Tahir Amin: Reforming Drug Patents

Transcript:

What types of reforms would you like to see in the US patent system?

So the types of reforms we would like to see in the patent system, what I would like to call inventions, I believe the patent system has conflated innovation with invention. Those are 2 distinct concepts. Innovation has all sorts of ingredients in it; it could be marketing or just commercializing existing technology.

So what we would like to see is returning back to what is a higher bar, in our opinion, of inventiveness, and we believe the patent system has, at least in the US, lowered the bar so that we get more patents coming through, and we believe that there’s a desire to increase investment, but those are different issues when it comes to dealing with monopolies.

Our first real concern is how do we raise the bar and how do we improve the standards of patentability so that we are getting real, genuine inventions and not these low-bar little minor, marginal changes which really, in my opinion, fit the description of innovation but are not inventive for the purpose of getting a 20-year monopoly.

Secondly, we believe, and we’ve seen this across the 12 top-selling drugs in our studies and particularly with Humira, is patent applicants or patentees can keep filing the same applications over and over again. These are called continuation applications, and essentially what you end up with is a system where the company is never refused a patent, and if the USPTO, the US Patent and Trademark Office, refuses an initial application, the applicant can keep refiling it in a slightly different claim form and keep getting those applications; essentially, it’s a war of attrition. And so you keep filing these, and what these continuation applications can also do strategically is, if you see a competitor coming to the market with a slightly different formulation or different method of use, you can slightly tweak your existing patent application as it lingers in the system, even if it may be even 10 years after the original patent is filed.

And so these are all strategic behaviors that branded companies have adopted in order to delay competition, and we believe that the continuation system should be, if not removed, at least severely restricted so that companies don’t abuse it and keep stacking up these patents to delay and extract litigation.