Synergy won’t get you a patent term extension

One way drug companies are compensated for the regulatory burden of seeking FDA approval is the extension of patent terms. One of the eligibility requirements for a patent term extension is that the permission for the commercial marketing or use of the product be the first permitted commercial marketing or use of the product.

Stephen Albainy-Jenei
At the beginning of the last century, the majority of drug products available were ineffective for their stated purpose at best and did more harm at worst. It is noteworthy that for many of these so-called Patent Medicines, the main active ingredient was alcohol—often 30 percent or more.

Since 1962, before a new drug can be marketed in the United States, the Food and Drug Administration (FDA) must approve it, after it is shown to be safe and effective. This also has not been without side effects, since it means that a company must complete clinical trials, which increases the cost of developing new drugs and delays their introduction.

One way drug companies are compensated for the regulatory burden is the extension of patent terms. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) makes it possible for drug patentees to have the term of their patent extended for as much as five years if they meet certain criteria. In the EU, there is the Supplementary Protection Certificate (SPC).

Amidst this backdrop, along comes AstraZeneca with an application for a patent term extension of the patent term of U.S. Patent No. 5,674,860, based the time for FDA review of Symbicort.

The Patent Office determined that the '860 patent was ineligible for patent term extension based upon the regulatory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort under the provision of law under which such regulatory review period occurred, and (2) the PTE Application was not timely filed.

Based on this statutory language, one of the eligibility requirements for a patent term extension is that the permission for the commercial marketing or use of the product be the first permitted commercial marketing or use of the product. The term product is defined as a single entity or in combination with another active ingredient.

In this case, AstraZeneca indicated that Symbicort contains two active ingredients: formoterol fumarate dihydrate and budesonide, both of which were approved for commercial marketing or use before the approval of Symbicort. AstraZeneca argued that since the product Symbicort is a synergistic combination of formoterol fumarate dihydrate and budesonide, it should be considered as a single active ingredient for patent term extension purposes.

The Patent Office begged to differ, stating that the synergistic effect of the active ingredients formoterol fumarate dihydrate and budesonide has no relevance in determining "first permitted commercial marketing or use of the product."

Since the term "product" includes any new drug or antibiotic drug "as a single entity or in combination with another active ingredient" the court found that synergistic effects are not an appropriate distinction for term extension policies.

AstraZeneca could appeal.

Side note: Some consumer products were once marketed as patent medicines but have been reformulated and are no longer sold for medicinal purposes. Their original ingredients may have been changed to remove drugs; such is the case with Coca-Cola. Others, like Vicks VapoRub, still exist.

Stephen Albainy-Jenei is a patent attorney at Frost Brown Todd LLC, serving up chat at PatentBaristas.com. Feel free to write him with comments or questions at mailto:stephen@patentbaristas.com. Stephen doesn't own shares of any company mentioned in this article. DDN

Stephen Albainy-Jenei

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