Sleet Upholds Patent for Anti-Inflammatory Drug, Blocking Generic

A Delaware federal judge on Tuesday upheld the validity of Shire Orphan Therapies' patent for Firazyr, blocking a Germany-based pharma company from launching a planned generic version of the anti-inflammatory drug until 2019. The ruling from U.S. District Judge Gregory M. Sleet of the District of Delaware rejected the argument that Shire's patent was invalid as an "obviousness-type double patenting." The German pharma company, Fresenius Kabi, argued in extensive post-trial briefing that Shire tried to extend its term of exclusivity on the groundbreaking drug by obtaining a second patent with only slight variations from the first. The opinion comes in the wake of a four-day January bench trial. Sleet found key chemical differences between the two, even though both patents shared "some inventors and are assigned to the same company." He also cited the commercial success and long-felt need for Firazyr in finding that Shire's drug was not obvious. Under the ruling, Fresenius will not be able to launch its generic until Shire's patent expires in July 2019. The Irish drugmaker had sued Fresenius in 2015 to generic competition for Firazyr, which is used to treat acute attacks of hereditary angioedema—or HAE—in adults with an injection under the skin, prompting the challenge from Fresenius. In his analysis, Sleet said his finding was supported by evidence that Firazyr was the first safe, convenient and effective self-administered treatment for acute attacks of HAE, a potentially life-threatening condition that causes severe swelling of the limbs, face, intestinal tract and airway. According to Sleet's opinion, the benefits of the treatment also translated into commercial success, which also stood in "stark contrast" to Fresenius' obviousness argument. In addition to outperforming other treatments, Firazyr has generated more than $1.2 billion in global operating income with a roughly 74 percent profit margin and was available at $1,000 to $3,000 less than competing treatments per attack, according to the ruling. "The court finds that Firazyr is a commercial success due to its safety, convenience and efficacy, compared to other acute treatments, as evidenced by its sales, profitability and share of the acute HAE market," Sleet wrote in a 48-page memorandum. Sleet's ruling also held that Shire had not tried to game the statutory patent system under the doctrine of prosecution laches by unreasonable or unexplained delay in prosecuting the patent. Both issues were "relatively rare" for a court to touch on, said Ed Haug of Haug Partners, the New York firm representing Shire in the case. Haug called the ruling a "very well-reasoned opinion," which would have a significant impact for Shire and Sanofi-Aventis, which owns the patent-in-suit. "This is of significant commercial value to Shire and Sanofi as the annual sales of Firazyr exceed about 500 million," Haug said in a statement. Counsel for Fresenius did not return a call Wednesday seeking comment on the decision. Shire was also represented by Daniel G. Worley Jr., Elizabeth J. Murphy, Laura Chubb and Sandra Kuzmich of Haug Partners and Jack B. Blumenfeld and Derek J. Fahnestock of Morris, Nichols, Arsht & Tunnell. Fresenius was represented by John W. Shaw, Karen Elizabeth Keller, Jeffrey Castellano and David M. Fry of Shaw Keller in Wilmington and Charles T. Cox Jr., Daryl L. Wiesen, John Coy Stull, Kathleen McGuinness, Samuel Sherry and William G. James of Goodwin Procter. Cox, Stull and James are Washington-based, while Wiesen, McGuinness and Sherry are Boston-based. The case was captioned Shire Orphan Therapies v. Fresenius Kabi.