Tonight we ask whether -- for a revolutionary and life-extending cancer drug -- a 32 year period of patent protection is excessive. The drug?
Schering's Temodar® -- my backgrounder may be found, here. Barr Labs has, earlier this year, tried the issue of the validity of Schering's efforts to extend the life of the Temodar® '291 patent before a federal district judge in Delaware -- it is presently awaiting a ruling. At right (click to enlarge) is page 7 of Barr's post trial brief.
More background: most drug patents last either 17, or 20 years, by statute -- but are often extended in various ways -- per the kind collection of volunteer knowledge at Wikipedia:
. . . .In the United States, under current patent law, for patents filed on or after June 8, 1995, the term of the patent is 20 years from the earliest claimed filing date. For patents filed prior to June 8, 1995, the term of patent is either 20 years from the earliest claimed filing date or 17 years from the issue date, whichever is longer. Extensions may also be had for various administrative delays. The exact date of termination may be zealously litigated, especially where daily profits from a patent amount to millions of dollars, e.g., pharmaceuticals. . . .
"Zealously litigated", indeed. After 32 years of exclusive sales, shouldn't we say "enough, already" -- and allow lower cost generic versions onto the market, to allow more people of limited means, or no insurance, a more cost-effective but nonetheless life-extending cancer option?
I am a capitalist -- I am in favor of the pharmaceutical companies recouping very-generous returns -- on the considerable investments each must make to bring a new drug candidate to market.
But I think it fair to ask whether "gaming the system" -- for 32 years (as opposed to the usual 20). . . . is simply beyond the pale. There is no doubt that Schering has made ten or twenty times its investment in Temodar, over all these years. Is that not adequate incentive?
I am interested in serious replies to this question.