6 replies to this topic

[justinb]

(Sorry about the repost -- this is my first time posting and I think this discussion is better suited in this section)

Hi to all,

My mother was diagnosed with CML almost two years ago, and since then I have tried my best to keep updated on new developments that may affect her.  I have been following the health care debate particularly closely as my mother is now locked into her current job since she cannot afford to lose the insurance she depends on for her Gleevec.  She is a nurse, and it has been particularly frustrating to watch someone who has spent decades taking care of others now forced to work until she reaches Medicare age.  Given the choice, I know she would prefer to cut back her hours and spend more time with her young grandchildren, who live several states away and who see her rarely.  From reading some of your posts, I know this work/insurance conundrum is not unique to my mother.

So it has been with some hope that I have followed the health care bills working their way through Congress.  The thought that some day soon (if you can call a few years soon) my mother might be able to quit her job and buy her own insurance at a decent price is encouraging.  However, I was deeply disturbed to discover the Eshoo Amendment today, which has been attached to the House version of the health care bill.  This amendment will extend the monopoly protection on biologic drugs to 12.5 years.  Reading up on the amendment, it also appears that it throws up so many new regulatory hurdles on generics that in effect it may prevent generic biologics from ever coming to market in the US.  For those of you, like me, who have been hoping that, if nothing else, at least the cost of the Gleevec would plummet once the patent expires, this is extremely upsetting news.

Regardless of what you might think of the overall health care bills taking shape, I think it is important for our community to do what we can to stop this Eshoo Amendment from becoming law.  I found at least one website that is advocating to remove the amendment, and they are asking for people who use these drugs to contact them.  (Incidentally, I didn't find Gleevec on the list of drugs at that site, but I assume it is an oversight).  If anyone has any more information on the Eshoo Amendment, please post.  I will keep looking into it and will probably write a letter to the editor of my local paper as well.

Thanks everyone,

Justin

[Trey]

Gleevec is not affected either way since it has "orphan drug" status and patent protection through 2015.

[ROM1212]

Trey,

Can you provide any links to reputable websites that provide more detail about Gleevec's orphan status, and the implications on patent expiration?  I am especially interested in this status being extended as a result of Gleevec's effectiveness against other cancers.  Dr. Druker recently stated in a NY Times interview that Gleevec is now FDA approved for 10 types of cancers.

Thanks.

[CMLMN]

http://theoncologist...nt/full/7/5/390

[ROM1212]

Thanks for the link, however the only information I found in the document was "7 years of exclusive marketing".  Gleevec was FDA-approved in 2001.

It appears the document referenced in the link is dated in 2002.

Thanks.

[Trey]

http://online.wsj.co...020-707841.html

http://www.pharmafoc...-353040,00.html

http://www.drugbank.ca/drugs/DB00619

Patents

Novartis has several patents on Gleevec, but generally the main U.S. patent expires in 2015 (it was extended from the original expiration date of 2013). It was granted "orphan drug" status, meaning that it had a limited population that would benefit, so patents are favorable to those companies that will develop new drugs to fill these "orphan drug" needs, granting extended patents. In this case, the original patent was 17 years, and another 1.6 years was later added (now Jan 4, 2015). Novartis has a program to help those who cannot afford the drug that might be a fallback position, if needed. Just so you know, it is illegal to import any "generic Gleevec" into the US.

The patent for Gleevec in Canada expires April 1, 2013

There is a "method of use" patent on Gleevec covering treatment of GIST tumors that does not expire until June 2022.  The implications for GIST patients until 2022 are unclear.

http://patft.uspto.g...5&RS=PN/6958335

http://treyscml.blogspot.com/

[Buzzm1]

Thanks for the information Trey.