All Posts Tagged With: "pharma patent"
Provectus Pharmaceuticals Receives Patent Allowances In Europe And China
February 28, 2008
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received allowance of its patent applications in Europe and China covering diagnostic use of PV-10 and a number of related agents in CT and MRI imaging. The pending patents cover products for diagnosis of cancer and other serious diseases.
"These cases augment our international portfolio of twenty-six issued patents and four pending patents, along with our U.S. patent portfolio of sixteen issued and five pending patents," said Craig Dees, PhD, CEO of Provectus Pharmaceuticals. "As important milestones, they demonstrate the scope of our patent activity that spans markets ranging from the developed world to the rapidly developing world."
Read the rest of this press release on Provectus Pharmaceuticals pharma patent .
The Pharmaceutical Industry and the Patent System
Executive Summary
Patents are exclusive property rights in intangible creations of the human mind. They exist only as provided in the laws of sovereign states, and can be enforced only to the extent that application has been made and a patent granted covering the territory of an individual state. Patent rights are limited in duration, with the global standard being 20 years from the date of application. The new product, article of manufacture or process described in the patent application must be something that has never been previously disclosed anywhere in the world and something that would not be obvious to a person ordinarily skilled in the field involved. Determinations of whether these requirements have been met are made by comparing the claims of the patent applicant against the body of published literature in the field, including previously issued patents. This process is called examination, and it assures that no one is able to claim patent rights on anything that already is existence.
Patents work differently indifferent industries. In the electronic industry patents are often shared among competitors through pooling or cross licensing. This sharing is necessary because a given product often contains many patented technologies. However, in the pharmaceutical, chemical and biotechnology industries the patent normally equals the product, and protects the extensive investment in research and clinical testing required before placing it on the market. Patent protection for chemical and pharmaceutical products is especially important compared with other industries because the actual manufacturing process is often easy to replicate and can be copied with a fraction of the investment of that required for the research and clinical testing.
The extensive cost required to produce a new pharmaceutical product has meant that private sector investment in pharmaceutical innovation has been disproportionately directed to products meeting the needs of patients in developed countries, particularly in the United States, which combines strong patent protection with a market free of price controls.
Until the TRIPS Agreement in 1994 many developing countries provided no patent protection for pharmaceutical products. And, while countries that have joined the WTO have obligated themselves to provide such protection, least developed countries are not required to meet this obligation until 2016. The continuing lack of patent protection for pharmaceutical products makes it very difficult to establish research-based industries in most developing countries. Most medical research in these countries takes place in the public sector. The lack of any means of patenting these inventions and the related lack of experience in licensing them to the private sector, suppresses the development of commercial enterprises focused on alleviating the disease burdens common to developing countries.
The controversy over availability of patented therapies for the treatment of HIV disease has resulted renewed interest in the compulsory licensing of pharmaceutical products. After two years of discussion, the WTO Council recently affirmed that the TRIPS Agreement permits such compulsory licenses in health emergencies, even in cases where the compulsory license is for an imported product. However, to date, no compulsory licenses actually have been issued, even though the threat of compulsory licensing has been used as a means of seeking lower prices.
One danger in compulsory licensing is that it will discourage further the commercial R & D necessary to new drugs to fight global epidemics. Another danger is that compulsory licensing can be used to seek price levels below what a given national market is capable of supporting, further concentrating the burden of financing pharmaceutical innovation on developed country consumers and discouraging development of drugs targeted at the disease burdens of countries using compulsory licenses.
There are promising developments in countries such as India and Brazil that are beginning to use patents to develop commercial pharmaceutical industries that produce products directed at local diseases and available at price that patients in those countries can afford. Foundations and nonprofit organizations such as the Bill and Melinda Gates Foundation and OneWorld Health, Inc. are supporting such efforts. These efforts show that developing countries have the capacity to build research-intensive pharmaceutical industries capable of operating profitably in the conditions of the local market. However, for such local industries to take root and grow, effective patent protection must be made available, the commercialization of publicly funded research must be encouraged, and compulsory licensing must be kept to a minimum. Wealthy countries can assist this process by subsidizing local markets for the purchase of drugs through the Global Fund, and by direct programs of assistance such as that recently proposed by President Bush. Consumers in all countries can share the burden of drug development equitably by paying for medicine at a price level consistent with their means, rather than attempting to shift the costs of drug development to others.
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Pharma Patent Protection: A Platform for Investment, Markets and Improved Health in the Americas
(Paper presented to Workshop ID, Cartagena, March 1996)
By: Harvey E. Bale, Jr., Ph.D., Senior Vice President International
Pharmaceutical Research and Manufacturers of America
"Without the sense of security which property gives, the land would still be uncultivated. "
François Quesnay (1694-1774), Maximes Générales (1760)
In this forum on policies affecting development and technology, I highlight the importance of the role of providing strong protection of intellectual property rights. In a study published in 1995 by the World Bank-affiliate — the International Finance Corporation (IFC) — it was concluded that "a country’s system of intellectual property protection seems to have a substantial effect in relatively high technology industries like chemicals, pharmaceuticals, machinery and electrical equipment on the kinds of technology transferred to that country and the amount of direct investment in that country … by Japanese and German, as well as U.S., firms."
If we consider this fact in light of the global competitive position of the Americas in relation to that other great region where economic development is accelerating –Asia– I am afraid we have to be quite concerned. With the exception of India, all major developing countries in Asia have adopted much stronger industrial property protection — covering patents, trademarks, etc.– than is the case in many countries of the Americas. The effect on investment and technology has been dramatic. Having been in China recently, I have seen the investment enthusiasm that has led to 12 joint-ventures between American and Chinese firms in the pharmaceutical sector following passage of China’s 1992 patent legislation. As the head of China’s Patent and Trademark Law Office said last week, "New technology is the most important thing brought in by external investment and patents are a way to protect that technology." Unfortunately, in our own hemisphere, there are still forces fighting rearguard actions to protect their privileged position by preventing early action on patent legislation.
On a global plane, there is very little debate today about whether there should be strong intellectual property protection for pharmaceutical products. Debates of the past about the so-called "monopoly" effects of patents on the market place have been resolved in favor of the recognition that adequate patent, trademark, and trade secret protection for pharmaceutical products is absolutely essential for the development of new pharmaceutical compounds. In other words, without adequate intellectual property protection, we would not see the new miracle drugs for mental depression, heart disease, etc. that have benefited patients in recent years. New pharmaceuticals that result from strong patent protection are saving lives, money and improving the quality of life of patients around-the-world.
A decade ago, Professor Edwin Mansfield of the University of Pennsylvania described in a simple table (Table 1) how pharmaceutical innovation and development were dependent, in absolute terms and relative to other industries , on strong patent protection. This ranking is not very surprising when you consider that the ratio of R&D expenditures of the pharmaceutical/biotechnology industry is far higher than in any other important industrial sector (PhRMA companies spend 20 percent of their revenues on R&D, compared to less than 4 percent for U.S. industry overall). It costs hundreds of millions of dollars in the United States to do R&D for each new marketed drug discovery; and it takes an average of a decade or more to bring each new pharmaceutical compound to the marketplace.
If it has been conceded that patent protection is essential for pharmaceutical products, it has been argued by some that such protection should be: 1) very limited compared to other sectors, perhaps subject to compulsory licensing; and 2) restricted only to advanced industrial countries. These arguments, too, have lost out to the recognition that the term of patent protection (because of regulatory delays) needs to be lengthened beyond the normal standard for other products; that compulsory licensing provisions such as previously existed in Canada, need to be repealed; and that, in fact, developing countries themselves have much to gain in providing pharmaceutical patent protection.
Looking over the past twelve years, in the United States, Europe and Japan the term of patent protection for pharmaceuticals has been uniquely extended to make up for some of the economic benefits lost during the life of a patent in the process of obtaining necessary regulatory approvals (e.g., from the FDA) for marketing pharmaceutical products.
Canada and New Zealand, several years ago, repealed onerous compulsory license measures that eroded the effect of intellectual property protection; and since 1986 developing countries of Asia and the Western Hemisphere have adopted strong intellectual property protection for pharmaceutical products as Table 2 shows. The fact is that, today, there is only a small minority of important developing countries that still do not provide adequate intellectual property protection for pharmaceutical products. A number of those countries unfortunately are in Latin America. But even this is changing. Aside from the fact that the U.S. Government has made strengthened intellectual property protection abroad a major priority in its negotiations with foreign governments, there are other — even more compelling — reasons for developing countries in the Western Hemisphere and elsewhere to change their current or past anti-patent policies.
Increasingly, it has been recognized that the non-patentability of pharmaceutical products is a growing economic and health burden on the economies of Latin America — leaving aside the fact that it sours the trade relationships between Latin America and the United States, and increasingly Europe and Japan. Inadequate intellectual property protection is disguised protectionism for local industry. A 1990 study by the Latin American Economics Foundation FIEL states that: "the non-patentability of pharmaceutical products, that was in its beginning a device designed to safeguard public health, has presently turned into an instrument used to protect local industry." It has also become another basis for the corruption of public officials. Further, in this age of emerging and re-emerging serious infectious diseases, particularly in tropical climates, the lack of intellectual property protection for pharmaceuticals is an example of national and regional disarmament against the invasion and destruction of such diseases. Without patents, where is the incentive for local companies and research institutions to exploit the biomedical promises of Latin America’s rain forests? Why must Latin American scientists go to the United States or Europe to win Nobel prizes for the discovery of new pharmaceutical compounds? These are issues and questions which every government in the hemisphere is asking as they review their intellectual property policies.
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Pharma Patent category on Diffusion Pharmaceuticals
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Alvine Pharmaceuticals Obtains Pharma Patents For Celiac Disease Therapies
February 25, 2008
Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, announced that the United States Patent and Trademark Office has issued two key patents, 7,320,788 and 7,303,871, covering gluten detoxification with proline specific prolyl endopeptidases (PEPs) and with mixtures of a PEP and a glutamine specific protease. Alvine has an exclusive worldwide license to these patents under an agreement with Stanford University. Both patents provide important protection for ALV003, Alvine’s lead product currently in clinical development for use in the treatment of celiac disease.
"Alvine is delighted that these two patents have issued," said Dr. Abhay Joshi, Alvine’s President and Chief Executive Officer. "Alvine and others have shown PEPs to be efficient at degrading gluten. With these patents and our recently announced initiation of clinical trials of ALV003 (a combination of a PEP and a glutamine specific protease), we believe Alvine is well positioned to capitalize on the potential use of proteases as therapeutic agents to treat celiac disease. ALV003 is more efficient at degrading gluten than either a PEP or a glutamine specific protease alone."
Read the rest of this article on Alvine Pharmaceuticals’ pharma patent .
Pharma Patent Trolls: Cheap Drugs At A Steep Price
by Andrew Beattie
Pharmaceuticals is an industry exposed to many unique risks. The capital intensive research and development (R&D), the uncertainty of Food and Drug Administration (FDA) approval, and a constant shroud of legislative risks may seem like a lot to deal with, but one of the fastest growing threats for pharmaceuticals are patent trolls.
The Pharmaceutical Process
FDA approval is already a long process, and even properly-approved drugs have left companies open for litigation. To take just one example from 2008/2009, there is an ongoing legal argument about whether federally approved warning labels pre-empt state law. The main problem was that if the Supreme Court ruled that warning labels didn’t pre-empt state law, or if Congress changed the rules to give state law equal importance, then drug companies could find themselves facing more lawsuits. In addition, the drug companies would have to go through FDA approval followed by state by state compliance checks - all of this adding to the already considerable costs of doing business. (This volatile sector can provide huge gains, but there’s also lots of downside, read The Ups And Downs Of Biotechnology.)
Patent trolls, by either attacking existing patents or hoarding vague patents, hurt pharmaceutical companies more acutely by reducing returns on investment at a time when both the companies’ costs and risks are rising. Drug companies need large cash reserves/war chests at all times to pay for capital-intensive research, FDA approval and settling lawsuits. To maintain this war chest they need strong and, more importantly, stable profits from their products.
Risk and Return
These companies pay out the huge R&D costs in return for huge possible rewards on patented drugs. The rewards are more or less proportional to the risks, as many drugs never make it to market, meaning they never pay back their R&D costs. Drug companies want their patents, essentially their intellectual property rights, protected for as long as possible. They want an exclusive monopoly over their product in order pay back the costs of development along with a profit equal to the risks taken on by the company. Excess profits will either go to the shareholders or cover the costs of the many failed drugs that never make it out of developmental stages. (Investors take note: companies that cut research and development are in danger of saving today but losing big tomorrow, see Buying Into R&D.)
Trolls Provide Short-Term Benefit
Whether it is generic aspirin or generic Viagra, the patient receives an immediate benefit from patent trolls in the form of a lower price for medicines. This short-term benefit is no doubt much appreciated. The government also tends to think short-term - a cynic would say in four-year cycles - and generally in line with patients. They want cheap pills for voters and are more than willing to see corporate profits take a hit to meet that end. Governments have shown their support for patent trolls by creating legislative loopholes and eroding patent rights.
By attacking long-term patents, trolls are able to open up specific formulas for generic mass production and bring cheap generic drugs to market quicker. In the short-term, it’s hard to argue that cheap medicine doesn’t benefit the general population. In the long-term, however, the actions of patent trolls may actually hurt everyone.
Long-Term Problems
Bringing cheap pills to market quickly makes patent trolls look like important middlemen in the process towards generic drugs, but their long-term impact is more subtle and devastating. In the current pharmaceutical structure, drug companies pony up the cost of R&D. Therefore, even a slow drain on their reserves means less R&D and less new drugs in the future.
You might disagree with how much these companies take as profits for their shareholders, but it is those same profits that motivate the best corporate and scientific minds to keep searching for new medicines - and it is those profits that convince investors to put their capital behind the research rather than investing it somewhere else. (Valuing firms in this sector can seem like a black art, but there is a systematic way to pin a price on potential. For a better understanding, see Using DCF In Biotech Valuation.)
Possible Fallout
There are a lot of possible outcomes for the rise of the patent trolls. One is that drug companies will be pushed further away from high-cost, high-risk research and into simple domestic products like mouthwash and skin cream. Some of this can be seen in the 2009 acquisitions by Pfizer (NYSE:PFE), Merck (NYSE:MRK) and others. These companies have focused on other companies that have strong brands in household goods. These products and markets will be used to hedge against losses in the pure drug research, but they will also divert capital and research from the R&D. Instead of a pharmaceutical industry, we’ll end up with a bunch of Johnson and Johnson (NYSE:JNJ) clones that occasionally make medicine.
Along with a more domestic focus, the trend of buying companies to fill existing and upcoming holes in the pipeline will intensify. As patents end prematurely and new drugs have yet to fill their place, many drug companies acquire other companies’ products to prop up revenue. Unfortunately, the merger of two pipelines and two corporate cultures often leads to less overall spending on R&D rather than any significant synergy. Many drug companies are focusing ever more on pills with commercial appeal (erectile dysfunction, weight loss, etc.) and tightening their spending on expensive research into cures for rarer but more critical maladies. (Innovation is the key to staying on top. Find out how companies protect their ideas and how to figure out how much they’re worth in Patents Are Assets, So Learn How To Value Them.)
Read the rest of this article on pharma patent trolls.