Posts Tagged: "Gilead"

The U.S. District Court for the Eastern District of New York unsealed multiple documents last week that named the kingpins behind an alleged counterfeit HIV medication conspiracy. An unsealed amended complaint filed in late September names the two alleged kingpins as Lazaro Roberto Hernandez and Armando Herrera, both of Florida. The two “kingpin defendants” are accused of being “at the head of the conspiracy” and “career criminals who organized the conspiracy and controlled the flow of the counterfeits, all while operating from the shadows and using extensive measures to conceal their identities.” Hernandez was identified by basic geolocation data associated with burner phones used to communicate details about the conspiracy.

On April 7, 2021, the European Patent Office (EPO) Opposition Division (OD) issued a comprehensive written decision in the Opposition by Gilead Sciences, Inc. against NuCana plc’s European Patent No. B-2 955 190, upholding amended compound claims that include Gilead’s blockbuster hepatitis C drug, Sovaldi (sofosbuvir). The claims were upheld over various arguments made by Gilead, including an assertion that the NuCana patent did not teach the skilled worker how to make the nucleoside component of Sovaldi (which is a nucleotide phosphoramidate). Gilead alleged, as it did in the myriad of global Idenix litigation cases, that a skilled person in 2003 who tried to make the nucleoside of Sovaldi “would be required to undertake extensive experimentation, if indeed he would be able to succeed at all. This represented an undue burden.”

By now, everyone in the IP arena has heard about the demands of more than 30 state and territorial attorneys general (AGs) regarding the promising COVID treatment remdesivir. These AGs seem to disrespect the exclusive rights of limited duration that patents afford. California Attorney General Xavier Becerra (D) and Louisiana Attorney General Jeff Landry (R) led a bipartisan effort getting colleagues to write the U.S. Department of Health and Human Services and call for what’s tantamount to eminent domain on intellectual property. To a conservative who works on IP matters, this demand in and of itself is troubling. Bedrock conservative principles include property rights, free enterprise and the rule of law. The AGs advocate government’s abrogation of all three of these foundational principles.

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.

Since China announced the first fatality caused by a virus about which little was known at the time, coronavirus and the disease it causes, COVID-19, has grown to pandemic proportions. In the less than three months since that first death, this new strain of the severe acute respiratory syndrome-related (SARS) coronavirus has shuttered social gatherings, precipitated a mandatory work-from-home revolution and decimated large parts of the world’s economy. As of the afternoon of March 27, the Coronavirus Resource Center at Johns Hopkins University reports that more than 585,000 cases of COVID-19 infection have been confirmed worldwide, resulting in a total of 26,819 deaths. Those figures have been increasing exponentially each day.

In most respects, the widely reported patent complaint recently filed against Gilead is perfectly ordinary. It was filed in the U.S. District Court for the District of Delaware, the most common venue for patent infringement lawsuits, and alleged that a pharmaceutical company’s drug sales infringed the plaintiff’s patents on uses of the sold drug. The defendant’s response has so far been similarly unexceptional:  Gilead has filed petitions for Inter Partes Review (IPR) of each asserted patent (see links below), arguing that those patents are invalid over the prior art, either as obvious or as entirely anticipated. What is remarkable about this lawsuit, however, is that the plaintiff is the government of the United States.

This week in Other Barks & Bites: the Trump Administration sues Gilead for infringement over HIVE PrEP treatment patents; Senators Inhofe and Wicker ask President Trump to show no leniency on Chinese IP theft; the Supreme Court hears the Allen v. Cooper copyright appeal; the Federal Circuit issues precedential opinions on PTAB evidence admissibility and limitation in patent claim preamble; the Copyright Office says that its digital recordation pilot project is on track for Spring 2020; the PTAB Precedential Opinion Panel (POP) will review the Board’s rejection of substitute patent claims in a motion to amend; “This Is Spinal Tap” creators settle copyright suit; and T-Mobile announces December launch for nationwide 5G network.

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee. However, because of two differences in this hearing from its predecessor things didn’t quite go as planned. This time, the Committee invited both sides to appear, not just the critics; and one member dared to challenge its underlying premise, leading to an electrifying exchange with the Chairman. We’ll examine that shortly.

This week in Other Barks & Bites, IPWatchdog’s IP news roundup: the House of Representatives passes drug patent legislation, while antitrust legislation targeting patent-related activities is introduced into the Senate and the Trump administration mandates pricing information for pharmaceutical ads; the Patent Trial and Appeal Board (PTAB) issues a pair of precedential decisions on cases with multiple petitions; the USPTO issues marijuana-related trademark guidelines and a notice on modifying patent term adjustment practices; Gilead strikes a settlement with Teva to bring generic Truvada to the U.S. market in 2020; a new music licensing entity is created in Canada; Fourth Circuit rules that bankruptcy can eliminate damages for trade secret violations; and several amicus file briefs asking the U.S. Supreme Court to eliminate the Federal Circuit’s “blocking patent” doctrine.

This week in other IP news, recently released data shows that worldwide revenues for music copyright exceeded $28 billion in 2017, up $2 billion over 2016; reports surface about the  “reverse patent trolling” issue in China; Google retains Williams & Connolly for Supreme Court battle with Oracle despite Shanmugam exit; the Copyright Office holds roundtable discussions on detecting online copyright infringement; Twitter takes down a tweet from President Donald Trump after a copyright complaint; “KINKEDIN” trademark for computer dating site successfully opposed in the UK by LinkedIn; EU antitrust regulators are petitioned to look into Nokia patent licensing practices; and loss of patent exclusivity leads to major job cuts at Gilead Sciences. 

The original motivation for the Bayh-Dole Act was to encourage the commercialization of academic innovation so that new technologies could be available for the benefit of all. Yet today, I feel compelled to call attention to a compliance landscape that is significantly different than that of the past four decades—one that could have dire consequences for institutions if they choose to be complacent. Not only do sponsoring agencies have an interest in how tech transfer complies with Bayh-Dole regulations, other entities have entered the competitive landscape looking for opportunities to turn lack of compliance to their advantage. In just the past two years we’ve seen a spike in requests for the government to exercise march-in rights by a variety of non-governmental advocacy groups (NGOs). These NGOs are staffed by PhDs who are well-versed in the academic tech transfer ecosystem and they actively seek out pockets of non-compliance. An attempt is then made to extricate key technologies using non-compliance as a lever and the NGOs become the primary influence on how innovation is put into the marketplace. I would ask the question, “Who will pick up on these inventions?” If you follow this chain of events we may find ourselves in a situation where innovation is not freely available to all (the original intent of Bayh-Dole) but an endpoint where NGOs and their backers control how technologies get into the marketplace.

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.

Those who believe that patents aren’t important or that companies would undertake the rigors of commercial development with only non-exclusive licenses don’t understand the realities facing innovators like Inovio… Unfortunately, there’s good reason for anxiety. If they are successful their patents could be subjected to years of post-grant reviews by competitors and those who believe life science patents harm the public interest. Even if their IP holds up, they may face howls from critics and politicians demanding that the government step in to issue compulsory licenses so others here and abroad can copy the vaccine. For the 35 million living with HIV, the scientific barriers aren’t the only ones standing in the way of effective treatments.

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.