Cure-All Drugs: Realities and Roadblocks

By Jill StarbuckPellegrino & Associates

Imagine a drug that can take away all of your ailments, maybe even cure or prevent them. Now, believe it. Those drugs—called biotech drugs or personalized drugs—are a reality today. They are produced from living organisms instead of chemicals found in standard prescription drugs. Typically administered via injection or intravenously, biotech drugs are used to treat the following types of diseases: autoimmune, cancer, degenerative, infectious, and neurological.

But these amazing drugs may be in jeopardy if a recent suggestion by the Supreme Court to invalidate two gene patents upholds.[1] The Supreme Court requested that an appeals reconsider its decision to uphold the patents involving genes associated with breast and ovarian cancer, claiming that a diagnostic blood test used involved a law of nature, and therefore is not patentable. The Supreme Court’s ruling regarding the diagnostic test patent may affect the patentability of genes in the future. Patent owner, Myriad Genetics, a biopharmaceutical company focused on drug development and genetic testing for cancer, has been arguing its case that these types of patents have been upheld by the Supreme Court for more than 30 years.

Patents are important to inventors because they protect new inventions and improvements made to those inventions for a specified amount of time. During that specified time, the inventors have to reveal to the public their inventions and all the components that make those inventions function. While this may seem counterproductive, patents give the inventors the right to exclude others from entering the market with the same idea. Therefore, if the Supreme Court’s suggestion to invalidate gene patents is upheld, it could have huge implications for the future of medicine.

If genes and diagnostic tests cannot be patented in the future, then biotech drugs would essentially be removed from the pharmaceutical industry. Because of the complexity of biotech drugs, inventors spend a tremendous amount of time and money on trying to prove the therapeutic value of the drugs and that they work. Without patents, all the time and money would be wasted as others could imitate and sell the drugs without any effort.

Thus, eliminating patents would result in an abrupt halt to new treatment methods because there would be no incentive for companies to create, research, or introduce new drugs in the market.

Statistics from 2010 show that there are approximately 294[2] public biotechnology companies in the United States, which was a 25% decrease from 2007. While most biotech companies were made up of small, privately owned companies that relied on venture capitalists for funding, many have been acquired by large pharmaceutical companies looking for the perfect drug or cure.

According to Freedonia, an international business research company, the U.S. biologics industry is worth $74.3 billion, with an expected 6.5% increase annually through 2015.[3]What this all means is that scientists are getting closer to finding cures for debilitating and life-threatening diseases. The enabling factors are genes and diagnostic tests to target specific individuals with specific conditions, thus becoming more “personalized.” Without these factors, cure-all drugs may not become a reality. Without patents, companies may end up with no way to ensure exclusivity in the market, which will deter investment in new biotech products.




By Jill StarbuckPellegrino & Associates

ICLEF • Indiana Continuing Legal Education Forum, Indianapolis, IN

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