The Novartis v. HEC patent case on the drug fingolimod is pending in the Supreme Court and has a unique history. Therefore, a group of retired federal appeals court judges wrote an amicus brief telling the Supreme Court that the Federal Circuit wrongly overturned its own previous decision by a newly reshuffled panel.
Procedurally, you may recall that the district court found that Novartis’s blockbuster multiple sclerosis patent on Gilenya (fingolimod) adequately described the invention and held that the patent was not invalid. A Federal Circuit panel of three judges, composed of Judge Kathleen O’Malley, Judge Richard Linn, and Judge Kimberly Moore, in a 2-1 decision upheld this ruling. HEC immediately requested a rehearing. In the meantime, Judge O’Malley, who had penned the majority decision, retired and was replaced by Judge Todd Hughes. This new panel of Judges granted the rehearing and overturned the earlier decision in a 2-1 vote, holding that the Novartis patent was invalid for lacking an adequate written description.
Panel rehearing is not uncommon, but a judge replacement during a rehearing is rare. The losing party almost always requests a rehearing, and it is granted a small percentage of times. Sometimes, the panel rehearing the case can revise its own decision as it did in GSK v. Teva case on section viii carve-out. However, a replacement of a retired panel judge in the same panel to rehear the case is rare. Still, it is more likely to happen in the future as almost a third of the currently seated judges are considering retirement. Only Federal Circuit and Ninth Circuit have a practice of replacing judges while the case is in the rehearing phase. Therefore, the amicus asks the Supreme Court for consistency through all the appeals courts and also asks that decisions rendered by judges before they depart the bench be given the same respect and rules as those penned by their remaining colleagues because they cannot remain on the bench forever to fight for their decisions. As the Supreme Court once wrote, “federal judges are appointed for life, not for eternity.”
Regardless of the merits of a patent, a three-member panel of reshuffled judges should not be permitted to overturn a previous decision because, on a three-judge panel, a single judge’s vote will make all the difference. A better approach after a judge’s departure can be to either rehear the case en banc if there is a particular issue on the law or to simply deny the rehearing unless the remaining two judges on the panel both agree to rehear the case. The losing party has the right to file certiorari with the Supreme Court. A link to the amicus brief can be found here.