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LEGAL PROCEEDINGS
9 Months Ended
Sep. 30, 2014
Commitments and Contingencies Disclosure [Abstract]  
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS
     
CUBICIN Patent Inter Partes Review Proceedings

On October 23, 2014 and October 24, 2014, Agila Specialties Inc. and Mylan Pharmaceuticals Inc. filed seven petitions before the Patent Trial and Appeal Board (the Board) of the U.S. Patent and Trademark Office requesting inter partes reviews of U.S. Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and U.S. Patent Nos. 8,058,238 and 8,129,342, which expire on November 28, 2020. On November 3, 2014, Fresenius-Kabi USA LLC (Fresenius) filed two petitions before the Board requesting inter partes reviews of U.S. Patent Nos. 6,468,967 and 6,852,689. Each of these patents is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for CUBICIN. The petitions assert that certain claims in the respectively referenced patents are unpatentable and should be canceled.

While we intend to continue to vigorously defend our patent rights, we cannot predict the outcome of these proceedings. Until these proceedings are finally resolved, the uncertainty of the outcomes may cause our stock price to decline. An adverse result in any of these proceedings, whether appealable or not, would likely cause our stock price to decline. In addition, any final, unappealable adverse result in any of these proceedings would likely have a material adverse effect on the continued commercialization of CUBICIN, our business, results of operations and financial condition, and cause our stock price to decline.

CUBICIN Patent Infringement Litigation

In 2012, we filed patent infringement lawsuits in the U.S. District Court for the District of Delaware against Hospira, Inc. (Hospira) in response to certain Paragraph IV Certification Notice Letters from Hospira notifying us that Hospira had submitted an Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) to the FDA seeking approval to market generic versions of CUBICIN. The trial in these related actions was held in the U.S. District Court for the District of Delaware in February 2014. We entered into an agreement with Hospira in July 2014, which we amended in October 2014, under which Hospira has agreed not to launch a daptomycin product in the U.S. before the earlier of: (i) January 9, 2015; or (ii) the court’s decision on the validity and/or infringement of all asserted claims of the relevant patents in these actions.

In October 2013, we filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Strides, Inc., on behalf of Agila Specialties Private Limited (collectively, Strides), in response to a Paragraph IV Certification Notice Letter from Strides notifying us that Strides had submitted an ANDA to the FDA seeking approval to market a generic version of CUBICIN.

In July 2014, we filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Fresenius in response to a Paragraph IV Certification Notice Letter from Fresenius notifying us that Fresenius had submitted an ANDA to the FDA seeking approval to market a generic version of CUBICIN.

We cannot predict the outcome of these CUBICIN patent infringement litigations, and any final, unappealable adverse result in any of these litigations would likely have material adverse effects on our business, results of operations and financial condition.

Optimer U.S. Governmental Investigations

We are continuing to cooperate with the investigations by the SEC and the U.S. Department of Justice in their review of potential violations by Optimer of certain applicable laws, which occurred prior to our acquisition of Optimer. The investigations relate to an attempted share grant by Optimer and certain related matters in 2011, including a potentially improper payment to a research laboratory involving an individual associated with the share grant, that may have violated certain applicable laws, including the Foreign Corrupt Practices Act (FCPA). Optimer had already taken remedial steps in response to its internal investigation of these matters; nonetheless, these events could result in lawsuits being filed against us or Optimer and certain of Optimer’s former employees and directors, or certain of our employees. Such persons could also be the subject of criminal or civil enforcement proceedings and we may be required to indemnify such persons for any costs or losses incurred in connection with such proceedings. We cannot predict the ultimate resolution of these matters, whether we or such persons will be charged with violations of applicable civil or criminal laws, or whether the scope of the investigations will be extended to new issues. We also cannot predict what potential penalties or other remedies, if any, the authorities may seek against us, any of our employees, or any of Optimer’s former employees and directors, or what the collateral consequences may be of any such government actions. We do not have any amounts accrued related to potential penalties or other remedies related to these matters as of September 30, 2014, and cannot estimate a reasonably possible range of loss. In the event any such lawsuit is filed or enforcement proceeding is initiated, we could be subject to a variety of risks and uncertainties that could have material adverse effects on our business, results of operations and financial condition.