The blockbuster baby-saver Synagis may be more profitable if this week?s ruling by the U.S. Patent Office holds.
MedImmune has fought for three years against a California company?s patent on the process by which it makes Synagis. The Patent Office rejected the Cabilly patent of San Francisco-based Genentech Feb. 21. However, MedImmune must continue paying royalties on the drug pending the results of its antitrust suit.
MedImmune officials would not disclose how much they pay a California biotech firm in royalties related to the production of Synagis ? a blockbuster drug that prevents hospitalizations in some vulnerable newborns.
Genentech announced it would fight a U.S. Patent Office decision rejecting its claims on the Cabilly patent ? a process MedImmune uses to produce Synagis.
Since its approval in 1998, Synagis has been administered to more than 800,000 patients, said MedImmune spokeswoman Jamie Lacey. “It?s an important medicine. It serves a vital purpose.”
Known by the generic name palivizumab, Synagis is an indictable antibody that fights respiratory syncytial virus, according to the MedImmune Web site. It is administered monthly in children born premature or with heart or lung conditions in order to prevent the serious lower respiratory tract disease.
The most common cause of bronchiolitis and pneumonia among infants and children less than 1 year old, the virus can cause fever, runny nose, cough and sometimes wheezing, according to the Centers for Disease Control and Prevention. Most children recover in eight to 15 days.
“These children don?t have developed immune systems like we do,” Lacey said. Rather than vaccinating them and waiting for their body to develop a response, Synagis provides the antibodies directly and must be readministered as a protective measure.
Although the Patent Office ruling bolsters MedImmune?s three-year battle with Genentech over the drug-making process, the war is not over. A concurrent civil suit in the federal courts seeks to determine unfair competition and antitrust allegations made by MedImmune.
Genentech issued a statement that they plan to aggressively appeal the patent office?s decision.
“The patent remains valid and enforceable through the appeals process,” the statement read. “The company estimates that the entire appeals process may take approximately one to two years, or longer.”
An SEC Commission filing by the company indicates they derive significant income from royalties on patents, and losing those patents could harm their business.
