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Legal Issues
Dec 14, 2018

The Battle Over Biotechnology Inventions Part III

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

In the first two installments of this article, we discussed the U.S. Supreme Court cases that interpret 35 U.S.C. §101. 

Next, we will turn to the Federal Circuit[1] cases acting on those decisions – specifically those cases in which the Federal Circuit has invalidated patent claims under Section 101. 

Less than six months after the Alice Corp. decision, the Federal Circuit decided another case involving Myriad Genetics’ patents to the BRCA1 and BRCA2 genes and methods of using them[2]. The inventors had discovered that certain mutations in the BRCA1 and BRCA2 genes were correlated with certain types of cancers. 

In the earlier case, the U.S. Supreme Court decided that naturally occurring segments of DNA are not patent eligible under Section 101, but non-naturally occurring cDNA segments are. In this case, Myriad was trying to assert patent claims not previously considered in the earlier case.  In the present case, the Court considered two types of claims – claims to individual DNA sequences or primers used to locate the genes of interest and claims to methods of using the primers. 

Analogizing to the earlier Myriad case, the Court concluded the primers were patent ineligible under Section 101 as they were identical to naturally occurring DNA sequences. The Court rejected the argument that single stranded DNA sequences are not naturally occurring based on the holding in Myriad that isolated DNA segments are not patent eligible. The Court went on to point out that the claimed primers do not function any differently than the naturally occurring DNA sequences they are identical to – a fact that is exploited when amplifying the DNA. 

The Court also concluded the method claims were patent ineligible as they amounted to little more than an application of an abstract idea[3].  The Court had already concluded in the earlier Myriad decision that the method claims reciting steps of comparing and analyzing gene sequences represented an abstract concept or mental step.  Finding that the rest of the claims recited conventional or routine steps, the Court concluded the claims did not recite patent eligible subject matter under the Alice Corp. test. 

Similarly, in Ariosa Diagnostics, Inc. v. Sequenom, Inc.[4] , the Federal Circuit invalidated a patent claiming a method of using a DNA sample found in maternal blood to detect a fetus’s genetic characteristics.  The inventors’ discovery was that the cell-free fetal DNA (cffDNA) is naturally occurring in maternal blood samples that were previously thought to be and treated as medical waste. The researchers used previously known techniques to manipulate the cffDNA once it was identified. 

After accusing competitors of patent infringement, Ariosa, the company holding the patent rights, was sued in federal court by companies asking the court to invalidate their patent. The Federal Circuit noted the case was very similar to that in Mayo in which the U.S. Supreme Court invalidated a patent that claimed a method of using a naturally occurring phenomenon, i.e. the correlation of a metabolite with the dosage of a particular drug. 

Because the techniques used to manipulate the cffDNA were routine and conventional at the time the patent application was filed, the Court reasoned that the only new and useful discovery was the discovery of the presence of the naturally occurring cffDNA itself. Because the patent was directed to a method of using a naturally occurring phenomena, the Federal Circuit held the claims in the patent were ineligible for protection. 

Likewise, in Cleveland Clinic Found. v. True Health Diagnostics LLC[5], the Federal Circuit invalidated a set of patents claiming a method of treating cardiac disease by testing levels of an enzyme (MPO) that is released in response to damage to arteries. 

As with Ariosa, the Federal Circuit concluded that the invention claimed in the patent was the naturally occurring correlation between MPO levels and cardiovascular disease.

Utilizing the two-step test in Alice Corp., the Federal Circuit concluded that (1) the claims were directed towards a process of observing a law of nature, i.e. that heightened MPO levels are correlated with cardiovascular disease and (2) that the claims merely recited instructions to apply the law of nature.

In Genetic Techs. Ltd. v. Merial L.L.C.[6], the patent that was invalidated claimed a method of detecting certain regions of DNA based upon their natural correction with other sequences of DNA. Specifically, DNA contains coding and non-coding regions. The inventors discovered certain noncoding regions of the DNA were naturally associated with coding regions of interest – a phenomenon known as linkage disequilibrium. The patent disclosed a method of detecting these coding regions using conventional techniques to identify the noncoding region. 

Reasoning the claims were directed to a naturally occurring phenomenon and that the patentee admitted during prosecution they had not invented any new techniques, the Federal Circuit held that the claims were directed to a law of nature and thus were invalid under Section 101. 

On the other hand, the Federal Circuit declined to invalidate patent under Section 101 in Rapid Litig. Mgmt. v. CellzDirect, Inc[7]. The patent at issue in that case described a method of freezing liver cells (hepatocytes). Previously, the field used known cryopreservation techniques to freeze individual samples of hepatocytes from a single donor. Because the cells typically did not survive more than one freeze-thaw cycle, it was difficult, if not impossible, to produce hepatocyte cultures with cells from more than one donor (as those cells would be collected and frozen separately). 

However, the inventors discovered that a small percentage of hepatocytes are capable of surviving multiple freeze–thaw cycles.  As a result, they developed a process for harvesting hepatocytes that involved freezing samples from multiple sources, thawing them, spinning them down in a centrifuge to separate the still living cells and then creating a new frozen culture with those combined cells.

In finding the claims valid, the Court reasoned that the claims were not directed to the cells themselves or their ability to survive multiple free-thaw cycles, but rather to a new and useful technique for preserving those cells. In reviewing the cases in which the Federal Circuit and the U.S. Supreme Court found patents invalid under Section 101, the Court concluded the claims in the patent at issue did not simply instruct someone to observe or detect the natural ability of the hepatocytes to survive freezing and thawing. 

The Court distinguished earlier cases reasoning the end result of the patent at issue was not merely the observation or detection of the ability for hepatocytes to survive multiple freeze-thaw cycles, stating “…one way of describing the process is to describe the natural ability of the subject matter to undergo the process….[8]” That does not mean the claim is directed to ineligible subject matter.  

The key to understanding the decision Rapid Litig. Mgmt. v. CellzDirect, Inc. is in a statement the Court makes about what was known in the field already.  While the steps of the claimed method were known in the art, “…the process of preserving hepatocytes by repeating those steps was itself far from routine and conventional.[9]” 

With Rapid Litig. Mgmt. v. CellzDirect, Inc.¸ the Federal Circuit provides practitioners in the life sciences with at least some guidance on what is patent eligible under Section 101. Specifically, the Court relied on the proposition that a combination of steps may be patentable even though all the steps individually are already known in the art.[10] 

On the one hand, it seems that the claims in this case are directed to the natural ability of the hepatocytes to survive multiple freeze-thaw cycles and the inventors are using known techniques to take advantage of this discovery. 

On the other hand, the process itself was not routine and conventional (even if its individual steps were). It is important to remember that the Court is only assessing the claim under Section 101 and is not assessing whether the claims would have been obvious when analyzed against what methods of manipulating the cells were already known.

The Court found the claims to be patent eligible under Section 101 because the inventors used techniques that were not admittedly already being used to manipulate their discovery of a natural phenomenon. 

The next and final installment in this series will analyze other cases from the Federal Circuit finding claims eligible under Section 101.

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.

[1] The Court of Appeals for the Federal Circuit, of Federal Circuit for short, has jurisdiction over patent appeals from all over the country. 
[2] BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014)
[3] Oddly enough, the Court did not analyze or directly address arguments that the claims at issue amounted to the application of a law of nature or naturally occurring phenomenon.
[4] 788 F.3d 1371 (2015)
[5] 859 F.3d 1352 (2017)
[6]  818 F.3d 1369 (Fed. Cir. 2016)
[7] 827 F.3d 1042 (Fed. Cir. 2016)
[8] 1049.
[9] 1051.
[10] Citing Diamond v. Diehr, 450 U.S. 175, 101 S. Ct. 1048, 67 L. Ed. 2d 155 (1981)

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