The U.S. Patent and Trademark Office’s has agreed to review patents covering a drug used to treat rare blood disorders.
On Friday, the USPTO’s Patent Trial and Appeal Board announced in documents on its website that it would institute an inter partes review regarding Boston-based Alexion Pharmaceuticals’ drug Soliris (eculizumab), used to treat the disease paroxysmal nocturnal hemoglobinuria, or PNH, after Thousand Oaks, California-based Amgen filed a petition for the IPR. The biotech company has been developing a biosimilar version of Soliris called ABP 959, which is currently in a Phase III study enrolling up to 40 PNH patients.
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Shares of Alexion fell more than 11 percent on the Nasdaq Friday following the news. Soliris had sales of $3.6 billion last year, and in addition to PNH is also approved for atypical hemolytic uremic syndrome, or aHUS.
IPR is a legal proceeding that was created under the America Invents Act in 2012 and is a way to challenge the validity of a patent before the USPTO. In a statement emailed by a spokesperson, Alexion noted that the IPR process takes about 12 months, and a final outcome is expected about 18-24 months from now. The company said it was “disappointed” that the USPTO instituted IPR proceedings to review three of the patients covering Soliris in PNH that cover composition of matter, formulation and methods of use in the disease.
“However, the institution of these proceedings does not predict the outcome of the case. We strongly believe in the strength of our patents and will vigorously defend them in the course of the IPR proceeding,” the statement read.
Amgen declined to comment.
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Ahead of Soliris’ eventual patent expiration, Alexion has also launched a successor drug, Ultomiris (ravulizumab-cwvz), which belongs to the same class but is longer-acting than Soliris. In its statement, the company said data demonstrate a “strong preference” among PNH patients for Ultomiris, based on its being dosed every eight weeks, compared with every two weeks for Soliris. Ultomiris won approval for PNH last year and is in development for aHUS and other diseases as well.
Photo: Chris Ryan, Getty Images
