Friday, June 22, 2007

Genentech's Cabilly II Is Revoked

In February 2007, the USPTO announced that they would revoke Genentech's controversial Cabilly II patent (US 6,331,415), which is a continuation of US patent number 4,816,567 (known as the Cabilly I patent). [Click here to read our earlier post on this topic.]

The Cabilly patents pertain to fundamental methods of synthesizing antibodies, which are used across industry to manufacture therapeutic antibodies, such as Abbott's Humira and MedImmune's Synagis. The patent brought Genentech $106 million in royalties in 2006 alone - it is little wonder that many licensees are happy to see it quashed.

 

From the day the Cabilly I was filed, the Cabilly patents have been embroiled in high profile legal disputes. The first was a 10-year epic battle against Celltech over rights to the invention, which ended in 2001 with a settlement, from which the Cabilly II was born. The second is a still-ongoing dispute with MedImmune, which sued both Genentech and Celltech over violation of antitrust laws in their settlement.

The current revocation was initiated by a Chicago lawyer representing an undisclosed company. Judging from MedImmune's public statements, it appears that MedImmune is not behind this revocation.

Let us look at the reasons for the revocation. According to the USPTO final rejection document, all the claims in the Cabilly II are unpatentable over those in the Cabilly I, as they represented "nonstatutory obviousness-type double patenting". This means that the inventions patented in the two patents are so similar that the Cabilly II unfairly extends the legal protection for the Cabilly I. (For your convenience, we have uploaded the USPTO final rejection document to our server. Please click here to download it.)

In addition to double patenting, most of the claims in the Cabilly II were also deemed unpatentable over Moore et al.'s US 5,840,545, on the grounds that the claims did not satisfy the conditions of novelty and non-obviousness, especially in view of other literature. For instance, claims 1-7, 9-10, 14-18, 21 and 23-36 were rejected under 35 U.S.C. 102 (e) as being anticipated by Moore et al. The same claims, except for claim 21, were also rejected under 35 U.S.C. 103 (a).

As expected, Genentech has appealed for continued reexamination of the Cabilly II. This request was granted on June 1, 2007. The patent will remain enforceable during the appeals process.

(Written with the assistant of summer intern Adeline Sham)

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