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Legal Issues
Jan 4, 2019

The Battle Over Biotechnology Inventions Part IV:  Conclusion

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

After Rapid Litigation Management, the Federal Circuit issued two more cases under 35 U.S.C. § 101 that contribute heavily to this discussion[1]

In both of these cases, the Court decided the patents passed the U.S. Supreme Court’s test in Alice Corp. The first was Exergen Corp. v. Kaz USA, Inc[2] (”Exergen”). In March of 2018, the Federal Circuit examined claims directed to a body temperature detector and methods of detecting human body temperature. Exergen sold a body temperature detector that calculated core body temperature using measurements taken directly above the superficial temporal artery. 

Both parties agreed that the claims were directed to a law of nature, i.e. the mathematical relationship between ambient air temperature, the temperature of the skin above the superficial temporal artery and core body temperature. The dispute was over whether the claims recited more than well-understood, routine and conventional steps applying the natural law. 

The Federal Circuit Court decided the steps in the patent’s claims were patent eligible even though they were already known in the prior art[3].  The Court elaborated by saying that something is not routine and conventional just because it is known in the prior art as there are very obscure references that qualify as prior art. In addition, earlier cases decided that a new combination of steps that are already known in the field can be patent eligible.    

The Court went on to say that that even though the patent claims were directed to the measurement of a natural phenomenon, they used an unconventional method to measure it[4].  The Court distinguished prior cases, such as Ariosa Diagnostics, Inc. v. Sequenom, Inc. (“Ariosa”) and Mayo Collaborative Servs. v. Prometheus Labs., Inc. (“Mayo”), in which courts invalidated the patent claims by pointing out there was no dispute in those cases about whether the steps recited in the claims were routine or well-known. 

In those cases, the arguments were about whether the claims recited laws of nature. The Federal Circuit concluded that since the steps recited in the claims were not already well-known, the patents were valid under Section 101. 

In Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd. (“Vanda”), the Federal Circuit appeared to try to distinguish patent claims that merely tell a practitioner to observe a natural law and apply it from claims that apply unconventional methods to use a natural law. In Vanda, the Federal Circuit held patent claims valid that were rather similar to those the U.S. Supreme Court decided were invalid under Section 101 in Mayo. 

The inventors had determined that people expressing different genotypes (versions of a gene) produced different amounts of an enzyme known to metabolize a number of drugs, including one used to treat schizophrenia (iloperidone). The patent claimed methods of treating schizophrenia by first determining how well the patient metabolizes iloperidone by determining the patient’s genotype and then administering higher or lower dosages of the drug to the patient resulting in a safer treatment regimen. 

The Court drew a rather fine distinction between this decision and the Mayo decision. In Mayo, the claims were directed to a method of optimizing the treatment of a disorder that included the steps of administering a drug and measuring the level of a particular metabolite in the blood stream to determine how much to adjust the dosage of the drug.

The Court reasoned that Vanda Pharmaceuticals’ patent claims included a step of administering a specific dosage of the drug in response to determining the patient’s genotype whereas the claims in Mayo only stated a particular level of metabolite would indicate a need to increase or decrease the drug dosage. 

In doing so, the Court stated that the claims in Mayo were not directed toward the treatment of a novel disease and they were not directed toward the application of a drug to treat a particular disease. 
Judge Prost authored a scathing dissenting opinion criticizing the majority’s opinion for drawing a distinction without a difference and failing to follow the Supreme Court’s precedent in Mayo. Judge Prost rather accurately points that out the majority’s opinion failed to meaningfully distinguish the claims at issue in Vanda from those in Mayo. 

With the Rapid Litigation Management and Exergen cases, the Federal Circuit seems to be signaling that the bar set by Section 101 is a pretty low one. So long as the prior art does not disclose the exact same method being used to solve the same problem, the claims recite patent eligible subject matter even if they apply a natural law. A different combination of known procedures and methods will pass muster under Section 101 and, frankly, this makes sense, as it has been historically easy to meet the requirements of Section 101. The true gatekeepers to patentability have traditionally resided in other portions of the Patent Act. 

However, the Vanda case indicates some of the Federal Circuit judges may simply disagree with the Supreme Court over what should and should not be patentable under Section 101. This leaves patent holders in the life sciences in a difficult situation. 

On one hand, if a lower court finds their patent claims invalid under Section 101, there is a good chance that appealing to the Federal Circuit will solve the problem – with the caveat that an appeal to the U.S. Supreme Court could have the opposite effect. What is clear is that life scientists cannot patent naturally occurring molecules or DNA sequences – something the USPTO allowed for years.

However, if the subject of the patent application is something that has been entirely made in the lab and does not otherwise exist in nature, then patent protection is still available. What is also clear is that when the inventor’s most significant discovery is a natural relationship or the presence of a naturally occurring product, patent protection is not guaranteed at all – even if the UPSTO issues a patent on such a discovery, the Courts may not enforce it. There has been some talk of proposing legislation to remedy the situation but, as yet, nothing has been passed. 

For the time being, inventors in the life sciences can focus their patent strategies on patents that disclose truly novel methods and techniques and artificially synthesized molecules and should shy away from patenting mere discoveries of natural phenomena or methods of manipulating the same with routine and well-known techniques.   

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 Federal Circuit also decided Roche Molecular Sys. V. Cepheid, 905 F.3d 1363 (Fed. Cir 2018) in October of 2018.  The facts and analysis are so similar to the U.S. Supreme Court cases BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014) and Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S. Ct. 2107 (2013) that the case does not really add anything new to this discussion.
[2] 725 Fed. Appx. 959 (Fed. Cir. 2018)
[3] Prior art has a technical legal definition found in 35 U.S.C. §102, but essentially it includes all the knowledge that is available to those that work in a particular field. 
[4] Judge Hughes filed a dissenting opinion arguing that the Court decided the case incorrectly and that the patent claims began and ended with the observation of a natural law and therefore amounted to nothing more than observing and identifying the law of nature.

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