The United States Department of Health and Human Services (HHS) is a patent troll, at least if you define patent troll in the typical colloquial usage of the term, which seemingly characterizes all patent owners who enforce patent rights as patent trolls.
But wait, this gets better. HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need life saving HIV drugs an affordable generic version. Egad!
For the record, allow me to say that I believe every patent owner should have a right to enforce patent rights if there is ongoing infringement. Patent owners should be able to protect their rights without being called a patent troll, or vilified in the press, or subjected to ridicule in a Rose Garden ceremony, or in front of some Congressional tribunal. Abusive litigation process is a concern in a small number of cases, but district courts have ample ability to stop vexatious litigation, prevent the judicial process from being used to shakedown defendants, and now to award attorneys’ fees when warranted. Nevertheless, there is an enormous amount of irony involved in this case.
Say it out loud: The HHS is the owner of patents that relate to methods of treading patients with HIV and they are suing to keep patients from receiving cheap generic drugs. If a for-profit private sector company were pursuing this type of enforcement agenda they would be endlessly vilified and held up to public ridicule as an example of everything that is wrong with the patent system.
Surprisingly little has been said, or written, about this lawsuit, filed on April 10, 2015. Is the media giving the Obama Administration a pass? President Obama is the executive in charge of all administrative agencies, including HHS. This means he has the authority to prevent HHS from pursuing this case, but hasn’t yet exercised the power of his pen or telephone to shut down this litigation. Interesting given his stated distaste for patent enforcement and how his administration believes patents stifle innovation.
Perhaps President Obama doesn’t know about the case, or that the U.S. government is trying to stop affordable generic HIV treatments from reaching patients who need them. But at some point when the President does not act to stop this patent enforcement action the hypocrisy will be undeniable.
Patent owners have been berated, the Patent Office has been criticized for issuing bad patents, and just this week an Inspector General from the Department of Commerce threw the Patent Office under the bus in a one-sided, disingenuous review of patent quality. But apparently the patents owned by the federal government are different. They deserve to be enforced.
This type of double standard is all too typical in the debate about abusive patent litigation, patent trolls and patent reform. The problem is always the other guy’s patents. Still, it is almost hard to keep a straight face when you consider HHS bringing the full might of the U.S. government to stomp out this patent infringement, all courtesy of attorneys from the Department of Justice. Interestingly, if the Innovation Act were to pass the patent enforcement activities of the federal government would be studied by the Director of the Patent Office. See Section 8(b). That could be quite awkward, particularly in light of this case.
Putting the tremendous irony aside, and how uncomfortable it might be for government licensing and litigation practices to be spotlighted in a Congressionally mandated study, allow me to ask a critical question: Is there patent infringement here? In what could be one of the easiest legal questions of all time the answer is a resounding yes. We know there is patent infringement thanks to a quirky legal construct found within the famous (or infamous) Hatch-Waxman Act.
Under the Hatch-Waxman Act, a pharmaceutical company can seek approval to market generic versions of an approved branded drug without having to re-establish the drug’s safety and effectiveness by filing an Abbreviated New Drug Application (“ANDA”). Whenever a generic manufacturer seeks to enter the market before the expiration of the branded firm’s patent, it must file a pre-expiration challenge, which is commonly referred to as a “paragraph IV certification.” This certification requires the generic firm to demonstrate the bioequivalence of its proposed version of the drug and also requires it to state the generic drug will not infringe the underlying patent because the relevant patent claims are invalid or there would not be infringement. A paragraph IV certification is interpreted under Hatch-Waxman as an act of infringement, thereby allowing the patent owner the ability to sue for patent infringement immediately and solely based on the filing of a paragraph IV certification.
The defendant in this case, Cipla Ltd., included certifications in its ANDA that the relevant patents were invalid, unenforceable, and/or will not be infringement by the commercial manufacture, use, or sale of Darunavir Hydrate Tablets in an 800 mg dosage strength. Because Cipla sought approval of its propose generic before the expiration of the relevant patents, they have engaged in a technical act of infringement that is actionable thanks to Hatch-Waxman.
In any event, here is a copy of the complaint filed.
The patents involved are:
The attorneys representing the United States of America in this lawsuit are:
- Benjamin C. Mizer, Acting Assistant Attorney General
- Paul J. Fishman, U.S. Attorney, District of New Jersey
- Daniel Gibbons, Assistant Chief, Civil Division, District of New Jersey
- John Fargo, Director, Intellectual Property Staff
- Walter W. Brown, Trial Attorney, Intellectual Property Staff
- Corey R. Anthony, Department of Justice
The attorneys representing co-plaintiff, the Board of Trustees of the University of Illinois are:
- Charles M. Lizza, Saul Ewing LLP
- Sarah A. Sullivan, Saul Ewing LLP
- Jason G. Winchester, Jones Day
- Timothy J. Heverin, Jones Day