There is an old saying about what a difference a day makes. Well, what about 17 years? For Amgen, or any drugmaker that wins a new patent on an existing med, that can, of course, mean untold amounts of money. And this appears to be in the offing for the biotech, which was just awarded a patent that adds 17 years of protection to its best-selling Enbrel medication.
In a very brief statement issued last night, Amgen disclosed a new patent that means competition would be kept at bay until November 2028, instead of October 2012. By then, Enbrel will have been on the market 30 years which, as The New York Times notes, greatly exceeds the 20 years of patent protection that is usually expected.
Obviously, this is a big deal for the biotech, which garnered roughly $3.5 billion in sales from Enbrel during each of the past three years. The med, which is approved to treat rheumatoid arthritis and psoriasis, accounted for about 25 percent of all product revenue last year (read the 2010 SEC filing here). Enbrel costs about $20,000 or more a year.
The implications, however, extend beyond the Amgen bottom line. This is because the new patent may could mean payers and patients will not reap some of the savings that was intended by the health care reform legislation passed last year. The law opened the door to biosimilars, presumably lower-cost versions of expensive biologics such as Enbrel.
As the Times notes, "patents 20 years from the date of application, to avoid situations like this where an invention gets extended protection because of delays or maneuvers at the patent office. But since the latest Enbrel patent was filed before the law changed, the new patent "is governed by the old rules and lasts for 17 years from the date of issuance."
In other words, the price tag may remain high unless there is a successful patent challenge. Earlier this year, Amgen indicated competition was at least fve years away, due to other patents covering the use or formulations of Enbrel, the paper adds. Merck, for instance, struck a deal earlier this year with South Korea's Hanwha Chemical to develop a version (see this).
But as ISI Group biotech analyst Marc Schoenebaum notes, the new patent "provides additional barriers if biogeneric companies choose to litigate against Amgen’s patent estate for Enbrel...If biogenerics do not enter the market until 2028, we believe this patent could slow erosion, adding about $100 million in revenue every year beginning in 2019."
5 Comments
As I understood it, the extended protection reflects the fact that drugs developed like E are not covered under current patent expiration law. Any chance of the law being changed?
Human TNF receptor fusion protein
For the Science Types: Patent no. 8,063,182
Abstract:
The present invention is concerned with non-soluble proteins and soluble or insoluble fragments thereof, which bind TNF, in homogeneous form, as well as their physiologically compatible salts, especially those proteins having a molecular weight of about 55 or 75 kD (non-reducing SDS-PAGE conditions), a process for the isolation of such proteins, antibodies against such proteins, DNA sequences which code for non-soluble proteins and soluble or non-soluble fragments thereof, which bind TNF, as well as those which code for proteins comprising partly of a soluble fragment, which binds TNF, and partly of all domains except the first of the constant region of the heavy chain of human immunoglobulins and the recombinant proteins coded thereby as well as a process for their manufacture using transformed pro- and eukaryotic host cells.
For the wall Street types:
$60,000,000,000.
Ed,
I think there is something wrong with the last phrase in this statement "In a very brief statement issued last night, Amgen disclosed a new patent that means competition would be kept at bay until November 2028, until October 2012."
Justice,
You appear to be a bit confused. The reason Amgen's patent has a term that is 17 years from the date of issue is because it stems from an original filing prior to June 8, 1995 - the enactment of the Uruguay Round Agreements Act. This act changed the law of patent term from 17 years from issue date to 20 years from filing date.
Thanks to OII, I see that this application was filed 19 May 1995. Another way to look at it - it took the patent office 16 years to grant this patent!!
xtian, your note raises a very important issue. The United States Patent and Trademark Office (USPTO) is woefully behind other nations in speed of granting patents, which is a major reason why the US is losing it's competitive edge in many areas. I don't care whether you have the answer to cancer. No drug company will undertake the billions of dollars in R&D costs without bullet-proof patents.