Ever since I was an expert witness in one of the very first “pay-for-delay” cases back in the day, I have never understood how an arrangement that permits a drug to come to market well in advance of the expiration of a patent (and I am not talking about a weak patent that maybe never should have been issued), was anti-competitive in nature. While I will not get into the details of the above-referenced case, it allowed the generic company to bring the product to market 5 (five) years before patent expiration. That sounded like a pretty good deal to me, since otherwise a high quality, lower cost generic would not have been available until that patent expired. The firm lost that case and had to wait until patent expiry, and I have been perplexed ever since.
In the recently decided Endo case, the specifics have not yet been released because the judge filed his decision under seal so the parties could review it to make certain there was no need to redact any confidential information; however, the judge in the D.C. Circuit Court ruled that the “Patent Act protects the agreement”. While this may not be a classic “here’s X millions of dollars, don’t enter the market until I say so” kind of arrangement, I am heartened by the fact that there are at least some circumstances under drug patent settlement agreements where a generic firm received some benefit for the patent holder that was beneficial to both the innovator and the generic drug companies by reducing litigation costs, and to patients by allowing a drug product to come to market years before a valid (and strong) patent expires.
I can’t wait to see the decision in full!
