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Evergreening is any of various legal, business, and technological strategies by which producers (often pharmaceutical companies) extend the lifetime of their
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
s that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents (for example over associated delivery systems or new pharmaceutical mixtures), or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law.
Robin Feldman Robin Feldman is a law professor, researcher, and author best known for her contributions to intellectual property and health care law. Feldman is the Arthur J. Goldberg Distinguished Professor of Law at the University of California, Hastings C ...
, a law professor at
UC Hastings The University of California, Hastings College of the Law (UC Hastings) is a public law school in San Francisco, California. Founded in 1878 by Serranus Clinton Hastings, UC Hastings was the first law school of the University of California as ...
and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."


Overview

Evergreening is not a formal concept of patent law; it is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their high-earning
intellectual property rights Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...
, particularly over highly profitable (either in total sales volume or price per unit) "blockbuster" drugs. Thus, while the courts are an instrument frequently used by
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
brand name manufacturers to prolong their patent royalties, evergreening is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient.
Robin Feldman Robin Feldman is a law professor, researcher, and author best known for her contributions to intellectual property and health care law. Feldman is the Arthur J. Goldberg Distinguished Professor of Law at the University of California, Hastings C ...
has documented several types of patent tactics commonly used in the U.S. by pharmaceutical companies, including evergreening, pay-for-delay, gaming the citizen petition process, and the misuse of trade secrets, among others. In one study of the prescription drug market, Feldman found that 78% of new patents associated with prescription drugs were for existing drugs.


Controversy

The evergreening process has caused some controversy in the
pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...
. In this context, evergreening may be used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents to that drug. In 2002, an extensive and lengthy inquiry by the US
Federal Trade Commission The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction ov ...
(FTC) found, in the wake of the Hatch-Waxman legislation or
Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and e ...
(which was instrumental in establishing the US generic pharmaceuticals industry), as many as 75% of new drug applications by generic drug manufacturers had been contested with legal actions under patent laws by the original brand name patent owner. These were driving up US drug costs by keeping the cheaper generic versions off the market. The FTC recommended only one evergreening injunction against a potential generic market entrant be permitted per product, and an expedited process of resolving such claims.


Linkage evergreening and international trade law

The process of evergreening may involve specific aspects of
patent law A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
and
international trade law International trade law includes the appropriate rules and customs for handling trade between countries. However, it is also used in legal writings as trade between private sectors. This branch of law is now an independent field of study as mo ...
. Linkage evergreening is the process whereby pharmaceutical safety, quality and efficacy regulators are required to 'link' their normal evaluation with an assessment of whether an impending generic product may infringe an existing patent.


By country


Australia

A requirement for the AUSFTA to come into force was fulfilment of the article 17.10.4 linkage obligation; done by amendments to the ''Therapeutic Goods Act 1989 (Cth).'' The amendments inserted a new section 26B which required applicants for marketing approval to certify their product would not infringe a valid patent claim, or that the patent holder had been notified of the application. In response, the Australian government passed anti-evergreening amendments in Sections 26C and 26D of the Therapeutic Goods Act 1989 (Cth) designed to prevent patent holders from manipulating the court system to lengthen the term of the patent and delay the entry of generic pharmaceuticals into the market. They are a strong statement of Australia's legitimate expectations of benefit (that is of freedom from pharmaceutical price rises due to evergreening) in this area. The Chief Australian negotiator of this aspect of the AUSFTA stated: In November 2004, the US expressly signalled their disapproval of Australia's implementation of article 17.10.4 in an exchange of letters between the Australian Minister for Trade and the
US Trade Representative The Office of the United States Trade Representative (USTR) is an agency of the Federal government of the United States, United States federal government responsible for developing and promoting Trade policy of the United States, American trade ...
on the implementation of the AUSFTA, in which the USTR stated: The capacity of the US to make such threats is arguably facilitated by the linkage of article 17.10.4 of the AUSFTA to a
non-violation nullification of benefits Non-violation nullification of benefits (NVNB) claims are a species of dispute settlement in the World Trade Organization arising under World Trade Organization multilateral and bilateral trade agreements. NVNB claims are controversial in that the ...
provision.


Canada

In 1993, under the NAFTA-induced Canadian Notice Of Compliance (NOC) regulations, drug safety, quality and efficacy regulators at
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
were prevented from issuing an authorization for market entry, until all of the relevant patents on a brand name product had been proven to have expired. As a result, when a Canadian generic company (such as
Apotex Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding . By 2016, Apotex employed over 10,000 people as one of Canada's ...
) submits its application to get a product approved, it also sends a Notice of Allegation (NOA) to the patent holder claiming that no patents are being infringed. The patent holder then has 45 days in which to initiate an application in the
Federal Court of Canada The Federal Court of Canada, which succeeded the Exchequer Court of Canada in 1971, was a national court of Canada that had limited jurisdiction to hear certain types of disputes arising under the federal government's legislative jurisdiction. ...
, seeking an order to prohibit the relevant Minister from issuing a Notice of Compliance to the generic manufacturer for a period of 24 months, or upon resolution of the court application, whichever is sooner. The problems with this were analysed in the
Royal Commission on the Future of Health Care in Canada The Royal Commission on the Future of Health Care in Canada, also known as the Romanow Report, is a committee study led by Roy Romanow on the future of health care in Canada. It was delivered in November 2002. Romanow recommended sweeping changes ...
or
Romanow Report The Royal Commission on the Future of Health Care in Canada, also known as the Romanow Report, is a committee study led by Roy Romanow on the future of Medicare (Canada), health care in Canada. It was delivered in November 2002. Romanow recommend ...
. In 2006, the Supreme Court of Canada ruled against an instance of drug patent evergreening, two days before the Food and Drug Regulations extended data protection on brand-name drugs from 5 to 8.5 years.


India

Indian patent Act was amended in 2005 under obligations to TRIPS. Novartis v. Union of India & Others is a
landmark decision Landmark court decisions, in present-day common law legal systems, establish precedents that determine a significant new legal principle or concept, or otherwise substantially affect the interpretation of existing law. "Leading case" is commonly u ...
, in which
Indian Supreme Court The Supreme Court of India ( IAST: ) is the supreme judicial authority of India and is the highest court of the Republic of India under the constitution. It is the most senior constitutional court, has the final decision in all legal matters ...
upheld rejection of Novartis patent by Indian patent office. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."


South Korea

The US has achieved a similar provision to article 17.10.4 of the AUSFTA in article 18.9.4 of the
Republic of Korea-United States Free Trade Agreement A republic () is a "state in which power rests with the people or their representatives; specifically a state without a monarchy" and also a "government, or system of government, of such a state." Previously, especially in the 17th and 18th c ...
(KORUSFTA). Such provisions are sometimes referred to as TRIPS-plus meaning that they are in addition to the patent requirements of the
World Trade Organization The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and e ...
multilateral
Agreement on Trade-Related Aspects of Intellectual Property Rights The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by nat ...
agreement. Some academics prefer to refer to them as TRIPS-minus due to their potential, but controversial and still largely unproven, deleterious impact on public health.


United States

Various laws have provisions to limit the practice, but as of 2018 the issue remains a concern among legislators. According to one study, 12 top-selling drugs attempted an average 38 years of patent protection, above the granted 20 years. Another study found that nearly 80% of the top 100 drugs extended the duration of patent protection with a new patent. Issues which prevent generics from reaching the market include: * lack of availability of samples to do testing; the
CREATES Act The CREATES Act of 2019 is a U.S. federal law which includes measures intended to reduce prices and increase the competitiveness of generic pharmaceutical drugs. Originally standalone legislation sponsored by Patrick Leahy in the Senate and David ...
is a bill, intended to address issues in getting samples, was passed on December 20, 2019 * Risk Evaluation and Mitigation System ( REMS) requirements *reverse payment settlements, which involve payment to delay; these are required to be reported to the FTC for generics since 2004 and biosimilars since 2018 *“Citizen petitions”: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act allow the Food and Drug Administration to delay action on a pending generic drug application. By law, the FDA is required to prioritize these petitions. However, the citizens filing concerns are not individuals, they’re corporations. The FDA recently said branded drug manufacturers submitted 92% of all citizen petitions. Many of these petitions are filed near the date of patent expiration, effectively limiting potential competition for another 150 days. *“Authorized generics": an authorized generic is exactly the same as the brand name drug, but marketed without the brand name on the label. By law, the first generic company to market a drug gets an exclusivity period of 180 days. During this time, no other companies can market a generic product. But the company with the expiring patent is not barred from launching an “authorized generic.” By selling a drug they are already making under a different name, pharmaceutical firms are effectively extending their monopoly for another six months.


Regulation

The main arguments in favor of governments regulating against evergreening are that rapid entry of multiple generic competitors after
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
expiry is likely to lower prices and facilitate competition, and that eventual loss of monopoly was part of the trade-off for the initial award of patent (or intellectual monopoly privilege) protection in the first place. In
Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...
, the Office of Patented Medicines and Liaison under
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
has become an important regulatory mechanism for policing "linkage" evergreening. No attempt has been made to create a similar multidisciplinary regulatory agency in Australia. Yet, it appears that article 18.9.4 of the
Republic of Korea-United States Free Trade Agreement A republic () is a "state in which power rests with the people or their representatives; specifically a state without a monarchy" and also a "government, or system of government, of such a state." Previously, especially in the 17th and 18th c ...
(KORUSFTA) has been specifically drafted to permit the establishment of such a pharmaceutical patent "anti-evergreening" oversight agency. The Office of Patented Medicines and Liaison is located in the Therapeutic Products Directorate, Health Products and Foods Branch,
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
. The Notice of Compliance Regulations it administers require the Minister of Health to maintain a Patent Register. This consists of patent lists submitted in respect of eligible NOC-issued drugs. The Minister responsible for Health Canada may refuse to add, or may delete, information from this Patent Register. Each patent list is audited (for example as to whether potential inclusions are mere 'evergreening' attempts) by the Office of Patented Medicines and Liaison. Reports produced by that body outline statistics relating to the maintenance of the Patent Register, including the number of patents filed, the number of patents accepted and rejected, and litigation resulting from the acceptance or rejection of patents for listing on the Patent Register. In October 2006, the Canadian federal government recognized that some brand-name companies had been abusing the NOC Regulations. It limited their use of 'evergreening' follow-on patents by promulgating regulations that prevented any new patents they filed after a generic company had submitted an application for approval of its product from being considered in the NOC Regulations process. Moreover, the new regulations made it clear that patents covering areas without direct therapeutic application, such as processes or intermediates, could not be used to delay generic approval. In
Australia Australia, officially the Commonwealth of Australia, is a Sovereign state, sovereign country comprising the mainland of the Australia (continent), Australian continent, the island of Tasmania, and numerous List of islands of Australia, sma ...
, anti-evergreening amendments to the ''Therapeutic Goods Act 1983 (Cth)''were part of the package of legislation required to be passed by the Australian Government as a precondition to entry into force of the Australia-United States Free Trade Agreement (AUSFTA). They provide that where a certificate has been given under s26B by a generic manufacturer and the patent holder wishes to claim a
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
and institute infringement proceedings, he or she must first certify that the proceedings are being commenced in good faith, have reasonable prospects of success (as defined in s26C(4)) and will be conducted without unreasonable delay. If the certificate is found to be false or misleading, fines of up to $10 million apply and the Cth Attorney General is permitted to join the action to recoup losses to the PBS. Section 26D provides that a patent holder who seeks an
interlocutory Interlocutory is a legal term which can refer to an order, sentence, decree, or judgment, given in an intermediate stage between the commencement and conclusion of a cause of action, used to provide a temporary or provisional decision on an iss ...
injunction An injunction is a legal and equitable remedy in the form of a special court order that compels a party to do or refrain from specific acts. ("The court of appeals ... has exclusive jurisdiction to enjoin, set aside, suspend (in whole or in pa ...
to prevent the marketing of the generic pharmaceutical must obtain leave from the government to do so.


TRIPS

Both the International Federation of Pharmaceutical Manufacturing Associations (
IFPMA The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is a trade association that represents leading innovative pharmaceutical companies at the international level and in official relations with the United Nations. I ...
) and the US
PhRMA Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ...
have stated that the Australian anti-evergreening provisions are inconsistent with obligations under the
World Trade Organization The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and e ...
Agreement on Trade-Related Aspects of Intellectual Property Rights The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by nat ...
TRIPS article 27 which prohibits discrimination in an area of technology (in this case pharmaceuticals). The argument is that the Australian anti-"linkage evergreening" legislation affects only pharmaceutical patents and is therefore discriminatory under TRIPS. On the other hand,
international trade law International trade law includes the appropriate rules and customs for handling trade between countries. However, it is also used in legal writings as trade between private sectors. This branch of law is now an independent field of study as mo ...
recognises that where a unique problem arises specifically referable only to a particular field of technology, a solution applying ''sui generis'' only to that field of technology cannot be said to be discriminatory according to the ordinary meaning and purpose of the TRIPS agreement or the AUSFTA as required by article AUSFTA 21.9.2 (incorporating articles 31 and 32 of the ''Vienna Convention on the Law of Treaties'' (VCLT). The decision of the
World Trade Organization The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and e ...
Dispute Resolution panel in ''Canada – Patent Protection of Pharmaceutical Products case'', for example, accepted that it was not inconsistent with TRIPS to provide for distinct patent rules that responded to practical consequences of differences between fields of technology. Almost all nations including the United States now have anti-evergreening legislation as part of their public health policy and none of this legislation (which is clearly targeted at a problem particular to the pharmaceutical industry) has been argued to be contrary to TRIPS. Further, there are a number of obligations imposed by the AUSFTA that relate to the enjoyment of patent rights for pharmaceuticals alone, including extension of the terms of a pharmaceutical patent to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process(17.9.8(b)). This is clearly not discriminatory because the issue of delays in enjoyment of patent rights due to the marketing approval process arises only in the context of pharmaceutical patents.


Future

In terms of future evergreening strategies, patent holders may: # seek to make incremental patentable innovations to existing products with soon-to-expire patents through the generic arm of their own company and launch early to secure market share (supragenerics), # attempt to make separately patentable
nanotechnology Nanotechnology, also shortened to nanotech, is the use of matter on an atomic, molecular, and supramolecular scale for industrial purposes. The earliest, widespread description of nanotechnology referred to the particular technological goal o ...
or biologic versions of such pharmaceuticals through the generic arm of their own company and launch early to secure market share, # seek to exclude generic companies from the safety, quality and efficacy data they need to prepare for springboarding (early market launch after patent expiry) using TRIPs-plus data exclusivity protections and # seek to extend exclusivity on a soon-to-patent-expire-pharmaceutical by patenting a genetic test to establish potential toxicity or efficacy (
pharmacogenomics Pharmacogenomics is the study of the role of the genome in drug response. Its name ('' pharmaco-'' + ''genomics'') reflects its combining of pharmacology and genomics. Pharmacogenomics analyzes how the genetic makeup of an individual affects the ...
).


See also

* Chemical patent *
Patent cliff The term patent cliff refers to the phenomenon of patent expiration dates and an abrupt drop in sales that follows for a group of products capturing a high percentage of a market. Usually, these phenomena are noticed when they affect ''blockbuster p ...
*
Reverse payment patent settlement Reverse payment patent settlements, also known as "pay-for-delay" agreements, are a type of agreement that has been used to settle pharmaceutical patent infringement litigation (or threatened litigation), in which the company that has brought the su ...
("pay for delay") *
Submarine patent A submarine patent is a patent whose issuance and publication are intentionally delayed by the applicant for a long time, which can be several years, or a decade.
* Supplementary protection certificate


References

{{reflist, 30em Business terms Patent law