Category: DNA Nanotechnology

Victory for Biotech Patents Sheds Promising Light on the Future of Nanotechnology

Posted Aug.12, 2011 under Artificial Molecular Machines, Bionanotechnology, DNA Nanotechnology, Federal Circuit, Nanobiotechnology, Nanomedicine, Patents, Research
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In May 2009, the American Civil Liberties Union and the Association for Molecular Pathology filed suit, in the United States District Court for the Southern District of New York, against the United States Patent and Trademark Office and Myriad Genetics. The complaint pertained to patents that were granted on the BRCA1 and BRCA2 human genes that are mutations correlated to the increased risk of breast or ovarian cancer.  Myriad Genetics designed a procedure to test for these mutations to indicate the likelihood of a woman developing either or both of the diseases.  The complaint asserted that patents on genes should not be allowed because they are violative of § 101, patentable subject matter, of the Patent Act, namely all three of the judicially recognized exceptions to patentability:  natural phenomena, laws of nature, and abstract ideas. Subsequently, the American Civil Liberties Union and the Public Patent Foundation filed a motion for summary judgment, in August 2009.  On March 29, 2010, the District Court found that the isolated segments of DNA utilized for the diagnostic tests were “not markedly different from native DNA as it exists in nature” and held the patents granted to Myriad were not valid.  Ass’n. for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010).


On July 29, 2011, the United States Court of Appeals for the Federal Circuit reversed the decision of the district court stating “the molecules as claimed do not exist in nature.”  According to a report on msnbc.com, Bruce Wexler, a partner in the law firm Paul Hastings, commented “[t]he appeals court has now held that isolated DNA is patent eligible, and it recognized that isolated DNA has a different molecular structure than DNA as it exists in the body. That is a very significant result that is very important to the biotech industry.”

    
This decision is equally important to the future of the nanotech industry because the starting point for nearly all nanoparticle inventions is the same as biotech – nature.  While it is well established that those materials found in nature are not patentable, the Federal Circuit has signaled its acknowledgement of the intellectual investment inherent in the advancement of science.  There would have been seismic effects on the future of biotech and nanotech development had the district court’s decision been affirmed.  For now, it is full steam ahead for the scientists and investors.   

For further information, see an earlier post I wrote – Patents on Genes and the Future of Personal Nanomedicine.

Read the full Federal Circuit decision here: http://www.aclu.org/files/assets/10-1406.pdf

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Patents on Genes: A Preview of the Legal Battle to Come for Nanotechnology?

Posted Nov.15, 2010 under Bionanotechnology, DNA Nanotechnology, Governmental Interaction, Health, Litigation, Nanobiotechnology, Nanomedicine, Patents

nano 5

In an earlier post, I wrote about the consternation surrounding patents on genes and the potential implications to the developing realm of nanotechnology.  Recently, an amicus brief was filed with the Federal Circuit by the Department of Justice (DOJ) opposing the patents that were issued to Myriad regrding the testing for breast and ovarian cancer.  Interestingly, the United States Patent and Trademark Office (USPTO) did not join the DOJ, which indicates an idealogical rift in the Obama administration.  It was reported that Mr. Kappos, current director of the USPTO, ”seemed chagrined that the Department of Justice was taking a viewpoint very different from the patent office.”

The following is an excerpt from the amicus brief Table of Contents which is rather revealing and informative regarding the government’s opinion on the matter:

A. Section 101 Embraces Only “Human-Made Inventions”
B. Engineered DNA Molecules, Including cDNAs, are Human-Made Inventions Eligible For Patent Protection
C. Isolated But Otherwise Unmodified Genomic DNA Is Not A Human-Made Invention
1. Unmodified Genomic DNA Is A Product Of Nature
2. “Isolation” Does Not Transform A Product Of Nature Into A Man-Made Invention
3. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is A Literal Composition Of Matter
4. Isolated Genomic DNA Is Not Rendered Patentable On The Theory That It Is “Pure”
5. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify

It is important to note that the DOJ is not advocating an all-out ban on patents on genes, just those that are ‘unmodified.’  Initially, this will allow for further development of the information contained in the genomic code.  It seems as though the big argument revolves around the pieces of the code that are isolated, but not changed in any way.  Proponents assert that there should not be the reward of patent protection based solely on finding that which already naturally occurs.  Opponents argue that invention and development of specified uses for these segments of DNA would be stiffled, and the United States’ position as a global leader in the life sciences would be severely compromised.

It will be interesting to watch the development of the subject matter as it works its way through the Federal Circuit, and presumably the Supreme Court.  Not only for the impact it will have on the biotechnology arena, but also on nanotech.  As mentioned before, many argue that the majority of inventions involving nanotechnology do not qualify for patent protection because they are not far enough removed from the naturally occurring material they are comprised of.  We shall see.

Link to the DOJ brief:

http://graphics8.nytimes.com/packages/pdf/business/genepatents-USamicusbrief.pdf

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Patents on Genes and the Future of Personalized Nanomedicine

Posted Sep.18, 2010 under Bionanotechnology, DNA Nanotechnology, Health, Litigation, Nanobiotechnology, Nanomedicine, Patents, Statutes
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The nexus of a large number of nanotech inventions, specifically related to personalized medicine, is biological material and other naturally occurring materials.  In order to obtain a patent, the inventor is essentially required to create a new composition of matter from that which occurs naturally.  Until recently, scientists and inventors alike have been able to satisfy this requirement, but change might be on its way.

In May 2009, the American Civil Liberties Union and the Association for Molecular Pathology filed suit, in the United States District Court for the Southern District of New York, against the United States Patent and Trademark Office and Myriad Genetics. The complaint pertained to patents that were granted on the BRCA1 and BRCA2 human genes that are mutations correlated to the increased risk of breast or ovarian cancer.  Myriad Genetics designed a procedure to test for these mutations to indicate the likelihood of a woman developing either or both of the diseases.  The complaint asserted that patents on genes should not be allowed because they are violative of § 101, patentable subject matter, of the Patent Act, namely all three of the judicially recognized exceptions to patentability:  natural phenomena, laws of nature, and abstract ideas. Subsequently, the American Civil Liberties Union and the Public Patent Foundation filed a motion for summary judgment, in August 2009.  On March 29, 2010, the District Court found that the isolated segments of DNA utilized for the diagnostic tests were “not markedly different from native DNA as it exists in nature” and held the patents granted to Myriad were not valid.  Ass’n. for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010) available at http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf.

This particular case involved the nature of medical tests utilized to screen women for the specific types of cancer.   Myriad holds (held) patents on the two genes that indicate the likelihood of the woman developing cancer.  Two main issues precipitated the litigation.  First was the fact that Myriad charges more than three thousand dollars for its exclusive Comprehensive BRACAnalysis test.  This exorbitant cost prohibited many women from being able to have the test, placing them at an increased risk of developing cancer.  It was asserted that if Myriad would license the test, the cost would become more reasonable and allow for more women to benefit from the technology.  This is the specific goal of personalized medicine; however that goal is more often thwarted by the exclusionary nature of patents (absent licensing and/or collaboration).

The second concern arose from those women who actually undergo testing and are delivered a positive diagnosis for possible development of cancer.  Because Myriad held the patent on the test, the women were prevented from obtaining a second opinion to confirm the results prior to deciding to undergo preventative surgery. Examples of such prevention include radical mastectomies and ovarian removal surgery.  The combination of these concerns cuts directly to the heart of the ongoing debate:

Should patents on biological material be allowed, and if so, what does that mean for the future of scientific research and the development of personalized medicine?

The precursor to this debate harkens back to the California Supreme Court case of Moore v. Regents of the Univ. of Calif., 793 P.2d 479 (1990), where the court was asked to decide if a cancer patient had any property rights in a commercially viable invention created from his particular cancer cells.  The court ultimately decided that the plaintiff did not have any property rights in his biological materials because they considered the material discarded.  The same debate takes place today with regard to human DNA, but no specific human has a specific property right to a specific segment of the human genome.  As a result, scientists are able to use raw DNA and patents on genes are issued if the inventor/scientist has isolated a particular gene from its naturally occurring form, essentially creating a new composition of matter.  However, in light of the decision in Myriad, the fate of thousands of patents (issued and pending) might be uncertain.

Of course, I will bring the focus back to the challenges awaiting nanotechnology in the fields of personalized medicine, molecular biology, etc.  As I stated in the beginning of this post, the nexus of a large number of nanotech inventions is biological material and other naturally occurring materials.  We know from the patentable subject matter paradigm, now including Bilski, that there still exists a broad spectrum of possibilities of what is considered a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof . . . .”  35 U.S.C. § 101.  But, is there restriction on the horizon as a result of the Myriad decision?  Only time will tell.    

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Patentable Subject Matter Paradigm Evolves: Bilski’s Impact on Nanotechnology

Posted Jul.01, 2010 under Artificial Molecular Machines, Bionanotechnology, DNA Nanotechnology, Litigation, Nanobiotechnology, Nanomedicine, Research

supct

The paradigm to determine the patentability of inventions involving nanotechnology and biotechnology continues to evolve due to the Supreme Court deciding the case of Bilski v. Kappos, 2010 WL 2555192.  The Court heard oral arguments on November 9, 2009, and the opinion was issued on Monday, 28 June 2010.

The trouble for Bilski began when he and his business partner, Warsaw, applied for a patent on a computerized method for incorporating weather information into the speculation of future prices of commodities and energy costs (business method). The claim was denied by the Patent and Trademark Office (PTO) for lack of patentable subject matter (process), and the denial was affirmed in subsequent appeals to the PTO and the Federal Circuit. The Supreme Court decision affirmed the denial of the business method’s patentability, but it simultaneously held the test, utilized by the Federal Circuit, for determining if a process is proper patentable subject matter was not the exclusive and sole determining factor. Going forward, this decision will have a major impact on what constitutes patentable subject matter (the first hurdle on the road to a patent being issued), including those discoveries that have helped to fuel the explosion of cutting-edge bio/nanotechnology.

BACKGROUND OVERVIEW

Throughout the litigation history, the focus was squarely on the ‘machine or transformation’ requirements articulated by the PTO and further solidified by the Federal Circuit.  The court relied on the two prong test set forth in Gottschalk v. Benson to determine whether a process claim is tailored narrowly enough. “A claimed process is surely patent-eligible under § 101 if:  (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” The Federal Circuit outlined the task at hand, “It is undisputed that [Bilski’s] claims are not directed to a machine, manufacture, or composition of matter. . . . Thus, the issue before us involves what the term ‘process’ in [the law] means, and how to determine whether a given claim . . . is a ‘new and useful process.’”  Essentially, the legal issue generating all the consternation and strife is: “[W]hat test or set of criteria governs the determination by [PTO] or courts as to whether a process is patentable?”  The Federal Circuit opined that a process is not patentable subject matter unless it exactly conforms with the ‘machine or transformation’ test.

THE SUPREME COURT

The Supreme Court agreed to hear the case, but rarely hears a case from the Federal Circuit to explain that they reached the correct and appropriate conclusion. Quite to the contrary, the Supreme Court seems to take case after case in the patent area to fix a wrong perpetrated by the Federal Circuit. This tension has been in place for quite some time.

At oral arguments before the Supreme Court, Justice Sotomayor voiced concern over the harsh majority opinion of the Federal Circuit:

How about we say something as simple as patent law does not protect business matters instead of what the Federal Circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling will impose in the computer world, in the biomedical world, all of the amici who are talking about how it will destroy industries?

That sentiment reverberated in the unanimous majority opinion whereby the ‘machine or transformation’ test was relegated to the role of a helpful clue in determining whether or not a process is patentable subject matter. Essentially, the Court rejected the Federal Circuit’s exclusive reliance on the bright-line rule and threw the proverbial ball back into their court to develop an appropriate test. The bottom line, as it stands now, is that patentable subject matter is still quite broad, and the analysis to determine it includes the ‘machine or transformation’ test as one criterion with regard to processes, but it no longer is the sole deciding factor.

ONWARD

If the Supreme Court had required strict adherence to the machine or transformation test, it would have had seismic implications for patents already issued, and certainly would have caused trouble for pending applications relating to biotechnology and nanotechnology.  The trouble arises from the precarious position that biotech and nanotech patents are not theoretically involved with either a machine nor do they transform matter.  Generally speaking, they are processes involved with analysis, diagnosis, treatment or some type of function. Notable examples are those nanoparticles involved in drug delivery. Even though the particles behave differently at the nanoscale level, they essentially are not transformed or part of a machine and would thus fall outside patent protection under the rigid Federal Circuit test. Now, there is a least the possibility for these types of inventions to move forward in the process of patentability.

Ultimately, the parties in Bilski did not receive the patent on the specific business method that was applied for; however, the patent world at large was able to avoid the strictures of the rigid, bright-line ‘machine or transformation’ test utilized by the Federal Circuit .  In essence, the fields of nanotechnology and biotechnology research and development dodged a catastrophic bullet. In the coming weeks and months I plan to return to this discussion in relation to emerging technology, especially after the PTO, practitioners, judges, and legislators have had time to digest the nuances of this landmark decision.

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Nanobots, Patents, and Collaboration

Posted Jun.15, 2010 under Artificial Molecular Machines, Bionanotechnology, DNA Nanotechnology, Nanobiotechnology, Nanomedicine, Research
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It is clear that the time has come to integrate cutting-edge science and the law.  In addition to the policy issues involving individuals, it is important to our nation because we must continue our leading role as the innovators of the world.  Furthermore, there is a tremendous amount of money at stake for our economy.  Historically, the method by which to protect the vast amount of money that is invested and earned from scientific research is patent protection.  That must continue.  However, a possible starting point for compromise is collaboration between scientists who invent a new and useful product, derived from biological material, and those who wish to utilize the technology to further the development of particular areas of science leading to additional inventions.

A prime example of a partnering between two groups of scientists in the realm of nanotechnology and biotechnology is that of the DNA robot.  Researchers from Columbia University, Arizona State University, and Caltech have created a Nanobot that follows a programmable path on a surface patterned with DNA (more commonly referred to as DNA origami). Simultaneously, researchers from New York University, led by Ned Seeman, have combined multiple DNA devices to make an assembly line. The DNA robot picks up gold nanoparticles while navigating along a DNA-labeled surface.  The details were released in the May 13th edition of Nature:  http://www.nature.com/nature/journal/v465/n7295/pdf/nature09012.pdf.

Essentially, scientists are at the beginning stages of creating test-tube factories that have the potential to create self-assembling computers, rare chemical compounds or autonomous medical robots able to embark on specialized missions in the human bloodstream. “[We’re] moving from individual entities that do something interesting to systems of entities working on something with a more complex behavior and function,” says Lloyd Smith, a chemistry professor at the University of Wisconsin-Madison.

The California Institute of Technology has applied for a patent on DNA origami, invented by Professor Rothemund.  NYU owns a patent on nano-robotics as a result of the pioneering research conducted by Professor Seeman.  The collaborative effort of these two groups reflects the benefits that are possible through non-enforcement of patents in the early stages of scientific development.  Furthermore, as a result of the partnering, it would be unnecessary for the government to get involved in the regulation of innovation.  A natural outflow of a collective approach would be the development of self-regulating industry standards to shape and guide the evolution of  the interaction between science and the law.

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Nanotechnology, Biotech Patents, and Personalized Medicine

Posted Apr.08, 2010 under Bionanotechnology, DNA Nanotechnology, Health, Nanobiotechnology, Nanomedicine, Safety, Statutes
http://www.techwall.org

http://www.techwall.org

As technology in the bioscientific realm advances, there is an emerging body of law pertaining to patents on biological material, which focuses squarely on the hotly contested areas of personalized medicine and nanotechnology.  Personalized medicine is the practice of creating therapies for the specific genetic profiles of patients and their diseased cells.  Examples of the nanotechnology involved include cancer treatment, bio sensors, bio markers, bio imaging, and drug delivery systems.  The controversies are beginning to form and the potential for litigation is building.  Are these inventions worthy of patent protection?  What happens to these particles after they perform the specific task they were designed to carry out?  Is it a health issue, environmental issue, both?  These are the types of inquiries I am interested in exploring.  By no means do I purport to have expertise in ANY of the myriad fields I plan to touch on, but I am curious, though, and look forward to initiating a robust dialogue with those who are experts or those who are passionate about the direction of the law in these areas.

With that being said, I would like to begin with a broad and general overview of the current patentability issues.  The first hurdle in the patent process is actually having something that is patentable subject matter.  The nexus of the debate is 35 U.S.C. § 101 which provides:  “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.”  The statute is inherently ambiguous and has enjoyed broad interpretation, when applied by the courts, to determine if something is actually patentable subject matter.  See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (statutory subject matter “include[s] anything under the sun that is made by man.”).  However, the statute does not afford limitless possibilities and probabilities to the inventors of the world.

There are three specific categories that are off limits to the powers afforded by obtaining a patent:  the laws of nature, physical phenomena, and abstract ideas.  Diamond v. Diehr, 450 U.S. 175, 185 (1981).   The primary reasoning for unpatentability was articulated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), whereby the Court reasoned that, although these three categories could be discovered, they ultimately “are the basic tools of scientific and technological work.”  The rationale is simple, if these basic building blocks of nature were allowed the protective rights of a patent, specifically the right to exclude others from practicing the inventions or discoveries, the world of research would be drastically encumbered and hindered.  These excluded categories, the basic building blocks, are utilized by scientists, inventors, and theorists to create patentable subject matter.

While the discovery of any of the three excluded categories does not qualify for patentability, the application of them that leads to a new and useful process, machine, manufacture, or composition of matter, may very well lead to a patent, including those that have helped to fuel the explosion of scientific research in biotechnology.  Diehr, 450 U.S. at 187.  Those developments have spawned the creation of personalized medicine.  Science is moving forward and is forcing the law to keep pace.

The paradigm to determine the patentability of nanotechnology related to biological material might be altered in the near future due to the Supreme Court hearing the case of In re Bilski (the discussion of this case and the implications of the opinion has the potential to occupy many future posts).  The Court heard oral arguments on In re Bilski on November 9, 2009, and the forthcoming opinion in that matter will have an impact on the patentability of processes, including those that have helped to fuel the explosion of scientific research in biotechnology.  As a result, the development of personalized medicine hangs in the balance.

In addition to the legal, scientific, and ethical debates, there are the personal policy concerns.  A few worth mentioning are those relating to autonomy, freedom to make decisions about resolving/preventing health issues, the right to feel safe about the treatments we receive, and the list goes on.  The point I am trying to make is that we are on the precipice of a new era with the interaction of nanotechnology, personalized medicine, and the law, and we stand to gain more than we could ever have imagined or we stand to lose more than we ever bargained for.

Personalized Medicine Coalition,

www.personalizedmedicinecoalition.org/communications/TheCaseforPersonalizedMedicine _5_5_09.pdf

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