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Legal Issues
Oct 22, 2018

The Battle Over Biotech Inventions

Sponsored Content provided by Russell Nugent - Attorney, The Humphries Law Firm

Over the past several years, there have been a lot of high-profile lawsuits concerning what kinds of biotechnology inventions are eligible for patent protection. 

In essence, patent owners have been caught in ideological battle between the United States Patent and Trademark Office (USPTO), the government body that issues patents, and the Federal Circuit Court of Appeals, the court that has jurisdiction over most patent appeals, on one side and the U.S. Supreme Court on the other. 

Unfortunately, decades can pass between a patent being issued and that patent being litigated and appealed all the way to the U.S. Supreme Court. As a result, the USPTO has been issuing patents for years that the U.S. Supreme Court has ultimately decided are invalid. This has naturally resulted in a great deal of uncertainty in a field that often builds entire product lines around their patents.  

Section 101 of the U.S. Code (35 U.S.C. §101) defines the kinds of inventions that can be patented. Section 101 states that “…any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” can be protected by a patent if it complies with the other requirements of the Patent Act (the federal statute that governs patent rights). 

Traditionally, this included “anything under the sun made by man” Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S. Ct. 2204, 2207-08 (1980). However, the Courts have made it clear over the years that there are certain exceptions that are more relevant in certain fields, namely life sciences, software and business method patents. The exceptions that come into play when the Courts analyze biotechnology patents tend to be the prohibitions against patenting natural laws and phenomena and abstract ideas. 

The rest of this paper will survey the U.S. Supreme Court opinions interpreting Section 101 in the life sciences field, as well as the more recent Federal Circuit decisions that have been issued since the last word from the Supreme Court.  

In so analyzing, certain patterns emerge that can be used to guide life scientists when deciding what to claim in a patent. First, the Courts are instructed to look specifically at what is claimed. While this may seem like an obvious point, the analysis often hinges on whether a product or a process is being claimed.

If the claims recite a naturally occurring product, like naturally occurring segments of DNA, then the claims will not be invalidated under Section 101. If the claims recite a product that is engineered in the lab and does not naturally occur, then the invention will likely be patent eligible. 

On the other hand, if the patent describes a naturally occurring product, it should claim a process that is novel. Where inventors get into trouble is when the discovery that is exploited and claimed is a naturally occurring phenomenon or property of a natural phenomenon that is manipulated and/or commercialized using known techniques. 

For example, in 1948, the Supreme Court heard a case in which the inventor had patented an inoculum of nitrogen fixing root nodule bacteria. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S. Ct. 440 (1948) It had been previously known that different species of Rhizobia bacteria work with different types of plants, and the growth of some species has an inhibitory effect on the nitrogen fixing capabilities of other species. The inventor figured out which species of bacteria inhibited which and created an inoculate containing more than one strain of bacteria that could be grown together without inhibiting the functioning of the other strains in the same inoculate. 

Reasoning that there was no change in the bacteria itself, but rather the invention was an advance in packaging, the Court held the claims invalid under Section 101. The Court also noted the patent only claimed the inoculate; there was no claim to a process. However, the Court went on to remark the process of mixing the inoculate was routine and conventional so it likely would not have mattered if the inventor had claimed a process in addition or instead of the inoculate. 

In contrast, the U.S. Supreme Court upheld a patent claiming a genetically engineered bacteria able to metabolize hydrocarbons in 1980. Diamond v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204 (1980) In discussing the previous case, the Court distinguished the bacteria as being “man-made,” whereas the inoculate in the prior case contained naturally occurring bacteria exhibiting their natural properties. As a result, the Supreme Court upheld the claims to the genetically engineered bacteria. 

In Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 132 S. Ct. 1289 (2012), the U.S. Supreme Court was faced with a patent claiming a method of adjusting the dose of a thiopurine drug previously administered to a patient in response to measuring a metabolite of the drug in the patient’s blood stream after an initial dose.  

The invention or discovery in this patent was the measured correlation between the concentration of the metabolite and the effectiveness of the drug. Physicians had long known that different patients metabolize the drug at different rates making it difficult for physicians to know exactly what dose to administer to each patient. The inventor had merely calculated the correlation between the levels of the metabolite and the effectiveness of the drug. 

The Federal Circuit concluded that the claims were directed to a law of nature, i.e., the relationship between the drug dosage and the amount of the metabolite in the patient’s blood and a process of applying the relationship. 

Stating that the relationship between the metabolite and the drug dosage is the function of a natural process, the Court determined the process of applying the natural law was routine and conventional. Therefore, the Court concluded the claims were determined to recite natural law and instructions to apply the natural law and were therefore directed to patent ineligible subject matter under Section 101.     

The very next year, the U.S. Supreme Court decided in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S. Ct. 2107 (2013) that naturally occurring DNA sequences are not eligible for patent protection, but the cDNA sequences prepared from them are. In Myriad Genetics, the patentee failed to convince the Supreme Court that an isolated DNA molecule was a new molecule that did not exist in nature, largely because the claims recited DNA sequences and not the chemical structure of the DNA molecule. 

However, the Court did allow claims to the cDNA sequence made from the excised gene, reasoning that the cDNA sequence did not represent a naturally occurring molecule precisely because the cDNA sequences were not the sequences that existed naturally. So, in order to pass muster under Section 101, the patentee in this case needed only to show that the claims were directed to a sequence of DNA that did not exist in nature. 

These cases have provided the patent practitioner with some practical guidance on how to describe life sciences inventions in patent claims such that the patent can be enforced.

In the next installment, we will discuss the more recent Federal Circuit cases issued in the wake of the Alice Corp decision – the U.S. Supreme Court’s most recent word on these issues.

Russell is a native of Wilmington, N.C. and has been practicing law in Eastern N.C. since 2004. Prior to that, he worked in Chapel Hill and Durham as a research technician on teams exploring RNA-based gene therapies, viral fusion inhibitors, and the role Galactocerebroside plays in protein localization near nodes of Ranvier. After passing the patent bar in 2003 and becoming a registered patent agent, Russell received his law degree from Georgetown in 2004. He began his legal career representing clients in personal injury matters but later left personal injury to provide patent prosecution services to law firms in China and Taiwan prior to joining The Humphries Law Firm in 2014. Russell helps individuals and businesses protect their innovations, creations and business information using strategies based in patent, trademark, copyright and trade secret law. His work includes both strategic planning and dispute resolution. He assists clients who want to buy and sell businesses, and license or transfer their intellectual property assets. Russell also assists with the firm’s litigation practice, particularly in insurance and employment disputes.

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