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April 18 — AbbVie, which sells the world's best-selling drug Humira under a license with MedImmune, told a federal district court April 15 it shouldn't have to keep paying royalties because the patent covering Humira is invalid.
AbbVie reported $13 billion in global sales for the arthritis drug in 2015, which is 61 percent of AbbVie's total sales, according to Sam Fazeli, senior industry analyst for Bloomberg Intelligence.
In litigation filed in the U.S. District Court for the District of Maryland, AbbVie said it has been paying royalties on a license to make and sell Humira since 2003 and that the remaining patent covered by the license agreement is invalid under the doctrine of double patenting because it is identical to a patent that expired in 2011.
The elimination of Humira royalty payments could help AbbVie's financials. Fazeli noted that AbbVie's 2020 forecast is based on its projection that Humira will by then represent at least 50 percent of AbbVie's sales in spite of competition from the just-approved Inflectra, a biosimilar of Johnson & Johnson's Remicade and a competitor of Humira (10 LSLR 08, 4/15/16), and Amgen's planned biosimilar of Humira (10 LSLR 03, 2/5/16). Celltrion developed Inflectra and Pfizer is marketing it.
According to the complaint, Cambridge Antibody Technology Ltd. (CAT) and Knoll AG entered into a development and license agreement in 1995 to develop therapeutic human antibodies. The collaboration led to the antibody adalimumab, the active ingredient in Humira.
Under the 1995 agreement, Knoll received a license from CAT to certain patents claiming priority to International Patent Application No. PCT/GB91/01344, including U.S. Patent Nos. 6,248, 516 and 7,306,907 , and agreed to pay royalties on sales of antibodies resulting from the collaboration, including Humira.
AbbVie is Knoll's successor-in-interest under the agreement, and MedImmune is CAT's successor-in-interest as a result of AstraZeneca merging CAT into MedImmune upon acquiring both (1 LSLR 125, 4/27/07).
AbbVie said in the complaint that the '516 patent was filed on June 6, 1995, issued on June 19, 2001, and expires on June 19, 2018. The '907 patent was filed on Nov. 8, 2002, issued on Dec. 11, 2007, and expired in November 2011.
The two patents list the same inventors and owners, AbbVie said, and are identical except for the claims: Those of the '516 patent are directed to either methods for generating expression libraries or the resulting expression libraries, and those of the '907 patent are directed to methods of making an antibody to a target antigen by generating an expression library.
“Thus, the claims of the '516 and '907 patents are patentably indistinct,” AbbVie wrote.
And yet, AbbVie said, “the '516 patent expires more than six years after the '907 patent. The '516 patent thus provides MedImmune with an unjustified and improper time-wise extension of the right to exclude others from practicing the invention claimed in the '907 patent and its obvious variants. The '516 patent, therefore, violates the doctrine against double patenting and is invalid.”
Double-patenting prevents a patent owner from obtaining extended patent terms over inventions that aren't patentably distinct from each other. It is usually found when a patentee files a series of applications with different expiration dates for similar or identical inventions.
AbbVie asked the court for a declaratory judgment that each of the claims of the '516 patent is invalid and for a speedy hearing.
AbbVie is based in North Chicago, Ill. MedImmune is based in Gaithersburg, Md.
MedImmune declined Bloomberg BNA's e-mail request for comment.
The complaint was filed by Kramon & Graham P.A., Baltimore, with Munger, Tolles & Olson LLP, Los Angeles, of counsel.
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