Patent eligibility under Section 101 of the United States Patent Act continues to confound practitioners and create uncertainty as to the value of patents in the life sciences. Recent changes by the Supreme Court and the analyses applied by various tribunals have contributed to this confusion.
The Supreme Court recently upended the law of patent-eligibility in life sciences when it held that isolated segments of DNA were products of nature, not eligible for patent protection (Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107, 2117 ). This decision reversed the long-standing practice at the United States Patent & Trademark Office (USPTO), which had been issuing patents claiming isolated DNA segments for decades. Yet, the concept that natural products may not be patentable was not new. Seventy years ago, the Supreme Court held in Funk Bros. Seed Co. v. Kalo Inoculant Co. (1948) that a combination of naturally occurring strains of bacteria was not patentable, explaining that the claimed bacteria are “manifestations of laws of nature,” and the claimed combination produced “no enlargement of the range of their utility. Each species has the same effect it always had.” This case is often cited for the proposition that combinations of natural products are not eligible for patent protection absent a marked change in function or activity.
Despite these setbacks to patent eligibility in the life sciences, patents claiming combinations of natural products have continued to issue from the USPTO. When reviewing such patent applications, the USPTO considers whether such combinations have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. Where the combination itself does not exist in nature, the USPTO considers the combination a product of nature and compares the combination to the individual naturally occurring components. Applying these principles, the USPTO has issued patents claiming naturally occurring components (e.g., strains of bacteria), where the patentee established that the resulting combination exhibited activity not seen in the individual components. The USPTO has also issued patents claiming combinations with added features or functionalities that distinguish them from nature, including natural combinations contained in stabilized formulations, having an added bacterial spore coating, or existing in a different state (e.g., lysed versus live bacterial cells). On the other hand, the USPTO has rejected claims to combinations that do not differ markedly from their natural counterparts, including combinations containing potentially non-natural but arguably conventional ingredients (e.g., liquid carriers, surfactants, diluents, adjuvants and disease control agents). Formulating such combinations to have ratios, amounts or concentrations not found in nature does not typically alter this result.
The district court decision in NAI is presently on appeal to the United States Court of Appeals for the Federal Circuit. An amicus brief submitted by Biotechnology Innovation Organization (BIO) frames the issues well, arguing that laboratory-created biologically active compositions should be patentable under Section 101, because such combinations and related biological activities do not exist absent human innovation. This case may thus present the court with an opportunity to provide much-needed guidance on the patentability of natural product combinations.
Original Resource: www..naturalproductsinsider.com
Nov 09, 2018