William L. Jenkins

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 would like to recognize the outstanding humanitarian service and contribution made by Rotarian William T. (``Bill'') Sergeant on the occasion of his retirement from his position as Chairman of the International PolioPlus Committee of The Rotary Foundation of Rotary International--a committee that develops Rotary's policies and strategies to achieve polio eradication. Since the inception of Rotary's International PolioPlus Committee in 1994, Bill Sergeant, a retired Colonel, has served tirelessly as the General leading the efforts of Rotary's army of 1.2 million volunteers in the war against polio.

A member of the Rotary club of Oak Ridge, Tennessee for more than 50 years, Bill Sergeant held many leadership positions in Rotary, including Rotary International Vice-president, Director, and Foundation Trustee, before assuming leadership of PolioPlus, Rotary's flagship program. Bill Sergeant has traveled to countries on 6 continents to participate in polio eradication activities, represented Rotary International at strategic meetings, and promoted the cause of global polio eradication and ensured its prominence among the Rotary world as Rotary's highest priority.

Through his integrity, acumen and keen observation, Bill Sergeant quickly earned the respect of peers in the other three spearheading organizations: the World Health Organization, UNICEF, and the U.S. Centers for Disease Control and Prevention; thereby strengthening the efficacy of this unique public/private collaborative effort for the ultimate benefit of the children of the world. Under Bill Sergeant's leadership, Rotary established criteria for the strategic use of PolioPlus grant funds, launched the PolioPlus Partners program to provide supplemental support for critical polio eradication activities, and established international advocacy to ensure sufficient political and financial public sector support for global polio eradication efforts.

During his tenure as Chairman of Rotary's International PolioPlus Committee, three regions of the world have been certified polio-free and only four countries remain with endemic transmission of polio. Bill Sergeant has demonstrated, through his exemplary, single-minded dedication to the goal of a polio-free world, that one man can make the world a better place through commitment, determination, and a great deal of heart.

Mr. Speaker, I ask you and our fellow representatives to join me in recognizing Bill Sergeant for his outstanding leadership and service in support of the goal of a polio-free world--a goal which the United States Government shares.

Mr. Speaker, I was not present to cast my votes on rollcall votes 34 through 38 earlier today, March 9, 2006. Had I been present, I would have voted ``aye'' on the Chabot amendment--rollcall 34, ``aye'' on the Hooley amendment--rollcall 35, ``no'' on the Paul amendment--rollcall 36, ``aye'' on the Rehberg amendment--rollcall 37, and ``aye'' on final passage of H.R. 2829--rollcall 38.