On December 1, 2020, the United States District Court for the Northern District of Illinois issued an opinion denying plaintiff Abbott Laboratories’ motion to dismiss infringement counterclaims brought by defendants Grifols Diagnostic Solutions Inc., Grifols Worldwide Operations Ltd., and Novartis Vaccines and Diagnostics, Inc. Abbott brought a declaratory judgment action against defendants asserting that U.S. Patent No. 7,205,101 (“the ’101 patent”) is invalid. Defendants filed a counterclaim asserting that Abbott infringes claim 7 of the ’101 patent. Abbott moved to dismiss the counterclaim on the basis that claim 7 is invalid as a matter of law under 35 U.S.C. § 101 because it is directed to a patent-ineligible natural phenomenon.
The ’101 patent is titled “Human Immunodeficiency Virus (HIV) Nucleotide Sequences, Recombinant Polypeptides, and Applications Thereof.” The patent relates to the diagnosis, prevention, and treatment of HIV. Prior to the invention of the patent, the methods for replicating HIV in order to produce proteins to use in the diagnosis and treatment of the disease required workers to chronically infect immortalized cell lines with HIV in vitro
. These methods exposed workers to the risk of infection by the large amounts of live, intact HIV involved in this process. The inventors of the ’101 patent sought to solve these problems by producing recombinant
HIV proteins that would be useful in diagnosis, prophylactic, or therapeutic methods or products, and would not pose such a risk of infection to workers.
Specifically, claim 7 of the ’101 patent recites a two-step method for replicating HIV-specific DNA:
A method for replicating DNA specific for HIV, which comprises:
(a) providing a DNA construct comprising an origin of replication recognized by a unicellular microorganism and a DNA sequence comprising at least a 20 bp sequence of a human immunodeficiency virus (HIV) genome; and
(b) growing a unicellular microorganism containing said DNA construct under conditions whereby said DNA sequence is replicated[,] wherein the unicellular microorganism is a bacterial cell.
Abbott asserted that claim 7 is invalid because it is directed to a natural phenomenon, i.e.
, a specific strain of HIV DNA or the replication of HIV DNA.
The Court addressed Abbott’s claims under the two-step Alice
test for determining patent eligibility under 35 U.S.C. §101:
- determine whether the claims at issue are directed to one of the patent-ineligible concepts (such as an abstract idea); and if so, then
- determine whether the elements of the claim, considered both individually and as an ordered combination, recite an “inventive concept”—i.e., an element or combination of elements that is sufficient to ensure that the practice amounts to significantly more than a patent upon the ineligible concept itself.
The Court’s analysis focused on Step 1 of the Alice
Abbott first argued that the ’101 patent is directed to a product of nature—specifically pointing to a drawing in the patent specification showing a specific strain of HIV DNA—rather than a novel process for replicating DNA. The Court rejected this argument, noting that the focus of the Alice
analysis is on the language of the at-issue claim itself rather than the specification. According to the Court, claim 7 is not directed towards a newly discovered DNA Strain, as Abbott argued, but rather recites a two-step method for replicating HIV-specific DNA.
Abbott further argued that claim 7 is directed to the replication of HIV DNA, which is a natural phenomenon. The Court ruled that this contention overlooked the claim language, noting that “[a] claim is ‘directed to’ a natural phenomenon when it ‘amounts to nothing more than observing or identifying the [phenomenon] itself.’” Claim 7 does not fit within this framework, as it recites a two-step method for replicating DNA as a solution to the problems accompanying the existing processes for replicating HIV DNA. The Court further distinguished claim 7 from other claims that the Court of Appeals for the Federal Circuit (“CAFC”) has found invalid as directed towards natural phenomenon—“[i]n each of these cases, the method claims at issue used a law of nature, natural phenomenon, or mental process to detect or diagnose something.… In contrast, claim 7 provides a particular process for making copies of HIV DNA. This makes claim 7 more akin to a method claim directed to the preparation or production of something.”
Finally, the Court noted that Abbott did not contend that the particular method of HIV DNA replication recited by claim 7 naturally occurs. In fact, the court accepted defendants’ contention that the starting point for the claimed method was a human-made construct that does not exist in nature. The Court ruled that there was no dispute that claim 7 recites a method that (1) begins with the use of a human made construct, and (2) ends with the presence of replicated HIV DNA in an environment where such DNA does not naturally occur, and thus is not “directed to” a natural phenomenon.
Accordingly, the Court ruled that claim 7 is not directed to a patent-ineligible naturally occurring phenomenon and denied Abbott’s motion to dismiss.