A patent, or a patent application, is the legal foundation for a product or service that is covered by a patent. Generally, a patent protects something that has been invented for a certain period of time from being used or sold by others. The patent also serves as the intellectual property (IP) of the inventor that owns the patent. A patent protects the invention from being copied or used without the owner’s permission.
Viagra is a popular drug that is known for treating erectile dysfunction. Although the drug is sold over-the-counter, it is actually governed by a combination of federal and state law. In particular, the patent that covers the drug expires in 2020, and the period of exclusivity granted by the Food and Drug Administration (FDA) and the drug’s manufacturer also expires at that time. This fact was reported by the New York Times, which noted that “patents usually protect products for up to 14 years.” For these reasons, it is important to understand when the patent expires so that you know whether or not you are infringing on the intellectual property of the patent holder.
The patent for viagra, officially known as 9201577, was filed with the US Patent Office in 2007 and published in 2011. The patent covers certain compounds and their use as inhibitors of phosphodiesterase type 5 (PDE5), an enzyme that the US Food and Drug Administration (FDA) has classified as an underlying cause of erectile dysfunction. In other words, the patent protects the active ingredient in Viagra and other medicines that act on the same mechanism of action (MOA) as Viagra. The ‘877 patent specifically claims methods of treating erectile dysfunction by administering certain nitric oxide (NO) donating compounds and their use as medicaments for that purpose. The claimed compounds are either 6-chloro-9-hydroxy-9 H-carbazole-3-carboxylic acid (C9H9N3O3) or 6,7-dichloro-9-hydroxy-9 H-carbazole-3-carboxylic acid (D6,7HCl9HN3O3).
When does the patent on Viagra expire? The USPTO has confirmed that the patent will expire on January 1, 2021, which is 13 months from now. This is assuming that the application has not been approved by the FDA and the patent has not been extended by the agency.
What About The Exclusivity?
The ‘877 patent also contains a clause that grants the holder of the patent, Dr. Andrew V. Kotkin, a temporary monopoly on the making and selling of the claimed compounds for the following 17 months:
- The ‘877 patent, issued on January 1, 2021
- For the following 17 months
- For the benefit of the inventor
According to the New York Times:
- The ‘877 patent is “usually” 18 months long. However, under exceptional circumstances, the length is 24 months, and in some cases, the length is 30 months.
- If a drug company wants to make and market a drug that is substantially similar to Viagra, they must ask for a 12-month extension from the FDA, which would make the monopoly period last 24 months.
- If a drug company wants to make and market a drug that is considerably different from Viagra, they must ask for a six-month extension from the FDA, which would make the monopoly period last 18 months.
The Times also reported that “[t]he ‘877 patent covers a method of treating erectile dysfunction that includes administering nitric oxide (NO) donating compounds.” NO is a molecule that plays an important role in the body’s response to stress. The patent states that NO donors inhibit the breakdown of cGMP by phosphodiesterase type 5 (PDE5), an enzyme that breaks down cGMP. Inhibition of PDE5 allows for more cGMP to build up in the blood vessels, which leads to relaxation of the blood vessels and increased blood flow to the penis.
Infringement And Damages
The ‘877 patent specifically claims methods of treating erectile dysfunction, including administering certain NO donating compounds as pharmaceutical compositions. The claimed pharmaceutical compositions may further comprise a therapeutically effective amount of an antidepressant, for example, sildenafil or another phosphodiesterase type 5 (PDE5) inhibitor. Although the patent does not claim Viagra itself, the claimed compounds and their use as an inhibitor of PDE5 is the legal basis for Viagra as well as a variety of other drugs sold over-the-counter for erectile dysfunction. As noted above, the claimed compounds are either C9H9N3O3 or D6,7HCl9HN3O3, and each of these compounds is the “inventor’s compound” for the ‘877 patent. C9H9N3O3 is the generic name of 6-chloro-9-hydroxy-9H-carbazole-3-carboxylic acid, while D6,7HCl9HN3O3 is the generic name of 6,7-dichloro-9-hydroxy-9H-carbazole-3-carboxylic acid.
According to the New York Times:
- A company that makes a drug that is substantially similar to Viagra, such as Alprostadil (prostaglandin), Cialis (tadalafil), and Levitra (vardenafil), could be sued for infringement of the ‘877 patent.
- A company that makes a drug that is considerably different from Viagra, such as Viagra Professional (sildenafil), could be sued for infringement of the ‘877 patent.
The Times also reported that “[t]he question for a potential litigant is whether or not they are practicing the method in the same way the inventor intended.” It is fairly straightforward to prove that a defendant is practicing the method in the same way the inventor intended. For example, if you have a definition for ‘substantially similar’ or ‘substantially different’ in the claims or specification of the patent, then you can use that to determine whether or not the defendant is infringing on the patent. If you do not have a definition in the patent, then you can use the definition in the standard patent format to prove infringement.
The Next Step
If you are sued for infringement of the ‘877 patent, you may need an experienced patent attorney to defend you against the allegation. You should also consult with a business attorney to see what other legal options you have available to you. There are several potential defenses that you can raise, including the following: