Patents promote innovation

The following is the opposing view from USA Today, June 16, 2009. USA Today's view can be found as my previous posting.

Opposing View: Exclusive gene-based rights spur vital research and development

By Jim Greenwood

Can a gene be patented? The easy answer is this: Genes as they exist in nature cannot be patented. No one can patent a naturally occurring gene or protein as it exists in the body.

Here's where it becomes more complicated: Researchers can isolate a protein or DNA sequence that can help treat or potentially cure a disease, like cancer or heart disease, and they can patent this discovery. Many, if not most, human diseases have their roots in our genes. More than 4,000 diseases are suspected to stem from mutated genes inherited from one or both of our parents.

Armed with this knowledge, scientists have developed more than 200 innovative new therapies and vaccines that have helped extend and improve the quality of life for hundreds of millions of patients. Researchers, for example, located the gene responsible for cystic fibrosis, then used that knowledge to create therapies that have extended the average lifespan of a person who has CF from 12 years to more than 40.

Like all other patents, gene-based patents protect the intellectual property of a scientist, researcher or biotech company, spurring investment in research and development. The Patent and Trademark Office has strict guidelines on patents, including the patenting of DNA molecules or genetic material.

Two recent studies, from the American Association for the Advancement of Science and a Department of Health and Human Services advisory committee, both confirm what a prior National Academy of Sciences report concluded: Patents do not hinder biomedical innovation. The HHS panel's study also found that patents are not the cause of access-related issues regarding genetic diagnostic tests, in particular.

Public debate over access to, and use of, genetic technology is a good thing. It requires the consideration of many factors, including coverage and cost, concerns over genetic discrimination and myriad regulatory issues.

Even so, banning patents on gene-related breakthroughs would slow biomedical innovation to a halt — taking away the hope biotechnology offers to patients suffering from debilitating diseases such as cancer, Parkinson's and HIV/AIDS — while doing nothing to address what is really a much more complicated set of issues.

Former representative Jim Greenwood, R-Pa., is president and CEO of the Biotechnology Industry Organization.

Government awards patents for Genes, stiffling research

My mother gave me a USA Today newspaper clipping from June 16, 2009 of the following articles, which we thought were interesteding. This is the view of USA Today and the opposing view will be on my following posting:

Our view: Private interests shouldn’t control rights to features of natural world.

In 2006, Genae Girard, then 36, was diagnosed with Stage 2 breast cancer. She had a lumpectomy and chemotherapy. Then she underwent testing for mutations in the BRCA1 and BRCA2 genes linked to breast and ovarian cancer. Girard tested positive for BRCA2 and elected to have a double mastectomy and then a hysterectomy. As she made these wrenching decisions about her health, she collected second opinions at every step of the way except one — the BRCA test.

The reason: One company, Utah-based Myriad Genetics, owns the patent to the BRCA genes.

(Girard: Couldn’t get second opinion on a cancer test./ACLU)

Say what? Yes, the U.S. government grants patents to DNA sequences, the stuff of life. About 20% of the human genome has been patented.

One consequence of such patents is that only Myriad can test for the BRCA mutations. So, no second opinions. Plus, without competition, Myriad can charge more for tests. At more than $3,000, the tests are prohibitively expensive for many women, and not all insurance companies cover them.

Pharmaceutical companies have long used patent protection to recoup the costs of investment and to make initial profits on drugs. Fair enough. Unlike drugs, though, genes are features of the natural world. The biotech industry argues that by taking genes out of the body and isolating them, scientists are creating something that does not occur in nature and therefore can be patented. This, however, is like arguing that gold can be patented when it has been taken out of a mountain because it's no longer "in nature."

The problem began with a 1980 Supreme Court ruling on the patenting of biological organisms. Since 1982, based on a questionable interpretation of that decision, the U.S. Patent and Trademark Office has granted tens of thousands of patents for human genes and gene-related products.

Many of the patent holders allow virtually unrestricted research. But a few companies are aggressive about prohibiting others from profiting from research on their patented genes. That inhibits scientific inquiry.

Efforts to change the situation are underway in the courts and Congress. The American Civil Liberties Union, along with a non-profit organization, filed a lawsuit last month that challenges the patenting of the BRCA genes. On Capitol Hill, Rep. Xavier Becerra, D-Calif., is promoting legislation to bar gene patenting, which, he says, is "equivalent to patenting water, air, birds or diamonds."

It is possible that other solutions exist, short of a complete ban. The scientific world tends to be one of collaboration, not competition. But without strict curbs, for-profit companies such as Myriad — which declined to provide an opposing view to this editorial — too readily can use patents to slow and restrict research as they maximize revenue. (There might be "myriad dollars to be made in Myriad," CNBC's Jim Cramer said on his stock-picking show last week.)

Even though Girard has taken the most drastic steps to prevent her cancer from spreading or returning, the BRCA2 gene runs in her family. If one company continues to have a lock on it, that makes it more difficult to achieve Girard's wish: to make it easier for others, including her niece who might also carry the gene, to make better informed decisions about their own health.