question: how can companies like Walgreens and CVS make generic medication without being sued?
comment: They don't make the generic products, they just have their name on the box. Somebody else makes the generic medication because the patents have generally been expired for many years.
passages: Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud driven by off-label promotion, and inadequate manufacturing practices. With respect to off-label promotion, specifically, a federal court recognized that bills submitted to Medicare or Medicaid driven by off-label promotion as a violation of the False Claims Act for the first time in Franklin v. Parke-Davis, leading to a $430 million settlement. The civil portion of this settlement was $190 million, and it is the last settlement included in the below table. 
  
  Section::::See also.
  
  BULLET::::- Pharmaceutical fraud
   When faced with patent litigation from the drug innovator or patent holder, generic companies will often counter-sue, challenging the validity of the patent. Like any litigation between private parties, the innovator and generic companies may choose to settle the litigation. Some of these settlement agreements have been struck down by courts when they took the form of reverse payment patent settlement agreements, in which the generic company basically accepts a payment to drop the litigation, delaying the introduction of the generic product and frustrating the purpose of the Hatch–Waxman Act.
   Large pharmaceutical companies often spend millions protecting their patents from generic competition. Apart from litigation, they may reformulate a drug or license a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as authorized generics.
   DrugLogic, Inc. is granted or is in the process of applying for the following patents with the United States Patent and Trademark Office:
  
  BULLET::::- 6,778,994 Pharmacovigilance database
  
  BULLET::::- 6,789,091 Method and system for web-based analysis of drug adverse effects
  
  BULLET::::- 7,461,006 Method and system for the analysis and association of patient-specific and population-based genomic data with drug safety adverse event data
  
  BULLET::::- 7,542,961 Method and system for analyzing drug adverse effects
  
  BULLET::::- 7,925,612 Method for graphically depicting drug adverse effect risks
  
  BULLET::::- 8,694,555 Processing drug data
  
  BULLET::::- Method and system for drug utilization review
   Two women, each claiming to have suffered severe medical complications from a generic version of metoclopramide, lost their Supreme Court appeal on June 23, 2011. In a 5–4 ruling in "PLIVA, Inc. v. Mensing", the court held that generic companies cannot be held liable for information, or the lack of information, on the originator's label.
  
  Section::::Regulation.:India.
   There is now a similar case wherein a company was given extension under S.156 and the generic entrant arguing against such extension between Merck and Hi-tech for a drug called "dorzolamide" (TRUSOPT/COSOPT). Here too, the first company (Merck) had filed a standard form terminal disclaimer. This patent was later given an extension and became the crux of the litigation.
  
  Section::::Adjustments possible under current law.:FDA approval extension.
   While patent laws are written to apply to all inventions, whether mechanical, pharmaceutical, or electronic, the interpretations of patent law made by government patent granting agencies (the United States Patent and Trademark Office, for example) and courts, can be very subject-matter specific with significant impact on the incentives for drug development and the availability of lower-priced generic drugs. For example, a recent decision by the United States Court of Appeals for the Federal Circuit in Pfizer v. Apotex, 480 F.3d 1348 (Fed.Cir.2007), held invalid a patent on the “pharmaceutical salt” formulation of a previously patented active ingredient. If that decision is not overturned by the United States Supreme Court, generic versions of the drug in controversy, Norvasc (amlodipine besylate) will be available much earlier. If the reasoning of the Federal Circuit in the case is applied more generally to other patents on pharmaceutical formulations, it would have a significant impact in speeding generic drug availability (and, conversely, some negative impact on the incentives and funding for the research and development of new drugs).
   In most cases, generic products become available after the patent protections, afforded to a drug's original developer, expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection. However, many countries and regions, such as the European Union and the United States, may grant up to five years of additional protection ("patent term restoration") if manufacturers meet specific goals, such as conducting clinical trials for pediatric patients.
   Under the "paragraph IV route" of the Hatch-Waxman Act, a generic drug manufacturer can assure the U.S. Food and Drug Commission (FDA) that it would not infringe upon the patent of a brand-name drug by proving that the patent was invalid or that the sale of the generic drugs will not violate the brand-name's patent. This would constitute a challenge to the patent, and usually lead to litigation between the brand-name and generic manufacturers. The FDA then must withhold approving the generic drugs for a 30-month period while the courts resolve the dispute. If the dispute does not resolve within that period, the FDA could then approve the generic for the market.
   Section::::Off-label promotion settlements under the False Claims Act.:Biocompatibles Inc.: Off-label promotion of LC Bead, November 2016.
   Section::::Off-label promotion settlements under the False Claims Act.:Endo Pharmaceuticals: Off-label promotion of Lidoderm, February 2014.
   Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. However, only after rigorous study and testing, which takes 10 to 15 years on average, will governmental authorities grant permission for the company to market and sell the drug. Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market. Restructuring has therefore become routine, driven by the patent expiration of products launched during the industry's "golden era" in the 1990s and companies' failure to develop sufficient new blockbuster products to replace lost revenues.
   In the case of a medical procedure patent issued after 1996, a U.S. infringer may also raise a statutory safe harbor defense to infringement.
  
  There is safe harbor for research conducted for "purely philosophical" inquiry, but research directed to commercial purposes has no safe harbor - unless the research is directed toward obtaining approval of the Food and Drug Administration (FDA) for introduction of a generic version of a patented drug (see Research exemption and Hatch-Waxman Act).
  
  Section::::Remedies.
   India's patent law also contained a "grandfather clause" in section 11A, subsection (7), that created "a special regime for generic versions of medicines if the initial patent application was made between the 1st of January 1995 and the 31st of December 2004 and if these medicines were already on the Indian market before the 1st of January 2005... Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, the Indian law requires that the producers of those generics then pay a “reasonable royalty” to the patent holder."
   Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.
  
  Section::::External links.
  
  BULLET::::- Orange book
  
  BULLET::::- Orange book archives
   Section::::Off-label promotion settlements under the False Claims Act.:Amgen: Off-label promotion of Aranesp, Enbrel and Neulasta, December 2012.
   Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.
   BULLET::::- Invanz (Ertapenem) is an injectable antibiotic, rights to which Merck has owned since 1999. As of 2015, Merck was in a legal dispute with the Taiwanese company Savior Lifetec over their attempt to secure rights to sell a generic version of this drug in the United States.
   In an opinion handed down on August 22, 2003, District Judge Patti B. Saris agreed with David Franklin, denying Warner Lambert's summary judgment motion to dismiss the lawsuit. Judge Saris found that, if it could be proven that the off-label marketing of Neurontin caused doctors to prescribe the drug and submit prescriptions to Medicaid, then the company would indeed be liable under the False Claims Act. In addition, Judge Saris found that the submission of false Medicaid claims was a foreseeable result of Warner-Lambert's marketing scheme. The case established for the first time that drug companies could be held liable under the False Claims Act for off-label promotion of pharmaceutical products.
   Par Pharmaceutical agreed to pay $22.5 million to the federal government and various states to resolve claims arising from its off-label marketing. Par made unsubstantiated and misleading representations about the superiority of Megace ES over generic megestrol acetate for elderly patients to encourage providers to switch patients from generic megestrol acetate to Megace ES, despite having conducted no well-controlled studies to support a claim of greater efficacy for Megace ES. Except as admitted in the plea agreement, the claims settled by the civil settlement agreement are allegations only, and there has been no determination of liability as to those claims.
   The following is a list of the four largest settlements reached with pharmaceutical companies from 1991 to 2012, rank ordered by the size of the total settlement. Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud, off-label promotion, and inadequate manufacturing practices.
  
  Section::::Developing world.
  
  Section::::Developing world.:Patents.
   Section::::Off-label promotion settlements under the False Claims Act.:Wyeth Pharmaceuticals: Off-label promotion of Rapamune, July 2013.
   Section::::Consumer record.:Use of proprietary drugs.
  
  Walgreens was named in a lawsuit by the Union Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund in the Northern District Court of Illinois in January 2012. The suit alleges Walgreens and Par Pharmaceutical violated the Racketeer Influenced and Corrupt Organizations Act "at least two widespread schemes to overcharge" for generic drugs.
  
  Section::::Consumer record.:Distribution of oxycodone.
   Section::::Off-label promotion settlements under the False Claims Act.:Par Pharmaceutical: Off-label promotion of Megace ES, March 2013.
   There have been issues with litigation incentivized by the Act. Once the parties are in litigation, they can choose to fight the litigation to the end, or they may choose to settle the litigation. Some of these settlements have been found to be invalid reverse payment patent settlement agreements and have been struck down in court.
  
presuppositions: Walgreens and CVS makes generic medication. Generic medications are still under patent.
corrections: Walgreens and CVS do not make generic medication, they just have their name on the box. The patents for generic medications have expired.
raw_presuppositions: Walgreens and CVS makes generic medication. Generic medications are still under patent.
raw_corrections: Walgreens and CVS do not make generic medication, they just have their name on the box. The patents for generic medications have expired.