Can Genes be Patented?

The interdisciplinary nature of nanotechnology suggests that a wide variety IP issues influence research and patenting in this area.  An example of current interest is the recent ruling in the case of Association for Molecular Pathology, et al. v. USPTO.  The case deals with the research and technology of genes; specifically, two tumor suppressor genes known as BRCA₁ and BRCA₂.    

Recently, a coalition led by the American Civil Liberties Union (a not-for-profit patent reform organization) challenged seven patents held by the company Myriad Genetics ³ in a New York District Court.  In March 29, 2010, the patents were found invalid for claiming unpatentable subject matter ⁴. In the decision, the judge held that DNA should not be regarded as a mere chemical compound and that isolating genes is not to be considered patentable subject matter.

On March 30, 2010, Myriad Genetics announced that it would appeal the decision.  The case has now been brought to The Court of Appeals for the Federal Circuit which will hear oral arguments related to the patentability, or not, of gene patents. 

This case, whose destiny will likely be decided at the Supreme Court level, could have implications on the entire field of gene patenting ⁵.  Approximately 20% of the human genome is currently patented.   If the Association for Molecular Pathology prevails, up to 5000 gene patents could become invalid.  This decision could cost companies billions of dollars in direct and licensing revenue.  It also affects researchers currently studying gene-related technologies and whether or not the incentive of ownership will exist in their field. 

Background on BRCA₁ and BRCA₂ genes.

BRCA₁ protein² 

BRCA₁ and BRCA₂ are tumor suppressor genes that produce proteins (Figure 1) used to fix damaged   DNA ².  The genes are expressed in breast cells (and other tissues) where it plays out its “fixing” role and prevents the formation of malignant cells.  Certain variations of the genes can lead to an increased risk of breast cancer.  The mutated BRCA₁ and BRCA₂ genes produce proteins that fail to function properly and are unable to fix certain mutations that occur in other genes. The defects accumulate allowing cells to uncontrollably grow and divide, increasing the chance of tumor formation.    As such, testing for these abnormalities can help identify individuals who are at a much higher risk for developing the disease.

There are two arguments being made in this case:

1) the patents covering these genes are simply a "law of nature" which does not constitute creating an invention; and

2) once the gene is isolated it is transformed chemically. Therefore this is an invention by mankind.

Under current U.S. law, life forms and products of nature are considered unpatentable. Has Myriad invented something beyond a product of nature? Does isolating a gene render a naturally-occurring gene something novel and patentable?  Is a gene simply a chemical compound or an information-carrying entity which, even if somehow transformed or isolated, retains this essence of being produced by nature?  Myriad said "isolated DNA is a chemical composition which is not found in nature or the human body, and which has important diagnostic and therapeutic uses that cannot be accomplished with a human's natural or native DNA ⁶."   Others argue that the mere act of isolating a gene sequence from the body does not make it man-made.

The following complaint has been put forward: if a single company owns the rights to test for this mutated gene, a number of women will not be able to afford the diagnostic. The test currently costs about $3000.  In addition, a diagnostic test that is locked up in patents prevents others from offering the test and giving a second opinion regarding subsequent treatment; something many patients find valuable.   

On the other hand, there is the issue of innovation.  Would this technology have developed without the investment backing garnered by these patents?  In the absence of this intellectual property, Myriad would not have had exclusive rights to research or test these genes.  One could argue that many more women are now able to receive this test thanks to the protection afforded Myriad by their patents. 

Nanotechnology may play a large role in gene-related technologies and this case could have large implications for a variety of potential nanotech patents.  The majority of nanotechnology-related research focusing on genes centers around drug delivery methods using nanoparticles.  For example, one group is using metallic nanostructures as a platform for surface-enhanced Raman scattering to detect BRCA cancer genes ¹³.  Another group has shown that using nanoparticle delivery systems extends the survival of mice bearing tumors derived from BRCA₁-deficient ovarian cancer cells ⁸. In yet another example, gold nanoparticles were used for label-free detection of BRCA₁ mutations utilizing DNA ligation on a DNA microarray ¹².  

In addition to nanoparticles, certain nanotechnology characterization methods are being explored as a detection method for BRCA genes. One technology, termed OPTONANOGEN (Integrated Opto-Nanomechanical Biosensor for functional Genomic Analysis), is a system being developed by the IST project  and will be used to detect mutations of the BRCA₁ gene ⁷.  The system utilizes nanotechnology to speed up the process of the genetic analysis.  According to IST, the device will be the size of a human hand will allow the test to be conducted in a matter of minutes compared to hours/days. The technology uses an array of 20 microcantilevers coated with nucleic acids that react when they come into contact with a DNA sample displaying the genetic anomaly. Interaction with the genes causes the cantilevers to deflect by a detectable amount.  This deflection, which is as little as 0.1 to 0.5 nm, is detected using lasers along with sensitive photodetectors.  The technology is similar to the Atomic Force Microscope (AFM); an instrument prevalent in nanotechnology research.  The OPTONANOGEN team has patented both the microcantilever set up and the optical detection system and more patents are currently being pursued.

There is still some debate regarding the connection between BRCA mutations and the role they play in cancer cell formation.  Some research suggests that the BRCA marker does not necessarily indicate an increased  risk of cancer ⁹. Other studies suggest that there is a difference in Ovarian cancer survival rates between women with BRCA₁ and women with BRCA₂ mutations ¹⁰.  Further studies argue that the presence of the gene is a definite marker for cancer in the opposite breast of already-diagnosed patients ¹¹.

Gene patents play a large role in both basic research and commercialization of new therapies and diagnostic testing.  As nanotechnology will undoubtedly play a role in this area of science, the fate of gene patents affects researchers and start-ups looking to protect their gene-related discoveries.  

Stay tuned for more developments in this case. 

References

 1. http://www.theatlantic.com/national/archive/2011/04/nature-vs-nurture-the-

continuing-saga-of-the-gene-patenting-case/73359/

2. http://en.wikipedia.org/wiki/BRCA1

3. http://www.myriad.com/

4. http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf

5. http://nysbar.com/blogs/healthlaw/2010/03/brca12_patents_ruled_invalid_i.html

6. http://www.ama-assn.org/amednews/2011/04/04/prsb0404.htm

7. http://www.ist-world.org/ProjectDetails.aspx?ProjectId=fb0c2149784d4f06a52dfc13b667b8b2&SourceDatabaseId=9cd97ac2e51045e39c2ad6b86dce1ac2

8. http://www.pnas.org/content/early/2010/12/21/1016538108.abstract

9.http://www.health.am/cr/more/breast-cancer-survival-rates-no-worse-for-women/

10. http://www.physorg.com/news/2011-04-brca2-mutations-survival-ovarian-cancer.html

11. http://insciences.org/article.php?article_id=8675

12. http://www.ncbi.nlm.nih.gov/pubmed/19441445

13. http://pubs.rsc.org/en/Content/ArticleLanding/2006/FD/b506341h

Patents and the Nanotechnology Age 

Nanotechnology has arrived, and with it, a whole new world of super-small structures with fascinating properties.  Since the introduction of powerful electron and atomic force microscopes, scientists and engineers have been able to peer deep into a world where objects are on the order of a billionth of a meter.  In the world of nano, objects behave differently, manifesting new and fascinating properties.  Super-hydrophobic surfaces, self-cleaning coatings, plastic electronics, ultra-small microprocessors, photonic crystals and lab-on-a-chip technology are but a few of the examples of groundbreaking research taking place in labs across the world. 

If nanotechnology fulfills its promise as the next great technological revolution, it will change the way we live.  Medical devices, clothing, coatings, cosmetics, military technologies, food products, solar power, catalysts, oil and gas…the list goes on.  The often-quoted estimate from the National Science Foundation (NSF) says the market for nanotechnology products will be over one trillion US dollars by 2015 ¹.  Other estimates have put the number even higher. Whatever the actual market numbers are, nanotechnology may prove to be one of the fastest growing industries and a strong economic force.   

Funding for nanotechnology has been aggressive. The proposed 2011 budget for the National Nanotechnology Initiative (NNI), which began in 2000, is 1.8 billion dollars.  Since 2001, virtually all developed countries have national activities in the area of nanotechnology ².  In addition to supporting basic research, commercialization incentives are assisting entrepreneurs and start-ups transfer these ideas from the bench to the market. 

A key aspect in the commercialization of any technology is obtaining patent rights.  Intellectual property rights can help secure venture capital and position both new and seasoned companies in key market areas.  Patents also provide the incentive of ownership and encourage innovation.  More than a dozen major U.S. law firms have established nanotechnology patent law specialties ⁷.

As with biotechnology in the early 80s, nanotechnology is witnessing a “land rush” to the patent office to protect new inventions as broadly as possible ⁴.  With nanotechnology poised to make such a large economic impact, the first-come-first-claim rush is inevitable.  As with any technology, claiming too broadly in a patent can spell disaster down the road if the patent does not meet the requirement for a full and complete disclosure of the invention.  Terms used in nanotechnology may be ambiguous or ill-defined making it difficult to prove a patent valid/invalid if it goes to litigation.  Litigation arises from the overlapping of patent claims and is a prominent outcome for patents with ambiguous terms. Such a situation makes litigation inevitable although only time will tell how serious the problem becomes ⁸.  Although the temptation to claim technology as broad a possible always exists, resisting such temptation and claiming with a reasonable scope may prove more valuable in the long run in terms of protecting your rights. 

In addition to dealing with a proper description and claim drafting, examiners will need to be trained to determine what does and does not constitute nanotechnology.  As such, patent offices will require individuals with the proper background.  As nanotechnology is a relatively new science, this process may take years to properly implement.

Efficient and accurate classification schemes are required to allow examiners to locate prior art related to the technology in the application.  If the terminology is vague, making a decent scheme can be problematic.   The EPO has introduced a tagging system (Y01N) and is focusing efforts on ensuring their examiners are prepared for the highly interdisciplinary nature of this new technology.  In 2004, the United States Patent and Trademark Office (USPTO) created a classification system (977) with 250 cross-reference art collection subclasses⁶ that uses the following definition:

 1) related to research and technology development at the atomic, molecular or macromolecular levels, in the    length of scale of approximately 1-100 nanometer range in at least one dimension, and

2) that provide a fundamental understanding of phenomena and materials at the nano-scale and to create and use structures, devices and systems that have novel properties and functions because of their size.

The World Intellectual Property Organization (WIPO) has identified two potential problems/challenges ⁵ that will need to be addressed regarding nanotechnology:

1) granted claims may be overly broad due to a lack of available prior art (or the ability to find it).

2) does the reproduction of a known product or structure at the nanoscale meet the requirements of novelty and/or inventive step?

The first issue may allow inventors to lock up unnecessarily large areas of technology, leading to many overlapping and invalidated patents.  Well-trained examiners and an accurate classification scheme will help to mitigate this issue.  The second part is perhaps more interesting.   If a researcher simply “shrinks” the material in question, is he/she infringing?  Could rights be granted without specification of the size?  What range of sizes are considered nano? 

These issues and many others will be explored throughout this blog site.  Nanotechnology is a fascinating area of study and an equally fascinating area of IP. Stay tuned for more nanotechpatents blogs. 

References 

1. There is an article suggesting this quote has been based on a questionable and hyped-up market analysis. See the discussion here: http://www.nanowerk.com/spotlight/spotid=1792.php

2. http://www.nano.gov/html/res/IntlFundingRoco.htm

3. http://www.ipfrontline.com/depts/article.aspx?id=708&deptid=5

4. http://www.nanowerk.com/spotlight/spotid=1919.php

5) http://www.wipo.int/patent-law/en/developments/nanotechnology.html

6) http://www.uspto.gov/web/patents/biochempharm/crossref.htm

7) http://www.azonano.com/Details.asp?ArticleID=1379

8)http://www.nanolabweb.com/index.cfm/action/main.default.viewArticle/articleID/175/CFID/549403/CFTOKEN/88339636/index.html

WELCOME

Welcome to nanotechpatents! I created this blog to highlight key issues related to intellectual property (IP) and the science of nanotechnology.  There are many issues that permeate the landscape of nanotechnology patenting.  What constitutes prior art when it comes to an extremely interdisciplinary field like nanotech? Is there a "land-rush" of researchers and companies racing to the patent office to claim their stake in nano and how does this impact your research or company? What implications are there to claiming broadly? Are the examining staff trained to deal with this relatively new field? What type of rejections/objections can you expect to be raised during prosecution?  Researchers, start-up companies, big companies, venture capitalists etc. all have a stake in this growing technology sector.  With the estimated global economic impact predicted to be anywhere between 1 - 3 trillion dollars (yes that's a t) by 2015, nanotechnology is poised to be a real game changer when it comes to investments in technology.  If you are interested in keeping up-to-date in the IP issues that relate to nanotechnology then this is the place for you.  Stay tuned. Hope you enjoy.