Johnson & Johnson holds the patent for Zytiga, a cancer drug used to treat prostate cancer. However, a U.S. district court just invalidated the company’s patent, which could open it up to competition from generic versions of the drug.
The company has filed an appeal and asked the court to hold off on allowing generics until the appeals process is finalized.
Zytiga may not be patentable
The Zytiga patent is good through 2027, but an invalidation would allow other companies to start producing generics much sooner. In January, the Patent Trial and Appeal Board ruled the patent for the drug was obvious, so it could not be patented.
A patent is granted by the United States Patent and Trademark Office (USPTO), and it allows the patent owner the right to stop others from using, making or selling the patented item in the U.S.
Patents must meet several criteria
To apply for a patent, a person must find or invent a new and useful process, machine, product or compounded material. Or they must create a substantial improvement to existing patents. A useful invention must be able to be used, so it cannot be a theoretical creation. The new requirement relates to the element of novelty, so a creation needs a characteristic that does already exist.
An invention must also not have been disclosed to public because it would then be public knowledge. Finally, a creation must be non-obvious, which the Patent Trial and Appeal Board ruled Zytiga was not. A non-obvious invention cannot take the next logical step a person educated in the field would take in its creation.
Companies looking to challenge Johnson & Johnson’s patent
Several companies, like Teva Pharmaceuticals and Mylan, plan to challenge the Zytiga patent in court. If the patent is invalidated, Johnson & Johnson would have no legal recourse to stop these companies from creating their own versions. Until that occurs, the company plans to sue any companies launching generic versions of the drug.