Is it legal to patent “genes”?

You are probably familiar with the ongoing debate concerning the ability of someone to patent mutations that occur within a sequence of a gene.

Recently, this topic has been in headline news due the legal battle between different groups (including ACLU) and Myriad Genetics (the patent holders for the DNA sequence containing BRCA1 and BRCA2 mutations – mutations responsible for most hereditary breast and ovarian cancers).

This story has been reported by several news outlets. You can read more at USA Today, Wall Stree Journal (subscription required), and Reuters.

The concept of patenting a human gene violates the rules of obtaining a patent (i.e. a patent cannot be placed on something that exists in nature). However, Myriad Genetics’ patent is not on the gene itself, the patent is on the mutations that occur in that gene. Identification of this mutation is used to determine someone’s risk of developing hereditary subtypes of breast and/or ovarian cancers.

Groups suing Myriad Genetics claim the patent is hampering scientific research/innovation. It is not clear to me, at this time, why/how the patent would prevent advancing research in this area. I will have to dig deeper into this.

Nonetheless, the objective of the lawsuit is to invalidate the patent. If the patent on the BRCA1/BRCA2 mutation is invalidated, a new start-up can develop a genetic test to detect this mutation. Since this new company did not invest any research money or time in identifying the mutations (which Myriad had to do), they can afford to price their genetic test very inexpensively compared to Myriad.

On the surface, an inexpensive test sounds appealing, doesn’t it?

The problem, however, is that Myriad will have to lower their prices too and, as a result, may be unable to recoup the money they invested in research, time, money, and resources. What would this mean to Myriad? Not clear, exactly, but it certainly would not be good news.

But, what would this mean to other companies who are trying to develop other innovative genetic tests to determine an individual’s susceptibility for a specific disease? Will anyone invest in these companies if such investment may not be financially worthwhile in the long term?

Companies and investors are willing to take a risk by spending money, time, and research with the hope that some day their investments will pay off when the product goes to market.

What happens, then, if that incentive goes away?

I think the answer is simple: no one would invest in generating scientific discoveries or translating these discoveries to products that would benefit society.

And this is certainly not good news for advancements in the field of genetic testing.

So what is the solution?

It is critical for the courts who are handling this legal battle to be careful not to compromise the future of ventures that aim to develop genetic tests.

Obviously, there is no straightforward solution. We must identify a balance; we have to figure out how a company that conducts research and develops a product can profit, without hampering scientific innovation or progress in that area of research.

Science Policy Fellowships

Do you want to take a break from the bench?

Do you want to apply your science skills and experience to serve society?

For 36 years, the AAAS Science & Technology Policy Fellowships have provided a very unique opportunity for scientists to apply their knowledge and skills to federal policy, while learning first-hand to craft science policy in Congress and/or implement science policies in federal agencies.

Eligibility & Criteria
Successful applicants must hold a doctoral level degree (PhD, ScD, MD, DVM, etc) in social sciences, biological sciences, mathematics, or others. Applicants with an MS in Engineering and 3 years of post-degree professional experience also qualify. You must have completed your degree by December 15, 2009. View complete eligibility and criteria details.

The fellowship is a year-long opportunity, beginning September 1, 2010 and ending August 31, 2011. Fellows in most executive branch agencies have the opportunity to renew their fellowship for up to 12 additional months.

Stipend and Benefits
Stipend ranges between $73,000 to $95,000. Benefits include relocation allowance, health insurance reimbursements, and $4,000 for assignment-related travel, conferences, and/or training. In addition, fellows will be exposed to professional development opportunities, including seminars, workshops, career sessions, and networking events.

The AAAS Science & Technology Policy Fellowships online application system is now open! The deadline is December 15, 2009. For full details, please visit the AAAS Policy Fellowship website.

To learn more details, RSVP for a webinar on October 2, 2009 at 12:00 pm ET. The webinar will cover more info about the fellowships application, selection, placement processes, and ask questions of former fellows.

Policy Decisions Based on Scientific Evidence

During her senate confirmation hearing to head the U.S. Environmental Protection Agency, Lisa Jackson firmly stated that she will rely on scientific evidence and data to guide her policy judgments and decisions. She stated,

Science must be the backbone of what EPA does… EPA’s addressing of scientific decisions should reflect the expert judgment of the Agency’s career scientists and independent advisers.

If I am confirmed, I will administer with science as my guide. I understand that the laws leave room for policy-makers to make policy judgments. But if I am confirmed, political appointees will not compromise the integrity for EPA’s technical experts to advance particular regulatory outcomes.

When it comes to science policy, I completely agree with Ms. Jackson; policies that are put in place need to be based on the related scientific evidence and findings, and I am quite ecstatic that she made the above statements publicly.

Interestingly, Erik Stokstad of Science Insider noted that Ms. Jackson’s statements, understandably, mentioned that science will be the “backbone” and will serve as a “guide”, which, as Mr. Stokstad highlights, leave some wiggle room to make judgment-based decisions.

I think we all agree that there is a necessary and inevitable wiggle room when crafting policies. However, it made me wonder about previous failed science policies…

Did they fail because they were not based on scientific evidence? Is it possible that the evidence turned out to be wrong or was used prematurely? Or is it possible that the “wiggle room” was sufficient to compromise the value and in some ways negate the scientific findings that the policy was trying to reflect?

I think it is crucial to identify and evaluate previous failed science policies and try to understand where they went wrong. Careful examination of the reasons behind past failed science policies will help us avoid previously-made mistakes when crafting new science policies.

Open Access for NIH-Funded Research

In April 2008, an ongoing debate has concluded when the NIH implemented the “Open Access” law, which requires NIH-funded research publications to be accessible to the public within 12 months of publication.

This makes perfect sense, since NIH funding originally comes from tax dollars… so why would the public have to pay again to read an article? Of course, generally, a very small percentage of the public would actually be interested in reading these articles, but this is a separate issue.

While exciting, I think this new law introduces a few questions. For example, how will this law be enforced and/or monitored? i.e. who will determine/verify whether the research was funded through NIH money or not. Also, how will this new law affect the bottom line for journals and publishers?

I think it will be interesting to observe as the implications of this new law unfold. However, it still stands that this new law is one step closer to bridging the gap between Pub-Med and the general public.

Realistic Public Expectations of Science

Conceptually, stem cell research provides a very promising potential to cure many diseases. But realistically, how far are we from harvesting the power of embryonic stem cells to cure diseases?

President-Elect Obama has promised to lift the ban on federal funding for embryonic stem cell research. Needless to say, this has led to a great deal of excitement among scientists.

Of course, scientists understand the length, hard work, and challenges that this opportunity presents… but does the public understand this?

Are scientists clearly communicating the potential while addressing realistic benchmarks and expectations? Or are we allowing the public to arrive to its own conclusions about what and when to expect results?

For example, in the past, the public has expected and waited for scientists to develop a cancer “silver bullet”. Given the extremely diverse nature of cancer, a “silver bullet” is of course not realistic… but perhaps the public did not know that it wasn’t realistic. Since it has yet to be achieved, some have grown cynical toward the field of cancer research.

What should and could we do as scientists to express excitement because of the potential of a drug, technique, or study, yet simultaneously communicate realistic expectations to the public?

Science Policy

The title of this post is somewhat misleading.  I do not intend to provide an introduction to what “Science Policy” is.  The truth is, I don’t know too much about this topic.  However, I would not be too far off if I speculated that many scientists don’t either.

This will change, however… at least for me!  My goal is to become more educated about this topic, and my hope is that this “Category” will serve to help other scientists become more aware and involved in this process.

No doubt, science policy plays a significant role in dictating what scientists can and cannot do.  And it only make sense that scientists would have a bigger role in this process.

Read our latest blog posts about Science Policy…