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Written by: Olena Yakobchuk, CEO of Intectica Group

Everyone who has ever faced the issue of protecting his / her own intellectual property knows that a patent for an invention is valid for 20 years. But is 20-year protection period enough from a practical point of view?

For example, consider a new drug protection in the United States. Patent life begins on the date of filing a patent application with the Patent Office. Often, to “mark out” the new drug for themselves, companies file patent applications at the stage of the new drug development, and often claim a wide group of compounds, which includes the active pharmaceutical ingredient of the new drug. At this stage, applications may include preclinical studies only. Further, a long process of clinical trials and regulatory approving for the new drug marketing in the United States is following.

According to various estimates, a period from the date of the first patent application filing to the beginning of the new drug sale on the US market can take from 5 to up 15 years. During these 5-15 years, the already obtained patent does not pay off either itself or the expenses invested in the new drug, but its life continues. In this case, pharmaceutical companies have two options for extending the new drug protection term: 1) to renew the patent life for another 1-5 years over 20; or 2) to file the following, more specific, patent applications, for example, for a narrower group of compounds, for a specific active pharmaceutical ingredient, its derivatives or prodrug forms, for a method for producing an active ingredient, for a drug composition, etc., each of which in one way or another will protect the active pharmaceutical ingredient or the drug itself.

According to Section 156 of Title II of the Drug Price Competition and Patent Term Restoration Act, a patent for a “product” can be renew if, among other conditions, “the product” has passed a regulatory review period, namely the FDA review period, before it is freely used or marketed in the US. In this case, the “product” refers to an “approved product” and means a pharmaceutical product, which, in turn, means the active ingredient of the new drug, antibiotic or human biological product, including any salts or esters of the active ingredient, alone or in combination with other active ingredients. The definition seems to be fairly exhaustive. However, history does not yet know legislative documents that could not be interpreted for someone own benefit.

Thus, 2004 was marked by litigation between the pharmaceutical companies Pfizer Inc. and Dr. Reddy’s Labs. Ltd. One of the patents owned by Pfizer Inc. protected the compound known today as amlodipine, and its salts. When applying for a patent renewal, as the “approved product” Pfizer Inc. indicated the Norvasc® drug, which does not contain amlodipine per se, but a specific salt, such as amlodipine besylate. That is, according to paragraph 156, the “approved product” is amlodipine besylate and protection renewal is possible for amlodipine besylate only. Dr. Reddy’s Labs. company might have thought the same, and received FDA approval to use another salt of amlodipine, such as amlodipine maleate. And, the company was mistaken, because the Federal Court ruled in favor of Pfizer Inc., which argued that the “active ingredient” is amlodipine, and not its salt, and the therapeutic effect of amlodipine is not affected by its salt form, therefore, the patent renewal applies to all claimed salts of amlodipine.

Similar litigation is taking place right now between pharmaceutical companies Biogen International Gmbh and Banner Life Sciences LLC. One of the patents of Biogen International Gmbh protects a method of treating multiple sclerosis by administering a pharmaceutical preparation containing dimethyl fumarate, monomethyl fumarate, or combinations thereof. At the same time, Biogen International Gmbh received FDA approval for the sale of the Tecfidera® drug, which contains only dimethyl fumarate, and Banner Life Sciences LLC has applied for approval of the drug with monomethyl fumarate. Banner Life Sciences LLC’s reasoning for the court is that the patent renewal only applies to the “approved product,” i.e. dimethyl fumarate and does not apply to monomethyl fumarate. The argument of Biogen International Gmbh is very similar to that of Pfizer Inc. and lies in the fact that the “active ingredient” is fumarate, and the therapeutic effect of fumarate is not affected by its ester form. However, the second instance court rejected this reasoning, and Biogen International Gmbh has lost the second instance court for now.

Development and implementation of the new drug is undoubtedly a very time-consuming and costly endeavor. And for the new drugs, renewing the patent life even for 1 year helps companies recover their expenses as fully as possible. The described litigations show how important it is to competently plan the protection of your intellectual property from a legal and legislative point of view and to achieve the maximum period of this property protection.

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