Patents for Drugs and Cosmetics

How Patents and the FDA Can Prevent the Sale of Effective AntiAging Products

Patents, Drugs and Cosmetics ... oh my

As "An" mentioned in this article, there is quite a bit of controversy swirling around the latest eyelash enhancement consumer products.

Doctors had long been aware of the lash-enhancing side effect of the glaucoma drug, Lumigan, patented by Allergan.

Many started prescribing it off-label to patients with thin or missing lashes.

When Allergan became aware that cosmetic companies were selling eyelash enhancement products containing the active ingredient in its FDA-approved glaucoma drug, it enlisted the FDA's support.

There were several products containing either bimatoprost itself or a bimatoprost analog.

Authorities chose perhaps the most popular such product to set an example.

In November 2007, 12,682 tubes of Jan Marini Age Intervention Eyelash (retail value just over $2 million) were seized from the company's San Jose warehouse by the FDA.

Further, the FDA issued a warning to ophthalmologists, dermatologists, estheticians and consumers that

"the eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye)."

Allergan proceeded to file suit against 11 companies that it claimed infringed on its Lumigan drug patent by using bimatoprost or an analog.

The suit is expected to come to trial in November 2009.

Jan Marini complied totally, reformulated her eyelash enhancement product (carefully avoiding anything even close to bimatoprost) and changed the name to Marini Lash.

Marini and three other companies were dropped from the suit after they acknowledged they had violated Allergan's patent and agreed to stop distributing the eyelash enhancement products in question.

Two other companies were dismissed from the suit after convincing Allergan that their products do not contain bimatoprost or its analogs.

In the meantime, Allergan developed Latisse, a drug specifically for the treatment of hypotrichosis (alopecia) around the eyes.

They received FDA approval for the drug in December 2008 and began marketing it to doctors.

Full retail price is about $200 for 3ml, though you can find it at discount for less.

You will need a prescription to buy it.

For the time being, you can buy a similar product, Peter Thomas Roth's Lashes to Die For, which costs $125 for 0.2 oz. which is almost 6ml. Here is my review of Lashes to Die For.

This article is for informational purposes only. It does not purport to offer medical advice.