Blog Tag: MDMA

Changes to PTAB Practice Proposed by STRONGER Patents Act of 2017

The STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2017 was recently introduced in the Senate by a bipartisan group led by Senator Chris Coons (D-Del.) and co-sponsored by Senators Tom Cotton (R-Ark.), Dick Durbin (D-Ill.), and Mazie Hirono (D-Haw.).  According to a press release by Senator Coons, “[t]he STRONGER Patents Act seeks to strengthen the U.S. Patent system through implementing measures to make it easier and less costly for patent holders to enforce their patents.”  The “Act is based on legislation that Senator Coons introduced last year with the goal of making the post-issuance proceedings before the Patent Trial and Appeal Board (PTAB) more fair and efficient.”  The bill asserts that “unintended consequences of the [AIA] are continuing to become evident, including the strategic filing of post-grant review proceedings to depress stock prices and extort settlements, the filing of repetitive petitions for inter partes and post-grant reviews that have the effect of harassing patent owners, and the unnecessary duplication of work by the district courts of the United States and the Patent Trial and Appeal Board.”

The following table illustrates several key changes proposed by the STRONGER Patents Act compared to the current PTAB practice under the AIA.

  Proposed Changes in STRONGER Patents Act Current Practice Under AIA
Claim Construction Same standard as that used in district court litigation (Phillips) Broadest reasonable interpretation
Burden of Proof Presumption of validity No presumption of validity
Standing IPR Petitioner must have been sued for infringement or have standing to bring declaratory judgment action in Federal Court


IPR Petitioner may be any third party who is not time-barred or estopped
Limitation on Reviews Review initiated only once per claim of a patent There is no formal limit, but the PTAB has discretion to deny multiple or follow-on petitions under §§ 314(a), 324(a) or 325(d).
Interlocutory Appeals from Institution Decisions A determination by the Director to institute an IPR may be appealed to the United States Court of Appeals for the Federal Circuit.  Patent owners may not appeal the PTAB’s determination in the institution decision that a challenged claim is likely unpatentable. Institution decisions are not appealable.
Eliminating Repetitive Proceedings Petitioners can only challenge a patent once, unless they are later charged with infringement of additional claims.  If an IPR is instituted, the petitioner cannot bring challenges of the same type in district court to eliminate duplicative proceedings. A petitioner who, in a final written decision, is unsuccessful challenging a claim in an IPR or PGR is estopped from raising or maintaining any ground of challenge for that claim that the petitioner raised or reasonably could have raised during the concluded IPR or PGR proceeding.
Real-Party-In-Interest Defines Real-Party-in-Interest as an entity making financial contributions to the challenge. A Real-Party-in-Interest is typically considered any party who exercises or could exercise control in the proceeding.
Priority of Federal Court Validity Determinations If a district court reviews the validity of a patent before the PTAB, the post-issuance proceeding should not start, or should be paused pending appeal.

Medical Device Manufacturer’s Association Comments on Senate Hearing

The Senate Committee on Small Business and Entrepreneurship held a meeting titled “An Examination of Changes to the U.S. Patent System and Impacts on America’s Small Businesses” on February 25, 2016.  The archived webcast of the hearing can be viewed here.

On Thursday, February 25th the Medical Device Manufacturers Association (MDMA) issued the following statement regarding the hearing:

“MDMA thanks Chairman Vitter and the committee Members for examining the unintended consequences that some proposed changes to the patent system would have on small businesses.  MDMA continues to support balanced efforts to curb abusive patent practices, but not in a manner that would be overly broad and would harm medical technology innovation and stifle the development of cures for patients who need them the most.

“MDMA remains committed to working with Congress on targeted efforts to improve the patent system, but we must not do so at the expense of innovators and inventors who are revolutionizing patient care and saving lives.”

House Committee Passes Innovation Act – Medical Device Group Expresses Opposition

The Innovation Act (H.R. 9), a patent reform bill introduced this congressional session, received bipartisan support in a 24-8 positive vote by the House Judiciary Committee on June 11, 2015. The bill is now scheduled to proceed to the full House of Representatives for consideration. A press release announcing the vote stated that a goal of the Innovation Act is to address, for example, the following:

  • Targets Abusive Patent Litigation;
  • Protects the Patent System;
  • Increases Transparency;
  • Prevents Extortion;
  • Provides Greater Clarity;
  • Provides Small Business Education;
  • Places Reasonable Limits on Venue in Patent Cases; and
  • Reduces Unnecessary, Expensive Discovery.

A related bill, the Protecting American Talent and Entrepreneurship (PATENT) Act (S. 1137), was also recently approved by the Senate Judiciary Committee for consideration by the Senate.

Prior to the vote in the House Judiciary Committee, the Medical Device Manufacturers Association (MDMA) issued a statement opposing the Innovation Act.  The statement, made by MDMA President and CEO Mark Leahey, asserts that the Innovation Act “remains overly broad and would harm medical technology innovation and stifle the development of cures for patients who need them most.”  Specifically, Leahey’s statement claims the Innovation Act “would severely weaken the ability of small companies and the innovators behind them to attract early stage investment for their inventions and defend them against infringement.”

The MDMA has been critical of the Innovation Act in the past, including sending a letter addressing its concerns in April.  The group has also  supported another patent reform bill, the Support Technology and Research for Our Nation’s Growth (STRONG) Patents Act of 2015 (S. 632), in the Senate.

Medical Device Industry Organizations Support STRONG Patents Act

(March 3, 2015)  Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued a statement regarding the Support Technology and Research for Our Nation’s Growth (STRONG) Patents Act of 2015.  According to the bill, the STRONG Patents Act aims to “strengthen the position of the United States as the world’s leading innovator by amending title 35, United States Code, to protect property rights of the inventors that grow the country’s economy.”  The STRONG Patents Act was introduced by U.S. Senators Chris Coons (D-Del.) and Dick Durbin (D-Ill.), members of the Senate Judiciary Committee, and Mazie Hirono (D-Hawaii), member of the Senate Committee on Small Business and Entrepreneurship.  According to a press release by Senator Coons:

The STRONG Patents Act would strengthen and combat abuse by:

  • Cracking down on abusive demand letters by empowering the Federal Trade Commission to target firms that abuse startups rather than invent anything;
  • Ensuring that pleading standards for patent-infringement cases match the standards used for all other forms of civil actions, creating a significant barrier to frivolous lawsuits before any funds are spent on discovery;
  • Eliminating fee diversion from the U.S. Patent and Trademark Office (PTO) so we can ensure that those who examine patents have adequate training and dependable funding;
  • Ensuring balance in post-grant proceedings at the PTO, so that this expedited form of patent litigation is both fast and fair; and
  • Analyzing the impact that our patent system has on small businesses, both from the perspective of startups reliant on patents and those small businesses facing allegations of infringement.
According to Mr. Leahey’s statement, the “MDMA applauds the introduction of the ‘STRONG Patents Act’ for its measured approach to address issues facing our nation’s patent system . . . While MDMA supports efforts to deal with patent litigation abuse, we must ensure that any legislation to address this problem does not have the unintended consequences of weakening one’s patent rights. The ‘STRONG Patents Act’ targets the concerns of patent holders to end abusive practices, while establishing balance in post-grant proceedings at the PTO and eliminating fee diversion.” The Biotechnology Industry Organization (BIO) also expressed support for the STRONG Patents Act stating, “BIO supports balanced reforms to reduce abusive patent practices, while maintaining the strong incentives necessary to sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country.  The STRONG Patents Act of 2015 achieves this critical balance.” The STRONG Patents Act provides an alternative vision for the patent system to the Innovation Act submitted in the House by Congressman Bob Goodlatte (R-Va.) last month.

Medical Device Manufacturer’s Association Submits Comments on USPTO’s Proposed Rule to Require Identification of Attributable Ownership

(April 24, 2014)  The Medical Device Manufacturer’s Association (MDMA) announced that it submitted comments to the United States Patent and Trademark Office (USPTO) in regard to the USPTO’s Notice of Proposed Rulemaking Proposing Changes to Require Identification of Attributable Ownership.  The proposed rule, published in the Federal Register at 79 Fed. Reg. 9677 on February 20, 2014, would require more transparent identification of the patent owner. In particular, the proposed rule would require that the attributable owner, including the ultimate parent entity, be identified during the pendency of a patent application and at specified times during the life of a patent.  Specifically, the attributable owner would need to be identified on the filing of an application (or shortly thereafter), when there is a change in the attributable owner during the pendency of an application, at the time of issue fee and maintenance fee payments, and when a patent is involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board (PTAB).

According to the announcement, the comments by the MDMA expressed concern over proposed changes that “would require identification of attributable ownership, which would be extremely costly and burdensome for innovative and entrepreneurial medical technology companies.”  The MDMA states that their position on patent reform is “supportive of efforts to curb abusive practices of patent assertion entities (PAEs) or ‘patent trolls’ but not while making it more costly and burdensome for innovators when defending or asserting their intellectual property rights.”

Several other organizations expressed similar concerns to the proposed rule; two public hearings were conducted in March. Final rulemaking is scheduled for later this month.