Zyprexa Patent Upheld on Appeal

Eli Lilly v. Zenith Goldline (Fed. Cir. 2006)

Lilly’s patent covers olanzapine (Zyprexa®) and its use for the treatment of schizophrenia. Three generic manufacturers (Zenith (IVAX), Dr. Reddy’s, and Teva) filed an ANDA and Lilly responded with a complaint in the Southern District of Indiana.  After a bench trial, the district court agreed with Lilly that the patent was valid, infringed, and enforceable.  The defendants appealed to the Court of Appeals of the Federal Circuit.

Anticipation: To anticipate the invention, a prior art reference “must disclose each and every feature of the claimed invention, either explicitly or inherently.”  However, in both Petering and Schaumann, prior art references that disclosed the family of the claimed compound were found to anticipate the claimed compound — even though the claimed compounds were not specifically discussed.

Here, the CAFC found that those cases were not applicable because the closest reference to olanzapine did not spell out “a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member in this limited class.”

Obviousness: The CAFC agreed that the prior art references did not suggest a the compound. In addition, Lilly provided strong evidence of secondary considerations, including: “(1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results.”

The record shows a long-felt need for a safer, less toxic, and more effective clozapine-like drug; a decade (or more) of failure to find a replacement for clozapine; a reasonable amount of commercial success for olanzapine; and a number of awards for olanzapine as indicators of industry acclaim.

Public Use: Prior to filing the patent application, Lilly conducted Phase I clinical safety trials. The court found, however, that the trials were well within the experimental use exception:

In this case, Lilly tailored its tests to their experimental drug safety and efficacy purpose, adequately monitored for results, and maintained confidentiality throughout the duration of the study. The trial court did not err in finding no public use.

 

Comments

[Virginia Simson]

Sad to read this.

Zyprexa is a NASTY drug .. generic or not.

This "legal" profiling of idiocy at the bar, just points out why a grassroots movement to recall the drug is a necessity.

Maybe the states that pay for the diabetic drugs necessary to help zyprexa "patients" will ally with the thousands of victims and we can get some Ministers of Health to get off their lazy duffs. Pancreatis and strokes are really "no fun". And the evidence that they cause monumental mental dysfunction resulting in criminal acts is mounting ....

[Leslie Handcock]

The thing that truly amazed me with allt he prescribing of this drug is that it only takes minutes.
A couple of questions that if anyone answered honestly would land the on the drug. It seems more like a stop gap for a failing medical system-globally

[Daniel Haszard]

Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
Not fair~Daniel Haszard

[Try 18 USC not 35 USC]

All the above comments, thankfully, have absolutely nothing to do with the validity of the patent.

Unthankfully, nor do they have much to do with intelligent debate or advancement of the issues of pharaceutical safety.

[Jim]

"All the above comments, thankfully, have absolutely nothing to do with the validity of the patent."

Why not? If this drug really is as bad as those above say, does it meet the useful portion of the utility requirement?

[Try 18 USC not 35 USC]

"Why not? If this drug really is as bad as those above say, does it meet the useful portion of the utility requirement?"

Even if Zyprexa killed 100% of patients who took it, it still meets every requirement of 35 USC 101. Do a patent search for suicide-enabling devices.

[Jim]

"Even if Zyprexa killed 100% of patients who took it, it still meets every requirement of 35 USC 101. Do a patent search for suicide-enabling devices."

So now you've got a 112 problem with the requirement of clearly disclosing how to use the invention. I mean, if the specification says the pill cures a disease and in reality it kills 100% of patients who take it, well, it seems like there would be a significant shortcoming re 112.

If there is a patent for a suicide-enabling device, I'd hazard a guess that the disclosure does not represent that it cures diseases. Maybe this is a silly assumption on my part.

[David Jaglowski]

Jim,

With respect, you were asking a question concerning utility, and now you're flippantly attacking an entirely appropriate answer that is plainly limited to sec 101. Why?

Zyprexa has beneficial uses that are clearly documented in its clinical studies and NDA, and the side effects that may be associated with particular cases involving the drug do not cause a problem under 35 U.S.C. 101. The statute does not require a net utility, it requires a utility, period

Regarding section 112, the statute also does not require a written description that meets any sort of truth-in-advertising standard, it merely requires a written description enabling a person skilled in the art to make and use the claimed subject matter. Unsurprisingly, USP 5,229,382 describes how to make and use the drug to treat the symptoms of certain mental disorders. Zyprexa plaintly does not kill 100% of the patients who take it. Non-existent 112 problem solved.

[Malcolm Mooney]

Mental illness in this country is like most "diseases": over-diagnosed and over-treated.

[Jim]

David,

Your explanation is appreciated. To answer your question of why: Because I dislike categorical statements such as "absolutely nothing" and "100%."

Could I get a patent on a suicide-enabling device by disclosing it as a new and useful fitness machine?

[Try 18 USC not 35 USC]

"Because I dislike categorical statements such as "absolutely nothing" and "100%."

Could I get a patent on a suicide-enabling device by disclosing it as a new and useful fitness machine?"

Jim -
First, I admire your candor, and I do regret that you dislike the correct answer. It simply remains that Congress did not consider patentability for "anything under the sun made by man... so long as it's safe to use" when drafting section 101.
Perhaps the better point is a normative one; that the patent laws *should* bar patentability to dangerous drugs (much like patentability is barred to inventions that are threats to national security or are nuclear weaponry). I tend to think that the law already has this covered though through tort law and FDA regs. Maybe you disagree?

Second, yes, you could, as long as you properly enabled it and it generated a physical result.

[steve]

Is there a web page where common drugs are cross referenced with their patent expiration dates. That would be cool and informative.

[DDG]

Steve,

Search here to your heart's content. http://www.fda.gov/cder/ob/

Wow, this thread is a trainwreck. There's pretty extensive law on 101/enablement/written description for chemical inventinos. There's even a case holding that a new drug does not have to be safe for humans as far as the FDA is concerned to meet 101. There are some 101 rejections in chemical cases, but they're for inventions that do not work at all. Brenner v. Manson and its progeny and earlier related cases come to mind.

[me]

1) Yes, it does meet the utility requirement under 101.
2) This is a regulatory issue, not a patent issue so keep it off these boards, please.

[Andrew]

Where did you find this guestbook by the way??? I'd like to have one like this on one of my sites!!!

[jplind]

Interesting comments. I've been taking Zyprexa for over 2 years; do not have diabetes or any other problems that have been mentioned. Other drugs for my condition have far more side effects than Zyprexa; liver damage, etc. It's interesting that people have the impression that if you take Zyprexa, you will get diabetes. This drug saved my job and allows me to have a happy life.

[Tanya Davis]

I have suffered from numerous psychotic episodes since 1977. This drug allows me to function at a high level. My blood work has not shown my sugar to be high since 2002 when I started taking Zyprexa.

My question is,"When does the patent expire for the pharmacutical company" I want to pay less for my medicaton and continue taking it.

Maybe I am lucky.

Tanya Davis

[Just an ordinary inventor(TM)]

Dear Tanya Davis,

I read your question about Zyprexa but I am unable to answer in any meaningful way because I am not an attorney, I’m just an ordinary inventor and because I have a layperson’s background regarding the pharmaceutical field.

But his may be helpful to consider: If a patent attorney was able to answer your question, his professional ethics might interfere with her or him doing so because of professional relationship(s) s/he may have.

You might consider writing a letter to Eli Lilly and Company at:
Lilly Corporate Center
Indianapolis, Indiana 46285 USA

Lilly’s phone number is: 1-317-276-2000: You might try asking for Customer Relations if you call, and ask for the name of whom you speak to, and also ask to speak to their supervisor.

It appears that Lilly has 36 U.S. patents relating to Zyprexa, an early one being Pat. No. 5,605,897. If you have a computer, click the link below if you want to read their patents but that may waste your time unless you are a “person having ordinary skill in the art”, PHOSITA, which is patent terminology some call “gobbledygook.”

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=olanzapine&FIELD1=&co1=AND&TERM2=lilly&FIELD2=ASNM&d=PTXT

Good luck, and may God Bless and keep you well.

[rachael]

Tanya Davis, you're lucky but keep your comments to yourself. Too many people suffered from zyprexa and that company is full of liars!!! It may not have happend to you yet but it will, then what will you say ? To most of you on this blog, you have no clue as to what is really going on. Try getting up when your glucose level is crashing , try to not shake when your level is low. Try being a vegetarian that exercise alot and all of a sudden some company lies about a product and you get sick from it. Try wondering everyday why did Eli Lilly shorten your life. Try pricking your finger 6 to 10 times a day. Try weighing 135 lbs. and take zyprexa and balloon to 277 lbs. in 1 year. Try having to spend money on larger clothes because the other ones don't fit anymore. Try being degraded by people who think they know it all and puts you down about your size. THIS IS A LOT TO THINK ABOUT ! I'm not mad. I just ask that people ,PLEASE THINK BEFORE YOU SPEAK.

[leslie]

SInce posting to this artcle, whch had nothing t do withthe actual studies of the drug (apparently)it has now come to light that the drug is now the number 1 orescribed drug for household pets. How many pets does anyone know of committed suicide or were suicidal or bipolar. It just shows the drug is no more than ameny making gambit. How could a pet be able to answer a questionaire or do any such testing to reveal the need for such treatment other than the need to increase profit margins in a sturated market ?

[vikbaba]

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