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Teva Pharmaceuticals will not suffer irreparable harm when a court removes the patent on its MS drug Copaxone next month, the Supreme Court said.

Loss of profit not 'irreparable harm' to Teva: Supreme Court

By Joe Carlson
Posted: April 21, 2014 - 6:45 pm ET

Teva Pharmaceuticals is likely to lose millions of dollars in revenue when a court removes the patent next month on its popular multiple sclerosis drug Copaxone.

But the U.S. Supreme Court's chief justice has ruled that the loss would not be “irreparable harm” if it later turns out Teva's patents were valid after all.

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The case, Teva Pharmaceuticals v. Sandoz, centers on whether an appeals court can disregard legal conclusions from lower-court judges.

The Jerusalem-based company has a decent chance of winning its case, John Roberts wrote (PDF), but that's not enough reason to keep the patent in force during the litigation.

Roughly 80% of all prescriptions filled in the U.S. are for generic drugs, which tend to cost about 80% less than the branded equivalents, according to the Food and Drug Administration. That wide use of generics is expected to accelerate after 2015, when several branded blockbuster drugs are slated to go off-patent.

Teva sells about $3 billion worth of Copaxone a year under patents scheduled to expire Sept. 1, 2015. But the U.S. Court of Appeals for the Federal Circuit issued a decision last year that effectively removed the patent on May 24, 2014. The Israeli company said in court filings that its Copaxone sales would be severely impacted by the decision to lift the patent early because generics-makers Sandoz and Momenta Phamaceuticals are planning to launch generic equivalents as soon as they can get FDA approval.

The Supreme Court has already agreed to decide whether Teva's patent is valid, but the justices granted oral arguments for the court's term that starts in October—five months after the patent lifts on a drug that does $250 million per month in average sales.

Attorneys for Teva had asked the high court to keep the patent in force by staying a July 26, 2013 decision from the federal appeals court. The Federal Circuit court ruled against Teva on a highly technical question of whether the company had adequately described the molecular weight of an active ingredient in Copaxone known as Copolymer 1 in its drug patents.

Roberts, who handles urgent legal requests arising from the Federal Circuit, ruled that Teva “has shown a fair prospect of success on the merits” of its case. But if it does win, Teva will be able to recover normal patent-infringement damages against Sandoz and Momenta, undermining the claim that Teva will suffer the “irreparable harm” if the Federal Circuit ruling is allowed to stand.

“Given the availability of that remedy, the extraordinary relief that Teva seeks is unwarranted,” Roberts wrote.

Regardless of the court fight, the company may get some reprieve through a lengthy FDA approval process.

In a public statement, Teva officials noted that Sandoz and Momenta will need FDA approval before they can sell their “purported generic” version of Copaxone—a process that may be complicated by the legal struggle to define the drug's active ingredients.

“The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints,” such as the relapse rate in patients with multiple sclerosis, the Teva statement says.

Sandoz officials said they're already working with FDA officials on approval for the drug.

“We continue to believe the U.S. Federal Circuit Court of Appeals correctly invalidated several patents asserted by Teva,” a company statement says. “Together with our collaboration partner Momenta, we continue to work with FDA to secure approval of our affordable, high-quality generic version of Copaxone when the remaining Teva patents expire on May 24, 2014."

Officials with Momenta in Cambridge, Mass., didn't respond to requests for comment Monday. Sandoz is owned by Swiss international drugmaker Novartis AG.

Follow Joe Carlson on Twitter: @MHJCarlson

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