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Message: Re: PTO: '148 Amendments/Remarks on Amendment 2-11-10
14
Feb 13, 2010 06:32PM

we're not alone in re-exam challenges:

>BPAI 2010)

Pfizer's broadest patent covering its bestselling drug Viagra is in the midst of an ex parte reexamination. See Patent 6,469,012. The reexamination was separately requested by Lilly & ICOS (makers of Cialis) and Bayer (maker of Levitra). In addition, the PTO director (then James Rogan) independently ordered reexamination. These separate actions were all merged into one proceeding before the PTO. In parallel, Pfizer has sued Lilly & ICOS – asserting that Cialis infringes the Viagra patent. See Pfizer Inc., et al. v. Lilly ICOS LLC et al, Civil Action No. 02-1561 (D. Del. Oct. 22, 2002). The litigation has been stayed pending reexamination since 2003.

The broad claim (that is said to cover both Levitra and Cialis) is claim 24:

24. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, of a pharmaceutical composition containing either entity.

During the reexamination, the examiner rejected Claim 24 as anticipated by each of five different references and also issued an obviousness-type double patenting rejection based on three other Pfizer patents. In a 56-page opinion, the BPAI rejected some of the examiner's reasoning, but affirmed the decision as a whole.

In particular, the Board agreed that prior art descriptions of oral administration of the herb Yin Yang Huo (AKA

Examiner Rejection Affirmed.

Notes

  • [Updated based on Jon's comment below] Pfizer has the opportunity to request a re-hearing and may also appeal the BPAI decision. Regarding a further appeal, the pertinent portion of 35 U.S.C. § 141 reads as follows: A patent owner, or a third-party requester in an inter partes reexamination proceeding, who is in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences under section 134 may appeal the decision only to the United States Court of Appeals for the Federal Circuit. Although the language is amenable to multiple interpretations, the best interpretation of this is that a patent owner undergoing an ex parte reexamination may only appeal to the CAFC.
  • The re-examination file history is quite long and includes over seventy-three-thousand pages (this total does not include the USPTO patent-documents cited as prior art).
  • What is the expiration date of this patent? Its earliest priority date is a Great Britain from June 9, 1993. A European PCT was then filed on May 13, 1994 which was published on December 22, 1994. The US National Stage application was filed March 4, 1996 and the patent issued October 22, 2002. There is no terminal disclaimer apparent from the file history and the PTO does not indicate any patent term extension due to FDA regulatory delay. [>Granted FDA Extensions][http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020895&Product_No=001&table1=OB_Rx">FDA Orange Book Listing]
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