Posts Tagged: "PhRMA"

Following a week of round-the-clock deliberations, the World Trade Organization (WTO) this morning announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The final text has made almost no one happy and largely mirrors the draft text going into negotiations, with a few key changes. With respect to open questions in the draft text, the final agreement indicates that all developing country WTO Members will be considered eligible to take advantage of the waiver, but that those with “existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this Decision.” This language is primarily targeted at China, which has publicly stated that it would not use the waiver provision but had objected to language based on percentage of global vaccine exports that would have categorically excluded it. The draft text had encouraged members with vaccine export capabilities to opt out rather than to make a binding commitment.

The United States is not even two weeks into the administration of President Joe Biden and it’s likely that the administration’s selection for Director of the U.S. Patent and Trademark Office (USPTO) will not become clear for a few months yet. Many members of the U.S. innovation community, however, are well aware of the high stakes in play with that selection. The tenure of outgoing Director Andrei Iancu was lauded across many sectors of the U.S. patent system, perhaps with the exception of the tech sector. As we consider candidates for the next USPTO head, perhaps we should look to the political moment in which we find ourselves to guide our search.  

On Monday, December 9, the U.S. Supreme Court will hear oral arguments in Thryv, Inc. v. Click-to-Call Technologies, LP. The case, which has gone through multiple name changes since its original appeal from the Patent Trial and Appeal Board (PTAB), will ask the nation’s highest court whether 35 U.S.C. § 314(d), which states that decisions to institute inter partes review (IPR) proceedings shall not be appealable, permits appeals of PTAB institution decisions based upon 35 U.S.C. § 315(b). Section 315(b) states that IPRs won’t be instituted if the patent owner served the petitioner with a complaint for patent infringement more than one year prior to the petition. To summarize the lower court proceedings in this case, the patent-at-issue was first asserted against Keen Inc. by Inforocket.com in 2001 in a case that was voluntarily dismissed. Click-to-Call acquired the patent and asserted it in 2012 against Ingenio, a company formed through a merger of Keen and Inforocket.com. Ingenio filed for an IPR petition and Click-to-Call challenged it based on the Section 315(b) time-bar and the former suit against Ingenio’s predecessor. The appeal reached the Supreme Court, where it was remanded in June 2016 in light of Cuozzo Speed Technologies v. Lee. Most recently, the U.S. Court of Appeals for the Federal Circuit rendered a decision last August where all 12 Federal Circuit judges joined a footnote finding that the Section 315(b) time bar applies even when the earlier infringement action had been voluntarily dismissed without prejudice.

November 1 was the deadline for filing amicus briefs to the U.S. Supreme Court, which is considering whether to grant a petition for writ of certiorari to take up Athena Diagnostics v. Mayo Collaborative Services on appeal from the U.S. Court of Appeals for the Federal Circuit. Almost every amicus filing to the Supreme Court in this case supported granting the petition or backed up the position of petitioner Athena, who is asking the Supreme Court to clarify its patent-eligibility doctrine under the Alice/Mayo framework on the subject of medical diagnostic patent claims. The appeal to the Supreme Court follows a hotly contested denial of an en banc rehearing of the Federal Circuit’s original panel decision in Athena, which produced eight opinions, including four dissents, with many judges agreeing that Athena’s invention should be patent eligible even while they disagreed over whether Supreme Court precedent allowed for patent protection of diagnostic methods.

A Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on May 8 (the “Final Rule”) that requires direct-to-consumer (DTC) television advertisements for a prescription drug or biologic covered by the Medicare or Medicaid programs to disclose the product’s “list price,” will become effective on July 9, 2019. The Final Rule mandates price disclosures for any covered drug that is $35 or more for a one-month supply or the usual course of therapy, and includes a unique enforcement mechanism whereby CMS would rely for enforcement on private lawsuits filed pursuant to Section 43(a) of the Lanham Act. In a conference call with reporters, Department of Health and Human Services (HHS) Secretary Alex M. Azar II analogized the new requirement to mandatory price disclosures required for the automobile industry—despite the fact that cars are not reimbursed by the government, subject to co-pays, prescribed by third parties who function as gatekeepers, or subject to complex arrangements with prescription benefit managers (PBMs) and other healthcare providers. The strained analogy to automobile price disclosures reflects the legal complexities implicated by this requirement and the absence of relevant precedent.

During a hearing of the Senate Committee on the Judiciary on Tuesday titled, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition,” senators heard from five witnesses about proposals to lower drug prices for Americans and what role the patent system plays in the high cost of prescription drugs. The witnesses included two professors, a patient advocate, the Director of South Carolina’s Department of Health and Human Services, and the Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA). The hearing is one of several so far this term on the topic. Judiciary Committee Chair, Lindsey Graham (R-SC), opened the hearing by summing up the problem they faced in a question: essentially, how do we make sure that America continues to be the most innovative place on the planet and avoid killing the “goose that laid the golden egg,” without having a system that drives up cost for the consumer? Graham said he expects the committee will move on legislation related to patents and prescription drug pricing this year, and there seemed to be broad agreement on at least one bill currently under consideration—the CREATES Act of 2019, which has been floating around Congress since 2016.

April 22 was the deadline for filing amicus briefs with the Court of Appeals for the Federal Circuit in Athena Diagnostics’ petition for an en banc rehearing by the court. The petition comes after a 2-1 panel decision in early February affirmed a district court’s ruling that patent claims covering methods of diagnosing myasthenia gravis (MG), an autoimmune disorder that causes weakness in skeletal muscles, were directed toward laws of nature and were thus unpatentable subject matter under 35 U.S.C. § 101. In an invitation to file briefs with the Federal Circuit in this case, Knowles IP Strategies Founder Sherry Knowles and AddyHart Partner Meredith Addy discussed the need for amici to hold the Federal Circuit accountable regarding its duty to apply a strict statutory construction of the literal language of Section 101 to ensure that patent eligibility cases are decided in a way that is consistent with Constitutional statutes. Knowles and Addy filed a brief on behalf of Freenome Holdings and Achillon Pharmaceuticals (discussed below). Theirs and other briefs that have now been filed raise concerns about the inability to patent life-saving diagnostic methods that are found ineligible under Section 101 using the Alice/Mayo framework simply because the invention or discovery involves monitoring natural processes.

This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women’s Day; Comments due today on USPTO Section 101 Guidance; FDA Commissioner Scott Gottlieb resigns; a Senate bill with six bipartisan co-sponsors would increase requirements on patent disclosures for biologics; USPTO Director Iancu speaks out on Alice; Apple announces its intention to increase its presence in San Diego while its patent battle with Qualcomm heats up; Chinese copyright registrations increased by double digit percentage points in 2018; Stanley Black & Decker faces off against Sears in a trademark infringement battle over branding for Craftsman tools; Amazon announces that it will close dozens of pop-up stores in the U.S.; and Democrats from both houses of Congress introduce a new net neutrality bill.

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”

On June 25th, the the U.S. Supreme Court agreed to hear Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., on appeal from the Federal Circuit. The case will ask the Supreme Court to decide whether an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention under the terms of the Leahy-Smith America Invents Act (AIA). In other words, is a secret sale prior art? To assess some of the reasons why the Supreme Court likely decided to take up Helsinn’s appeal, and some of the arguments we are sure to see again at the merits stage, we explore some of the amicus briefs filed with the Supreme Court encouraging them to take up the case on appeal.

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.

Doubtless there are some manufacturing firms, such as Telebrands, who are great endorsers of inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) and how that agency has found in favor of copy-cats even as federal courts have repeatedly issued injunctions and found in favor of the inventor of an award winning toy (see here and here).But the manufacturing sector did not all line up in favor of Greene’s Energy Group, although most did. Nevertheless, given that manufacturing firms tend to license patents and do not necessarily develop their own technologies, it is informative to see how this sector feels that the Supreme Court should decide Oil States.

Use of this phrase strikes me as indefensible because by its very nature it implies picking winners and losers after the Patent Office has already issued a patent and taken money from the inventor. Or worse, it reinforces the two-class patent system that we increasingly see today, between those that “have” the resources to attack or defend patents and the “have nots” (everyone else). Once a patent issues it is a private property right. Period. By definition a patent is legitimate because it exists!

Greenwood and Castellani will have two major problems as they seek relief. First, the IPR provisions do not include a standing requirement, which means that anyone can bring an IPR for any reason. The second problem is potentially more challenging. An IPR fix would create a so-called scoring problem with the Congressional Budget Office (CBO). What this means is that if this relief were provided for the biotech and pharmaceutical industries, as desired by Goodlatte and Castellani, it will cost the federal government money and increase the deficit unless it is offset.