pharmaceutical patents

January 16, 2010 3:20 PM

For the patent lawyers in the house... If a pharmaceutical company creates a me-too drug, (i.e. a drug that offers no improvement over the existing drug in its class--for instance claritin, allegra, zyrtec, etc.) is their burden of proof in the patent process that their drug is "better than placebo" or that it is "as good as the pre-existing drug in the class?"
posted by mert to law & government (9 answers total)

Not sure this addresses your question but it does talk about patents in the pharmaceutical industry, might provide some background. (Warning: Malcolm Gladwell article.)
posted by sexymofo at 3:26 PM on January 16, 2010

I am not a patent attorney. This is not legal advice. The Manual of Patent Examination and Procedure, the playbook for patent examiners, provides a good rundown of the law in this area. Some paraphrased highlights:

To receive a patent the claimed invention must have utility. This means that it must have a credible, specific, and substantial use. Inventions claimed to have a therapeutic or pharmacological utility are held to the same standard as other inventions. The utility requirement is not to be confused with the FDA requirements of safety and efficacy. Courts have repeatedly found that the mere identification of a pharmacological activity of a compound that is relevant to an asserted pharmacological use provides an "immediate benefit to the public" and thus satisfies the utility requirement.
posted by jedicus at 3:27 PM on January 16, 2010

I should add that in general the utility requirement is a very low bar. The Patent Office will usually only reject an application for lack of utility if 1) no claim to any utility is made 2) the claim is very vague (e.g., 'a compound for the treatment of a disease' or somesuch) or 3) the claim is facially absurd or unbelievable (e.g., 'an effective cure for all cancer' or 'a perpetual motion machine').
posted by jedicus at 3:34 PM on January 16, 2010

You're mixing up patent law requirements and regulatory (FDA) requirements.

The law generally requires a pharmaceutical company to prove to the FDA that the generic drug is bioequivalent to the brand name drug. The generic company can usually do this without the full-out clinical studies that the brand company has to do. (The law that allows generic companies to piggyback on the brand company like this is called the Hatch-Waxman Act.)

When the generic company is sued for patent infringement by the brand company, the brand company has to prove that generic infringes the brand company's patent, or the generic company has to prove that the patent is invalid.

The challenge for generic companies is to navigate successfully between these two spheres -- showing that the generic drug is similar enough to the brand to be "bioequivalent," but different from the brand in the specific ways that make it non-infringing of the brand's patent.
posted by pitseleh at 3:37 PM on January 16, 2010

I am an IP attorney, but I don't practice in pharmaceuticals or biology. IANYL. TINLA.

I believe Jedicus is correct: the Patent Office only cares that the drug is:

1. New,
2. Useful, and
3. Nonobvious

As far as I know, they don't care whether the drug works, or whether it's safe (that's the FDA's bailiwick).

The question, in the way you've framed it, is probably whether the me-too drugs are obvious in view of the originals. Again, I don't do drugs, so I can't say for sure, but I would imagine a designer drug that was the same as something else, except they replaced, say, a hydrogen with a methyl group, would be obvious (and therefore unpatentable) unless the modified drug was unexpectedly better, or at least different, from the original.
posted by spacewrench at 3:39 PM on January 16, 2010

...or the generic company has to prove that the patent is invalid.

Or show that they're not infringing the patent. Which, if the original patent was written badly, can be possible. In some cases developing a new synthesis may be enough, depending on how the original patent was written.

It's all about details. But the above responders are right that things like efficacy have nothing to do with patent infringement lawsuits.
posted by Chocolate Pickle at 5:14 PM on January 16, 2010

Generics have to prove bioequivalency without infringing on patents. A me-too drug is not the same as a generic. It treats the same patient population and is chemically similar, but not the same. They are approved independently of the similar drugs and must meet the same standards as any new drug on the market, ie, better than placebo.

The various statins for treating high cholesterol are good examples -- they are chemically different but do similar things.
posted by mneekadon at 5:50 PM on January 16, 2010 [1 favorite]

This is not about generics. Me-toos are different drugs in the same class like Zoloft is to Prozac. Not a lawyer, etc. but reasonably knowledgeable about pharmaceuticals and my understanding is that it only has to be superior to placebo.

Which is a good thing because for all the bitching about "me too's" there are people who get suicidally worse on Prozac who thrive on Zoloft and no one knows why but it's good to have more options.
posted by Maias at 8:07 PM on January 16, 2010

This is just a comment/question from a pharmacist, since I think mneekadon has the correct answer: they have to be proven better than placebo, not other drugs on the market.

To me, a me-too drug isn't another drug in the same class of drugs (i.e. Lipitor and Zocor), but more like Risperdal (risperidone) vs. Invega (paliperidone) or say, Celexa (citalopram) vs. Lexapro (escitalopram, or for those in the chemical know, S-citalopram). Specifically, just a metabolite or an enantiomer. Do the rest of you disagree? Interesting.

I can't tell you how much I hate these drugs and the headaches they give me with insurance rejections and prior-authorizations. And I especially hate the lack of information regarding head-to-head comparison of the me-too drugs to the class's pioneers.
posted by keribear at 10:57 PM on January 16, 2010