Chance to reconsider use of COX-2 inhibitor rofecoxib?
US Patent 6,063,811, assigned to Merck, has claims covering methods for the use of VIOXX:
1. A method of treating a disease susceptible to treatment with an non-steroidal anti-inflammatory agent comprising:
administration orally once a day to a human patient in need of such treatment 12.5 or 25 or 50 mg of 3-phenyl-4-(4-methylsulfonyl)phenyl)-2-(5H)-furanone.
2. A method according to claim 1 for the treatment of non-chronic headache, pain or swelling.
3. A method according to claim 1 for the treatment of osteoarthritis.
4. A method according to claim 1 for the treatment of rheumatoid arthritis.
5. A method according to claim 1 for the treatment of pain.
6. A method according to claim 1 for the treatment of fever.
7. A method according to claim 1 for the treatment of dysmenorrhea.
8. A method according to claim 1 for the treatment of Alzheimer's disease.
The priority cases are almost 20 years old
This is a National phase U.S. application of PCT/US97/08041, filed May 13, 1997, which claims priority from U.S. Provisional Application 60/017,878, filed May 17, 1996 and British application GB 9612063.9, filed Jun. 10, 1996.
This application is also a continuation of U.S. Ser. No. 08/851,756, filed May 6, 1997 now abandoned, which claims priority from U.S. Provisional application 60/017,878, filed May 17, 1996.
Merck removed VIOXX from the market. As noted in IPBiz at the time [ http://ipbiz.blogspot.com/2004/10/merck-recalls-vioxx-on-sept-30-2004.html ], this was a voluntary recall by Merck.
For details of the history see
https://en.m.wikipedia.org/wiki/Rofecoxib
http://www.npr.org/templates/story/story.php?storyId=5470430
http://www.nejm.org/doi/full/10.1056/NEJMp048286
**Separately, from L.B. Ebert, Increasingly Aggressive Efforts at Patent Enforcement, Intellectual Property Today (June 2000) page 22 (available LEXIS) -->
endnote 9:
n9 Curiously, shortly AFTER approval [of Celebrex], a scientific paper was published which raised issues with Celebrex. According to a report from the group of Dr. Ganet A. FitzGerald in the Proceedings of the National Academy of Science, 1999, 96:272-277, the drug may increase the risk of heart attack, stroke and blood clotting disorders. Many older people who may want to take COX-2 inhibitors for conditions like arthritis could be at risk for developing heart and blood vessel problems from the drug. Dr. Saul Bloomfield said that taking COX-2 inhibitors might be a matter of exchanging a gastrointestinal risk from one painkiller to a cardiovascular risk for another. See also Wall St. Jour., April 20, 1999. On April 27, 2000, there was a Reuters release "Merck's Vioxx seen facing FDA scrutiny on heart attacks." [Vioxx (rofecoxib) is a different COX-2 inhibitor.] On April 28, 2000, PR Newswire reported results of a study in which Pharmacia found even at very high doses, Celebrex showed no increases in stroke or heart attack with or without aspirin. [See Hoover's Online]
1. A method of treating a disease susceptible to treatment with an non-steroidal anti-inflammatory agent comprising:
administration orally once a day to a human patient in need of such treatment 12.5 or 25 or 50 mg of 3-phenyl-4-(4-methylsulfonyl)phenyl)-2-(5H)-furanone.
2. A method according to claim 1 for the treatment of non-chronic headache, pain or swelling.
3. A method according to claim 1 for the treatment of osteoarthritis.
4. A method according to claim 1 for the treatment of rheumatoid arthritis.
5. A method according to claim 1 for the treatment of pain.
6. A method according to claim 1 for the treatment of fever.
7. A method according to claim 1 for the treatment of dysmenorrhea.
8. A method according to claim 1 for the treatment of Alzheimer's disease.
The priority cases are almost 20 years old
This is a National phase U.S. application of PCT/US97/08041, filed May 13, 1997, which claims priority from U.S. Provisional Application 60/017,878, filed May 17, 1996 and British application GB 9612063.9, filed Jun. 10, 1996.
This application is also a continuation of U.S. Ser. No. 08/851,756, filed May 6, 1997 now abandoned, which claims priority from U.S. Provisional application 60/017,878, filed May 17, 1996.
Merck removed VIOXX from the market. As noted in IPBiz at the time [ http://ipbiz.blogspot.com/2004/10/merck-recalls-vioxx-on-sept-30-2004.html ], this was a voluntary recall by Merck.
For details of the history see
https://en.m.wikipedia.org/wiki/Rofecoxib
http://www.npr.org/templates/story/story.php?storyId=5470430
http://www.nejm.org/doi/full/10.1056/NEJMp048286
**Separately, from L.B. Ebert, Increasingly Aggressive Efforts at Patent Enforcement, Intellectual Property Today (June 2000) page 22 (available LEXIS) -->
endnote 9:
n9 Curiously, shortly AFTER approval [of Celebrex], a scientific paper was published which raised issues with Celebrex. According to a report from the group of Dr. Ganet A. FitzGerald in the Proceedings of the National Academy of Science, 1999, 96:272-277, the drug may increase the risk of heart attack, stroke and blood clotting disorders. Many older people who may want to take COX-2 inhibitors for conditions like arthritis could be at risk for developing heart and blood vessel problems from the drug. Dr. Saul Bloomfield said that taking COX-2 inhibitors might be a matter of exchanging a gastrointestinal risk from one painkiller to a cardiovascular risk for another. See also Wall St. Jour., April 20, 1999. On April 27, 2000, there was a Reuters release "Merck's Vioxx seen facing FDA scrutiny on heart attacks." [Vioxx (rofecoxib) is a different COX-2 inhibitor.] On April 28, 2000, PR Newswire reported results of a study in which Pharmacia found even at very high doses, Celebrex showed no increases in stroke or heart attack with or without aspirin. [See Hoover's Online]
posted by Lawrence B. Ebert at 1:16 PM
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