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.

GOP Close to Repeal of Medical Device Tax: Will Elimination of this Key Funding Also Eliminate the Affordable Care Act?

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

00011_RT8With the support of Democrats, Congressional Republicans may be close to getting the votes they want to push President Obama to accept a repeal of the medical device tax, which helps fund the Affordable Care Act. Some Republican candidates for president are pushing for change in the Senate’s filibuster rules so they can repeal the law. Click here for more info on the Medical Device Tax.

Congressional Republicans Want Repeal of Medical Device Tax to Eliminate ACA.

Congressional Republicans believe that the repeal of the tax on medical devices is the best way to weaken the Affordable Care Act. The House already voted to repeal the tax. The Senate Republicans are now also trying to undo the tax. With many Democrats also opposing the tax, lawmakers think they are getting closer to the ideal number of votes needed to override a presidential veto.

Obama Able to Veto GOP’s Changes.

With last year’s Supreme Court approval of the statute’s federal subsidies, millions of Americans have been able to afford health care for the first time. However, this seemed to crush the GOP’s plan to force President Obama’s health law out. House Republicans see a repeal of the medical devices tax as a roundabout way of repealing the ACA.

Click here to see what Hillary Clinton recently said about the GOP’s mission to repeal Obamacare.

New Fissures Being Made for 2016 Presidential Primary.

The Senate is creating new fissures for the 2016 election: Candidates outside of Washington are trying to terminate the filibuster to repeal the Affordable Care Act. Meanwhile, GOP senators are pursuing the White House, wanting to keep the 60-vote threshold.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

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

Comments?

Are you a Democrat who opposes the Affordable Care Act? What do you think of the GOP’s plan to weaken the ACA? Please leave any thoughtful comments below.

Sources:

Associated Press. “Clinton warns GOP will repeal Obamacare: Democratic candidate speaks in Hanover.” (July 4, 2015). From: http://www.wmur.com/politics/clinton-warns-gop-will-repeal-obamacare/33986414

Kaiser Health News. “GOP Eyes Medical Device Tax, Change To Filibuster Rules To Fight Health Law.” (July 1, 2015). From: http://khn.org/morning-breakout/gop-eyes-medical-device-tax-change-to-filibuster-rules-to-fight-health-law/

ObamaCare Facts. “ObamaCare Medical Device Tax.” From: http://obamacarefacts.com/obamacare-medical-device-tax/

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:
GOP, Congressional Republicans, Republicans, Affordable Care Act, ACA, medical device tax, attorney, health law lawyer, health law attorney, Senate, filibuster rules, tax repeal, Supreme Court, health care, health care lawyer, health care attorney, the health law, health law vote

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.

By |2015-07-10T17:29:50-04:00June 1st, 2018|Categories: In the News, The Health Law Firm Blog|Tags: , , |0 Comments

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.

Workers Can Be Fired For Using Marijuana Off-Duty

By Carole C. Schriefer, R.N., J.D., The Health Law Firm

Marijuana may be legal in Colorado, but you can still be fired for using it. Employers’ zero- tolerance drug policies trump Colorado’s medical marijuana laws, the Colorado Supreme Court ruled on Monday. In a 6-0 decision, the Supreme Court ruled that businesses can terminate an employee for the use of medical marijuana – even if it’s off-duty.

Coats v. Dish Network.

Brandon Coats became a quadriplegic after a car accident and has relied on medical marijuana to help with muscle spasms. Dish Network fired Coats after a failed drug test in 2010.  “As a national employer, Dish remains committed to a drug-free workplace and compliance with federal law,” company spokesman John Hall said in a statement.  To read about the Coats v. Dish Network case in its entirety, click here.

What is Lawful Activity?

This case was brought based on Colorado Revised Statute 24-34-402.5, Colorado’s “lawful activities statute.” The Supreme Court held the term “lawful” in the statute refers only to those activities that are lawful under both state and federal law. Therefore, employees who engage in an activity such as medical marijuana use that is permitted by state law but unlawful under federal law, are not protected by this statute.  Like Texas, Colorado law allows employers to set their own policies on drug use.  Unlike Texas, Colorado has a law that says employees can’t be fired for “lawful” off-duty activities.
To read C.R.S. § 24-34-402.5. – Unlawful prohibition of legal activities as a condition of employment, click here.

Legal Off-Duty Activity.

Coats claims that Dish Network violated C.R.S. § 24-34-402.5, by terminating him due to his state licensed use of medical marijuana at home during non-working hours. The Colorado justices ruled that because marijuana is illegal under federal law, Coat’s use of the drug couldn’t be considered legal off-duty activity.  State laws only govern the citizens within a particular state, but federal laws apply to all U.S. citizens. Therefore, federal laws trump state laws.

To read past blogs on this topic or any health law topic, visit our blog pages on our website : www.TheHealthLawFirm.com.

Visit our Colorado Health Law blog.

Comments?

Do you think medical marijuana is considered a “lawful” activity? Do you agree with Dish Network’s decision? Do you think Coats v. Dish Network was a fair case, why or why not? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys for Medical Marijuana Concerns.

The Health Law Firm attorneys can assist health care providers and facilities, such as doctors, pharmacists and pharmacies, wanting to participate in the medical marijuana industry. We can properly draft and complete the applications for registration, permitting and/or licensing, while complying with Florida law. We can also represent doctors, pharmacies and pharmacists facing proceedings brought by state regulators or agencies.

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

Sources:

Linsley, Brennon. “Colorado court: Workers can be fired for using pot off-duty.” The News Herald. (June 15, 2015) From:

http://www.morganton.com/colorado-court-workers-can-be-fired-for-using-pot-off/article_f4f67447-5d36-5e6e-9a67-8548d5fc77a4.html

“24-34-402.5. Unlawful Prohibition of Legal Activities as a Condition of Employment.” Department of Regulatory Agencies. (June 15, 2015) From:

http://www.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1=Content-Disposition&blobheadername2=Content-Type&blobheadervalue1=inline%3B+filename%3D%22Colorado+Anti-Discrimination+Act+statutes+-+unofficial.pdf%22&blobheadervalue2=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1251818317123&ssbinary=true

Coats v. Dish Network, LLC., CO 44. No. 13SC394. U.S. (2015)

About the Author: Carole C. Schriefer is an 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. The Health Law Firm also has offices in Fort Collins, Colorado and Pensacola, Florida.

KeyWords:  Employment Law, medical marijuana, medical cannabis, marijuana license, defense attorney, drug-free work place, Drug-Free Work Place Act, employee rights, employer rights, employment law, employment termination, Colorado marijuana laws, health care lawyer, health lawyer, law attorney, legalizing marijuana, licensed medical marijuana user, marijuana, medical marijuana license, medical marijuana policy, physician attorney, physician lawyer, workplace marijuana regulations, lawful activity, lawful off-duty activity, federal law, state law, Supreme Court, zero tolerance, zero tolerance drug policy, THC, compliance, Recreational drug laws and regulations, Government regulations, Courts, Colorado, health care, health issues, health law, health law attorney, health law lawyer

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

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