Tuesday, September 22, 2009

How Long Should A Cancer-Drug Patent Last? Is 32 Years Too Long?

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.


Anonymous said...

Temo was not discovered in the S/P labs but rather, it was licensed from Univ of Iowa. So, you gotta wonder if even 17 years was too much? How much did S/P really need to recoup?

Anonymous said...

Then to add to this all, when you have 'experts' opining this:


What else would you expect?

Greed is good~~right?!

Condor said...

Gordon Gecko, reprised -- eh?. . . .

And thanks for the reminder that a Hawkeye scientist discovered the active agent in Temodar. I had forgotten that.

Still, the cost of clinical trials, and GMP scale-up -- to say nothing of marketing expenses -- are all very significant here. But, for a drug like Temodar, coming to market in the 1990s -- there is no possibilty that all those costs, for the life of the pre-approval process -- exceeded $900 million.

So, Schering's life of drug ROI, fully-loaded, has to be approaching 2,000 percent.

I think that is more than adequate compensation for the risk Kenilworth had originally underwritten.

I trust the judge will see it the same way -- calling these "gaming the system" maneuvers. . . out of bounds.

Then Barr now Teva could enter with a cheaper generic.

If greed is a good thing, then so too is competition -- price competition.

Namaste -- do stop back!

Anonymous said...

Temo is one of the highest profit margin products that S/P sells. That is why they want to hold onto the patent life for so long.