Posts Tagged: "Adam Mossoff"

The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.

The Initiative for Medicines, Access & Knowledge (I-MAK) has responded to a letter it received from Senator Thom Tillis (R-NC) in January asking the organization to address claims that its data on the effects of pharmaceutical patents on drug pricing is faulty. In the letter, I-MAK defended its underlying patent data and, in reference to the question of why the data differs significantly from public sources like the Food and Drug Administration’s (FDA’s) Orange Book and court filings, explained that “relying on public sources and court filings is not an accurate methodology for identifying all patents on a drug.” I-MAK’s view is that the U.S. patent system creates patent monopolies that lead to the practice of “evergreening”, in which innovator pharmaceutical companies extend their rights beyond the original patent terms, preventing competition from generics, which in turn causes drug prices to remain high. As part of its mission, I-MAK has developed a database of patents covering key drugs. Its reports are often cited by academics, including in law journals, policymakers and in congressional hearings. As a result, I-MAK has become one of the most authoritative sources for information on patents in this space.

Earlier this month, Senator Thom Tillis (R-NC) sent a letter to the U.S. Patent and Trademark Office (USPTO) and to the U.S. Food and Drug Administration (FDA), expressing concern about policymaking on drug patents and drug prices being driven by a narrative rooted more in policy goals than in actual data. He sent another letter to a policy organization, Initiative for Medicines, Access, and Knowledge (I-MAK), which has held itself out as go-to source for data on the number of patents covering drugs. I-MAK has become very popular; its drug patent numbers are invoked as fact by congresspersons, academics, congressional witnesses, and policy activists. Senator Tillis is to be commended for expressing serious concerns about the unreliability of drug patent numbers repeatedly invoked in the policy debates over drug prices in Washington, D.C. His letter to the USPTO and FDA requests that the agencies engage in an “independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.”

Just over one week ago, Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University published a Policy Memo with the Hudson Institute charging that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. Now, Senator Thom Tillis (R-NC) has written letters to the key organization providing that data, the Initiative for Medicines, Access & Knowledge (I-MAK), as well as the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), expressing concern about the findings of Mossoff’s memo and requesting more information from I-MAK about its methodology.

Throughout its history, the United States has led the world in protecting intellectual property (IP) rights.  On that foundation, we have also led the world in artistic, commercial, and scientific innovation, particularly with life-saving medicines and vaccines. Yet patent rights are under increasing assault, with anti-patent activists charging pharmaceutical makers with “antitrust” violations for utilizing and building upon their patents…

At today’s Heritage Foundation event in Washington, D.C., titled Restoring American Leadership in Patent Law and Innovation Policy, former U.S. Patent and Trademark Office Director (USPTO) Andrei Iancu began by lamenting the failure of decision makers to make the connection between intellectual property and innovation. Increasingly, policy makers think innovation just happens, Iancu explained, with too many believing monetization happens after the fact, rather than driving innovation. “Without IP, the free market does not participate, or does not participate to scale,” Iancu told the Heritage audience. Laurie Self, Senior Vice President and Counsel, Government Affairs, Qualcomm, agreed with Iancu and added that, without a strong patent system, there is no opportunity to maintain a strong innovation leadership position. Presumably alluding to developments such as the Biden Administration’s support for waiving IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) related to COVID-19 inventions and the recent Executive Order on Competition, Self said: “We are seeing a series of policies that if implemented would undermine our system… this cognitive dissonance is a threat.”

On August 10, The Hudson Institute hosted an online video webinar featuring Matt Ridley, member of the UK’s House of Lords and author of the recent book How Innovation Works (And Why It Flourishes in Freedom). The book explores a series of case studies about innovation across history in order to upend some conventional wisdom and make the argument that major innovations typically arise as a result of a series of contributions from sometimes unconnected individuals rather than top-down legislative frameworks or what Ridley calls “the myth of the heroic single inventor.” Moderating the conversation was Adam Mossoff, Professor of Law at George Mason University Antonin Scalia Law School and Chair of the Forum for Intellectual Property at the Hudson Institute. The conversation was highlighted by an intriguing and well-reasoned critique of Ridley’s book by Mossoff, who challenged some of the book’s statements on intellectual property and patents in particular.

Through the first half of June, a series of hearings on the state of patent eligibility in America held by the Senate Intellectual Property Subcommittee rendered a variety of interesting exchanges regarding current U.S. subject matter eligibility under Section 101 relating to various important sectors of the U.S. economy. During the second hearing, Senator Richard Blumenthal (D-CT) talked to panelists regarding his concerns about patent abuses in the pharmaceutical industry. During his period of questioning, Blumenthal grilled witnesses on the subject of whether the expansion of subject matter eligibility that would result from the proposed Section 101 draft text would exacerbate issues related to “patent thicketing,” a process by which drug companies attain large patent portfolios covering various aspects of a single drug formulation. Along with Senators Thom Tillis (R-NC) and Mazie Hirono (D-HI), Senator Blumenthal entered a series of questions for the record to be answered by panelists attending the recent patent eligibility hearings. Although the questions don’t overtly single out the pharmaceutical industry, panelist answers largely indicate that this sector was on most people’s mind while responding.

What makes SCOTUS’s assertions in patent law jurisprudence that there are these “exceptions” or additional “requirements” particularly annoying to many of us in the patent bar is that patent law is essentially statutory.  In other words, there should be no “federal common law of patents” that allows SCOTUS (or any other court for that matter) to make “exceptions” to or make additional “requirements” for what is already expressly written in the patent statutes.  Indeed, in other areas of federal law, SCOTUS has made it abundantly clear that “federal common law” doesn’t exist.  The most famous example is Erie v. Tompkins where SCOTUS overturned its prior view of a “federal common law” applicable in cases involving diversity jurisdiction.  So we in the patent bar may rightly ask:  why does SCOTUS believe it can create what is, in essence, a “federal common law of patents” to supplant or modify the existing patent statutes?

While the goal of developing a US innovation policy bolstered by strong IP protections was the focus of the event it was clear that competition with China, who clearly has set their own innovation agenda on a country-wide level, created a clear sense of urgency in the discussions… Generally speaking, the panelists felt that the actions of the last few years had inflicted serious damage on the reliability of patent rights in the US and created substantial doubt about what those rights were worth economically with the changes. The panel was overwhelmingly in favor of making significant changes to the current environment especially with regard to the proceeding at the PTAB.

A group of six patent law professors filed an amicus brief with the Court of Appeals for the Federal Circuit in Cleveland Clinic v. True Health Diagnostics. The professors’ brief urges the Federal Circuit to reverse a finding by the lower court invalidating patents asserted by Cleveland Clinic covering diagnostic methods for atherosclerotic cardiovascular disease. According to the brief, the district court’s invalidation of Cleveland Clinic’s patents represents an improper application of 35 U.S.C. § 101, the basic threshold statute governing the patentability of inventions.

As judges, former judges and government officials, legal academics and economists who are experts in antitrust and intellectual property law, we write to express our support for your recent announcement that the Antitrust Division of the Department of Justice will adopt an evidence-based approach in applying antitrust law equally to both innovators who develop and implementers who use technological standards in the innovation industries. We disagree with the letter recently submitted to you on January 24, 2018 by other parties who expressed their misgivings with your announcement of your plan to return to this sound antitrust policy.

The Oil States v. Greene’s Energy Group case heard by the U.S. Supreme Court Nov. 27, 2017, has generated much ink, analysis and opinion. Rightly so, given the profound consequences for the security of exclusive private property rights of limited duration in patents. Among the worthy and constructive reflections, conservative experts and leaders have contributed a fair share… Heritage Foundation legal scholar Alden Abbott, whose background includes service at the Federal Trade Commission and as a senior corporate IP counsel, has summed up the shortcomings of PTAB “patent death squads.” Abbott suggests how the Supreme Court should rule in Oil States: “The best option to fix the Patent Trial and Appeals Board is to get rid of it. There is a powerful legal case that board review violates the U.S. Constitution, and therefore is invalid.”

The Senate Republican High-Tech Task Force convened in order to hear from patent experts on the impact of the U.S. Supreme Court’s ruling in TC Heartland, the IPR process and patent eligibility, and to discuss what Congress can do in terms of additional patent reform in order to improve the U.S. patent system… The Hatch op-ed would seem to be music to the ears of beleaguered patent owners in the life science and computer implemented innovation areas. The problem, however, is with those the Senate Republican High-Tech Task Force heard from during this private meeting.