Q: Hello, I have discovered that two companies that have fraudulent patents. What do I do?

A: Those are some very serious allegations that you are charging patent owners with. Fraud, if it can be proven, will likely make the patent not enforceable, and may present ethical problems for the patent attorney and possibly the patent owner.

If you want to pursue this issue, you will need to hire an attorney to represent you. However, there are few points for you to consider:

(1) A patent is not an academic paper. In an academic paper (presentation, poster, etc.), you present your experimental data, your analysis, and elucidation of the data. The analysis generally needs to be rigorous in order for the paper to be accepted. None of that is required for patents. You can have some data, and you may provide an explanation. I generally like to provide as much data as makes sense when writing a patent application, so that I can argue the claims during the prosecution in any number of ways. The data does not have to be scientifically rigorous, and even sloppy data, for better or worse, is successfully used to obtain a patent. Fraud is something else, but having poor data or poor interpretation of data, is not a barrier to securing a patent. What I am saying is that the clinical data may seem to you to be horrifically inadequate for scientific purposes, but that does not rise to the level of lack of candor, or fraud.

(2) I have a difficult time believing that their data is faked. The reason is that when a pharma/biotech company files for a patent, they generally already have the data for regulatory purposes. The data filed with the FDA to support their submission is much more extensive, and the patent drafter can pick any of data presented. There is little to be gained by faking data.

(3) You’ve mentioned clinical trials. Typically, patent applications are submitted with preclinical data. It is thus possible that any clinical data presented was not even considered during the examination. Although that still would not make it OK to commit fraud, the materiality portion of the fraud analysis would be very small.

(4) Although you could possibly challenge the patent with the help of an attorney as discussed earlier, an easy solution would be to publish your 40-page report publicly, so that it would show up on the radar of an attorney doing due diligence on the patent, or a litigation attorney. If the patent will be litigated, your report may be very helpful in getting the patent invalidated.

Good luck!

A: To augment the detailed response by Mr. Mlynek, there are two possibilities.

1) the patented process works and maybe the data while not perfect for the purpose of a scientific paper does actually support the premise that the patented process works,; or

2) the patented process does not work and the data presented does not really reflect support for the position that the process works but they fooled the patent examiner.

If the answer is 1) then it is hard to see what harm was done unless they somehow filed earlier than some other inventor of the same sort of process and fooled the patent office that they were in possession of the invention. (that does not seem to be your particular situation)

If the answer is 2) then it is unlikely that the company will profit in the long term as they should not make it through the independent process of getting FDA approval and acceptance into the marketplace. So the level of harm from this error should be small.

The one group of people that may be harmed are investors that believed that the process worked as documented in the issued patent. Those people may eventually sue if they believe they were intentionally mislead and your communications warning that the process did not work may become relevant.

If you found this answer helpful, you may want to look at my answers to other questions about patent law are available at the bottom of my profile page at https://lawyers.justia.com/lawyer/kevin-e-flynn-880338

Kevin E Flynn