Proposed Regulations Would Curtail Abusive Behavior By Patent Applicants
WASHINGTON, DC — A coalition of consumer advocacy and public interest groups today filed legal papers supporting new U.S. Patent Office (USPTO) rules that would curtail abusive behavior by patent applicants and improve patent quality. The tactics are used frequently by drug companies to get patents they don’t deserve.
In a friend-of-the-court brief filed in the U.S. Court of Appeals for the Federal Circuit in Washington, DC, the groups urged that a decision by the federal District Court for Eastern Virginia blocking the proposed rules be overturned. The groups urged the appeals court to implement the USPTO’s proposed rules immediately.
The proposed regulations ask applicants to justify the need for more than two continuations per application and to assist the USPTO in performing initial technological research on applications that contain an excessive number of claims.
The groups joining in filing the Public Interest Amici brief are: The Public Patent Foundation (“PUBPAT”), AARP, Computer & Communications Industry Association (“CCIA”), Consumer Watchdog (Formerly the Foundation for Taxpayer and Consumer Rights), Essential Action, Initiative for Medicines, Access & Knowledge (“I-MAK”), Prescription Access Litigation (“PAL”), Public Knowledge (“PK”), Research on Innovation (“ROI”), and Software Freedom Law Center (“SFLC”).
"The public interest overwhelmingly supports the USPTO’s Final Rules for at least two significant reasons," the brief said. "First, they will enable the USPTO to curtail abuses of the patent application process made by those patent applicants who seek to pervert the system to gain an unfair advantage. Second, the Final Rules will help the USPTO improve patent quality, which is a critical issue for ensuring the patent system benefits the American public."
The new rules were to have been implemented by the Patent Office on Nov. 1, 2007, but were blocked by suits brought by drug maker GlaxoSmithKline and inventor Triantafyllos Tafas.
Under current rules which allow unlimited continuations, USPTO examiners who have repeatedly rejected an application often face an endless stream of continuation applications that "may well succeed in ‘wearing down the examiner’, so that the applicant obtains a broad patent not because he deserves one, but because the examiner has neither the incentive nor will to hold out any longer," according to a study by Professor Mark A. Lemley of Stanford Law School and Kimberly A. Moore, now a Circuit Judge on the U.S. Court of Appeals for the Federal Circuit.
Pharmaceutical companies take advantage of continuations in order to help them keep monopolies over their drugs. According to the publication Nature Biotechnology, from 1995 to 1999, 41% of drug patents issued were based on continuations. In contrast only 22% of the patents issued in mechanical engineering were based on continuations.
The consumer and public interest groups’ brief said the new rules would:
– Curtail abuse of continuation applications.
– Help the USPTO improve patent quality.
– Increase patent office efficiency.
The legal papers, available at http://www.pubpat.org/assets/files/AmicusBriefs/PUBPAT_PTO_Rules_CAFC_Brief.pdf or at http://www.consumerwatchdog.org/resources/PTOAmicibrief.pdf, also noted that while briefs filed opposing the new rules claimed they were acting in the "public interest", in fact they represented the narrow interests of patent holders and patent attorneys.
"Congress has intentionally implemented a patent system that balances the incentives provided to patentees with the benefit to the public of the disclosure and ultimate dedication of the resulting inventions to society," the consumer groups said. "Thus, the public interest lies in an efficiently functioning patent system, not one that is subject to abuse and manipulation."
The consumer and public interest groups said that despite having various missions and activities, they are united in their belief that patent law and policy should be crafted to ensure that it benefits the public interest. They "firmly believe that the Final Rules would significantly advance both the general public interest and the specific aspects of the public interest that they each separately exist to represent. Thus, the Public Interest Amici have united in this brief to express a single voice in support of the Final Rules."
About the Public Interest Amici:
The Public Patent Foundation (“PUBPAT”) is a not-for-profit legal services organization that represents the public interest in the patent system, and most particularly the public interest against the harms caused by undeserved patents and unsound patent policy. PUBPAT provides the general public and specific persons or entities otherwise deprived of access to the system governing patents with representation, advocacy and education. PUBPAT has argued for sound patent policy before the Supreme Court, the Court of Appeals for the Federal Circuit, the USPTO, the European Union Parliament, and the United States House of Representatives. PUBPAT has also requested that the USPTO reexamine specifically identified undeserved patents causing significant harm to the public. The USPTO has granted each such request. These accomplishments have established PUBPAT as a leading provider of public service patent legal services and one of the loudest voices advocating for comprehensive patent reform. To be kept informed of PUBPAT News, subscribe to the PUBPAT News List by sending an email with "subscribe" in the subject line to [email protected].
AARP is a nonpartisan, nonprofit membership organization of over 39 million persons, age 50 or older, dedicated to addressing the needs and interests of older Americans. As the country’s largest membership organization, AARP has a long history of advocating for access to affordable health care and for controlling costs without compromising quality. AARP, therefore, has a strong interest in this case since pharmaceutical companies’ manipulation of the patent system has thwarted the entry of generics to the marketplace, thereby reducing access to affordable prescription drug treatments. Affordable prescription medication is particularly important to the older population which, because of its higher rates of chronic and serious health conditions, has the highest rate of prescription drug use. Persons over sixty-five, although only thirteen percent of the population, account for thirty-four percent of all prescriptions dispensed and forty-two cents of every dollar expended on prescription drugs. Prescription drug spending has skyrocketed over the last decade and a half. Since 1990, national health expenditures on prescription drugs have quadrupled from $40 billion to $188 billion in 2004. Because prescription drug spending has skyrocketed over the last fifteen years, thereby limiting AARP’s members’ access to medically necessary medicines, AARP advocates for policies that can broaden access to prescription drugs, such as adding prescription drug coverage to the Medicare program (Part D), and for policies that lower the cost of prescriptions for consumers. Since generic drugs generally cost much less than their brand-name counterparts, AARP has worked at the state and national levels to increase access to lower cost generic versions of drugs.
The Computer & Communications Industry Association (“CCIA”) is a not-for-profit trade association dedicated to principles of full, fair, and open competition. CCIA members participate in many sectors of the computer, information technology, and telecommunications industries and range in size from small entrepreneurial firms to the largest in the industry. CCIA members use the patent system regularly, and depend upon it to fulfill its constitutional purpose of promoting innovation. However, CCIA is increasingly concerned that the patent system has expanded without adequate accountability and oversight.
Consumer Watchdog is a nationally recognized non-partisan, non-profit organization representing the interests of taxpayers and consumers. Its mission is to provide an effective voice for taxpayers and consumers in an era when special interests dominate public discourse, government and politics. Its programs include health care reform, oversight of insurance rates, energy policy, protecting legal rights, corporate reform and political accountability. Consumer Watchdog’s Stem Cell Oversight and Accountability Project seeks to protect the interests of California taxpayers and patients as California’s landmark $6 billion stem cell research project is implemented. As part of its Stem Cell Project, Consumer Watchdog successfully sought re-examination of three patents on embryonic stem cells that were impeding research efforts. The organization continues to oppose unjust patents that hinder research and hurt patients. For more information visit Consumer Watchdog on the web at: http://www.ConsumerWatchdog.org
Essential Action is a project of Essential Information, a non-profit, tax-exempt organization founded in 1982 that encourages citizens to become active and engaged in their communities. Essential Action is concerned particularly about the harmful impact of poor quality patents on prescription drug prices and medicine affordability, and more generally about the negative impact the patent system can have on the public when it is abused by patent applicants.
The Initiative for Medicines, Access & Knowledge (“I-MAK”) is a not-for-profit group that provides technical assistance on intellectual property and pharmaceutical products to governments, suppliers promoting access, public health organizations and civil society groups. I-MAK challenges unsound patent systems globally and works toward creating systemic change so that newer and more affordable drugs are made available for the public. I-MAK also offers tools and resources to the public helping increase knowledge of the pharmaceutical patenting process.
Prescription Access Litigation LLC (“PAL”) is a project of Community Catalyst, Inc., a nonprofit, nonpartisan organization that builds consumer and community participation in the shaping of the U.S. Health system to ensure quality, affordable health care for all. PAL is a coalition of over 130 organizations in 35 states and the District of Columbia. The organizations in PAL’s coalition have a combined membership of over 13 million people, and include state and local organizations representing consumers and seniors, statewide health care access coalitions, and labor unions. PAL works to end illegal prescription drug price inflation by pharmaceutical manufacturers and others by facilitating the participation of consumers, advocacy organizations and third party payors (health plans, union benefit funds and others) in class action litigation challenging such price inflation practices. PAL joined the brief because PAL is concerned that abuse of the patent system leads to higher prescription drug prices for consumers.
Public Knowledge (“PK”) is a public interest advocacy and education organization that promotes a balanced approach to intellectual property law and technology policy reflecting the “cultural bargain” intended by the framers of the U.S. Constitution. PK promotes fundamental democratic principles and cultural values of openness, access, and the capacity to create and compete. PK advocates for patent law and policy that encourages innovation and creativity.
Research on Innovation (“ROI”) is a not-for-profit organization created to conduct, sponsor and promote research on technological innovation and to disseminate the results of this research to a broad audience, both in academia and in industry. ROI’s research indicates that patents can have a substantial positive impact on innovation if patent policy is sound and balanced.
The Software Freedom Law Center (“SFLC”) is a not-for-profit legal services organization that provides legal representation and other law-related services to protect and advance Free and Open Source Software (FOSS), software distributed under terms that give recipients freedom to copy, modify and redistribute the software. SFLC provides pro bono legal services to non-profit FOSS developers and helps the general public better understand the legal aspects of FOSS. SFLC is concerned about the impact the patent system has on the development and distribution of FOSS.
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