Teva plunges after US judge invalidates four Copaxone patents

Bloomberg

Teva Pharmaceutical Industries Ltd. plunged to the lowest in more than a decade following
a US court ruling that invali-dated four patents on its best-selling multiple sclerosis drug Copaxone.
The ruling may open the door to generic competition for a drug that generates a fifth of Teva’s $20 billion in annual sales. The introduction of two Copaxone copycats in the US could wipe out as much as $1.2 billion of revenue this year, according to the company’s own estimates. Teva pledged to appeal the decision in a statement.
The setback to Teva’s most precious prescription drug comes as the other arm of
its business — generic medic-ines — also struggles. The company cut its 2017 profit forecast earlier this month as prices drop for copycat treatments. Generic competition to Teva’s feature product would dim its outlook further and impair the company’s ability to swiftly pay d-own $35 billion of debt, an amount that now exceeds Teva’s market value.
Teva dropped as much as 7.6 percent in Tel Aviv to 120.40 shekels, the lowest since Feb. 28, 2005. It traded at 121.80 shekels at 10:39 a.m. local time. The original version of Copaxone, consisting of 20 milligrams taken every day, already has generic-drug competition but Teva has succeeded in switching many patients to the newer version.

NO DIFFERENT
The patents at stake, which expire in 2030, cover ways to administer the new Copaxone in a 40-milligram dosage three times a week. The judge found that’s no different than taking double the original 20-milligram dosage of a drug every other day. Teva owns a newly issued patent that also expires in 2030 and is similar to the four patents ruled invalid by US District Judge Gregory Sleet in Wilmington, Delaware.
The case next goes to an appeals court in Washington that specializes in patent law, which also will consider challenges that were filed with the US Patent and Trademark Office. The patent office has been taking a second look at the patents using a different legal standard. Last year, it said three of the patents were invalid and is considering whether to review the fourth patent.
Novartis AG’s Sandoz and Mylan NV are developing a generic of the thrice-weekly version of Copaxone, which awaits US regulatory approval. Shares of Mylan’s partner, Indian generic drugmaker Natco Pharma Ltd., rose 4.4 percent in Mumbai.
Teva, the world’s largest generic drug manufacturer, said it’s filed suit regarding the fifth patent on the drug, and also has sued numerous companies on an additional patent for a process to make the drug.
Teva claims the generic versions of the medicine would infringe those patents, and wants a court to block the competition until they expire.
Mylan said it believes it’s one of the first companies to apply to make a generic version of Copaxone. If so, it may be entitled to a six-month period of exclusivity where later-filing generic-drug makers are barred from entering the market.