Showing posts with label market exclusivity. Show all posts
Showing posts with label market exclusivity. Show all posts

Friday, April 4, 2008

Indian Government Should Be Applauded for Recognizing Need to Protect Private Property Rights in Costly Drug Patents

http://economictimes.indiatimes.com/News/Govt_may_use_compulsory_licensing_for_drug_companies_only_in_emergency/rssarticleshow/2921237.cms

Govt may use compulsory licensing for drug companies only in emergency


3 Apr, 2008


By Sanjeev Choudhary & Khomba Singh,


Economic Times from TNN

NEW DELHI: Global drug companies that under attack from Indian generic companies and healthcare groups on compulsory licensing (CL) issue can breathe easy. The government will not invoke CL unless the country is faced with an epidemic-like situation. It feels that the recent applications for CL may not be able to convince the government to take the extreme step. Hyderabad-based Natco Pharma has recently applied for CL to export generic versions of two cancer drugs —Roche’s Tarceva and Pfizer’s Sutent—to Nepal.


“We are not in favour of CL unless there is an extraordinary problem. There is no point in going in for CL unless there is an epidemic which impacts a large chunk of the population, and needs immediate solution, ” a senior official of DIPP (Department of Industrial Policy and Promotion), the nodal government department which oversees patent offices in India told ET.


On being asked if a disease like cancer may qualify under CL, he said, “It may not.” In addition to Natco Pharma, an NGO Cancer Patient’s Aid Association (CPAA) with the support of Indian and global NGOs is planning to demand CL for about 20 cancer drugs.


CPPA say that the cost of patented cancer drugs are highly expensive and deny access to treatment to thousands of cancer patients in the country. Once a drug gets patent, the government provides the innovator company with exclusive marketing rights of the drug for 20 years from the date of grant of the patent.


However, under the product patent laws in India and other countries, the government can invoke CL to enable non-patent drug makers to manufacture and sell patented drugs in national or public interest. The government is of the view that the provision in the law for CL is there to deal with extraordinary situations and safeguard national interest.


“Research-based companies invest millions of dollars and several years of research to develop new products and secure their patent. We respect genuine research and can’t infringe upon any company’s patent rights without much reason, ” the official added.


The government’s thinking seems to be in sync with the views of research-based drug companies. Organisation of pharmaceutical manufacturers and producers (OPPI) (which represents research based companies in India) VP Tapan Ray said, “CL is a provision in the patent law which the government can use to meet the demand in unusual circumstances like epidemic for a limited period. CL should not be invoked for anything else. If it is invoked for any other reason, the whole sanctity of patent gets lost.”

Thursday, February 7, 2008

Bush Administration Sees Wisdom of Preserving US Global Competitiveness in Life Sciences; IT Coalition Patent Reform Position Deemed Spurious

http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/05/BUOGURRUS.DTL


Bush staff, tech titans split over patent bill


Tom Abate, Chronicle Staff Writer


Tuesday, February 5, 2008


The Bush administration said Monday that it opposes a key provision of a patent reform bill that has passed the House of Representatives and is awaiting a floor vote in the Senate, taking sides in an intellectual war over how best to promote innovation.


The position puts the administration at odds with big technology firms like Intel, IBM, Apple, Google, Cisco and Hewlett-Packard that have banded together to push the bill, and squarely on the side of the biotech and venture capital industries, which say the proposed change would significantly weaken patents.


A patent is a government-issued monopoly that gives inventors the legal right to control the use of their discoveries for up to 20 years.


[A PATENT IS RECOGNIZED AS A PROPERTY RIGHT OF TEMPORARY DURATION UNDER U.S. CONSTITUTIONAL AND CIVIL LAW]


In a six-page letter written on behalf of the U.S. Patent and Trademark Office, the administration told senators that it disagrees with a provision that would change the way damages are calculated in cases when patent infringement is proven. That change "could promote infringement,"the administration warned, saying it would oppose the legislation unless the bill is changed to "protect the inventor."


"What the administration is saying on damages is our position as well," said Kelly Slone with the National Venture Capital Association, which has sent senators a letter signed by Kleiner Perkins Caufield and Byers, New Enterprise Associates and others.


Mark Isakowitz, a lobbyist with the tech-sponsored Coalition for Patent Fairness, downplayed the significance of Monday's letter, saying the administration made much the same argument before the House passed its patent bill by a 220-175 vote in autumn.


"We strongly and respectfully disagree with their view," said Isakowitz, adding that he still expects the bill to come up for a floor vote in the Senate around the end of February. "Between now and then we have to try and reach a broader consensus on damages," he said.


Patents are authorized in Article I of the Constitution, which gives Congress the power "To promote the Progress of Science." But the Constitution does not say exactly how, which has meant a never-ending series of arguments, said Kenneth Dobyns, a retired patent attorney who wrote a history of the system called "The Patent Office Pony."


"There's never been a time when it wasn't like this," Dobyns said.


At the heart of the current dispute is the fact that patents, which have been on a sort of pendulum swing throughout U.S. history, from worth very little to worth very much, are somewhere at the high end of their historical value.


The reasons have little to do with Congress, which has not really changed patent law since 1952, but rather with a reorganization of the federal court system in the 1980s. That change created what amounts to a special court of appeals for patent cases that has, generally speaking, ended up strengthening patent law, according to Bronwyn Hall, a UC Berkeley economist who has studied the situation.


Perhaps the high point of patent strength, at least to members of Congress, came in recent years when the Canadian company Research In Motion paid $612.5 million in March to settle a patent dispute that had very nearly lead to a court-ordered injunction stopping sales of the BlackBerry device, which is popular on Capitol Hill.


The size of the settlement and the drama leading up to it lent credence to tech industry complaints about patents.


"We have a system which is out of whack, out of balance," said Tim Sheehy, a Capitol Hill lobbyist for IBM Corp., which backs the current language on damages that the White House opposes.


Biotech industry leaders feel particularly threatened by proposed changes because their whole industry has grown up in the past 25 years when, largely thanks to court actions, patents have become more and more valuable.


"If it comes down to a choice between a tilt toward the iPod or a tilt toward cancer cures, I think that's a no-brainer," said James Greenwood, president of Biotechnology Industry Organization.


What remains to be seen is whether the disagreement over damages can be ironed out, or whether the bill will stall.


"A forced choice is a false choice. The current proposal forces a choice of promoting one innovation over another," said Patent Office Director Jon Dudas, who held out hope of an agreement being reached.


E-mail Tom Abate at tabate@sfchronicle.com.
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/05/BUOGURRUS.DTL

Sunday, January 20, 2008

Exclusive Private Property is Indispensable to Brazil’s Economic Development

Exclusive Private Property is Indispensable to Brazil’s Economic Development


The following article was authored by O. Lee Reed, Esq., Professor of Legal Studies and Meigs ProfessorUniversity of Georgia http://www.terry.uga.edu/spotlight/faculty/lee_reed.html


The article was prepared to support the manuscript entitled, Rediscovering the Value of Intellectual Property Rights: How Brazil's Recognition and Protection of Foreign IPRs Can Stimulate Innovation and Generate Economic Growth, International Journal of Economic Development, Vol. 8, Nos. 1-2 (Sept. 2006), at pp. 5-10,


at: http://www.spaef.com/IJED_PUB/v8n1-2.html


at: http://www.itssd.org/White%20Papers/ijed-8-1-2-reed.pdf


According to Nobel economist Douglass North, all the world was poor five-hundred years ago. Famines regularly swept through Europe, and when Europeans arrived in the New World, the Native Americans had a standard of living equal to or superior to the average Europeans. Yet today, throughout much of Europe, North America, and the Pacific Rim, people enjoy per capita income in many multiples of incomes in the rest of the world.


Peruvian economist Hernando De Soto used to ask the financial ministers and treasury officials of wealthy nations why their countries were so rich while his was so poor. Invariably, he was met with silence. De Soto now worries that wealthy nations may have forgotten what they did in generating conditions necessary for prosperous, modern economies.


Neither technology, education, infrastructure, natural resources, and temperate climate nor securities exchanges, banks, and the private market account most fundamentally for the dramatic economic development of certain nations in recent centuries. Instead, growing numbers of analysts point to the legal institution of private property as the primary catalyst of economic development.


Only when an adequately enforced legal system secures private resources can education, natural resources, technology, infrastructure, and financial institutions unleash through the private market sustained per capita income growth. In an infelicitous yet apt metaphor, private property is the goose that lays the golden wealth of nations.


As used here, “property” refers not to something owned but to ownership itself. Most clearly, it is the legal right to keep others from interfering with an object or resource. Property implies lawful boundaries that protect the object, good against all others. Importantly, the object protected within property boundaries can have both tangible and intangible aspects to it. Within protected boundaries can be included not only physical objects like land and intangible objects like market exclusivity but uses of these resources as well. The uses of the resources are themselves resources and are part of the protected object.


By this definition, property is absolute. Inasmuch and only inasmuch as a person can keep others from interfering with a resource, does the person have property. If a person cannot keep others— including the state— from interfering with a resource, to that precise extent the person lacks property. However, absolute resource boundaries do not mean infinite resource boundaries and an owner’s property, especially in the use of a physical object, is always limited by the property of others. An adequate legal system of property law includes formal ways of determining the extent of property boundaries and of providing enforcement against and compensation for their harmful crossing. Criminal law, tort law, and government regulations provide that function, just as contract law and commercial codes specify the rules by which owners exchange objects in a private property-based legal system.


Private property provides the certainty and incentive necessary to free people from having to protect their possessions and to make them willing to invest resources in fixed locations for production. That the institution of private property generates the maximum human effort and ingenuity in the production of what society needs and wants comes from a deeply ingrained human characteristic which brings people to work harder for themselves and their families than for needy humanity in general, what economists refer to as “self interest.” Consequently, nations should enforce private property in whatever tangible or intangible resources they wish people to produce in greater quantities. It is entirely proper to teach and encourage the compassionate sharing of resources, but the development of national wealth in the last several centuries is almost entirely associated with the development of strong private property systems. No nations with such systems are poor, and no nations lacking them have diversified, prosperous economies.


First in the Netherlands, then in England, private property in land and the productive use of resources we today call “business” took hold. Also during this period, the American colonies were beginning a period of ferment over private resources that led eventually to a new nation. Historians of the colonial era are virtually unanimous in concluding that the American Revolution was fought over private property and the English refusal to apply to their own colonists the great constitutional principle of England: legitimate taxation of privately owned resources can derive only from the people’s elected representatives. Said John Wilkes, Lord Mayor of London, during this time, “If we can tax the Americans without their consent, they have no property, nothing they can call their own.”


The Constitution of the United States itself arose to protect the concept of what was frequently called in the 18th century “sacred property.” Without any opposition whatsoever, no fewer than five members of the Constitutional Convention observed that the purpose for which the political state comes into being is the protection of property. James Madison, who recorded these statements in his minutes of the Convention, himself held this belief, and in 1792 wrote a famous essay in which he extended the established constitutional cachet of private property to such objects as speech and the practice of religion. Madison said that even as people have a “right to property” so also do they have a “property in their rights,” thus representing individual liberty as nothing less than self-ownership. Thomas Jefferson’s “pursuit of happiness” phrase from the Declaration of Independence is likewise property based, deriving from John Locke’s belief that one’s privately directed acquisition of the means of life is the highest political happiness.


The path dependence or societal inertia of this kind of constitutional, legal, and social tradition brings us to the carefully analyzed, yet impassioned, article Rediscovering the Value of Intellectual Property Rights. Like Hernando De Soto, Lawrence Kogan recognizes the importance of private property to nations, but he extends this recognition
to the increasing globalization of trade in the vital area of IP rights. He fully embraces Article 1, Section 8, of the U.S. Constitution, which acknowledges that the purpose of patent and copyright protection is “to promote [give incentive to] the Progress of Science and useful Arts [business],” all done to serve the nation’s general welfare or common good. He vigorously promotes this justification for private IP in global trade as well.


Rediscovering the Value of Intellectual Property Rights focuses principal concern on Brazil’s continuing abridgment of IP rights and that nation’s efforts in international fora — assisted by certain European views— to justify the abridgment of trade secrets and patents and of the limited, exclusive markets that are the objects of IP boundaries. Although the opportunistic appropriation of valuable resources others have worked to create may have temporary, situation-specific economic and human advantages to Brazil, it fosters only long-term poverty in the development of new pharmaceuticals, quick growing, disease-resistant crops, energy efficient invention, and other information technology-based goods and services. From the perspective of private companies that spend billions to create the “Progress of Science and useful Arts,” actions to deprive them of the fruits of their research differ little from the predations of the Barbary Coast pirates, who plundered trade routes until the early 19th century. To eliminate or substantially reduce private property in new ways of generating w hat the world’s people need and want can only stifle incentive to create these resources in the first instance and lead companies to avoid dealing with nations who take IP resources without permission.


With a meticulously documented case, Lawrence Kogan shows that Brazil itself will benefit in the long-run from curbing its efforts to impair private property in what is currently protected by trade secret and patent law. From increasing foreign direct investment and providing incentive to its own private investors, Brazil will ultimately benefit more under— rather than out of— the private property regime. Lawrence Kogan provides an important service in reminding us why some nations are rich and others are poor.


International Journal of Economic Development Volume Eight, Numbers 1-2, pp. 5-10 2006