Santarus Announces Receipt of Notice of Allowance for Additional U.S. Patent Covering Zegerid Products

Santarus, Inc. specialty pharmaceutical company today announced that its licensor, the University of Missouri, has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. patent application number 10/641,732, which has claims covering methods for treating acid-caused gastrointestinal disorders by administering a solid pharmaceutical composition comprising non-enteric coated omeprazole and certain antacids. Subject to final issuance by the USPTO, the newly allowed claims will have a July 2016 expiration date.

"We are pleased to receive this Notice of Allowance and believe that the allowed patent claims, when issued, will further enhance the intellectual property coverage for our immediate-release (R) (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension products," said Gerald T. Proehl, president and chief executive officer of Santarus.

Santarus has licensed rights to the 10/641,732 patent application, as well as other patents and pending patent applications, under an exclusive, worldwide license agreement with the University of Missouri relating to specific formulations of proton pump inhibitors (PPIs) with antacids and other buffering agents and methods of using these formulations. Currently, five U.S. patents have been issued and several U.S. patent applications are pending. In addition to the U.S. patent coverage, several international patents have been issued, including in Australia, Canada, India, Mexico, New Zealand, Russia, Singapore, South Africa and South Korea, as well as in countries within the European Patent Organization, and several international patent applications are pending.

 

 

FW: Federal court strikes down new patent rules

Federal court strikes down new patent rules

 

The US District Court for the Eastern District of Virginia on Tuesday rejected new US Patent and Trademark Office rules that would have retroactively limited the number of claims that can be included in a patent application and the number of times a continuation application can be filed for a given invention. The court ruled that the new rules were "substantive in nature" and therefore beyond the scope of the USPTO's authority to govern the submission procedure of patent application.

 

The lawsuit challenging the new rules was brought by pharmaceutical company GlaxoSmithKline, which has approximately 100 applications pending at the USPTO. Supporting the company was the American Intellectual Property Law Association, which filed an amicus curiae brief. In October, a judge enjoined decision, the USPTO from implementing the new rules pending a ruling on their validity.

 

In a twenty-six page opinion, District Court Judge Cacheris has granted GSK’s and Tafas’s Motions for Summary Judgment — finding the PTO’s proposed limitations to the number of continuation applications and claims per patent to be improper extensions of PTO authority:

 

“Because the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2) does not extend to substantive rules, and because the Final Rules are substantive in nature, the Court finds that the Final Rules are void as ‘otherwise not in accordance with law’ and ‘in excess of statutory jurisdiction [and] authority.’ 5 U.S.C. § 706(2).”