Developing a new pharmaceutical and bringing it to market can be incredibly expensive, in the range of hundreds of millions to a few billion dollars. Thus, when a brand name drug’s patent is about to expire, allowing it to be undermined by cheaper generic versions, drug companies often look for creative ways to patent new indications of the patented drug. These patents are known as “indication patents” or “second indication patents.” In the medical context, an “indication” means using a specific drug or therapy to treat the condition it was specifically designed to treat—for instance, using insulin to treat diabetes or Viagra to treat erectile dysfunction.
It’s not unusual for drugs to have a wide variety of observable effects outside of their intended use. This is why the practice of prescribing drugs for unapproved “off-label” use is incredibly widespread. While this is controversial, it gives drug companies a way of taking old drugs whose patents are about to expire and giving them a fresh new face.
For instance, back in the 1970s, Merck developed the drug finasteride, which was patented in the early 1990s for use in treating enlarged prostates in older men under the name Proscar. Several years later, finasteride was granted an indication patent for treating an entirely different condition: hair loss. In this context, the drug was marketed under the far more widely known brand name Propecia.
Another example is the antidepressant bupropion, which was patented for use in treating depression under the name Wellbutrin in 1974. In 1997, the drug was granted a second indication patent as a smoking cessation aid under the name Zyban.
Additionally, here is an indication patent that I previously filed. Beginning in 2006, cross-linked hyaluronic acid was sold under the brand name Juvederm for the purpose of reducing wrinkles and smoothing facial skin. An innovative physician discovered that the compound could also be used to treat a certain kind of pain. This indication was granted a new patent, even though the chemical was already known.
Drug companies will also occasionally seek indication patents for medications that aren’t particularly effective in treating their intended conditions, but which show promise elsewhere. One such drug was an antianginal drug that was patented for use in treating high blood pressure and angina. While the drug was ultimately found to note be particularly effective in these contexts, doctors noticed that it was very effective in improving blood flow in a certain other area of the body, which led to the granting of an indication patent for the treatment of impotence. This drug was eventually marketed under the name Viagra.
Indication patents can be a very useful means for extending the profitable lifespan of older pharmaceuticals, when applied for correctly. However, it’s advisable to consult with an experienced patent lawyer in order to see if an indication patent is right for your product.