Resultados 1 a 4 de 4
  1. #1
    WHT-BR Top Member
    Data de Ingresso
    Dec 2010

    [EN] American tribe sues Amazon, Microsoft for infringing supercomputer patents

    Jan Wolfe
    October 18, 2017

    A Native American tribe sued Inc and Microsoft Corp in federal court in Virginia on Wednesday for infringing supercomputer patents it is holding for a technology firm.

    The Saint Regis Mohawk Tribe was assigned the patents by SRC Labs LLC in August, in a deal intended to use the tribe’s sovereign status to shield them from administrative review.

    SRC is also a plaintiff in the case.

    Microsoft and Amazon did not immediately return requests for comment.

    The tribe, which would receive a share of any award, made a similar deal in September to hold patents for Allergan on its dry eye medicine Restasis.

    SRC and Allergan made the deals to shield their patents from review by the Patent Trial and Appeal Board, an administrative court run by the U.S. patent office that frequently revokes patents. The tribe would get revenue to address environmental damage and rising healthcare costs.

    Companies sued for patent infringement in federal court often respond by asking the patent board to invalidate the asserted patents. Both Microsoft and Amazon have used this strategy to prevail in previous disputes.

    A federal court in Texas separately invalidated Allergan’s Restasis patents on Monday. The company responded that it would appeal that ruling.

    Allergan’s deal with the tribe has drawn criticism from a bipartisan group of U.S. lawmakers, some of whom have called it a “sham.” Missouri Senator Claire McCaskill on Oct. 5 introduced a bill to ban attempts to take advantage of tribal sovereignty.

  2. #2
    WHT-BR Top Member
    Data de Ingresso
    Dec 2010

    New bill would end Native American “sovereign immunity” for patents

    Sen. McCaskill: “One of the most brazen and absurd loopholes I’ve ever seen.”

    Joe Mullin

    Allergan's move to stop its patents from being reviewed by handing them off to a Native American tribe is winning support from few people outside the drug company. Now one lawmaker is seeking to ban it.

    Sen. Claire McCaskill (D-Mo.) has introduced a bill that would head off Allergan’s strategy without waiting to see whether the judges at the Patent Trial and Appeals Board will even approve it.

    “This is one of the most brazen and absurd loopholes I’ve ever seen, and it should be illegal,” McCaskill said last week in a statement to a pharmaceutical lobby group.

    The Native American patent shelter, promoted by Allergan's outside law firm, seeks to avoid the process of “inter partes review,” or IPR, for the patents protecting the blockbuster drug Restasis. The IPR process is a kind of quasi-litigation that takes place at the Patent Trial and Appeals Board for the sole purpose of determining whether a patent is valid or not.

    Now that the Restasis patents are owned by the St. Regis Mohawk tribe and licensed back to Allergan, the drug company’s lawyers have asked for an impending IPR to be dismissed. The tribe argues that it's protected from IPRs by “sovereign immunity.”

    Allergan has said the IPR process, which was implemented in 2012, is “flawed and broken.” The company says it has no problem with the validity of its patents being challenged, as long as that challenge takes place in federal court.

    Sovereign immunity is a concept that descends from the idea that you can’t haul a king or other monarch into court. In US law, it’s enshrined in the 11th Amendment to the US Constitution, which prevents states from being sued in federal court without the state’s consent.

    In some cases, Native American tribes are protected by a different version of sovereign immunity—one that is not constitutionally mandated. Thus, Native American sovereign immunity can be altered or removed by a simple vote of Congress. McCaskill’s bill would do just that by simply stating that “an Indian tribe may not assert sovereign immunity as a defense” in an inter partes review of patents.

    The bill, which was introduced Thursday and referred to the Senate's Committee on Indian Affairs, only affects IPR proceedings, not patent disputes in federal court. It was reported earlier by Patently-O.

    Restasis earns revenue of around $1.5 billion per year. The original patents that protected Restasis expired in 2014, but Allergan filed a new batch of patents that will keep out generic competition until 2024. Generic drug companies have challenged the validity of those follow-on patents at both the US Patent Office and in federal courts.

    McCaskill has attacked what she sees as abuses of the patent system before. In 2013, she sought to take action against patent owners who send out masses of demand letters, calling them “bottom feeders.” While that didn’t result in any new federal law, many states ultimately passed laws limiting how patent demand letters can be used.

    The St. Regis Mohawk tribe will get paid $15 million annually as long as the Restasis patents are valid. The tribe has also cut a deal with an unnamed technology company.

    The strategy is being used in the tech sector as well. A lawsuit against Apple has been handed off to a patent-holding company that’s wholly owned by the Mandan, Hidatsa, and Arikara Nation, also known as the Three Affiliated Tribes.

  3. #3
    WHT-BR Top Member
    Data de Ingresso
    Dec 2010

    St. Regis Tribe reacts to legislative moves to thwart pharmaceutical patent deal

    OCTOBER 16, 2017

    Politicians in the U.S. House of Representatives and the U.S. Senate are launching assaults against the patent transfers between drugmaker Allergan and the St. Regis Mohawk Tribe.

    The House Committee on Oversight and Government Reform has ordered the maker of Restasis to answer several questions about the deal.

    Allergan is facing an Oct. 17 deadline for the information.

    Meanwhile, in the Senate, Claire McCaskill, D-Mo., has drafted a bill stating that tribal sovereignty cannot be used to block a patent review.

    Ms. McCaskill is not just using a legislative route; she has also written a letter to the Stephen J. Ubl, president of the Pharmaceutical Research and Manufacturers of America, to look into the tactic.

    Drugmaker Allergan announced on Sept. 8 it had transferred its patents on a best-selling eye drug to the St. Regis Mohawk Tribe to protect the drug from a patent dispute.

    Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the U.S. Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as they are valid.

    On Sept. 22, the tribe moved to dismiss a patent challenge on jurisdictional grounds.

    In her letter to Mr. Ubl, Sen. McCaskill wrote, “I urge you to review whether the recent actions Allergan has taken are consistent with the mission of your organization. More broadly, I ask that PhRMA review whether actions to block patent challenges through claims of tribal sovereign immunity align with PhRMA efforts to promote innovation and discourage predatory pricing practices and anticompetitive conduct. Strong action by PhRMA on this issue may discourage other pharmaceutical actors from employing similar tactics — with the end result of promoting and protecting affordable drug prices for American Consumers.”

    The St. Regis Mohawk Tribe responded to Sen. McCaskill with a strongly worded letter decrying her effort to “abrogate tribal immunity.”

    In part, the letter says, “the Saint Regis Mohawk Tribe is outraged that U.S. Senator Claire McCaskill (D-MO), has introduced legislation that specifically targets Indian tribes, yet exempts state universities and other sovereign governments engaged in the very same IPR process. The double standard that is being introduced by the Senator as a solution for a perceived abuse of the IPR proceedings does nothing to solve the underlying problem. The Tribe’s authority is inherent and has been reaffirmed through treaties and legislation from the earliest days of the country.”

    “It is cruelly ironic that Indian Tribes, with the highest unmet health care needs in the entire country, are being attacked for exercising their sovereign obligation to fill gaps in health coverage caused by the federal government’s abject failure to uphold its trust responsibility. The fact that the Mohawk community is home to three unmitigated EPA Superfund sites that harm the health of the community and surrounding non-Native communities is a stark example of the government’s failure. Congress shouldn’t double down on its mistakes by denying the Tribe’s sovereign authority in the IPR process.”

    McCaskill’s bill has been read twice and referred to the Committee on Indian Affairs.

  4. #4
    WHT-BR Top Member
    Data de Ingresso
    Dec 2010

    Here's How Drug Companies Game the Patent System

    Only Congress can rewrite the laws that keep prices high. Ask the judge

    Joe Nocera
    October 17, 2017

    The Senate Health Committee held a hearing Tuesday morning about why prescription drugs cost so much and what might done to make them more affordable. According to the committee’s website, the witnesses include a lobbyist for the pharmaceutical industry, a lobbyist for the pharmacy industry and a lobbyist for the pharmacy benefits-management industry.

    Might I make a small suggestion? The Republican chairman, Lamar Alexander of Tennessee, and the ranking Democrat, Patty Murray of Washington, should begin their next hearing with a reading of the decision issued on Monday by Federal Judge William Bryson in the matter of Allergan, Inc. v Teva Pharmaceuticals USA, Inc. et al. Rarely will you find so clear an explanation for why consumers can’t get relief from spiraling drug prices.

    Bryson is a veteran appeals court judge; since 1994, he has sat on the U.S. Court of Appeals for the Federal Circuit, the panel that hears patent litigation appeals. From time to time, Bryson has been designated by Chief Justice John Roberts to hear patent cases at the district court level. That’s how he wound up hearing the Allergan case.

    Or perhaps I should call it the Restasis case, since that is what the dispute is about. Restasis, Allergan’s $1.5 billion 1 dry-eye medication, made headlines last month when Allergan pulled a now-infamous patent ploy, transferring its patent rights to New York State’s Saint Regis Mohawk Tribe. The idea was that because the tribe had sovereign immunity, potential generic competitors trying to overturn the drug's patents at the Patent Trial and Appeal board would be stymied.

    But this bit of tribal trickery was only the most recent effort by Allergan to keep generics off the market. The Restasis patent, granted in 1995, was set to expire in 2014. Under the 1984 law that established the generic drug industry, once the patent on a branded drug expires, generics are supposed to flood into the market and bring the price down by 90 percent or more.

    But for some time now, big pharmaceutical companies have found ways to extend their monopolies on branded drugs by preventing lower-priced generics from entering the market. The primary way they’ve done this is by abusing the patent system. In effect, that is what Bryson called Allergan out on.

    He issued two rulings on Monday. In the smaller one, he allowed the Saint Regis Mohawks to join Allergan as a co-plaintiff in the litigation, while also making it plain that he found the ploy disgraceful. "What Allergan seeks," he wrote, "is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits."

    The bigger ruling was his decision to invalidate the patents Allergan was using to fend off Teva, Mylan NV and other generic manufacturers—the very patents that Allergan was trying to protect by shifting them to the tribe. In a short conclusion at the end of his highly technical, 135-page decision, Bryson outlined, in plain English, how Allergan tried to scam the patent system.

    “There is no doubt,” he wrote, “that Allergan has invented a useful and successful pharmaceutical product.” But, he added, the company had been “richly rewarded” for its development of the drug, with a patent that had given Allergan a monopoly on Restasis for two decades.

    The key patent was named Ding I after its inventor, Shulin Ding. Although Allergan filed a handful of what’s called "continuation applications" over the years, in 2009 it conceded that it would probably lose additional efforts to extend the life of the Ding I patent. Its reasoning was that a follow-on patent would probably not be granted because the next refinement of the drug was too obvious to merit patent protection.

    But in 2013, with the expiration of Ding I imminent, Allergan "withdrew its concession of obviousness" and began a serious effort to obtain further patent protection. It applied for, and received, patents that would continue its monopoly until 2024.

    The judge then described some of the moves Allergan made to justify its add-on patents: for instance, it put forth "evidence" that "the Restasis formulation resulted in efficacy levels up to eight times as great as would be expected based on studies of the formulation" of the Ding I patent. In fact, this supposed evidence was bogus: "The actual clinical results,” the judge wrote, “show no significant difference in efficacy."

    Another move Allergan made was to use its new patents to preemptively sue the potential makers of generic versions. Bryson called these moves "blocking patents,” which they certainly were.

    Because it wasn’t part of the litigation, Bryson didn’t mention another sleazy maneuver Allergan used to maintain its Restasis monopoly: It issued a series of "citizen's petitions" to the U.S. Food and Drug Administration. Citizen's petitions were created to give individuals and community organizations a voice at the federal regulatory agency. But pharmaceutical companies have essentially commandeered the practice, using citizen’s petitions to delay approval of a generic drug. As of this summer, Allergan had submitted three such petitions related to Restasis.

    And there's more: According to Shire PLC, Allergan has been cutting deals with insurance companies that effectively prevented Shire from selling a competitive product. (Shire recently sued Allergan.) Allergan, meanwhile, has sued the compounding company Imprimis, claiming that it is in violation of FDA regulations. Needless to say, Imprimis makes a dry-eye medication. And of course there was the effort to shift the Restasis patents to the Saint Regis Mohawk Tribe.

    Restasis is Allergan's second-biggest moneymaker, after Botox. There appears to be very little it won't do to hold onto to its monopoly. After Bryson's ruling on Monday, the company quickly came out with a statement saying that it "remains committed to vigorously defending the intellectual property of our products."

    But if Allergan were to truly abide by the spirit of the law, its hold on this particular bit of intellectual property should have expired three years ago. Yet it feels perfectly justified in asking—nay demanding—at least another seven years, until 2024.

    With billions of dollars at stake, it is probably too much to expect pharmaceutical companies to start abiding by the spirit of the law. So the only way to fix the problem is for congressional committees to radically reshape the law surrounding pharmaceutical patents. I have some ideas about how to do that. I plan to lay them out within the next few weeks.

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