Abbott must face HIV testing patent suit, rules judge

Abbott Laboratories must face allegations brought by  Grifols Diagnostic and a  Novartis subsidiary that its HIV testing products infringe a patent covering a method to create HIV proteins using recombinant DNA.

In an opinion and order filed on Tuesday, December 1, Judge Sara Ellis of the US District Court for the Northern District of Illinois concluded that Abbott had failed to show that the patent claim was directed to a patent-ineligible natural phenomenon.

Abbott, in October last year, filed a complaint against Grifols Diagnostic Solutions and Novartis Vaccines and Diagnostics, seeking to invalidate US patent number 7,205,101.

The patent, called “Human immunodeficiency virus (HIV) nucleotide sequences, recombinant polypeptides, and applications thereof”, relates to the diagnosis, prevention, and treatment of HIV.

Novartis, which later acquired patent applicant Chiron, and Grifols Worldwide jointly own the ‘101 patent.

Grifols and Novartis hit back with claims of infringement, alleging that Abbott was infringing claim 7 of the patent. Abbott subsequently moved to dismiss the counterclaim.

However, Ellis was not persuaded by Abbott’s argument that claim 7 was invalid because it “impermissibly claims a natural phenomenon”.

Abbott argued that the patent was directed to a “product of nature”, ie “the HIV DNA strain identified by the inventors” in figure 4 of the ‘101 patent, “as opposed to a novel process for replicating DNA”.

But this was rejected by the court, which found that the plain language of claim 7 doesn’t “purport to claim a newly discovered HIV DNA sequence, let alone the particular DNA sequence identified in figure 4”.

Abbott also contended that the claim was “directed to” the replication of HIV DNA, which is a natural phenomenon.

“But this contention overgeneralises the claim and fails to consider the claim’s language,” said Ellis. “The fact that the subject matter of the claimed process, HIV DNA, may undergo replication in nature does not make claim 7 ‘directed to’ that ability.”

The judge added: “The claim does not recite a method that merely observes the replication of HIV DNA or detects the existence of such replication; rather, it recites a particular two-step method for replicating HIV-specific DNA that the inventors of the ‘101 patent believed was a solution to the problems accompanying the then-existing processes of replicating HIV DNA.”

The court denied Abbott’s motion to dismiss.

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