Generic Copaxone Wins in Federal Circuit: Teva’s Patent Loss and Its Immediate Effects
On October 12, 2018, the United States Court of Appeals for the Federal Circuit ruled in favor of generic drug manufacturers in a series of cases, collectively known as the Copaxone Consolidated Cases.[1] Copaxone is an injection treatment for relapsing-remitting multiple sclerosis (“RRMS”).[2] RRMS is a form of multiple sclerosis (“MS”), which is an autoimmune disorder that causes the body to attack its own nervous system.[3] RRMS is characterized by attacks, called relapses, followed by a period of partial or complete recovery, called remission.[4] Copaxone’s main ingredient is glatiramer acetate (“GA”) which targets RRMS relapses.[5] Various clinical trials conducted by Teva and others, between the years of 1987 and 2009, established that a dosage of 40mg GA every other day over the course of one week is just as effective as a dosage of 20mg a day over the course of one week.[6]
Generic drug manufacturers—the defendants/appellees in this case—submitted Abbreviated New Drug Applications (“ANDAs”) to the FDA for approval to manufacture generic versions of Copaxone at 40mg doses administered three times a week.[7] The District Court of Delaware ruled in favor of the defendants on January 30, 2017.[8] In October 2017, the FDA approved Mylan’s, one of the generic manufacturers, generic version of Copaxone.[9] At this time, Teva’s stock price fell by 11%, while Mylan’s stock price rose 18%.[10] The drug’s injection form classified it as a “complex generic drug” by the FDA, forcing Mylan to spend “many years” of work to bring the generic drug to the market.[11] In July 2018, when Mylan drastically dropped the price of their generic Copaxone from $5,000 to $1,950,[12] resulting in a plummet of the U.S. sales of the drug for Teva, as well as similar drugs from other generic companies.[13]
The main issue on appeal in the Federal Circuit was whether, under 35 U.S.C. § 103(a), the 40mg GA dosing regimen was obvious to try “to a person having ordinary skill in the art.”[14] The court identified the “obvious to try” standard as “when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options…” [15] The court found that, since Teva only offered two effective dosages in their patent and they did not fall into an exception to KSR, the district court did not err in its finding that the 40mg regimen used by the generic manufacturers satisfied the “obviousness” test.[16] The court also noted that “conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.”[17]
MS drugs are incredibly expensive, which limits their accessibility to those suffering from the debilitating and incurable disease.[18] The first wave of MS drugs were released in the 1990s and ranged in price from $8,292 to $11,532.[19] Since then, costs of the drugs have increased more than 30% annually.[20] Mylan’s generic version of GA, priced lower than Teva’s Copaxone, may help patient gain access to MS treatment, but the difference chemically is not substantial.[21] It typically takes “four to six manufacturers before competition starts to drive down costs significantly.”[22] Hopefully, the effect of the Copaxone Consolidated Cases decision lead to an increase in generic competitors, leading to greater accessibility to treatment for MS patients.
Footnotes
