Chief Justice John G. Roberts, Jr., refused on Friday afternoon to delay generic drug manufacturers from offering, as early as next month, competing and lower-priced versions of a widely used drug for treating multiple sclerosis.  In a one-page ruling, Roberts said he was not convinced that Teva Pharmaceuticals USA, Inc., would suffer serious harm from the competition because it can later sue the generic companies for damages if its key patent on the drug Copaxone is ultimately upheld.

The generic companies will be in position to enter the market with their versions as of May 24, if they receive final approval from the government by then to do so.  In any event, they have indicated that they plan to start selling their products within a matter of weeks.  One major consideration for company executives, as they make their plans, will be the prospect of potentially having to pay Teva damages that could run into the hundreds of millions of dollars, if they ultimately lose the current fight over the validity of Teva patents on Copaxone.

Technically, under the Court’s rules, Teva could take its plea for protection from its rivals to another Justice, but getting a favorable result from that maneuver is not a strong prospect.

Teva has brought in huge revenues — sometimes as much as $4 billion a year, most of it profit — from selling Copaxone.  It has held a series of patents on that drug which have given it a monopoly over its distribution.  The first several patents are due to expire on May 24, but the patent that Teva regards as its key protection is not due to expire until September 15 of next year.

That longer-running patent has been ruled invalid by the special federal appeals courts that handles patent cases, the U.S. Court of Appeals for the Federal Circuit.  The Supreme Court has agreed to review that appeals court decision, but its agreement to do so apparently added nothing to Teva’s plea to the Chief Justice to put that ruling on hold while the Justices review it — something they will not do until their next Term, starting in October.

Before the Court had agreed to take on that case, Teva had asked the Chief Justice — in his role as the Circuit Justice for the Federal Circuit — to delay the lower court ruling.  Roberts refused to do so.  After the appeal was accepted for review, Teva renewed its plea to Roberts.  He had the authority to decide the issue of delay on his own, and he did so, apparently deciding not to share the task with his colleagues.

What Teva is most concerned about, it told the Chief Justice, was that the generic companies will put their cheaper version of Copaxone on the market, and start absorbing the market for that drug, even as Teva seeks to revive the validity of its more important patent.

The company’s generic company rivals had urged the Chief Justice not to delay their entry into the market, saying that Teva had asked for the wrong kind of legal relief and, in any event, was not entitled to any.  The Court’s willingness to review the Federal Circuit decision striking down the key patent is not a guarantee that Teva ultimately will win its pending appeal.

Although Roberts said he thought Teva had a “fair” chance of getting the key patent revived, that conclusion does not bind the Court when it actually takes up the issue of the Federal Circuit’s ruling.  That case will be pursued by full briefing and oral argument at its next Term.

Moreover, the rivals argued, Congress has long been interested in encouraging makers of generic versions of drugs to get their products to the market, so that consumers can get the benefit of lower prices as soon as possible. Commonly, generic drugs are sold for considerably less than brand-name, patented drugs.

In the Chief Justice’s opinion issued Friday denying Teva’s plea for temporary protection, he said that company was asking for “extraordinary relief.”  While he noted that the Court had agreed to review the validity of Teva’s major patent, and while he said the company had shown “a fair prospect” that it would win its appeal, its plea for temporary protection faltered on its failure to show that it would suffer “irreparable harm.”

The generic companies, he said, had agreed “that, should Teva prevail in this Court and its patent be held invalid, Teva will be able to recover damages from [them] for past patent infringement” — that is, presumably, infringement of the key patent that, if revived, would be in effect until September 2015.

 

Posted in Teva Pharmaceuticals USA v. Sandoz, Featured, Merits Cases

Recommended Citation: Lyle Denniston, Court won’t block Teva rivals, SCOTUSblog (Apr. 18, 2014, 4:04 PM), http://www.scotusblog.com/2014/04/court-wont-block-teva-rivals/