Pharmaceutical Business review

Enzymotec announces final decision issued by USPTO rejecting all claims in Neptune’s patent

Neptune may appeal this decision, but cannot submit any additional evidence or claim amendments.

Enzymotec president and CEO Dr Ariel Katz noted that this final decision by the USPTO further reinforces our belief that Neptune’s patents can be invalidated.

"The current USPTO decision followed previous unfavorable decisions of the USPTO regarding members of the 8,030,348 patent family and the European Patent Office’s revocation of Neptune’s corresponding European patent. Neptune appealed the decision revoking the European patent and their appeal was dismissed in April 2013.

"As we already announced, we will continue in our efforts to challenge Neptune’s patents and to vigorously contest their complaints," Dr Katz added.

As previously disclosed by Enzymotec, it is a party to a number of actions initiated by Neptune in the United States District Court for the District of Delaware, in which Neptune has claimed that Enzymotec’s krill oil products infringe certain of its patents, namely U.S. Patent Nos. 8,030,348, 8,278,351 and 8,383,675, (the "’348 patent," the "’351 patent" and the "’675 patent," respectively).

Additionally, in April 2013, Enzymotec received notice of an investigation by the ITC following complaints filed by Neptune and its subsidiary, Acasti Pharma Inc., alleging a violation of section 337 of the Tariff Act of 1930 by reason of alleged infringement of the ‘351 patent and the ‘675 patent.

In December 2013, the parties entered into a settlement term sheet that was subject to negotiation of a final written settlement agreement and the ITC case was stayed. On February 11, 2014, the parties informed the ITC Administrative Law Judge ("ALJ") that they would request mediation and would be filing a motion for a further stay of ITC proceedings.

The motion was granted and the stay was extended until 14 April 2014. The ITC hearing is scheduled to commence on 28 April 2014, and a decision by the ITC is expected by January 2015.