Category: Nanomedicine

Biotech Industry Has Reason to be Concerned About Supreme Court’s Patent Ruling

Posted Jun.30, 2012 under Bionanotechnology, Nanobiotechnology, Nanomedicine, Patents, Research, Supreme Court

On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).  A year ago, when the Court decided to hear the case, I wrote about it in this blog.  Now – a little belatedly – I am discussing the Court’s decision, as it has given the biotech industry reason to be concerned about its scope.

Prometheus was the sole and exclusive licensee of certain patents on methods for determining the optimal dosage of thiopurine drugs used to treat autoimmune diseases.  When Prometheus sued Mayo for patent infringement, Mayo argued that the patents in question were invalid because they claimed subject matter unpatentable under the Patent Act, 35 U.S.C. § 101. Specifically, Mayo argued that the patents impermissibly claimed natural phenomena – i.e. the correlations between drug metabolite levels and efficacy and toxicity – and not patentable inventions.  The district court had agreed with Mayo, but the Federal Circuit Court of Appeals reversed and held the patents valid.  In a unanimous opinion written by Justice Breyer, the Supreme Court reversed the Federal Circuit, stating that the Prometheus patents were invalid under § 101 because the process incorporates the unpatentable laws of nature and “well-understood, routine, conventional activity previously engaged in by researchers in the field.”  (p. 1294)  The Court stated:

    “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” (p. 1297)

The Court determined that the patent in question in this case did not have such “additional features.”  The Court was especially concerned that future innovation could be stifled by allowing patents on certain uses of the laws of nature.  The Court said that the measurement processes at issue in this case stated such a broad use of conventional procedures that they could be read to monopolize the field, making them unpatentable subject matter.  The Court stated:

    “We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. . . .The presence here of the basic underlying concern that these patents tie up too much future use of laws of nature simply reinforces our conclusion that the processes described in the patents are not patent eligible . . . .” (p. 1302)

Not surprisingly, the decision has raised red flags in the biotech industry, particularly in the areas of medical diagnostics and personalized medical treatments.  In an article in the most recent issue of the ABA Journal, author Steven Seidenberg examined the impact that the Mayo decision is likely to have on such innovation.  The experts consulted for the article all had concerns about the breadth of the decision and the chilling effect it might have on future innovation.  See Steven Seidenberg, New Laws of Nature Law:  Ruling Questions Scientific Patents,ABA Journal (Jul. 2012), at 20-21.

There are some issues that may need resolution going forward:

●  When a procedure is “less conventional” than the procedure at issue in Mayo, will it be patentable?  Or must it be “unconventional” to be patentable?

●  What exactly is a “conventional procedure”?

●  To what degree does the case represent a broadening of the “laws of nature” exception to §101?Those in the biotech industry will need to mull over this decision as new innovations are developed.

Those in the biotech industry will need to mull over this decision as new innovations are developed.

The Supreme Court’s decision is available at

www.supremecourt.gov/opinions/11pdf/10-1150.pdf

 The ABA Journal article is available at

www.abajournal.com/magazine/article/new_laws_of_nature_law_ruling_questions_scientific_patents/

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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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U.S. Supreme Court to Address an Issue Left Open in Bilski

Posted Jul.21, 2011 under Bionanotechnology, Litigation, Nanomedicine, Patents, Statutes, Supreme Court

supctIn 2010, the U.S. Supreme Court issued a closely-watched decision on patentable subject matter under § 101 of the Patent Act, Bilski v. Kappos, 130 S. Ct. 3218 (2010).  The Court has now granted cert in another case on patentable subject matter – Prometheus Laboratories, Inc. v. Mayo Collaborative Services, in which the Federal Circuit Court of Appeals held in 2010 that certain medical inventions met the requirements of patentable subject matter in § 101.  Prometheus was the sole and exclusive licensee of certain patents that claim methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases.  When Prometheus sued Mayo for patent infringement, Mayo filed a motion for summary judgment of invalidity, arguing that the patents in question were invalid because they claimed subject matter unpatentable under the Patent Act, 35 U.S.C. § 101. Specifically, Mayo argued that the patents impermissibly claimed natural phenomena – i.e. the correlations between drug metabolite levels and efficacy and toxicity – and not patentable inventions.  In 2008, the district court granted Mayo’s motion for summary judgment of invalidity.

In 2009, the Federal Circuit reversed and upheld the patents under the “machine or transformation” test (the sole test at the time).  The U.S. Supreme Court then decided Bilski v. Kappos, which we discussed in this blog a year ago.  In Bilski, the Court rejected the “machine or transformation” test as the definitive test of patentability, relegating that test to one factor – “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.”  130 S. Ct. at 3227.  The Supreme Court then granted Mayo’s petition for certiorari in the Prometheus lawsuit, vacated the Federal Circuit’s 2009 decision, and remanded the case for further proceedings consistent with Bilski.  The Federal Circuit decided the case on briefs, without further oral argument, and held, in light of Bilski, that Prometheus had recited patentable subject matter under § 101.  628 F.3d 1347 (Fed. Cir. 2010).  Once again, the Supreme Court granted certiorari, and the Court will hear the case in the term that begins in October, 2011.

Although the Supreme Court has consistently construed § 101 broadly, the section does have limits.  The Federal Circuit described one limitation as follows:

The Supreme Court has . . . established that while a law of nature, natural phenomenon, or abstract idea cannot be patented, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”

628 F.3d at 1354 (quoting Bilski, 130 S.Ct. at 3230) (emphasis added).  This is the core of the issue to be decided by the Supreme Court. 

As my co-blogger, Eric Laury, now J.D., stated in his earlier post about Bilski, “biotech and nanotech patents are not theoretically involved with . . . a machine nor do they transform matter.”  Bilski was good news for the bionanotech industry, but the case left loose ends.  Now it appears that the Supreme Court will take another step in the direction of defining patentable subject matter for the brave new world of modern inventions.  Nanotech firms, particularly those working in the area of biotechnology, should be closely watching the Supreme Court’s next move.

Mayo presented the following question in its cert petition:  “Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations’ of body chemistry.”

I suspect the fact that the Court granted cert a second time in Mayo v. Prometheus may not be a good sign for Prometheus.  It may mean that the Court had been expecting the Federal Circuit to reach the opposite result and wants to set the record straight.  On the other hand, the Court may further refine its definition of patentable subject matter under § 101 in a way that may achieve middle ground between innovation and patent protection.

The Federal Circuit’s 2010 decision may be accessed at

http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1403.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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The Gulf Spill and 9/11: What These Disasters Can Teach Us About Studying the Health Impacts of Nanotechnology

Posted Sep.02, 2010 under Chemicals, Cosmetics, Drugs, Environment, EPA, Food, Governmental Interaction, Health, Nanomedicine, Nanotoxicology, Pesticides, Research, Safety
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What do the Gulf oil spill, the attacks on the World Trade Center on September 11, 2001, and nanotechnology have in common?  On the surface, it would seem to be nothing.  But all three involve responses to potential health and environmental threats that are instructive about how we as a society respond to such threats.  Collectively, they raise some important issues regarding how our society views health and environmental risks in general.

 Don’t get me wrong.  In no way am I suggesting that nanotechnology is comparable to the disasters at Ground Zero or in the Gulf.  Rather, I am asking that you look at how government and funded research institutes manage long-term health and environmental effects that occur as a result of chronic low-dose exposures over time.  The potential health hazards of nanotechnology fall into the long-term category.  We don’t expect to see any acute health problems associated with nanotechnology, but we should be concerned about long-term exposures, and existing efforts to study the effects should be expanded.

 Let’s contrast what happens when there is a disaster.

 On August 19, 2010, administration officials reaffirmed their commitment to the recovery and restoration of the Gulf in the aftermath of the Deepwater Horizon oil rig explosion and the subsequent movement of oil into the waters and the ecosystems of the Gulf.  The media outlets have been full of video, photographs, and articles about the efforts of many organizations, companies, and governmental entities to clean up and minimize the potential harm to natural resources, the environment, and all forms of life.

 Not so long ago, something similar went on at Ground Zero in the aftermath of the collapse of the World Trade Center towers following the 9/11 terrorist attacks.  Early on, the focus of efforts at Ground Zero was on the search for survivors.  On September 29, the focus turned to recovery and cleanup, including removal of debris.  But even before that date, the federal, state, and local governments were engaged in managing the environmental disaster that resulted from the release of hazardous substances into the air, including asbestos, silica, lead, mercury, polycyclic aromatic hydrocarbons (PAHs), dioxin, polyvinyl chloride (PVC), Freon, and polychlorinated biphenyls (PCBs), to name a few.  Workers from FDNY, NYPD, Port Authority of New York and New Jersey, emergency medical personnel, and a host of volunteers worked at the site.

 It is easy to assign massive resources to the acute phase of a disaster, but much harder to sustain interest and funding as time goes on.  Eventually the media will move on to other stories now that the Macondo well is just about sealed, as it eventually did when the cleanup at Ground Zero was completed.  Funds have been established to make payments, lawsuits commenced.  But what lingers is the reality of long-term health effects that could emerge over time – ecosystem damage or cancer or other health risks.  Society has a certain myopia about such things.  Perhaps it is human nature to not want to think about the health problems that could arise years down the line.

 The protracted task of developing valid scientific studies on the health effects of any exposures, including nanoparticles, and interpreting the results is as essential as responding to the acute phase of a disaster.  Disasters like the Gulf spill and 9/11 suggest a kind of false dichotomy – that acute harms are more worthy of recognition in the law than chronic long-term harms.  The long-term harms may seem less urgent, but there is nevertheless an urgency about them as well.

 For example, following the Exxon Valdez oil spill in 1989, no concerted effort was made to assess the health effects of the cleanup on workers.  Years later, surveys told the story of respiratory and neurological illness.  This month, the National Institute of Environmental Health Sciences announced it would begin a study of the potential health effects of exposures of workers and residents as a result of the Gulf oil spill.  Even in the 9/11 context, where health screenings of Ground Zero responders have been ongoing since 2002, and a data base has been established, acceptable compensation has come nearly a decade after the disaster.  The law is slower to recognize the harms from chronic exposures, and slower to act to both compensate the injured and prevent further harm.  Clearly, some of this is a result of symptoms and other harms emerging over time.  But this is all the more reason to be vigilant and investigative from the start.

 Far from the spotlight of a high-profile disaster, and in the absence of a clearly exposed population to screen, studies on the health and environmental effects of exposures to substances about which we know little is essential.

 As mentioned, nanotechnology is not a disaster.  Far from it.  It is a means for creating better medical therapies, making some of our technology perform better, and offering consumers desirable features in everyday products such as textiles and cosmetics.  But this does not eliminate the need to make a concerted effort to study the long-term health and environmental effects of nanoparticles and nanomaterials.  No matter how long it takes; no matter how far out of the spotlight.

 For those interested in knowing more about the toxic aftermath of Ground Zero, see my article, Toxic Torts at Ground Zero, 39 ARIZ. ST. L.J. 383 (2007).

On the need for studies of the health impact of the Gulf spill, see

Gina M. Solomon & Sarah Janssen, Health Effects of the Gulf Oil Spill, J.A.M.A. (Aug. 16, 2010), available at http://jama.ama-assn.org/cgi/content/full/jama.2010.1254v1

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The Coming Age of Nanomedicine

Posted Aug.31, 2010 under Artificial Molecular Machines, Bionanotechnology, Drugs, Health, Nanobiotechnology, Nanomedicine, Patents
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I recently came across a very interesting article that was written in the Summer of 2008, Nanoparticle-based Therapies in Humans: A Survey, available at http://www.rpitechnology.com/files/NANOPA4.pdf. The subject matter deals with medical therapies for humans that contain nanoparticles. The author explores the emerging area of medicine that incorporates nanotechnology to fill the gaps of traditional delivery systems (i.e. poor water solubility and lack of target specificity). In addition to gap filling, the therapies stand poised to take the medical field to a whole new level, and will pose a myriad of challenges for the FDA, the U.S. Patent and Trademark Office (PTO), and patent attorneys worldwide.

Some Broad Background:

It is important to understand why nanoparticles are responsible for the proliferation of a new way to deliver medicine to the ailing human body. Traditional delivery systems lack the specificity element and the medicine tends to be delivered in higher than necessary doses that could lead to possible toxic exposure to the patient. Also, the human body is a hostile environment which reduces the effectiveness of traditional drugs.

The author of the article pointed out the following benefits with regard to the developments in nanomedicine:

Nanoparticles are selected for properties such as biodegradability, biocompatibility, conjugation, complexation or encapsulation and their ability to be functionalized. There are two types of nanoparticle-based therapeutic formulation: (1) those where the therapeutic molecules are the nanoparticles (therapeutic functions as its own carrier); and (2) those where the therapeutic molecules are directly coupled (functionalized, entrapped or coated) to a carrier.

Another important and desirable property of nanoparticles is the “surface area effect” that occurs. As a particle’s size decreases, the number of atoms on its surface increases relative to those at the core. This results in an exponential increase in reactivity which equates to increased efficiency and effectiveness over larger molecule delivery systems.

Patents and Commercialization:

It is critical for a company to obtain valid patents if they have any hope to profit from the research and development efforts of producing a new drug delivery system. According to the author of the article I read, the current state of nanoparticle patents is confusing at best. He states, “the proliferation of nanoparticle patent applications filed at the PTO, coupled with the continued issuance of surprisingly broad patents by the PTO, is creating a chaotic, tangled patent landscape where competing players are unsure as to the validity and enforceability of numerous issued patents.”

In an earlier post, Nanobots, Patents, and Collaboration, I proposed that innovation through collaboration is likely the most ideal way to navigate in this emerging area of technology. It seems as though there is no clear guidance in light of the Bilski decision, other than the probability is high that broad patents will continue to issue (not a bad thing, but not helpful to those involved in developing the multilayered drug delivery systems). I find myself a bit conflicted because I am a proponent of patent protection, but I am a realist and understand that the smaller the technology goes, the more overlap that occurs between competing patents. Again, I assert that collaboration is key and I look forward to participating in the process.

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Remote Control Behavior: The Latest Development in Magnetic Nanoparticles

Posted Jul.15, 2010 under Artificial Molecular Machines, Bionanotechnology, Health, Nanobiotechnology, Nanomedicine, Research

nanotechnology-on-health-area-photoThe University of Buffalo recently unveiled a dramatic development in the nanotech realm. Through the use of magnetic nanoparticles it is possible for scientists to “remotely control ion channels, neurons and even animal behavior.” There are many possible real-world applications of this technology including targeted cancer, diabetes, and neurological disorder treatments.

The method utilized in the control of animal behavior involves the use of magnetic nanoparticles which have entered into the cell membrane of the nematode C. Elegans. The size of the particles, only six nanometers, is essential for the easy movement into the cell membrane. Once situated, the subject was exposed to a magnetic field (much like the intensity of an MRI) and the nanoparticles were heated to 34 degrees Celcius (93.2 degrees Fahrenheit). The worms, which had been moving in a forward direction, move in the opposite direction when the temperature rose.


Group of C. Elegans worms prepared by UB team with nanoparticles at their sensory neurons respond to the application of a magnetic field. To learn more, visit http://www.buffalo.edu/news/11518

“We targeted the [magnetic] nanoparticles near what is the ‘mouth’ of the worms, called the amphid,” explained Arnd Pralle, PhD, assistant professor of physics. “You can see in the video that the worms are crawling around; once we turn on the magnetic field, … most of the worms reverse course. We could use this method to make them go back and forth. Now we need to find out which other behaviors can be controlled this way.”

The implications of this breakthrough could just as easily be applied to humans. Already, there are groups utilizing magnetic nanoparticles to battle cancer cells in a very targeted manner. But, the net is cast wider with the application to remotely controlling animal and human behavior.

In the legal arena, one could pose the question “Is this discovery worthy of patent protection?” Post Bilski, 2010 WL 2555192, the question might easily be answered with regard to patentable subject matter and processes. Now that the machine or transformation test is not exclusively definitive, it is more likely than not the process of heating magnetic nanoparticles to cause a living organism to behave differently would clear the first hurdle on the path to a patent. Of course, the battle would continue in the ‘non-obvious’ and ‘prior publication’ stages, however, innovation is not stifled and the legal battles rage on.

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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
Wikimedia

Wikimedia

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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