Federal Circuit Refuses To Find Implied License For Endo Opana Patents

In Endo Pharmaceuticals, Inc. v. Actavis, Inc., the Federal Circuit reversed the district court’s decision denying Endo’s motion for summary judgment of infringement based on an implied license. The Federal Circuit found that Roxane and Actavis did not have an express or implied license to practice the Endo Opana patents at issue, even though they were related to licensed patents.

The Previous ANDA Litigation and License Agreements

The patents at issue relate to Endo’s Opana® ER product, which is an extended release formulation of oxymorphone. The parties were involved in earlier ANDA litigation over different Orange Book listed patents for Opana® ER, which was settled by a license and covenant not to sue. Continue reading this entry

The USPTO Does Not Need The Onerous Proposed Attributable Owner Rules

The Federal Register Notice promulgating the proposed Attributable Owner rules offers some lofty justifications for the rules. Because the rules have been promulgated pursuant to a White House initiative, they are likely to take effect in some form, but applicants and stakeholders should not miss the opportunity to submit comments and suggestions to the USPTO in an effort to make the final rules less onerous. Continue reading this entry

The USPTO Glossary Pilot Program

In a Federal Register Notice published March 27, 2014, the USPTO announced a Glossary Pilot Program that will offer expedited examination to new patent applications in certain technology areas that include a glossary of terms that meets certain formal requirements. The program will commence on June 2, 2014, and run for six months or until the USPTO accepts 200 applications into the program (whichever comes first). Continue reading this entry

The State Of Vaccines Under The USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical fields.

State Of The Union Address 2014

(Original Official White House Photo by Pete Souza,
licensed under Creative Commons Attribution License 3.0)

How would “vaccines that stay ahead of drug-resistant bacteria” fare under the new USPTO 101 Guidelines? Continue reading this entry

Delayed Restriction Requirement Does Not Result In Patent Term Adjustment For Divisional Application

In Mohsenzadeh v. Lee (decided March 19, 2014), the U.S. District Court for the Eastern District of Virginia held that the Patent Term Adjustment (PTA) statute does not provide PTA to a divisional application when the USPTO takes longer than 14 months to issue a Restriction Requirement in the parent application. While this decision is not surprising, it is a reminder that applicants may have to choose between the protections offered to divisional applications by 35 USC § 121 and the possible impact on enforceable patent term of filing related applications in series rather than in parallel.  Continue reading this entry