Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

–  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

–  “One who makes such a payment may be unable to explain and to justify it.”

–  “Such a firm or individual may well possess market power derived from the patent.”

–  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

–  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Federal Health Officials Propose Medicare Paying Doctors to Discuss End-of-Life Issues

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Centers for Medicare and Medicaid Services (CMS) released a new plan for doctors to discuss end-of-life issues with their patients. The plan is part of the CMS annual Medicare physician payment rule. This comes six years after the original controversy when President Obama first announced his health care legislation.

Doctors Will Be Paid for Discussing Treatment Options with Elderly Patients.

In what can only be described as welcomed and needed relief, the rule would reimburse doctors for discussing living wills and end-of-life medical treatment options with older patients. The medical discussions include long-term treatment options, like heart transplants. It also handles advance care planning, including a patient who desires treatment for a condition that affects his or her decision-making. These are conversations already taking place, but physicians are not currently paid for them.

The Pressure is on Medicare.

Medicare reimbursement is extremely important for elderly and disabled persons. As the second-largest insurer, many private insurers also follow the same rules Medicare adopts. Their place in the end-of-life care has long been debated. Whether or not health care professionals should be reimbursed for hospice and end-of-life treatment talks has been the center of debate. Physician groups and patient advocates have been pushing the health program to pay doctors for these consultations.

Many advocacy groups, including the American Medical Association (AMA), support the proposal. The AMA believes it’s the patient’s choice to plan advance-care decisions. Research has shown that there are great benefits to elders in advance-care planning and having their end-of-life wishes known to others. Receiving timely knowledge from physicians and health professionals can result in better decisions and ease of mind.

Rules Previously Criticized as “Death Panels” by Ignoramuses.

Sarah Palin, the towering mountain of medical knowledge and intellectual analysis, who dragged down John McCain into defeat during the elections of 2008, previously denounced similar payment provisions in the past. Sparking a great deal of unnecessary controversy, Palin claimed the health care reform legislation would create “death panels.” As a result of these and other similar accusations, the provision was removed from the final Affordable Care Act legislation. This deprived elders of useful knowledge and deprived health care providers of payment for their services. To read more about the “death panel” controversy, click here.

Comments?

What do you think of end-of-life discussions? Do you think they should be in place? Should physicians be reimbursed?  Please leave any thoughtful comments below.

Sources:

Grier, Peter. “ ‘Death Panel’ Controversy Very Much Alive.” The Christian Science Monitor. (Aug. 21, 2009). From: http://www.csmonitor.com/USA/Politics/2009/0821/death-panel-controversy-remains-very-much-alive

Sun, Lena H. “Medicare Proposes to Pay Doctors to Have End-of-Life Care Discussions.” The Washington Post. (July 8, 2015). From:
http://www.washingtonpost.com/national/health-science/medicare-proposes-to-pay-doctors-to-have-end-of-life-care-discussions/2015/07/08/1d7bb436-25a7-11e5-aae2-6c4f59b050aa_story.html

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


About the author:
George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Medicare, federal health, health law, health law attorney, health law lawyer, end-of-life issues, The Centers for Medicare and Medicaid Services (CMS), CMS, Medicaid, healthcare, health care, health care attorney, health care lawyer, physicians, physician attorney, health care legislation, Affordable Care Act, ACA, medicine, the health law firm, death panel, death panel controversy, Medicare investigations, Medicaid investigations, elderly healthcare, senior health care, American Medical Association

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law firm. All rights reserved.

Nurses Fight for Lawmakers to Relax Laws Requiring Doctors to Oversee Their Work

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

There’s a controversial tug-of-war in the health care industry. According to The Washington Post, in 11 states nursing groups are pushing legislation that would permit nurses with master’s degrees or higher to order and interpret diagnostic tests, prescribe medications and administer treatments without the supervision of a physician. Similar legislation is likely to be introduced in three other states. Currently, each state decides how much supervision nurses must receive from physicians.

This legislation faces strong opposition from physicians, led by the American Medical Association (AMA). This is according to an article in The Washington Post, published on March 24, 2013. Click here to read that article.

The Fight for Autonomy.

According to The Washington Post, the American Association of Nurse Practitioners (AANP) and other nursing groups are coordinating this legislation effort. These groups are receiving support from consumer advocates and state officials concerned about the possible doctor shortage.

Physicians’ groups are arguing that with little or no supervision, patient care will be compromised, according to a Bloomberg News article. The physicians’ strongest argument is the difference in education between them and advanced practice nurses (APNs). To read the Bloomberg News article, click here.

Difference in Education.

Advanced practice nurses obtain a bachelor’s degree in nursing, then spend between two and three years studying for a master’s degree. A master’s program includes extensive clinical training in addition to class work. One additional year of school is needed to get a Doctor of Nursing Practice (D.N.P.) degree.

Physicians obtain a bachelor’s degree, then continue on with four years of medical school. This is followed by at least three years in a residency program.

Laws for Nurse Supervision Differ State-by-State.

Each state regulates how much oversight nurse practitioners must have. According to Bloomberg News, in 16 states, including Colorado, New Hampshire, New Mexico and Washington, nurses can evaluate and diagnose patients, order diagnostic tests and prescribe drugs. Nurses in these states can start a practice or work in a clinic with no physician present.

Florida and Alabama nurses can’t prescribe controlled substances, including medications for pain, insomnia and attention deficit disorder and must have a supervisory agreement in place with a physician supervisor. Their practice is limited by what the physician places in the agreement.

Court Cases of Nurses vs. Doctors.

According to Bloomberg News, physicians in Iowa sued the state in 2010, after it allowed nurses with advanced training to perform a fluoroscopy, which is a radiographic procedure that takes pictures inside the body. The physicians do not believe nurses have the proper training to carry out this procedure. The case is before the Iowa Supreme Court after a lower court sided with the physicians.

Physicians sued the state of Colorado when the governor allowed nurse anesthetists to work without supervision. An appeals court sided with the nurses in 2012. There is a discussion of this case on our blog. Click here to read it.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, nurses, nurse practitioners, pharmacists, pharmacies and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you think nurses with advanced degrees should be allowed to practice without the supervision of physicians? Do you think it is necessary for patient care for physicians to be present? Please leave any thoughtful comments below.

Sources:

Pettypiece, Shannon. “Nurse Practitioners, Doctors in Tug-of-War Over Patients.” Bloomberg Business Week. (March 7, 2013). From: http://www.businessweek.com/printer/articles/100802-nurse-practitioners-doctors-in-tug-of-war-over-patients

Aizenman, N.C. “Nurses Can Practice Without Physician Supervision in Many States.” The Washington Post. (March 24, 2013). From: http://www.washingtonpost.com/national/health-science/nurses-can-practice-without-physician-supervision-in-many-states/2013/03/24/98b241cc-8745-11e2-999e-5f8e0410cb9d_story.html

About the Authors: Carole C. Schriefer is a nurse-attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal

7 Indest-2008-4By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court’s decision may be worth billions to pharmaceutical companies and consumers.

In January 2013, the American Medical Association (AMA) teamed up with the American Association of Retired Persons (AARP) and other organizations seeking to eliminate pay-for-delay agreements. The groups filed a friend-of-the-court brief in the Supreme Court case.

Click here to read the friend-of-the-court brief.

History of Pay-For-Delay Agreements.

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

The Impact of Pay-For-Delay Agreements.

It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs.

According to an article on National Public Radio (NPR), the number of pay-for-delay agreements is increasing. Click here to read the entire NPR article.

Legalized Extortion Causes Patients to Pay High Drug Prices.

This type of legalized extortion does nothing more than drive up drug prices for all patients by keeping generic drugs off the market. On the other hand, it vastly increases the profits made by big name pharmacy companies who are able to derive even more money from expired patents.

AMA Fights to Get Rid of Pay-for-Delay Agreements.

According to a press release, AMA, AARP, the National Legislative Association for Prescription Drug Prices and the U.S. Public Interest Research Groups all signed onto the friend-of-the-court brief filed in the Supreme Court.

The AMA is concerned that pay-for-delay agreements extend patent monopolies, increase health care costs and restrict doctors’ ability to treat patients. To read the entire press release from the AMA, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care professional, how do you feel about pay-for-delay agreements? Please leave any thoughtful comments below.

Sources:

Mills, Robert. “AMA Joins Other Groups Seeking to Overturn Pay-for-Delay Drug Agreement.” American Medical Association. (January 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013-01-30-amicus-brief-ftc-vs-watson-pharmaceuticals.page

Federal Trade Commission v. Watson Pharmaceuticals, Inc. Case Number 12-416. Brief for AARP, American Medical Association, National Legislative Association for Prescription Drug Prices and U.S. Public Interest Research Groups as Amici Curiae in Support of Petitioner. January 29, 2013. From: http://www.thehealthlawfirm.com/uploads/2013-01-29-amicus-brief-ftc-vs-watson-pharmaceuticals.pdf

Purvis, Leigh. “Pay-for-Delay Agreements and Prescription Drug Costs.” AARP. (May 13, 2013.) From: http://blog.aarp.org/2013/05/13/pay-for-delay-agreements-and-prescription-drug-costs/

Totenberg, Nina. “Supreme Court Hears ‘Pay to Delay’ Pharmaceutical Case.” National Public Radio. (March 25, 2013). From: http://www.npr.org/2013/03/25/175043758/supreme-court-hears-pay-to-delay-pharmaceutical-case

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Go to Top