Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

By Gene Quinn
April 17, 2015

Onkel SamThe 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.

[Varsity-5]

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

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 12 Comments comments.

  1. Nick White April 17, 2015 10:22 am

    How do you know the plaintiffs want to stop the drugs from being sold? They just want paying I would imagine.

    Just another thought. How many lawyers does it take to prepare, execute and manage a patent action?

    How many lawyers are Cipla Ltd using?

  2. Gene Quinn April 17, 2015 11:57 am

    Nick-

    So you are suggesting that the government might be using litigation to gain leverage and that the assertions in the complaint are disingenuous? That they might just want money to allow Cipla to go to market?

    When others engage in similar activity they are labeled patent trolls and accused of stifling innovation. I don’t see it that way, but then again I’m not the one making those claims. If it is good for the goose then it is good for the gander. So if private companies suing is a problem then certainly the government suing is a problem as well. Hence the hypocrisy.

    -Gene

  3. Pro Se April 17, 2015 2:50 pm

    All I can say is WOW..

    I have never thought for a second that the United States of America itself owned patents.. So how does the USA reject it’s own applications?

    I feel betrayed!!! The US government removed my ability as an independent patent owner to stop infringers in court and at the ITC but yet they can use a “God” patent to stop entities operating against their interest…

    I wonder if the EU owns patents.

  4. Pro Se April 17, 2015 3:10 pm

    I am blown away after reading this story.. and I looked around.. and for sure, if any other entity owned and asserted patent claim 1 as found in U.S. owned 6,630,507 (medical cannabis) – would it survive 101?

    This must be wrong in some way…

  5. angry dude April 17, 2015 3:25 pm

    2Pro Se:

    United States of America owns lots and lots of patents

    E.g. US 7464006 is among many others I’m personally familiar with

    Patent on “analyzing nonstationary financial time series” …. assigned to NASA 🙂

  6. Anon April 17, 2015 4:35 pm

    Nick,

    To answer your question directly, see the attached complaint and the prayer for relief, pages 8 and 9: “preliminarily and permanently
    enjoining Cipla, its officers, agents, servants, employees, and those persons in active concert or participation with any of them, from commercially manufacturing, using, offering to sell, or selling Cipla’s 800 mg ANDA Product within the United States, or importing Cipla’s 800 mg ANDA Product into the United States…

    You don’t have to imagine.

    Likewise, I don’t see how your “imagining” how many lawyers Cipla may have involved has anything to do with the topic here.

    Gene,

    I have to say, surprisingly, that this article is understated as to the rhetorical shenanigans involved in the ongoing attacks on the patent system, including the notion that enforcing one’s rights – in the ascribed manner under law – must somehow be deemed “improper” and wrong (unless the “right entity” is the one doing the enforcing).

    I am reminded of my mother, and her admonition against finger pointing, with the vision in my head of Obama and the “Troll” witch hunt ( which by the way, I was delighted to see Ron’s action covered over at that over patent blog), pointing his finger at all those “bad” trolls, now with four (or more) fingers pointing right back at his Presidency.

  7. Pro Se April 17, 2015 5:09 pm

    “preliminarily and permanently enjoining Cipla, its officers, agents, servants, employees, and those persons in active concert or participation with any of them, from commercially manufacturing, using, offering to sell, or selling Cipla’s 800 mg ANDA Product within the United States, or importing Cipla’s 800 mg ANDA Product into the United States…”

    No other patent holding entity that does not have a popular selling competing product can make this prayer and have it respected in court…

  8. publius April 18, 2015 9:49 am

    Gene –

    Normally your posts here are carefully researched but I’m afraid you really missed the boat today. A more careful search of the public record would have revealed that this this is the 4th or 5th time that the USG has had to defend this patent against ANDA actions; that the patent in question is still available for non-exclusive licensing and is also part of the HIV Medicines Patent Pool; that it is only a method patent with the composition patents(darinivir) owned by pharma. The real story here I think is why do attorneys spend big sums of their clients money on ANDA litigation when a low-cost non-exclusive license is readily available?

  9. Anon April 18, 2015 10:05 am

    publius,

    I will have to disagree with your assessment on a number of points.

    First, the fact that other ANDA actions have taken place is a point that strengthens the thrust of Gene’s article – not weakens it. Read again the complaint and see what the government asks of the court.

    Second, whether the item is part of a patent pool or not is immaterial here.

    Third, you are incorrect as to the ownership (elementary standing would dictate that the court would not entertain the government action if the government was not the owner or had that particular aspect of ownership).

    Fourth, I find offensive your attempt at “real story” being the “attorney spending big sums of money” smokescreen, as that point has already been addressed.

    You seem intent on not grasping the point of the article.

  10. Nick White April 18, 2015 10:06 am

    Gene,

    Yes I was just emphasising that there is no apparent benefit to the plaintiffs if Cipla is prevented from market entry so I assume the litigation is to secure money for that market entry. They want a settlement.

    The lawyer issue is not related to the key point of your post. But I noted you had listed the various lawyers on the plaintiff side of the equation (10) but not the defendants. It was a rhetorical question with irony. To me one of the reasons why US patent litigation is so expensive is just staring us in the face on this case. Looks like the only real winners are the attorneys on this one.

    I agree about the finger pointing and trolls. Especially when those pointing the fingers happen to be owners of major piles of patents (many junk) that are used in “troll like” fashion to control market entry for real innovators. For me that is the most damaging aspect of all of this shenanigans in the US. The trolls are being attacked by the Patent Ogres or Gorillas and the real us inventor/innovators are in the cross-fire. There are bad actors on all side but only one side….the wrong side…is being villified.

  11. Nick White April 18, 2015 10:12 am

    Publius,

    My assumption in the USA is that even if there are “low cost non-exclusive licences” on offer they are never willingly taken.

    The USA is the land of “economic infringement”; much rather spend money on litigation than licensing. That’s probably why the vast majority of licensing in the US is assert licensing and run by lawyers.

  12. Gene Quinn April 19, 2015 5:35 pm

    publius-

    Nothing you say suggest anything I wrote is wrong. The fact that the government has defended this patent previously only supports the point more. It is hypocritical for the federal government to be defending any patent they own if the President is says, as he does, that patents stifle innovation. It is hypocritical and yet very common in this arena. Everyone else’s patents are the problem.

    -Gene