Harvard Crimson on Evista/Xigris case by Harvard et al against Lilly; but will the verdict stick?
The biggest winner May 4 was Ariad Pharmaceuticals, a small firm that was exclusively licensed the patent by Harvard, MIT, and the Whitehead Institute for Biomedical Research, the other plaintiffs in the case.
In the 1980s, scientists from those institutions discovered a method of treating diseases by regulating the activity of a molecule called NF-kB—a transcription factor involved in protein production.
When the discovery was eventually awarded a patent in 2002, Ariad and the three institutions sued Eli Lilly in the U.S. District Court for the District of Massachusetts.
(...)
If the decision stands, it might open the door for holders of similar patents to target other drug makers with infringement claims. Signaling of the NF-kB molecule—the process at issue in Ariad’s dispute—is used by more than 200 compounds, including aspirin, according to Science magazine.
Perhaps anticipating a future lawsuit, biotech company Amgen last week filed a pre-emptive motion asking a Delaware court to find Ariad’s patent invalid. The Thousand Oaks, Calif.-based firm also sought a ruling that its drug products do not infringe on the patent.
***
The Harvard Crimson did not get into details of the patents.
The academic entities obtained a number of patents in the area.
The patent asserted in the litigation, US 6,410,516, issued on June 25, 2002, and claims priority to U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned. The first claim of the '516 states:
A method for inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-.kappa.KB, the method comprising reducing NF-.kappa.KB activity in the cell such that expression of said gene is inhibited.
This is a method claim comprising a single step. Schematically, the claim reads: inhibit X in a cell by reducing activity of Y such that X is inhibited.
In all, there are 203 claims in the '516 patent, all to methods.
One has earlier patents in this patent family; for example, US 6,150,090, which issued in 2000, describes the following patent family:
This application is a division of application Ser. No. 08/418,266 filed Apr. 6, 1995, U.S. Pat. No. 5,804,374, which is a continuation of U.S. Ser. No. 07/791,898, filed Nov. 13, 1991, abandoned, which is a continuation-in-part of U.S. Ser. No. 06/946,365, filed Dec. 24, 1986, abandoned, and of U.S. Ser. No. 07/318,901, filed Mar. 3, 1989, abandoned; and of U.S. Ser. No. 07/162,680, filed Mar. 1, 1988, abandoned, and of U.S. Ser. No. 07/341,436, filed Apr. 21, 1989, abandoned, and of U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned, and of U.S. Ser. No. 07/155,207, filed Feb. 12, 1988, abandoned, and of U.S. Ser. No. 07/280,173, filed Dec. 5, 1988, abandoned.
If the rules on continuing practice proposed by the USPTO on 3 Jan 2006 were implemented, the sort of practice in the '516 family would likely not be allowed.
***Ariad won at trial, but will this verdict stick?
I don't know how this case was argued. If, hypothetically, taking aspirin did fulfill the elements of claim 1 of the '516 patent, then the case Schering
Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (CAFC 2003) would seem to require invalidation of claim 1 under inherent anticipation. If it were true that taking aspirin (before Jan. 9, 1986, and particularly before Jan. 9, 1985) reduced NF-.kappa.KB activity in a cell such that expression of said gene is inhibited, it simply does NOT MATTER THAT HUMAN BEINGS DIDN'T LEARN THIS UNTIL A PATENT DISCLOSURE ON Jan. 9, 1986.
Even BEFORE the Schering case, text I had written in 1999 was quoted by Feit and Warrick in Inherency in Patent Law, 85 JPTOS 5: Ebert reasons that: "One cannot patent 'scientific understanding' of that which already was being done." [The example I used in 1999 concerned buckminsterfullerene but the concept applies to the various drug cases.]
This reality was made clear in the Schering case, and was further strengthened in SmithKline v. Apotex in 2005 (the appeal of the decision by Judge Posner (sitting by designation)). The Ariad verdict, with high probability, is a dog that won't hunt.
***Background. Priority chain for the '516:
This application is a division of application Ser. No. 08/418,266 filed Apr. 6, 1995, U.S. Pat. No. 5,804,374 which is a continuation of U.S. Ser. No. 07/791,898, filed Nov. 13, 1991, abandoned which is a continuation-in-part of U.S. Ser. No. 06/946,365, filed Dec. 24, 1986, abandoned and of U.S. Ser. No. 07/318,901, filed Mar. 3, 1989, abandoned and of U.S. Ser. No. 07/162,680, filed Mar. 1, 1988, abandoned and of U.S. Ser. No. 07/341,436, filed Apr. 21, 1989, abandoned and of U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned and of U.S. Ser. No. 07/155,207, filed Feb. 12, 1988, abandoned and of U.S. Ser. No. 07/280,173, filed Dec. 5, 1988, abandoned. All of the above applications are incorporated herein by reference in their entirety.
Yes, the '516 came through federal funding:
The work leading to this invention was supported in part by a grant from the National Cancer Institute. The Government has certain rights in this invention.
In the 1980s, scientists from those institutions discovered a method of treating diseases by regulating the activity of a molecule called NF-kB—a transcription factor involved in protein production.
When the discovery was eventually awarded a patent in 2002, Ariad and the three institutions sued Eli Lilly in the U.S. District Court for the District of Massachusetts.
(...)
If the decision stands, it might open the door for holders of similar patents to target other drug makers with infringement claims. Signaling of the NF-kB molecule—the process at issue in Ariad’s dispute—is used by more than 200 compounds, including aspirin, according to Science magazine.
Perhaps anticipating a future lawsuit, biotech company Amgen last week filed a pre-emptive motion asking a Delaware court to find Ariad’s patent invalid. The Thousand Oaks, Calif.-based firm also sought a ruling that its drug products do not infringe on the patent.
***
The Harvard Crimson did not get into details of the patents.
The academic entities obtained a number of patents in the area.
The patent asserted in the litigation, US 6,410,516, issued on June 25, 2002, and claims priority to U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned. The first claim of the '516 states:
A method for inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-.kappa.KB, the method comprising reducing NF-.kappa.KB activity in the cell such that expression of said gene is inhibited.
This is a method claim comprising a single step. Schematically, the claim reads: inhibit X in a cell by reducing activity of Y such that X is inhibited.
In all, there are 203 claims in the '516 patent, all to methods.
One has earlier patents in this patent family; for example, US 6,150,090, which issued in 2000, describes the following patent family:
This application is a division of application Ser. No. 08/418,266 filed Apr. 6, 1995, U.S. Pat. No. 5,804,374, which is a continuation of U.S. Ser. No. 07/791,898, filed Nov. 13, 1991, abandoned, which is a continuation-in-part of U.S. Ser. No. 06/946,365, filed Dec. 24, 1986, abandoned, and of U.S. Ser. No. 07/318,901, filed Mar. 3, 1989, abandoned; and of U.S. Ser. No. 07/162,680, filed Mar. 1, 1988, abandoned, and of U.S. Ser. No. 07/341,436, filed Apr. 21, 1989, abandoned, and of U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned, and of U.S. Ser. No. 07/155,207, filed Feb. 12, 1988, abandoned, and of U.S. Ser. No. 07/280,173, filed Dec. 5, 1988, abandoned.
If the rules on continuing practice proposed by the USPTO on 3 Jan 2006 were implemented, the sort of practice in the '516 family would likely not be allowed.
***Ariad won at trial, but will this verdict stick?
I don't know how this case was argued. If, hypothetically, taking aspirin did fulfill the elements of claim 1 of the '516 patent, then the case Schering
Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (CAFC 2003) would seem to require invalidation of claim 1 under inherent anticipation. If it were true that taking aspirin (before Jan. 9, 1986, and particularly before Jan. 9, 1985) reduced NF-.kappa.KB activity in a cell such that expression of said gene is inhibited, it simply does NOT MATTER THAT HUMAN BEINGS DIDN'T LEARN THIS UNTIL A PATENT DISCLOSURE ON Jan. 9, 1986.
Even BEFORE the Schering case, text I had written in 1999 was quoted by Feit and Warrick in Inherency in Patent Law, 85 JPTOS 5: Ebert reasons that: "One cannot patent 'scientific understanding' of that which already was being done." [The example I used in 1999 concerned buckminsterfullerene but the concept applies to the various drug cases.]
This reality was made clear in the Schering case, and was further strengthened in SmithKline v. Apotex in 2005 (the appeal of the decision by Judge Posner (sitting by designation)). The Ariad verdict, with high probability, is a dog that won't hunt.
***Background. Priority chain for the '516:
This application is a division of application Ser. No. 08/418,266 filed Apr. 6, 1995, U.S. Pat. No. 5,804,374 which is a continuation of U.S. Ser. No. 07/791,898, filed Nov. 13, 1991, abandoned which is a continuation-in-part of U.S. Ser. No. 06/946,365, filed Dec. 24, 1986, abandoned and of U.S. Ser. No. 07/318,901, filed Mar. 3, 1989, abandoned and of U.S. Ser. No. 07/162,680, filed Mar. 1, 1988, abandoned and of U.S. Ser. No. 07/341,436, filed Apr. 21, 1989, abandoned and of U.S. Ser. No. 06/817,441, filed Jan. 9, 1986, abandoned and of U.S. Ser. No. 07/155,207, filed Feb. 12, 1988, abandoned and of U.S. Ser. No. 07/280,173, filed Dec. 5, 1988, abandoned. All of the above applications are incorporated herein by reference in their entirety.
Yes, the '516 came through federal funding:
The work leading to this invention was supported in part by a grant from the National Cancer Institute. The Government has certain rights in this invention.
posted by Lawrence B. Ebert at 3:46 AM
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