Alexion Gains Patent Protection Extension for Rare-Disease Drug

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The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

On August 15, 2017, Alexion Pharmaceuticals announced that the US Patent and Trademark Office (USPTO) issued three patents to Alexion, which extends patent protection for the company’s rare-disease drug, eculizumab, for the next 10 years. The USPTO issued U.S. Patents No. 9,732,149; 9,718,880; and 9,725,504, which are directed to the composition of matter of eculizumab (marketed under the brand name Soliris), pharmaceutical formulations of eculizumab, and methods of treating paroxysmal nocturnal hemoglobinuria (PNH) with eculizumab, respectively. The patents will expire in 2027.

“Alexion is the leader in complement biology and has invested decades of ground-breaking research and development in Soliris. We continue to strengthen our patent portfolio around this unique complement inhibitor,” said Ludwig Hantson, CEO of Alexion in a company press release. “These new patents work in concert with other patents and regulatory exclusivities to protect Soliris in all indications.”

The new composition-of-matter patent is directed to the full-length amino acid sequence of eculizumab and covers molecules that contain the same sequence. The new formulation patent is directed to pharmaceutical compositions that contain eculizumab, independent of their intended use. The new method-of-use patent is directed to treating PNH with eculizumab, and supplements other patents that are directed to treating atypical hemolytic uremic syndrome (aHUS) and other complement-mediated diseases with eculizumab.

Alexion is pursuing corresponding patent applications in other regions and countries, including Europe and Japan. In addition, Alexion is pursuing patent applications for pending additional indications of Soliris, such as for treating refractory generalized myasthenia gravis (gMG).


Soliris is approved in the United States, European Union, Japan, and other countries for treating PNH and aHUS. In addition, Alexion has submitted applications in the US, EU, and Japan for Soliris as a potential treatment of refractory gMG in patients who are anti-acetylcholine receptor (AChR) antibody-positive. In June 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for this new indication. Soliris is not indicated for treating patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).

Source: Alexion Pharmaceuticals