Patent Reform: Senate Debate to Begin February 28, New Sponsors, For and Against

Senate Calendars Patent Reform Debate for February 28, 2011

       Today the U.S. Senate indicated that upon the conclusion of Morning Business on Monday, February 28, 2011, it will proceed to consider S. 23, the Patent Reform Act of 2011.  S.23 was reported out of the Judiciary Committee on February 3, 2011, with few changes from the version introduced on the Senate floor by Sen. Patrick Leahy (D-VT).

 

New Bill Sponsors Come Forward

          GovTracks is reporting additional sponsors of S.23: Sen. Richard Blumenthal (D-CT), Sen. Kirsten Gillibrand (D-NY), and Sen. Herb Kohl (D-WI), bringing the total number of Senators co-sponsoring S.23 to 11 (six Democrats, four Republicans, one Independent). No Maryland Senator is a co-sponsor.

 

For and Against Patent Reform

          MapLight is reporting the following organizations and interest groups as publicly supporting or opposing S.23:

Support:

  • American Institute of Certified Public Accountants (AICPA)
  • Association of University Technology Managers (AUTM)
  • Biotechnology Industry Organization (BIO)
  • Consumer Action
  • Innovation Alliance
  • International Association for Registered Financial Consultants
  • Microsoft
  • Partnership for Philanthropic Planning
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Public Interest Research Group
  • Tax Justice Network USA
  • The American College of Trust and Estate Counsel

Oppose:

  • Cisco
  • Dell
  • Financial Services Roundtable
  • Generic Pharmaceutical Association
  • Independent Community Bankers of America
  • Securities Industry and Financial Markets Association
  • The Clearing House Association
  •  

          The Biotechnology Industry Organization (BIO), indicated as in favor of patent reform, is comprised of hundreds of bio and pharma companies, organizations, universities, and governmental agencies, including over 60 based in or operating in Maryland.



 

Patent Reform Act of 2011: Innovating America to Prosperity

Senator Patrick Leahy

    Patent reform is once again on the Senate Judiciary Committee's legislative agenda.  S.23--the Patent Reform Act of 2011--was introduced on the Senate floor by Committee Chairman Patrick Leahy (D-VT) on January 25, 2011.  The bill, which resembles previous reforms, is co-sponsored by eight: three Republicans, four Democrats, and one Independent.

     In his introductory remarks on the floor, Leahy suggested that failing to pass patent reform this year would allow China to dominate the world in innovation activity.  Quoting a Newsweek study published last year, he said that only "41 percent of Americans believe that the United States is staying ahead of China on innovation. A Thompson Reuters analysis has already predicted that China will outpace the United States in patent filings this year. China, in fact, has a specific plan not just to overtake the United States this year in patent applications, but to more than quadruple its patent filings over the next 5 years." Leahy also called for reforming the patent system to "stimulate the American economy" through innovation.  He quoted Thomas Freidman, who wrote "We might be able to stimulate our way back to stability, but we can only invent our way back to prosperity."

     Senatory Orrin Hatch (R-UT), also speaking on the Senate floor in support of S. 23, noted that patent reform was needed to address the backlog of 700,000 patent applications pending in the Patent Office.  He said that number "reflects the vibrant, innovative spirit that has made America a world-wide leader in science, engineering, and technology, but also represents dynamic economic growth waiting to be unleashed."

     The current version of patent reform looks like previous ones.  A quick summary of the major provisions is shown below:

Sec. 1: Short Title
Sec. 2: First Inventor to File
Sec. 3: Inventor's Oath or Declaration
Sec. 4: Damages
Sec. 5: Post-Grant Review Proceedings
Sec. 6: Patent Trial and Appeal Board
Sec. 7: Preissuance Submissions by Third Parties
Sec. 8: Venue
Sec. 9: Fee Setting Authority
Sec. 10: Supplemental Examination
Sec. 11: Residency of Federal Circuit Judges
Sec. 12: Micro Entity Defined
Sec. 13: Funding Agreements
Sec. 14: Tax Strategies Deemed Within the Prior Art
Sec. 15: Best Mode Requirement
Sec. 16: Technical Amendments
Sec. 17: Effective Date; Rule of Construction

     What will be the fate of S.23?  If history is any indication, the reform measure may go the way of previous legislative attempts and end up scuttled before it gets much traction.  But at least this Congress is starting the process early.  Below is a list of previous Congressional attempts to reform the Patent Act and the fate of each bill.

111th Congress: S. 515 (Patent Reform Act of 2009: Dead)
111th Congress: S. 610 (Patent Reform Act of 2009: Dead)
111th Congress: H.R. 1260 (Patent Reform Act of 2009: Dead)
110th Congress: S. 1145 (Patent Reform Act of 2007: Dead)
110th Congress: S. 3600 (Patent Reform Act of 2008: Dead)
110th Congress: H.R. 1908 (Patent Reform Act of 2007: Passed House)
109th Congress: S. 3818 (Patent Reform Act of 2006: Dead)
 

     As it has in the past, the Biotechnology Industry Organization (BIO) came out in support of S. 23, with BIO President and CEO Jim Greenwood noting the legislation's benefits to bio: "Innovation in biotechnology is based upon the strong and predictable protection of intellectual property provided by our nation’s patent system. Without strong and predictable patent protection, investors would shy away from investing hundreds of millions of dollars, over a decade or more, in high-risk biotechnology companies, and will simply put their money into projects or products that are less risky or offer a more immediate return but are of less value to society."  Other stakeholders, as they have in the past, will undoubtedly step forward for or against the legislation.

Patent Reform Act of 2008: News, Commentary, and Analysis

     Seven weeks after Senator Jon Kyl (R-AZ) introduced S.3600, the Patent Reform Act of 2008, on September 25, 2008 (source: GovTracks), the reaction has been predictable, with stakeholders on the pro- and anti-reform sides making their views known. The Advanced Medical Technology Association (AdvaMed) said “improving and modernizing the patent system is clearly important to all sectors of the U.S. economy and we applaud Sen. Kyl and his staff for their leadership and inclusive approach to developing this legislation.” The Biotechnology Industry Organization’s (BIO) President and CEO Jim Greenwood immediately praised Kyl’s legislation, stating that "BIO appreciates the efforts of Senator Kyl and his staff to address the concerns of many stakeholders with the patent reform legislation currently pending in the Senate, and commends him for introducing the Patent Reform Act of 2008 (source: IPWatchdog).

     How will other stakeholders react? If past efforts are any indication, technology companies like Blackberry-maker RIM, which reportedly spent hundreds of thousands of dollars lobbying Congress on legislation including patent reform in 2007, may take the same stance with the 2008 legislation, as will Microsoft, Google, and other tech companies, which formed the Coalition for Patent Fairness and fought big pharmaceutical companies to keep portions of the existing patent system in tact during the battle over the 2007 patent reform effort.

     Bloggers have weighed in on the new legislation, too. “There is practically zero chance that this bill will pass in the current [110th Congress] session” (source: Peter Zura at the 271blog). Ex-AIPLA executive director Michael Kirk agrees. "Even if the Democrats get to 60 seats in the Senate, I would not count on the legislation being passed,” Kirk said in an exclusive interview with IAM (source: IAM Blog).

To the Blogosphere, And Beyond

New PTO Rules

Patent practitioners and others are keenly aware of the looming effective date for the new "claims and continuation" practice rules (November 1st, in case you forgot). Here are what people are saying about the pending rules.

    • Peter Weissman at Blank Rome suggests that "[i]t may be prudent to describe patentably “distinct” subject matter in separate applications rather than combining common subject matter in a single application. This could support an argument that the claims are truly patentably distinct"

    • Dr. Charles F. Louis, Vice Chancellor for Research, University of California, Riverside said in testimony before the Senate Judiciary Committe "any rules promulgated by the U.S. Patent and Trademark Office that make it more burdensome and expensive for universities to obtain patents on their inventions, such as the new claims and continuation rules, would be detrimental to university technology transfer." (Source: IPWatchdog)

    • Hal Wegman at Foley notes that "[i]f cloture is voted by the Senate on patent reform and ultimately patent reform includes the House-passed version on delegation of rulemaking authority, whatever happens in the near term on Continuation Rules will be superseded by the new law. Yet, the great bulk of the focus of the patent community is on the sideshow in Alexandria." (Source: PatentHawk)

    • That "sideshow" includes GlaxoSmithKline's Motion for Temporary Restraining Order and Preliminary Injunction to halt implementation of the new PTO rules. A hearing on GSK's motion is set for October 31, 2007.

Favorable Patent Lawsuit Forums

Move over Eastern District of Texas, more and more other districts are being eyed as the place to file patent lawsuits, especially since patent reform will make it harder to go forum shopping. Take the Western District of Wisconsin, for example, mention of which continues to be linked with terms like "speedy justice."  The Wisconsin court boasts a filing-to-trial time of 11.3 months, which compares to a pokey 12 months at the Eastern District of Virginia (the average, in case you're wondering, is about 22 months, so says Dewey Ballentine co-authors last year in an IPToday article).

Patent Reform

It's no secret that the bio industry is against patent reform. At last week's 2007 Mid-Atlantic Bio Conference, held in Bethesda, MD, a representative from the Biotechnology Industry Organization (BIO) made the organization's views plainly clear in a presentation about patent reform legislation. Saying that bio was being thrown in front of the bus to save the IT industry, BIO urged member organizations to call their Senators to fight passage of the legislation.

Tired of Trademark Oppositions? Call Your Senator

In an opinion issued last week relating to a lawsuit against the PTO, the Fourth Circuit Court of Appeals overturned an Eastern District of Virginia decision, effectively sanctioning the practice used by Montana Congressmen of using the political appropriations process to halt the registration of the trademark THE LAST BEST PLACE, which was being sought by a Nevada company. Hopefully, I'll have more on this later (here's a preview: "Senate approves ‘Last Best' measure").

 

Biotechnology and Pharmaceutical Associations Thwart DC's Drug Price Control Law

Summary:  Federal Circuit affirms judgment declaring D.C.'s Prescription Drug Excessive Pricing Act of 2005 preempted by federal patent laws and enjoining its enforcement.


In Biotechnology Industry Organization v. District of Columbia, No. 2006 Civ. 1593 (Fed. Cir. 2007), the Federal Circuit affirmed the District Court for the District of Columbia's judgment in favor of the Plaintiffs declaring the District’s Prescription Drug Excessive Pricing Act of 2005 preempted by the federal patent laws and enjoining its enforcement.  The Plaintiffs' complaint centered on the following provision of DC's law:

"It shall be unlawful for any drug manufacturer or licensee thereof, excluding a point of sale retail seller, to sell or supply for sale or impose minimum resale requirements for a patented prescription drug that results in the prescription drug being sold in the District for an excessive price. *** A prima facie case of excessive pricing shall be established where the wholesale price of a patented prescription drug in the District is over 30% higher than the comparable price in any high income country in which the product is protected by patents or other exclusive marketing rights."

Plaintiff Pharmaceutical Research and Manufacturers of America ("PhRMA") filed suit in the District Court for the District of Columbia, alleging that the Act was invalid in light of the Commerce Clause of the Constitution and it was preempted by the federal patent laws. Plaintiff Biotechnology Industry Organization ("BIO"), which includes as its members nearly 60 Maryland biotechnology companies, filed a similar suit, which was consolidated with PhRMA's.

On appeal, the Federal Circuit stated:

"There is no express provision in the patent statute that prohibits states from regulating the price of patented goods; indeed, 'the federal patent laws do not create any affirmative right to make, use, or sell anything.'  Nevertheless, state law must yield to congressional enactments if it 'stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'"

The court then noted that "the value of patents lies in the patentees right to foreclose competitors from making, using, and selling the invention," which may allow them an opportunity to obtain above-market profits during the patent’s term.  As stated in the legislative history of the Drug Price Competition and Patent Term Restoration Act of 1984 (popularly known as the "Hatch-Waxman Act"), "patents enable innovators to obtain greater profits than could have been obtained if direct competition existed. These profits act as incentives for innovative activities.  The court found that DC's Act stands exclusively within the scope of the patent laws, and its effect is to shift the profit incentive benefits of a patented invention from inventors to consumers:

"By penalizing high prices—and thus limiting the full exercise of the market power that derives from a patent—the District has chosen to re-balance the statutory framework of rewards and incentives insofar as it relates to inventive new drugs. *** The fact that the Act is targeted at the patent right is apparent on its face. It applies only to patented drugs."

Comments:

  • According to PhRMA's web site, "Winning approval [to market a new drug], on average, takes 15 years of research and development and costs over $800 million dollars."  Any effort that stands in the way of recouping that investment will likely have a target on its back from its inception.

  • Would the result of this case have been different had DC's Act not been directed "only to patented drugs"?

  • See Maryland Representative Chris Van Hollen's (D-MD) proposal for the states: Voluntary State Discount Prescription Drug Plan Act of 2007

  • Carol Leonnig's article in the Washington Post