Rival Claims Novartis Tried to Patent the Hep C Virus

SAN FRANCISCO (CN) — A Chicagoland pharmaceutical company claims in court that Swiss drug giant Novartis “has sought to patent the hepatitis C virus, itself,” so that anyone who tries to study or cure the disease must license the Novartis patents.

In its March 31 federal complaint, AbbVie, of North Chicago sued Novartis Vaccines & Diagnostics and Grifols Worldwide Operations, of Spain and Ireland, claiming Novartis’ so-called “inventions” are based on “natural laws” and not patentable under U.S. Supreme Court precedent.

AbbVie challenges 11 patents relating to the study and treatment of hepatitis C.

“In essence, Novartis has sought to patent the Hepatitis C virus, itself, so that anyone seeking to use or study the virus in order to invent new therapies must license the Novartis patents,” AbbVie says in the 39-page complaint.

In the past, treatments for HCV, such as Interferon, had success rates hovering around 50 percent and came with a host of negative side effects, including nausea, fatigue and depression.

AbbVie says it “invested immense resources” to develop new HCV therapies that can cure HCV in weeks with few side effects, and success rates exceeding 95 percent. One of those therapies is a once-daily pill called Viekira XR, approved by the FDA in July 2016. AbbVie also introduced Technivie, a combination HCV therapy, in July 2015, and Viekira Pak, a twice-daily pill, in December 2014.

AbbVie say Chiron Corp., which was acquired by Novartis in 2006, pushed “an aggressive licensing program, demanding that any company seeking to undertake research in the area of HCV therapies” pay for its suite of patent licenses.

AbbVie says that when it agreed to pay Chiron for patent licenses in 2002, the U.S. Patent and Trademark Office had a common practice of granting patents covering “naturally occurring” biological sequences and conventional methods for working with them.

But recent Supreme Court rulings have changed that approach, holding that discoveries based on “natural laws” and phenomena are not patent-eligible, AbbVie says in the complaint.

AbbVie cites three recent Supreme Court rulings, starting with Mayo Collaborative Services v. Prometheus Laboratories in 2012. That ruling invalidated the patent for a dosage test for autoimmune disease treatments, finding it relied too heavily on a “natural law” without sufficient steps to avoid inhibiting research or preempting the use of that natural law in the future.

In the 2013 ruling in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court partially invalidated patents based on the location and sequence of genes that identify an increased risk of breast or ovarian cancer. The Supreme Court found that Myriad could not patent that invention because the company neither created nor altered the composition of the naturally occurring genetic information.

AbbVie also cites the 2014 ruling in Alice Corp. v. CLS Bank International, which found the use of a computerized platform to eliminate “settlement risk” was based on an abstract idea, and therefore not patentable

AbbVie says in the new lawsuit that Novartis has acknowledged in declarations filed in previous lawsuits that “the novel aspect” of its patented methods and inventions is “the genomic sequence of HVC.”

AbbVie says Novartis cannot “recite minor variations” to make its inventions “‘markedly different’ from what exists in nature” because such tactics have been summarily rejected by the Supreme Court.

“Indeed, the heart of every claim of the Novartis patents is directed to the naturally occurring genomic sequence of HCV,” AbbVie says. “The mere recitation of routine and conventional techniques or research tools that were widely known at the time does not avoid that analysis, let alone establish patent eligibility.”

AbbVie asks the court to invalidate three groups of 11 Novartis-owned patents related to hepatitis C research and treatment. It is represented by Gregory Sobolski of Latham & Watkins in San Francisco.

Novartis did not immediately respond to an email seeking comment Monday.

AbbVie reported $25.6 billion in revenue last year; Novartis reported $48.5 billion in sales, according to recent financial reports.

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