Intellectual Property Jurisdiction Clarification Act of 2006

Thank you, Chairman Sensenbrenner, for yielding this time.

Mr. Speaker, H.R. 5120, which is incorporated into section 202 of S. 1785 has drawn bipartisan sponsorship from 23 of our colleagues in the House. I introduced this measure because I believe it is both good patent policy and sound health care policy.

It corrects an inequity in the patent law and will encourage important innovation in medical research, precisely the purpose that Congress sought to accomplish in enacting the Hatch-Waxman Act. In the patenting process, there are several examples of relief that are available for late filings, late payments and deficient filings.

By enacting section 202 of S. 1785, we are continuing to promote the basic purpose of Hatch-Waxman, and we are strengthening Hatch-Waxman. It is important to do this so that our Nation will continue to lead the way in medical research, and so that patients will not be denied promising new innovative developments.

Mr. Speaker, I include for the Record letters from medical practitioners and consumer groups from across this country supporting this legislation. Included are letters from the Cleveland Clinic Foundation Heart Center, the Emory University Healthcare Heart Center, and the University of California Los Angeles Medical Center Cardiology Section. Their credentials and their views are impressive. They emphasize the health care advantages of this measure, particularly its effect on opening up new advantageous avenues of medical research to prevent and treat stroke.

The Carlyle Fraser Heart Center

at Crawford Long Hospital,

Athens, GA, June 15, 2006.

Congressman John Lewis,

House of Representatives,

Washington, DC.

Dear Representative Lewis: I received a phone call today

from Clive Meanwell, Chief Executive Officer of The Medicines

Company, regarding H.R. 5120, relating to the patent

restoration provisions of the Hatch-Waxman law. I am the

Director of Interventional Cardiology at Emory Crawford Long

Hospital and have been on the faculty of Emory University

School of Medicine for thirteen years. I am also the

President of the Greater Atlanta Division of the American

Heart Association (AHA), and a medical reporter for FOX-5

television. The major focus of my profession is the care of

patients with advanced and complex cardiovascular disease,

particularly those undergoing interventional procedures

(commonly known as stents) of the arteries of their heart and

elsewhere in the body.

I am writing in support of H.R. 5120 because I understand

that, if it passes, the anticoagulant drug Angiomax may

become eligible for patent term restoration. This would allow

for further investment in clinical development. Angiomax is a

critically important product which is used in the

overwhelming majority (thousands) of the interventional

procedures at Emory. Angiomax is an important therapy because

it provides safe, effective, and cost-effective anti

coagulation during interventional procedures. In addition,

several Emory physicians have performed extensive research on

Angiomax. Emory was one of the leading U.S. centers in a

recent trial studying this product. I am perhaps one of the

Nation's leading experts and researchers in this area and

have lectured internationally and published extensively in

this area. Within the last month, we submitted approximately

twenty individual research abstracts on Angiomax to the

American Heart Association and Transcatheter Cardiovascular

Therapeutics national meetings. Our research shows that

Angiomax provides equal efficacy to other drugs, costs less,

is easier to use, and causes less risk of bleeding

complications. Bleeding complications have been shown to

increase mortality and are particularly common in patients

who are: elderly, female, African-American, and those with

kidney disease, anemia, and high blood pressure. I have

attached two of our abstracts highlighting the consequences

of bleeding complications. These types of patients make up

the majority of the patients at our institution. Better

outcomes and a reduction in healthcare costs with Angiomax is

what we want for the patients of our community.

But that is only part of the story. Patent term restoration

for Angiomax is important because preliminary experience

suggests that Angiomax may be useful in preventing and

treating stroke but more studies are needed. Stroke is the

Nation's number one cause of disability and third leading

cause of death. Over 700,000 Americans suffer strokes each

year--one every 45 seconds; over 165,000 die and many

thousand more are disabled for life. I know that you are

aware that Georgia is part of the high-risk ``stroke belt''.

In my capacity with the AHA, one of our major initiatives is

reducing the risk of stroke. Unfortunately, the blood

thinning and clot-busting agents currently utilized to treat

stroke patients can cause dangerous side effects, including

intracranial bleeds (as was seen so vividly with Israeli

Prime Minister Sharon). Angiomax may be useful in the

prevention and treatment of strokes with fewer bleeding side

effects. But the very costly and time-consuming clinical

trials (which Emory will likely be involved with) which will

be needed to explore this and other promising new uses (such

as patients undergoing open-heart surgery) will not be

feasible unless patent term restoration under the Hatch-

Waxman Act is available to the drug's developer.

It is vital that H.R. 5120 be enacted so that research in

stroke is undertaken to evaluate the use of Angiomax in the

treatment and prevention of this debilitating disease. I

would be happy to discuss this matter further with you at

your convenience.

Very truly yours,

Steven V. Manoukian, M.D.,

Director, Interventional Cardiology, Emory Crawford Long

Hospital, Emory University School of Medicine.

Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 1785) to amend chapter 13 of title 17, United States Code (relating to the vessel hull design protection), to clarify the distinction between a hull and a deck, to provide factors for the determination of the protectability of a revised design, to provide guidance for assessments of substantial similarity, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on S. 1785 currently under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of S. 1785, a bill to amend the Vessel Hull Design Protection Act. The version before us is the manager's amendment to the bill. In addition to the vessel hull design amendments, S. 1785 includes the text of three other intellectual property bills that have been the focus of considerable bipartisan discussion and deliberation. These bills are not controversial and therefore have been included as a part of the manager's amendment.

First, S. 1785 amends the Vessel Hull Design Protection Act by requiring courts to examine the statutorily protected components of a vessel, the hull as well as the deck, separately when determining whether a third party has infringed on a design.

This change responds to a Fifth Circuit Court case which, if allowed to stand, will render the statute meaningless, thereby encouraging knock-off artists to sell boats with inferior-designed hulls to consumers. The Judiciary Subcommittee on the Courts, the Internet, and Intellectual Property reported this bill favorably to the full committee on March 1, 2006.

Second, S. 1785 includes the text of House Concurrent Resolution 319, which commemorates the Bayh-Dole Act on its 25th anniversary. This is the law that enables inventors to retain their property interest in patented products that are subsidized by Federal financing. The concurrent resolution was unanimously approved by the Judiciary Committee earlier this year.

Third, S. 1785 includes the text of H.R. 5120, a bill that amends title 35, United States Code, to conform certain filing provisions within the Patent and Trademark Office. This legislation allows the director of the PTO to accept a pharmaceutical patent extension request for not later than 5 days after the current statutory deadline, which is 60 days from the date that the Food and Drug Administration approves the drug for use.

The applicant must prove to the director's satisfaction that the delay in filing was unintentional. In any event, the director retains the discretion to grant or to deny an extension. It is not automatic. The Subcommittee on Courts, the Internet, and Intellectual Property conducted a hearing on H.R. 5120 on September 14.

Finally, S. 1785 includes the text of H.R. 2955, the Intellectual Property Jurisdiction Clarification Act. This measure responds to a recent court case by reaffirming the plenary authority of the Federal Circuit to hear all patent appeals, which was the clear intent of Congress since the circuit's creation in 1982. This bill was reported by the Judiciary Committee on April 5 of this year by a voice vote.

Mr. Speaker, S. 1785 incorporates timely bipartisan legislation to enhance public safety, commemorate the Bayh-Dole Act and make other needed clarifications and improvements to U.S. intellectual property law.

I urge my colleagues to support the legislation and send it to the other body to ensure its timely consideration and passage.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Tennessee (Mr. Jenkins).

Mr. Speaker, I yield back the balance of my time.

I thank the ranking member, and I thank the chairman.

Mr. Speaker, I rise in support of section 201 of S. 1785 and, in particular, its well-deserved commendation of the Bayh-Dole Act of 1980. This act, and its 1984 amendments, were cited by The Economist in December 14, 2002, as possibly the most inspired piece of legislation to be enacted in the past half century.

The reasons are apparent if one looks at the revolutionary changes that began with Bayh-Dole. In 1980, perhaps half a dozen universities were strongly committed to commercialization of university research results. Today, it is hard to find a university that does not have a tech transfer licensing program to take advantage of this legislation.

In the 1970s, we were struggling to keep up with international competition. Bayh-Dole made research universities a major tool in our tool box as an antidote to that decline.

Initially, by keeping the intellectual property rights to the ideas they generated, universities were able to bring in revenues, share with professor inventors, as industry began to commercialize the fruits of university research. Some of the inventions in biotechnology and computer software and hardware by institutions such as the Oregon Health and Science University, the University of Oregon and Stanford University, were listed by AUTM, the Association of University Technology Managers, in the top 100 inventions that changed American life.

As success has mounted and more and more university professors thought about the commercial implications of their work, new opportunities opened

up for professors. This led to university research centers, research parks and technology transfer offices, adding many more services as professors began startup companies. Bayh-Dole is a major reason why both research universities and small high-tech companies with university roots are such major drivers of today's American economy.

None of this would have been possible without the cooperation of the Committee on the Judiciary and its Courts Subcommittee and the Committee on Science and its Technology Subcommittee, where I am proud to serve as subcommittee ranking Democratic member.

It is fitting that Chairman Sensenbrenner, who was on both committees at the time of the 1984 amendments, and who went on to serve as chairman of both full committees, has chosen to bring this commemoration forward in a bipartisan manner that involves both committees.

I thank both gentlemen. I thank him for his continued leadership, and I look forward to working with him, not only to commend Bayh-Dole today, but perhaps also to update and improve in the coming years after a successful quarter century run.

Mr. Speaker, I am pleased to yield myself as much time as I may consume.

Mr. Speaker, I rise in support of the legislation consisting of these intellectual property bills that have been very fully and accurately described by our Chairman Sensenbrenner.

I rise in support of this legislation, which consists of three intellectual property bllls.

vessel hull protection

First, the bill amends the Vessel Hull Design Protection Act by requiring courts to examine the copyright protected components of a vessel--the hull as well as the deck--separately when determining whether a third party has infringed a design. This change responds to a 5th Circuit case that would render the statute meaningless, thereby encouraging knock-off artists to sell boats with inferior designed hulls to consumers.

Bayh-Dole Resolution

Section 201 of the package consists of H. Con. Res. 319, a resolution that commemorates the Bayh-Dole Act on its 25th anniversary. The Bayh- Dole Act, named after Sen. Birch Bayh (D-IN) and Sen. Bob Dole (R-KS), is the law that enables inventors to retain their property interests in patented products that are subsidized by federal funding. It is fitting that we again have senators named Bayh and Dole in the Senate. The Committee reported this bill favorably in April.

Patent Term Extension Applications

Section 202 consists of the text of H.R. 5120. It permits the Director of the Patent and Trademark Office to accept late-filed requests for patent term extension. The applicant must prove that the delay in filing was unintentional. In addition, the Director retains the discretion to grant an extension and is not required to issue one.

I urge my colleagues to vote ``yes'' on this legislation.

Mr. Speaker, I am now pleased to recognize the gentleman from Oregon (Mr. Wu), from the Science Committee, for as much time as he may consume.

Mr. Speaker, I yield back the balance of my time.