Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 1350

MOTION to Submit Supplemental Demonstratives from the October 4, 2007 Hearing on Obviousness-Type Double Patenting by Amgen Inc.. (Attachments: #1 Supplement Demonstratives)(Rich, Patricia)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Obviousness-Type Double Patenting
Amgen's Supplemental Demonstratives October 4, 2007
Amgen Inc. v. F. Hoffmann-La Roche, Ltd., No. 05-cv-12237-WGY

Dockets.Justia.com

Doc. 1350 Att. 1

D500

Total Claims In `179 Application "As Filed" = 1

TX 2012.1513 (PTO file wrapper for `179 application) D501

MPEP § 201.06(a): Preliminary Amendment Not Entered Until After Filing Date Has Been Granted

MPEP § 201.06(a) (5th Ed., Rev. 11, Apr. 1989); see also Docket Item 676, at 3-4. D502

Differences Between All `008 and `868 Asserted Claims

`008 Claims
The `008 claims are to compositions of matter The `008 claims require neither glycosylation nor a polypeptide The `008 claims do not require either in vitro or in vivo biological function The `008 claims do not require the production of any amount of EPO

`868 Claims
The `868 claims require a specific recited combination of steps The `868 claims require production of a glycosylated polypeptide The `868 claims require that any EPO expressed have the stated in vivo biological function The `868 claims require that the recited host cell be capable of producing isolatable quantities of EPO

See also Docket Item 1310, at 38-42. D503

Additional Differences Between Certain `008 and `868 Asserted Claims
`008 Claims
`008 claim 7 covers an enormous number of DNAs coding for EPO analogs and `008 claims 25 and 27 cover host cells transformed or transfected with any of those numerous DNAs coding for EPO analogs `008 claims 7, 25 and 27 have been held invalid for lack of sufficient enablement `008 claims 2 and 7 do not require any host cell, and `008 claims 4 and 6 broadly cover any procaryotic and any eucaryotic host cell transformed or transfected with the recited DNA sequence
See also Docket Item 1310, at 38-42. D504

`868 Claims
The `868 claims exclude DNAs coding for EPO analogs

It is undisputed that the `868 claims are sufficiently enabled The `868 claims require mammalian host cells

Additional Differences Between All `008 and `698 Asserted Claims
`008 Claims
The `008 claims do not require "amplified DNA" The `008 claims do not require "amplified marker gene DNA"

`698 Claims
The `698 claims require "amplified DNA" `698 claims 7 and 8 require "amplified marker gene DNA"

See also Docket Item 1310, at 43-44. D505

Judicial Estoppel
Two elements: (1) the party's previously asserted position and presently asserted position must be "directly inconsistent, that is, mutually exclusive"
­ ­ Alternative Sys. Concepts, Inc. v. Synopsys, Inc., 374 F.3d 23, 33 (1st Cir. 2004). See also Simon v. Safelite Glass Corp., 128 F.3d 68, 72 (2d Cir. 1997) ("[T]here must be a true inconsistency between the statements in the two proceedings. If the statements can be reconciled there is no occasion to apply an estoppel.")

(2) "the first forum [must have] accepted the legal or factual assertion alleged to be at odds with the position advanced in the current forum . . ."
­ ­ In re Gens, 112 F.2d 569, 572 (1st Cir. 1997) (emphasis in original) See also Merrill Lynch, Pierce, Fenner & Smith Inc. v. Georgiadis, 903 F.2d 109, 114 (2d Cir. 1990) (Judicial estoppel "applies only if the party against whom the estoppel is claimed actually obtained a judgment as a result of the inconsistent position.")

D506

The Board Referenced G.I.'s Position, Not Amgen's

G.I.'s `097 Priority Position "Accordingly, as in the `096 interference, priority turns upon the first conception of the purified and isolated EPO gene. The record establishes that Dr. Fritsch, not Dr. Lin, was the first to make such a conception of the isolated EPO gene and thereafter exercised reasonable diligence in reducing it to practice."
Ex. GXH, at 24-25 ("FB-24") (emphasis added)

Amgen's `097 Priority Position "The findings of the District Court, affirmed by the Federal Circuit, clearly show that Lin carried out the expression process using the DNA sequence to produce in vivo biologically active recombinant human EPO before Fritsch et al even conceived the DNA sequence."
Ex. GUK, at 29 (emphasis in original)

BPAI Ruling "With regard to the issue of prior inventorship in particular, we note that Fritsch conceded at the final hearing that priority in each of the related interferences turns on isolation of the EPO gene, i.e., determination of priority in Interference No. 102,096 is dispositive on the issue of priority in the present interference (also see FB-24)."
TX 2012.1044-45 (emphasis added)

D508

Amgen's Position: Lin Had In Vivo Activity Before Fritsch Even Had The Gene

Ex. GUK, at 46 D507