- Mylan is attempting to have a lawsuit reinstated against the manufacturer of the antibiotic Doryx (doxycycline), because it says that Allergan (which originally owned Doryx, but sold it to Mayne Pharmaceuticals this year) tweaked the drug to keep it proprietary through a new patent, thereby cutting off the possibility of generic competition.
- Previously, a trial judge in Pennsylvania had dismissed claims of violation of antitrust laws in the Doryx case.
- The U.S. Federal Trade Commission (FTC) maintains that companies that make minor tweaks to brand-name drugs to avoid generic competition may be violating anti-trust laws. The agency is asking a federal appellate court to reinstate the lawsuit.
There are many examples of product tweaking intended to extend patent life based on insignificant changes. For instance, there's the well known case in which New York sued Actavis over Namenda (memantine), a widely used Alzheimer's disease (AD) drug, after the company altered the formulation and tried to force patients to switch by slowly discontinuing the older version.
Another instance involved Teva's case against Abbott Labs regarding TriCor, which is used to lower cholesterol. When Abbott patented new formulations of TriCor, with very minor changes, Teva sued and won $184 million.
Patent law exists for a reason—to protect IP and encourage innovation. But it does not exist to thwart competition or to rob consumers of the right to access generic drugs. This practice costs consumers millions of dollars per year, and will continue to be actively policed by the FTC.
"Such conduct could deprive generic companies of their most efficient means of distribution—automatic substitution at the pharmacy—and, as a result, maintain the brand’s monopoly through illegal means,” said the agency in a statement.