By Bruce Sunstein. A member of our Patent Practice Group
Although these pages have frequently discussed recent Federal Circuit decisions concerning the eligibility of software inventions for patenting, there is less to discuss concerning the eligibility of biotechnology and pharmaceutical inventions for patenting, because there have been fewer Federal Circuit decisions in this area. Nevertheless, the first decision to trigger a new round of concern about patent eligibility was the Supreme Court’s 2012 decision in Mayo v. Prometheus, concerning a diagnostic relating to dosage of a pharmaceutical, which, in turn, paved the way for the equally important decision, in 2014, relating to computer software, Alice v. CLS Bank.
Together, in patent prosecution, these two decisions have created similar barriers to obtaining patents in their respective fields of biopharmaceutical and computer-related inventions. In this article we show how recent decisions of the Federal Circuit concerning patent eligibility of computer-related inventions also portend parallel grounds for asserting patent eligibility of biopharmaceutical inventions.
We begin our discussion by first explaining the barriers created by the Supreme Court in Mayo and Alice. What we might well call the “Mayo-Alice” dogma provides the rationale for the barriers:
- Patent protection should not extend to claims in a patent that monopolize the “building blocks of human ingenuity.”
- “Therefore” patent claims directed to laws of nature, natural phenomena, and abstract ideas are not eligible to be included in the patent and are invalid.
In Part B, the word “therefore” is in quotation marks because claims in issued patents are not really directed to laws of nature, natural phenomena, or abstract ideas. Instead, claims in issued patents are directed to practical applications, and not to these concepts per se. In other words, the Mayo-Alice dogma is precisely that–dogma.
Nevertheless, the Mayo-Alice dogma gives rise to a two-step rule, which we here call the Mayo-Alice rule.
Under step 1: First, we determine whether the claims at issue are directed to a patent-ineligible concept.
Under step 2: If so, in a search for an “inventive concept”, “we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.”
Although this two-step procedure is hopelessly subjective, it is prescribed by the Supreme Court in both Mayo and Alice. Decisions of the Federal Circuit in the wake of those decisions have done some good in clarifying the Mayo-Alice rule, including two biopharmaceutical decisions that have interpreted step one of the Mayo-Alice rule.
In Rapid Litigation Management Ltd. v. CellzDirect, Inc., discussed here, the technology involved a method of providing hepatocytes having greater viability after freezing. The court held that the technology was patent eligible and not directed to a natural law. The court held that the patent claims were not directed simply to the ability of hepatocytes to survive multiple freeze-thaw cycles (which would be a natural law), but instead are directed to “a new and useful technique for preserving hepatocytes.”
The court explained that “[t]he inventors certainly discovered the cells’ ability to survive multiple freeze-thaw cycles, but that is not where they stopped.” The claims are directed to a method of producing a desired preparation of multi-cryopreserved hepatocytes. In this case, claim drafting played an important role, for the court found that the inventors “employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use.”
The decision in CellzDirect has something in common with the Federal Circuit’s decision in Enfish v. Microsoft (discussed here), a computer software case, because both decisions found the claimed subject matter to be patent eligible, and the finding of eligibility occurred in step 1 of the Mayo-Alice rule. In each case, the language of the claims was specific enough to avoid a finding that the subject matter was “directed to” ineligible subject matter.
Ironically, the Supreme Court in Mayo argues that its decision is a backstop against merely clever claim drafting. In referencing its prior decisions, the Court admonishes:
Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].”
Nevertheless, claim drafting may well make a difference in dealing with step 1 of the Mayo-Alice rule. As an example, let us consider one of the most famous (or infamous) of Federal Circuit decisions involving biotechnology, Ariosa Diagnostics, Inc. v. Sequenom, Inc. The inventors in this case discovered cell-free fetal DNA (“cffDNA”) in blood of the mother. The inventors developed ways of using this fetal DNA obtained from blood of the mother to gain diagnostic information about the fetus. In characterizing the invention in this case, the inventors included the following language in the patent (reproduced by the Federal Circuit in its decision): “we have demonstrated the feasibility of performing non-invasive foetal RhD genotyping from maternal plasma. . . . These observations indicate that maternal plasma/serum DNA may be a useful source of material for the non-invasive prenatal diagnosis of certain genetic disorders.”
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