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Court Suggests Abbott Lawyer Cheated on Hytrin Patent

By Jim Edwards | Jan 26, 2009

A federal appeals court has strongly suggested that an “Abbott in-house attorney” is a cheat. In a ruling on whether Abbott Labs broke antitrust law in consipiring with generic makers to keep Hytrin, a hypertension and prostate enlargement drug, off the market, the judges described why they were sending the  case back to court for a jury trial.

An unnamed, male Abbott in-house lawyer, they said, had failed to include an English translation of some Japanese information in its patent filings, and the same lawyer then ommitted a citation of important case-law in the preparation of some briefs. The two events together, the court suggested, are enough to support a jury’s conclusion that the ommissions were deliberate.

By keeping Hytrin on-patent, Abbott safeguarded four years of revenues from 1996 to 2000, at a time when the drug brought in $540 million a year in revenues and was 20 percent of the company’s sales.

The court ruling is a dense discussion of the arcana of patent law on Hytrin. But don’t worry — BNET has digested the gossipy bits for you:

In 1998, Hytrin generated $540 million in sales, accounting for more than twenty percent of Abbott’s domestic sales of pharmaceutical products.

An “Abbott in-house attorney” was grilled in a deposition about the details of the Japanese patent translation:

Q: Did you submit an English-language translation
of Japanese Patent Application 5-78,352 to the
United States Patent Office during the prosecution of
the application upon which the ’207 patent was
issued?

A: That was certainly my intent and —

Q: Well, did you do that?

A: Do I recall specifically doing that? No.

The patent examiner could not read Japanese.

several things suggest that the failure to include the English translation of the Sumika reference was not inadvertent. We begin with the unavoidable fact that the English translation of the Sumika reference was the only document in the initial application that, if fully understood by the patent examiner, would have resulted in a denial of the application. There was thus a substantial incentive not to include the translation.

Later conduct by Abbott’s in-house attorney in connection with the application for the ’207 patent suggests that the omission of the English translation was not inadvertent. When the attorney submitted supplemental information to the PTO about prior sales of Form IV terazosin hydrochloride, he failed to mention the LaPorte case … The attorney’s failure to mention LaPorte was unlikely to have been inadvertent, given that the attorney took his argument from a litigation brief filed by Abbott that had specifically mentioned and distinguished LaPorte.

Prior conduct by the same in-house attorney, in connection with Abbott’s application for the ’095 patent, also suggests that the omission was not inadvertent. Five months before its application for the ’207 patent … Abbott submitted its application for the ’095 patent for Form III terazosin hydrochloride. In connection with this ’095 application, the in-house attorney submitted the English translation, as well as a different English abstract, of the Sumika reference.

Why, if he had submitted the translation with the application for the ’095 patent, would he have failed to include it with the application for the ’207 patent? A possible answer is that the Sumika reference was fatal to the patentability of Form IV terazosin hydrochloride (the ’207 patent), but did not pose a substantial threat to the patentability of Form III (the ’095 patent).

… the in-house attorney knew he had more to fear from an accurate description of the Sumika reference in the ’207 application than in the ’095 application.

The judges conclude by reminding everyone that the lawyer is innocent until proven guilty, so to speak:

We do not, of course, ourselves conclude that Abbott’s in-house attorney deliberately failed to include the English translation of the Sumika reference. But we hold that there is enough circumstantial evidence in the record to support a jury’s conclusion to that effect.

BNET would love to receive an email with the name of the in-house attorney.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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