Patent Issues
Medical technology research is extremely expensive and a particularly difficult market for new, innovative entrants to compete. Attracting the necessary investment into companies developing the next generation of treatment, therapies, and technologies, depends on a strong and reliable patent system to ensure that these critical innovations remain proprietary for a period of time, especially for a new entrant.
The Patent Reform Act of 2007 includes provisions that, when combined with the changes taking place as a result of recent Supreme Court decisions, threaten to devastate life sciences investment, and thereby, innovation. MDMA is particularly concerned with the provisions dealing with PTO rule making authority, apportionment of damages, the open-ended nature of the post-grant review window, and the lack of redress for the growing use of the inequitable conduct defense.
What is MDMA doing?
MDMA has been actively lobbying Capitol Hill to make the necessary changes to the Patent Reform Act of 2007 to ensure that innovation flourishes. MDMA highlighted this issue during our 2007 Annual Meeting, held numerous Hill meetings during the congressional fly-in and are active participants in a cross-coalition of organizations representing medtech, biotech, nanotechnology, universities and technology companies. The cross coalition is working together with key members of Congress to reform the current bill to strengthen the patent system, not weaken it.
MDMA's Position Paper on Patent Reform 
Recent Articles
Two Views of Innovation, Colliding in Washington
The New York Times
By John Markoff
January 13, 2008
Below are two articles from China and India that support the patent reform bill because it will make it cheaper and easier to infringe US patents.
The Greatest Changes of the U.S. Patent System in the Last 50 Years
By Yongshun Cheng and Li Lin
China Intellectual Property News
November 11, 2007
Local cos can eye patents in US
By Gireesh Chandra Prasad,
The Economic Times
July 23, 2007
Additional Articles
Proposed Patent Reforms Worry Device Industry
Devices & Diagnostics Letter
April Astor and Breda Lund
June 25, 2007
Device Industry Intesifies Efforts to Protect IP, Modify Patent Reform Bills
The Gray Sheet
Chloe Taft
June 4, 2007
NEWS
Proposed Patent Rules Exceed PTO’s Authority
April 7, 2008 - The US District Court for the Eastern District of Virginia granted GlaxoSmithKline a summary judgment in its challenge to the final rule on continuation applications issued by the PTO last August. In sum, the judge ruled that the proposed rules exceed PTO's statutory rule-making authority which does not extended to "substantive" rule-making. MDMA is pleased with the court's decision. It will ensure that innovators will be able to protect their IP in the medical technology field.
MDMA’s Comment Letter 
Report Challenges Need for Damages Reform in Patent Bill
Febraury 15, 2008 - A report called into question a major tenet of the proposed Patent Reform Act of 2008. The report, issued by the Innovation Alliance, concludes that there is no pattern of extraordinary jury damages awards for patent litigation. The report is based on a survey of over 90 patent cases for the past three years.
One of the principle arguments relied upon by proponents of the Patent Reform Act is that the current system is flawed based on the extraordinary damages awards for patent infringement. The report demonstrates that this is not the case and the current patent legislation attempts to remedy a non-existent problem.
The complete report entitled, Moving Beyond the Rhetoric: Jury Damage Verdicts in Patent Infringement Cases, 2005-2007, can be found on the Innovative Alliance website:
www.innovationalliance.org
Opposition to Patent Reform Act Increases
February 8, 2008 - Opposition to the Patent Reform Act grew this week with more influential stakeholders voicing public concern with the current form of the legislation. The Administration as well as diverse groups of unions and university stakeholders, sent letters to the Senate expressing their collective concern about the harm that the Patent bill will bring to innovation.
While many in the media have characterized the patent debate as being simply, “big-tech” vs. “big-pharma,” stakeholder letters such as these represents the substantial diversity in opposition to the proposal.
Copies of the letters
Administration Letter
Judge Orders Injunction Blocking PTO Rules
November 1, 2007 - The US District Court of Eastern Virginia granted GlaxoSmithKline's preliminary injunction blocking the United States Patent and Trademark Office (PTO) from implementing its controversial rules on continuations and claims which were scheduled to take effect today. The PTO rules would have limited the number of claims and continuations filed by a patent holder. Although the court schedule has not been announced, some expect further proceedings to resume in January.
MDMA is very pleased that the court issued a temporary injunction in the GSK case. Consistent with the comments MDMA and hundreds of others filed with PTO, the rule changes are beyond PTO's authority and would severely undermine the ability of life science companies to innovate.
To view the Court's opinion please click here
MDMA Board Members Attend Patent Reform Press Conference
October 25, 2007 - Several members of the Medical Device Manufactures Association board were in Washington, DC last week to share their views at a press conference on/of the Patent Reform Act of 2007. The event was a joint effort by MDMA, Bio, NVCA and the Innovation Alliance to present to the public some of the potentially devastating consequences the proposed measure could bring about if implemented in its current format. Joe Kiani, Chairman of the MDMA Board of Directors, and Mark Wan, also on the Board, spoke on behalf of the organization. Both Kiani and Wan emphasized that the proposed changes to the patent system would create uncertainty about the validity of patents and drive venture capital away from innovative device companies.
Please click here to see a recent article about the press conference:
http://www.pcworld.com/article/id,139005-c,proposedlaws/article.html
Patent "Reform" Bill Narrowly Passes House, MDMA Seeks Critical Improvements in Senate
September 7, 2007 -- Today, the House of Representatives narrowly passed HR 1908, The Patent Reform Act of 2007. The bill significantly weakens the intellectual property rights of patent holders and eliminates many deterrents that currently exist against infringers. However, proponents of the bill were only able to muster 2 votes more that a simple majority of House Members and 175 Members from both parties opposed the legislation. MDMA executive director, Mark Leahey stated, "Serious deficiencies remain with the patent "reform" bill passed by the House. MDMA will attempt to work with the Senate to make these critical changes. Failure to address these issues will result in the bill doing more harm than good."
Ongoing Efforts to Improve Patent Reform Act of 2007
August 3, 2007 -- Congressman Donald Manzullo (R-IL) and Congressman Michael Michaud (D-ME) co-authored a letter to House Majority Leader, Steny Hoyer (D-MD), and Minority Leader, John Boehner (R-OH), expressing the need to provide more time to deliberate and make additional modifications to the Patent Reform Act of 2007. Specifically, the letter highlights the need to address three critical issues: 1) apportionment of damages;
2) an open ended post-grant review process; and
3) expanding the rulemaking authority of the US Patent and Trademark Office (PTO)
The letter was signed by 65 other Members of Congress from both parties.
To read the letter click here.
MDMA Calls for Changes to The Patent Reform Act of 2007
June 19, 2007 -- MDMA joined over 200 other organizations to express concerns with The Patent Reform Act of 2007, S.1145 and H.R. 1908. In a letter sent to key members of the House and Senate Judiciary Committees, a diverse set of stakeholders stated that the Patent Reform Act would “hinder innovation across the diverse sectors of the American economy we represent, including academia, agriculture, alternative energy, biotechnology, chemical, electronics, environmental technology, financial services, information technology, life sciences, nanotechnology, and telecommunications.”
To read the letter, click here.
To read MDMA's press release click here.
Senators Call for More Hearings on Patent Reform
June 11, 2007 -- A majority of the Republicans on the Senate Judiciary Committee sent a letter to Chairman Leahy and Ranking Member Specter calling for additional hearings on the issue of patent reform. The letter states in part, "we believe the issue of mandatory apportionment of damages, post-grant opposition, and broad rulemaking authority for USPTO need to be more carefully examined to ensure that they do not undermine innovation, increase frivolous litigation, or undermine property rights."
To view the letter, please click here.
Senate Holds Hearing on Patent Reform
June 6, 2007 -- The Senate Judiciary Committee held a hearing on patent reform. Members of the Cross Coalition expressed concerns with provisions in the current bill dealing with post-grant review, apportionment and expanding PTO’s rulemaking authority.
MDMA issued comments on two proposed rules issues by the USPTO.
May 3, 2006 -- The proposed rule changes would severely limit the ability of medical device companies to secure appropriate patent protection on their inventions in exchange for the disclosing the technology to the public – the quid pro quo in the patent system. Without this patent protection, medical device companies would not be able to attract financing for products when the scope of protection is left diminished or ambiguous. Moreover, MDMA believes these rules, if adopted, would likely increase both the backlog and pendency of applications.
To read the comment letter, please click here.
The Patent Reform Act of 2007 Will Stifle Innovation in Medical Technology
Life science research is extremely expensive, and a particularly difficult market for new innovative entrants to compete. Attracting the necessary investment into companies developing the next generation of treatment, therapies, and technologies, depends on a strong, reliable patent system to insure that these critical innovations remain proprietary for a period of time, especially for a new entrant. However, due to abuses by a few, resulting in high profile and large damage awards to entities not developing products, a public perception has evolved that the patent system needs significant reform. However, the current bills being considered by Congress would would significantly weaken the current patent system rather than strengthen it. Specifically, MDMA is concerned with provisions in the bill dealing with post-grant review, apportionment of damages and expanding the USPTO's rulemaking authority.