A federal appeals court found yesterday that Purdue Pharma had deliberately misled the government to win patent protection for its powerful painkiller OxyContin. The ruling, which makes patents on the drug not enforceable, opens the door to increased generic competition, as well as potentially huge legal awards against Purdue.
The unanimous ruling by a three-judge panel of the United States Court of Appeals for the Federal Circuit in Washington is a victory for Endo Pharmaceuticals Holdings, which is seeking to market a generic form of OxyContin.
Shares of Endo, based in Chadds Ford, Pa., closed yesterday at $24.63, up $4.60. Purdue Pharma is privately held.
OxyContin is a time-release formulation of a long-used narcotic known as oxycodone. Over the last five years, its annual sales have averaged about $1.5 billion. The drug also gained notoriety because it was widely abused.
Purdue Pharma, a company based in Stamford, Conn., said yesterday that it believed that it had properly obtained patent protection for OxyContin and that it planned to seek to have the court's full panel of 12 judges hear an appeal.
"Purdue believes that the court's decision is contrary to principles of patent law," the company said.
Yesterday's appellate decision surprised some analysts and lawyers because it upheld the most critical and damaging portion of a trial court ruling against Purdue Pharma last year.
The ruling last year, by Judge Sidney H. Stein of United States District Court in Manhattan, found that Purdue Pharma had intentionally deceived patent officials to secure OxyContin's patent by implying that the company had clinical evidence to show that OxyContin was easier for doctors to use to control pain, when in fact such data did not exist. --NYT
You know, I find it crazy that the Patent Office doesn't, you know, ASK TO SEE the details of these things. I can look at Biotech and Software patents and see how messed up they are. I am willing to bet that this extends into the Pharma world too.
The problem is, while there is nothing wrong with the idea of a patent (except in the software world :P), the PTO is obviously incapable of having patent applications reviewed by experts in a field to validate that a company has what they say they have, to establish a prima facia statement of "novel and non-obvious" relative to the state of the art in a field. How could they have GOTTEN a patent without presenting their data? Of course, how do people get software patents without presenting an implementation?
Comments
RE: Hillbilly Heroin Loses Patent
And I read that and thought - how is it relevant for a patent if the drug is easier for doctors to administer? It's either a new drug or not? Really how is it relevant if it really works or not? It seems that for a mechanical device I don't even have to have a working model, just a napkin with some scribbles on it.
RE: Hillbilly Heroin Loses Patent
Because if it isn't, there is (wait for it) no substantive difference with oxycodone. Not that "hey, let's take a 50 year old narcotic and make a time released version" seems really "non-obvious" to me.
RE: Hillbilly Heroin Loses Patent
ahhhh the old rtfa bug....
So how could they even think about patenting the same drug?
We could submit patents for all those drugs where you have to take 2 pills a certain number of days, double the dosage and patent the fact that it is easier for the patient to swallow one pill instead of 2.
RE: Hillbilly Heroin Loses Patent
Yeah. There are all kinds of crazy new exception to IP law now based on stupid stuff like this.
Like, if you buy a public domain book in Microsoft's ebook format -- Merchant of Venice for example -- even though the work isn't copyrighted, if you export it to plain text you are violating the copyright because somehow the ebook counts and a "performance" and breaking the DRM is a DMCA violation.
The whole thing is just crazy.