ITC Says Novo Nordisk Hemophilia Drug Infringes Baxter Patent

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By John T. Aquino

March 11 — Novo Nordisk's hemophilia drug Novoeight infringed claims of a Baxter International Inc. patent, a U.S. International Trade Commission court ruled in an opinion released March 7.

The ITC administrative law judge's determination was issued in late February, but wasn't released until March 7. On March 9, the court posted a redacted version of Novo Nordisk's petition for a review of the infringement determination that asked the ITC to rework the claim construction ruling in accordance with the plain meaning of the terms at issue and, consequently, to reverse the court's patent infringement ruling (In the Matter of Certain Recombinant Factor VIII Products, I.T.C., Investigation No. 337-TA-956, redacted petition for review 3/9/16).

A May 2015 study by Frost & Sullivan found that the global hemophilia treatment market earned revenues in 2014 of $9.9 billion and estimated that they would reach $13.4 billion in 2019.

U.S. companies and foreign companies with a U.S. presence have increasingly turned to the ITC as a forum to litigate patent infringement disputes because an ITC investigation can lead to swift resolution of disputes and the granting of broad exclusion orders ( 5 LSLR 1174, 12/2/11). Novo Nordisk is a Danish company; its U.S. subsidiary, Novo Nordisk Inc., has offices in Plainsboro, N.J. Baxter International Inc. and Baxter Healthcare Corp. are based in Deerfield, Ill., and Baxter Healthcare SA is based in Switzerland.

District Court, Then ITC Filing

On March 26, 2015, Baxter filed litigation in the U.S. District Court for the Northern District of New Jersey, alleging that Novo Nordisk's Novoeight (turoctocog alfa), a recombinant factor VIII treatment for hemophilia A, infringed eight patents.

Baxter filed an ITC complaint on April 16, 2015, alleging violations of Section 337 of the Tariff Act by reason of Novo Nordisk's infringement of U.S. Patent Nos. 6,100,061, 6,936,441 and 8.084,252 by its product Novoeight.

The district court litigation was stayed on June 18, 2015, pending the resolution of the ITC proceedings.

Claim 19 of the ‘061 patent reads:

A method of producing a recombinant product under serum- and protein-free conditions on a large technical scale comprising the steps of

providing an isolated, stable recombinant original cell clone, said original cell clone being stable in serum- and protein-free medium for at least 40 generations and expressing a recombinant product,

multiplying said original stable cell clone in serum- and protein-free medium so as to obtain a cell culture,

culturing said cell culture containing stable cells in a bioreactor, thereby obtaining said recombinant product, and

harvesting said recombinant product from supernatant of said cell culture.

The parties disagreed over the meaning of several terms in the claim.

ITC Court Construes

The ITC court, in a ruling by Administrative Law Judge Dee Lord, construed the term “protein-free conditions” to mean “conditions that do not include any protein-containing additives of human or animal origin that could potentially cause contamination”; “protein-free medium” to mean “a medium that does not contain any protein containing additives of human or animal origin that could potentially cause contamination”; and “stable” to mean “maintaining the ability to express a product over a number of generations.”

Baxter moved for summary determination of infringement. As a result on the meanings the court gave to the disputed terms, Novo Nordisk conceded that, under those definitions, it did infringe the claims-at-issue of the ‘061 patent.

With Novo Nordisk not disputing infringement, the court granted Baxter's motion for summary determination of infringement.

Novo Wants ‘Plain Meaning' of Terms

In its petition for a review of the ruling, Novo Nordisk wrote, “It is black-letter law that a proper claim construction must ‘stay true' to the language of the claim. Thus, there is a ‘heavy presumption' that the ordinary meaning of claim terms expressed in plain language will control. The plain meaning can be overridden only if the patentee acts as his own ‘lexicographer' to redefine a claim term contrary to its ordinary meaning or disavows claim scope. Nothing of that sort took place here.”

Baxter's former BioScience business was spun off into the independent company Baxalta Inc. on July 1, 2015. Neither Baxalta nor Novo Nordisk immediately responded to Bloomberg BNA's e-mail requests for comment.

Baxter was represented by Adduci, Mastriani & Schaumberg, LLP, Washington, and K&L Gates, Chicago and Irvine, Calif.; and Novo Nordisk by Foster, Murphy, Altman & Nickel, P.C., Washington.

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information 
The ITC judge's written decision, dated Feb. 26, 2016, but released in a public, redacted version on March 7, is at