Pharmaceutical News 2.0

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.

Read the rest of this article on pharma patent trolls.

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Roy Bodem

Without the potential for patent profits, there would be no reward for innovative ideas that lead to beneficial products. These products are the technological advances that make life better. Pharmaceutical companies have the ability to develop new drugs that can prolong life and provide cures to diseases that affect people worldwide. Patents are especially important to these drug companies because they can guarantee profit and make all the time and cost put into developing their new drug worthwhile. A patent is an economic catalyst to these pharmaceutical companies who push to research new and beneficial drugs on the premise that they will be able to reap rewards by way of profits.

Profits for patented pharmaceutical represent a reward that pharmaceutical companies earn through years of research and development and only then will they be able to profit from their work. The patent system allows drug companies to profit from patents by prohibiting any other company from marketing and selling an identical prescription drug. This system seems to be the best way to provide drug companies with the reward of potential profit for the research and development spending that in necessary to develop new and innovative prescription drugs.

What is a patent?

A patent is a property right to a product and in the case of pharmaceutical companies is usually in the form of a chemical formula that may not be duplicated by any rival company. The life of a patent is 20 years from the time the patent is issued. (Lehman, 2003) This gives the company ample time to profit from its invention. An invention is “any new or useful process, machine, article of manufacture, or composition of matter.” (Lehman, 2003) This means that the inventor has the guarantee that that his or her product will be the only product of its exact kind on the market for 20 years.

Inventions can also be new improvements to previous inventions. New inventions are evaluated by National Patent Offices to compare new inventions with previous inventions that are similar to be sure that the invention is novel and not just an obvious replica of a previously patented invention. (Lehman, 2003)

Thomas Jefferson reviewed and granted the first patent and the patent review process has remained the same ever since. (Roth, 2005) Patents are reviewed by searching through previously granted patents to make sure that the patent is new and unique. This patent provides the researcher with the incentive to spend the costs, time, and effort to be granted a patent. (Roth, 2005) The inventor knows that his work will be rewarded with potential profits once a patent is granted because a patent ensures no competitor will be able to copy his or her idea and prevent the inventor from profiting. (Roth, 2005)

Patents must be enforced.

Patents are enforced by the National Patent Offices, World Trade Organization (WTO) and evaluated by the World Intellectual Property Organization (WIPO). (Lehman, 2003) These organizations provide the patent protection to those seeking the protection by giving judicial enforcement of the intellectual property rights. (Lehman, 2003) This means that a company could sue a rival if it felt its patent was being violated and have official documents at the National Patent Offices to substantiate its claim to a product.

Patents are available for a variety of products including prescription drugs. Patents in the pharmaceutical industry are somewhat different and possibly more important than in other industries because of the laboratory research and clinical trials that must be done beforehand. This research costs the pharmaceutical company and is usually accomplished through capital investment on the basis that the result will lead to profit for the company. (Lehman, 2003)

Read the rest of this article on pharmaceutical patent protection.

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Table of Contents

* Overview of patent system
* Patents provide incentive to innovate
* Process of innovation is long, risky and expensive
* Patents help save lives, enhance life
* Strong IP protection is needed to ensure pharmaceutical innovation continues
* IP: The key to innovation and growth

Overview

* Abraham Lincoln said that patents “added the fuel of interest to the fire of genius.” But, it was not genius alone that Lincoln and our founding fathers desired from a patent system. Rather, their objective was innovation. Innovation is why we protect intellectual property.
* The founding fathers felt so strongly about the importance of innovation that patent and copyright protection is the only right expressly mentioned in the original articles of the Constitution.
* Patent protection in the United States gives inventors the exclusive right to sell an invention for up to 20 years before others may copy and sell it. However, the effective patent life, which only begins to run when the patent is granted and the invention can be marketed, is closer to 18 ½ years. For pharmaceuticals, the effective patent life is actually closer to 11 or 12 years since federal law requires a company to test its product for safety and efficacy and secure regulatory approval before marketing it, a process that can take years.
* Patents are a kind of agreement in which an inventor is given a limited period of time of exclusivity to make and sell a product incorporating an invention in exchange for agreeing to make his or her invention public, thus enabling and encouraging the continuation of scientific discovery.

Read the rest of Innovation.org’s pharmaceutical patent paper (pdf).

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