A Medical Device Daily

Advanced Cell Technology (ACT; Alameda, California) reported that it has settled a patent dispute involving certain nuclear transfer cloning patents and patent applications owned or licensed by the University of Massachusetts (Boston), Roslin Institute (Edinburgh, Scotland), Geron (Menlo Park, California), Start Licensing and ACT. The dispute involved appeals to the U.S. District Court by ACT and UMass that sought to overturn rulings by the U.S. Patent and Trademark Office against ACT and UMass in patent interference numbers 104,746 and 105,192.

In the settlement, Start agreed to an initial payment to ACT of $500,000 and milestones of up to $750,000. Start, Geron, Exeter and Roslin each further agreed not to sue ACT or UMass under the involved Roslin patent applications. In exchange, ACT and UMass dismissed their appeals with prejudice, transferred control of related UMass patents and patent applications to Start in the non-human animal field, and ACT paid certain legal fees.

ACT said it also retained its rights under the UMass patents in the human field.

The underlying interference proceedings centered around patent applications owned by Roslin against U.S. Patents 5,945,577, and 6,234,970 owned by UMass and exclusively licensed to ACT. The interference proceedings were initiated by Roslin's licensee, Geron. In late 2004 and in early 2005, the Board of Patent Appeals and Interferences of the U.S. Patent Office ruled in favor of Geron in both interferences. UMass and its licensee, ACT, immediately filed appeals, naming Roslin, Geron and Exeter Life Sciences, a Roslin licensee, as defendants.

In mid-2005, Geron and Exeter established Start Licensing as a joint venture company to license intellectual property rights for animal reproductive technologies and exclusively licensed their rights in Roslin patent applications to Start in the non-human animal field.

“This settlement resolves the parties' various patent rights with respect to nuclear transfer cloning in the non-human field. The parties are now free to move forward with their respective business models,” said William Caldwell, CEO of ACT.

In other legalities:

A Plano, Texas, woman who suffered a miscarriage and developed potentially life-threatening blood clots after using the Ortho Evra birth control patch has filed a federal lawsuit against Johnson & Johnson (New Brunswick, New Jersey) in Marshall, Texas.

Elizabeth Barroso said she began experiencing chest pains and difficulty breathing after using Ortho Evra for three weeks in 2004 and then was treated for blood clots in her lungs. Barroso then was prescribed blood-thinning medication for 10 months.

She became pregnant in October 2004 but suffered a miscarriage. When she became pregnant in 2005, she had to do daily self-injections of blood thinners to prevent another miscarriage. Barroso's future pregnancies will carry a risk of miscarriage and will require similar treatment due to the use of Ortho Evra, her lawsuit alleges.

Her attorney, John David Hart of Fort Worth, Texas, said, “the tragic thing is the company continues to market and sell this product even today.”

The case is the latest of many against J&J, which earlier this year settled other cases involving Ortho Evra and the development of blood clots.

Filed in U.S. District Court in the Eastern District of Texas, Marshall Division, the complaint alleges that the package insert for Ortho Evra was misleading and in conflict with J&J's own data. The insert suggests the risk of blood clots among Ortho Evra users is equivalent to that of women using oral contraceptives. However, from April 2002 to December 2004, the company logged 27,974 adverse events among Ortho Evra users. During that same time period, J&J noted only 5,571 adverse events for one of its oral contraceptives, even though it was used three times more than Ortho Evra.