U.S. Supreme Court Gives Teva Mixed Reception on Copaxone Patent Case

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by Patricia Silva, PhD |

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about_copaxone_img1The U.S. Supreme Court deliberated on a request from Teva Pharmaceutical Industries Ltd. to preserve the patent of its multiple sclerosis drug Copaxone from generic competitors until September 2015. Recent reports indicate that the court gave the company a mixed opinion. The hearing occurred this Wednesday in Washington and concluded with a division of the federal appeals court’s decision regarding the invalidation of the patent.

Teva is attempting to protect their MS drug, which has earned the company $4.3 billion last year alone and represents about half of its profit, by buying more time to avoid the competition of generic drugs until 2030. The case has further implications, including if the federal appeals court specialized in patents will accept the trial judge’s reading of the patent.

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Teva is fighting both Mylan Inc., which is working in collaboration with Natco Pharma Ltd., and Momenta Pharmacauticals Inc., which has teamed up with Novartis AG. While Synthon BV has not been involved in the case, the company is also seeking approval for a generic MS drug modeled after Copaxone with an undisclosed partner.

The U.S. Court of Appeals for the Federal Circuit has decided to reverse Teva’s case and invalidate the patent, as it was argued that the drug did not specifically outline what the pharmaceutical company said was invented, and that the patent had ambiguities about its development. While some justices supported Teva’s position, others expressed skepticism.

One of the supporters, Justice Stephen Breyer, believes that in technical cases, at least, the trial judge was the one who “sat there the whole time and listened to these experts talking, and that, I think, is a very powerful reason for saying, in a technical case, don’t overturn the judge’s factual findings.” Justice Samuel Alito, on the other hand, argued that Teva is willing to “introduce a level of complication” into patent law, and questioned if it is “worthwhile as a practical matter.”

Teva is being represented by the lawyer William Jay, which has argued to the justices that in cases like this, federal litigation laws offer a standard practice for appeals courts to defer the factual conclusions of the trial judges. It is common practice for the Federal Circuit to review patents without the help of the interpretations of the trial judges, since it is often difficult for them to understand the difference.

On the other hand, lawyer Carter Phillips, who is representing all of the generic drug companies, noted a decision from the Supreme Court, ruled in 1996, which determined that it was the judge and not the jury’s duty to decide on the patent coverage. The lawyer believes that it is logical to allow the appeals court to have a fresh look of the trial judge’s conclusions.

The generic drug companies involved in the case are now waiting for the approval of the Food and Drug Administration to start commercializing their generic versions of Copaxone, which could happen prior to a final decision, since the Federal Circuit decision is currently in force. However, the companies still have to decide if they want to take the risk of compensating Teva for its lost sales, in case the company wins the case.

The court decision is planned for the end of the 2014-2015 term, which means that it has to be made until June of the next year. There is still the possibility that the court will ask the Federal Circuit to reexamine the case within other legal standards, which would benefit Teva, by extending its fight and the risk for the other companies for months.

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