Patent application final rule will not apply retroactively if PTO wins lawsuit
RICHMOND, Virginia The Patent and Trademark Office will not retroactively apply a final rule affecting patent application procedures if an injunction against the rule is removed.
The U.S. District Court for the Eastern District of Virginia permanently enjoined the rule in April after Triantafyllos Tafas and GlaxoSmithKline challenged it. Tafas, an inventor listed on several patents, sued the PTO in August 2007, and GSK filed suit that October. The two cases were later consolidated.
The rule would create a presumption that inventions are patentably indistinct if an applicant files multiple submissions to the PTO that include common inventors or overlapping disclosures on the same date or within two months of a previous filing. Applicants would be required to identify all related patents and applications.
Tafas alleged that the government agency issued rules that were “arbitrary, capricious, an abuse of discretion, otherwise not in accordance with law, contrary to plaintiff’s constitutional rights and in excess of the USPTO’s statutory jurisdiction and authority,” according to court documents.
In its decision, the district court found the final rule is “substantive in nature and [exceeded] the scope of the USPTO’s rulemaking authority.”
The PTO has appealed the case to the U.S. Court of Appeals for the Federal Circuit. If the court lifts the injunction, the new rule would apply only to applications filed on or after a future effective date, according to the PTO’s notice.
ImClone to pay $17.5 million to Abbott in Erbitux settlement
BOSTON ImClone Systems, manufacturer of the cancer drug Erbitux, has agreed to pay Abbott Laboratories $17.5 million to end a patent-infringement lawsuit over the medicine, according to Bloomberg.
The companies said in an Aug. 4 notice to U.S. District Judge Richard Stearns in Boston that they had reached a “confidential settlement.” Stearns put the case on hold so the companies can finish the paperwork on the agreement.
Abbott sued ImClone last year, claiming its patented method for creating antibodies is infringed by Erbitux. In May, ImClone filed a lawsuit accusing Abbott of withholding information that could have been used by ImClone to defend itself against a patent suit by Repligen. ImClone paid $65 million to end that case.
“We have reached an agreement in principle that would conclude all outstanding litigation with ImClone,” said Abbott spokesman Scott Stoffel.
FDA warns about muscle damage from drug combo
WASHINGTON Combining some heart drugs could cause muscular damage, Reuters reported the Food and Drug Administration as warning.
The FDA said it had received reports of the muscle injury rhabdomyolysis, which can cause kidney failure or death, related to combining the cholesterol drug simvastatin and the arrythmia drug amiodarone. The agency issued a warning about the risks of combining the drugs in 2002.
All statin drugs have the risk of causing rhabdomyolysis, but the risk becomes greater when simvastatin is combined with amiodarone.
Simvastatin is the active ingredient in Merck’s Simcor and Abbott Laboratories’ Zocor, as well as an ingredient in Merck’s and Schering-Plough’s Vytorin. Amiodarone is the active ingredient in Wyeth’s Cordarone and Upsher-Smith’s Pacerone.