Biotech Values

[DewDiligence]

Re: GTCB’s nuclear-transfer IP

[This USPTO decision affects GTCB indirectly because GTCB licensed its nuclear-transfer technology from Advanced Cell Technology (ACT). Thus, GTCB may now owe license fees/royalties to GERN instead of to ACT.

Importantly, the USPTO action does not affect GTCB’s lead, drug, ATryn, because the goat herd for ATryn was created using microinjection rather than nuclear transfer.]

http://biz.yahoo.com/bw/050106/65359_1.html

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U.S. Patent Office Enters Final Judgment in Nuclear Transfer Patent Interference in Favor of Geron

Thursday January 6, 7:30 am ET

MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 6, 2005--Geron Corporation (Nasdaq:GERN - News) announced today that the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office has issued a final judgment ending patent interference number 104,746 between Geron and Advanced Cell Technology Corporation ("ACT") of Worcester, Mass. The Board ended the interference by entering judgment against ACT on all counts in the priority phase of the interference, thereby invalidating U.S. Patent No. 5,945,577, which is licensed to ACT from the University of Massachusetts.

Geron obtained rights to the pioneering nuclear transfer technology, originally used to clone Dolly the sheep, when it acquired Roslin Bio-Med (now Geron Bio-Med) in 1999. As part of that acquisition, Geron obtained a worldwide license from the Roslin Institute to the nuclear transfer patent portfolio and assumed management of the patent applications. Under Geron's management, patents covering the technology have been issued in the United States, Europe, Australia and several other jurisdictions. Geron requested that the U.S. Patent Office declare interferences between some of Geron's pending nuclear transfer patent applications and certain ACT patents because, in Geron's view, the technology claimed in those patents was first invented at the Roslin Institute and was covered by the patent portfolio licensed to Geron.

An interference is a proceeding conducted by the Patent Office when two or more parties claim the same invention in patent filings. The Patent Office first determines whether the claims of either party are supported by the specification of its patent filing. In a second stage of the proceeding, the Patent Office may look to determine "priority of inventorship," i.e., which party was the first to invent the subject matter of the claims. Under U.S. law, only the party that is the first to invent a new technology is entitled to claim it in a patent.

The claims in this interference relate to a method of cloning animals by transferring the nucleus of a cell from the animal to be cloned into an enucleated oocyte (egg). In a previous ruling, the Board found all of the claims of ACT's patent to be unpatentable, and upheld all of the Roslin/Geron claims involved in the interference. The Board then moved on to determine priority of inventorship and, in this final judgment, concluded that ACT's arguments that the U. Mass. scientists had invented the subject matter of the claims prior to the Roslin scientists "fail at virtually every level."

"We are pleased with the Board's ruling," said David J. Earp, J.D., Ph.D., Geron's chief patent counsel and senior vice president of business development. "The technology covered by the Roslin/Geron patents and patent applications has been widely adopted and is of increasing commercial importance -- it has been used to clone a broad range of species including cattle, sheep, pigs, goats and cats. With the Board's decision, the ACT patent has been invalidated and Geron's pending claims have been upheld. This brings significant clarity to the patent landscape surrounding animal cloning."

A second interference between ACT and Geron (Interference No. 105,192) is still pending before the Board. In the pending interference, the claims at issue relate to the production of inner cell mass cells from embryos made by the nuclear transfer technique. As in the concluded interference, Geron is the senior party and ACT is the junior party. In January 2004, the Board entered final judgment in Geron's favor in a related nuclear transfer patent interference with Infigen, Inc. of DeForest, Wisconsin, upholding the validity of all of Geron's claims and denying a patent to Infigen.
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