of this caselaw, and their applicability to biotechnology patent prosecutions.

The author discusses the U.S. Patent and Trademark Office Revised Interim Guidelines for Examination of Patent Applications Under the 35 U.S.C. s. 112, s. 1 "Written Description" Requirement. The discussion focuses on procedural matters but includes substantive and policy issues.

The article discusses two rulings of the United States Court of Appeals for the Federal Circuit confirming that 35 USC 101 provides basis for the granting of patents for business-related processes. The first, State Street Bank & Trust Co. v. Signature Financial Group, was handed down in 1998, while A.T.&T. v. Excel Communications came a year later.

The Freeman-Walter-Abele doctrine will remain useful for protecting computer-based inventions such as mathematical algorithms, although the Patent and Trademark Office indicates that it is no longer the sole standard. In re Walter produced guidelines including the statement "implemented ... to refine or limit claim steps." This is central to proving that an algorithm is practically applied, by permitting a claimant to focus upon the data gathering refinement steps of an algorithm.

Courts and commentators have considered the application of the description, novelty and nonobviousness requirements to DNA sequence patents, but the degree to which biotechnology patents must be useful has not been defined. The Brenner v. Manson line of cases established that inventions must have some practical utility beyond research to be patentable. While the commercial potential of genome research is clear, the particular use of a DNA sequence may be uncertain when first isolated. Claiming utility as a probe, a DNA fingerprint tool, or marker may satisfy the utility requirement for patent claims.

Computer programs and mathematical algorithms are generally not patentable. Claims for patents can be dismissed as violating Article 1 of the Constitution even if they satisfy 35 USC 101. The Supreme Court provides guidelines for patentability as physical structures or phenomena limited to physical structures. These guidelines emerged from decisions in Gottschalk v Benson, Parker v Flook and Diamond v Diehr.