The Copaxone Trial

Generic challengers face an uphill battle in their challenge of Teva’s Copaxone patents on indefiniteness, but Teva’s statements on the difficulty in manufacturing Copaxone could hurt them in a potential patent enablement argument, patent attorneys said.

Teva is presently engaged in an ANDA patent infringement litigation with generic challengers Sandoz and Momenta (NASDAQ:MNTA). The lawsuit was filed by Teva on 28 August 2008, and asserts four patents covering Copaxone, Teva’s multiple sclerosis drug. The case is currently pending in a New York federal court. In addition, Teva announced in a press release today that it has also sued Mylan (NASDAQ:MYL) again for infringement of several patents covering Copaxone. Teva had previously sued Mylan in October 2009 with respect to patents covering the chemical composition of Copaxone.

On 7 September 2010, the district court judge presiding over the case denied a motion for summary judgment filed by Sandoz and Momenta, which argued that the patents asserted by Teva are invalid due to indefiniteness. A summary judgment motion can be granted when there is no remaining material issue of fact with respect to the issues raised in the motion. The court has not yet set a trial date for the litigation.

Indefiniteness Arguments

The indefiniteness argument in Sandoz and Momenta’s summary judgment motion relates to whether the patents at issue teach the claimed molecular weight, and whether someone with ordinary skill in the art could understand the scope of what the claimed molecular weight of the compound should be, said Robert Gould, a partner at Duane Morris. It will be an “uphill battle” for the generics to prevail on this argument at trial as the molecular weight is a well-understood term, while the standard for prevailing is clear and convincing evidence.

It is not surprising that the defendants lost on summary judgment, said Thomas Haas, counsel at Sullivan & Worcester. It will be difficult for the challengers he added, noting that Teva probably has the advantage, although the arguments will be very fact-intensive. He noted that the generics’ failure to present their own expert arguments as part of the summary judgment motion was a weakness for the defendants’ motion.

Patent Attorneys Provide Insight

Kirby Drake, a senior associate at Klemchuk, agreed and noted that the judge was not persuaded by the defendants’ summary judgment argument on indefiniteness. The lack of experts on the defendants’ part probably hurt the motion, she added. However, she said that having an expert may not have changed the judge’s opinion. “My impression is that the judge did not buy the indefiniteness argument based on the prior art and file histories, as it looks like it is known from the patent that the molecular weight is the peak average,” Drake explained. The defendants are unlikely to prevail on this argument at trial, she said.

However, Laura Masurovsky, a partner at Finnegan Henderson said that the indefiteness argument is the strongest argument for the generics. She added the generics however, do face a “tough road” in establishing obviousness of patents. A spokesperson for Teva stated via e-mail: “Given the complexity of Copaxone, we do not believe it is possible to prove sameness with this product. On the questions of enablement or non-infringement we disagree with these claims and plan to vigorously defend our patents.”

Another attorney said that both sides will likely continue to debate the indefiniteness argument at trial. According to this attorney, it is likely that Teva will not prevail at trial, whether due to indefinites or enablement, because of Teva’s overreaching regulatory premise that "no one else" can figure out how to manufacture Copaxone. Based on patent law, which requires that a valid patent enables one of ordinary skill in the art to make and use the claimed invention, Teva cannot simply rely on in-house knowledge and trade secrets, the source said.

Enablement Problems in Copaxone Trial

The source added that there may be an enablement problem, prior art problem, or further indefiniteness problem that Teva’s patents do not adequately teach the claimed invention. It will be a “battle of experts” at trial, the source said. There is an enablement issue based on presiding Judge Jones’ description of the patent claims, and “I would push the enablement issue if I were the generics,” the source said. Other sources agreed that Teva’s statements on the difficulty of manufacturing generic Copaxone could present an enablement issue at trial. Teva has publicly said that the product is so complicated to develop and manufacture that other companies developing a generic would be unable to make a bioequivalent from the patent, said Howard Susser, a partner at Burns & Levinson added that the judge may want expert testimony at trial on the indefiniteness issue, which could have an impact on the matter. Susser. Haas added that this argument could be turned against Teva at trial in terms of an enablement or best mode argument.

Copaxone Trial Defenses

With respect to non-infringement, the defendants may be able to come up with products that are outside of the claimed molecular weight and do not infringe, said Gould. This is a good defense for the litigation, he added, but noted that getting FDA approval for genetic products at different molecular weights could be a challenge. Drake said that the defendants will have to tailor their non-infringement position based on the judge’s recent summary judgment order. They could have a strong argument for non-infringement if the molecular weight falls outside of the patent, she said. If defendants have a strong non-infringement argument, they will want to minimize the indefiniteness argument at trial, because the two arguments may conflict, she explained.

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