Teva records another victory in US Supreme Court Copaxone ruling

The US Supreme Court has vacated an appeals court judgment that invalidated a patent covering Teva’s blockbuster drug Copaxone (glatiramer acetate).

In an opinion published today (January 20), the court said that the US Court of Appeal for the Federal Circuit’s decision to invalidate a patent protecting the $4-billion-a-year multiple sclerosis drug should be vacated, and remanded the case for further review.

It is the latest development in the patent war between Israel-based pharmaceutical company Teva and generic drug makers Sandoz and Mylan.

The case hinged on the construction of one of the patent’s claims.

Sandoz argued that the patent was invalid and that a claim covering the molecular weight of the drug’s active ingredient was “fatally indefinite” because the claim did not state how it was calculated.

After the US District Court for the Southern District of New York ruled that the patent claim was sufficiently definite, and that Teva’s patent was valid, Sandoz, seeking to make a version of Copaxone, appealed against the decision to the Federal Circuit.

Upon reviewing the claim construction de novo, the Federal Circuit agreed with Sandoz and invalidated the patent.

Teva then filed a petition for certiorari, seeking the Supreme Court’s determination on whether the Federal Circuit should have reviewed the construction of the patent’s claim de novo or only for clear error.

The court held oral arguments on the case in October last year.

In a 7-2 decision, the Supreme Court held that the Federal Circuit should have applied a clear error standard of review, rather than de novo.

The decision means that the disputed patent, US number 5,800,808, is again valid. It is due to expire in September.

Teva’s president and chief executive Erez Vigodman said: “We are encouraged by the US Supreme Court’s decision and look forward to the Federal Circuit’s review.

“We will continue to explore all available avenues to protect our intellectual property for Copaxone proprietary, a global market leading product for the reduction in the frequency of relapses in patients with relapsing forms of MS, over the product’s lifecycle.”

A spokesperson for Sandoz told LSIPR that the company was evaluating the ruling, but could not comment further.

Mylan’s chief executive Heather Bresch said in a statement: “We continue to believe that the ‘808 patent is invalid as indefinite and we will address that issue with the Federal Circuit Court of Appeals. Nevertheless, Mylan’s global platform has consistently demonstrated that our success is not about any one product. With that said, we look forward to bringing our generic version of Copaxone to market.”

Felicia Boyd, a partner at law firm Barnes & Thornburg in Minneapolis, said that from the oral arguments it was clear the Supreme Court was likely to change the review standard, so the ruling was not unexpected.

“The Federal Circuit will need to review the record and the district court's decision again, likely with additional briefing by the parties, with the proper review standard in mind. With that standard and the record evidence, it is possible that the Federal Circuit will affirm the district court's decision,” she added.

“The Federal Circuit properly used the de novo standard for many claim construction decisions,” Boyd continued. “The standard remains appropriate. Even after the Teva decision, where the record for claim construction is limited to the patent, the patent claims and the prosecution history, the review standard will continue to be de novo. Where claim construction includes ‘evidentiary underpinnings’ outside of these materials, the standard of review will be a mixed standard."

Boyd said it is likely that companies locked in litigation will now focus, at the district court level, on developing factual evidence for the district court to consider in the claim construction process.

“This may narrow the Federal Circuit's subsequent review of the decision and result in more affirmances,” she said.