- A gene patent is a patent on a discrete sequence of genes (particularly those that make a particular protein), the chemical composition of that sequence, and the method of making the sequence. These patents are governed by federal patent law.
35 U.S.C. 101 limits what inventions are patentable to "any new and useful process, machine, manufacture, or composition of matter." Although living organisms are not included in this, the scope of inventions that are patentable has expanded to include plants and gene sequences. This area has become the subject of much rule making by the United States Patent and Trademark Office (PTO), and the subject of hotly contested lawsuits.
- This type of patent is very controversial because patenting genes is equated with patenting life. Moreover, patenting the method to make a particular gene sequence is construed as limiting research because genes are research tools. A 2005 article in the Harvard Journal of Law and Technology likens patenting biotech research tools to patenting prisms; the author claims that if Newton had patented prisms, he would have "achieved a monopoly over the study an application of basic optical properties." Such practices are seen as defeating the PTO's mission of promoting progress.
- Section 2400 of the Manual of Patent Examining Procedures (MPEP) sets forth the rules for examining patents that claim the nucleotide sequences that make up genes. This section states that "these sequences are thus deemed to normally constitute independent and distinct inventions." This section states that "up to ten independent and distinct nucleotide sequences will be examined" in a single patent application as long as they do not code for the same protein.
- In his March 29, 2010 decision "Association for Molecular Pathology et al. v United States Patent and Trademark Office, et al.," Justice Sweet expressed the opinion of the United States District Court of New York. Justice Sweet reaffirmed that laws of nature cannot be patented. He excluded "products of nature" such as genes from patent protection. Quoting Supreme Court Justice Stephen Breyer, he concluded that "sometimes too much patent protection can impede rather than promote the "Progress of Science."
This case has been closely watched because it involves BRCA1 and BRCA2 genes which are involved in breast cancer.
- It remains unclear what implications this suit has on patents that were already issued for gene sequences and whether it invalidates those patents.
Plaintiff Myriad Genetics plans to appeal the case. As of April, 2010, the law on biotech patents in general continues to rapidly evolve.