Archive for the ‘Intellectual Property’ Category

Four patents and one patent application on Nanopore Sequencing and methods of trapping a molecule in a nanopore assigned to Genia, is been claimed in a Law Suit by The Regents of the University of California, should be assigned to UCSC

Reporter: Aviva Lev-Ari, PhD, RN


The university claims that while at UCSC Roger Chen’s research focused on nanopore sequencing, and that he along with others developed technology that became the basis of patent applications filed by the university. However, when Chen left the university in 2008 and cofounded Genia, he was awarded patents for technology developed while he was at UCSC, but those patents were assigned to Genia and not the university, according to the suit.

In the suit, the university notes four patents and one patent application assigned to Genia that it claims should be assigned to UCSC: US Patent Nos., 8,324,914; 8,461,854; 9,041,420; and 9,377,437; and US Patent Application 15/079,322. The patents and patent applications all relate to nanopore sequencing and specifically to methods of trapping a molecule in a nanopore and characterizing it based on the electrical stimulus required to move the molecule through the pore.

Genia was founded in 2009, and in 2014, Roche acquired the startup for $125 million in cash and up to $225 million in milestone payments. Earlier this year, the company published a proof-of-principle study of its technology in the Proceedings of the National Academy of Sciences.

Roche’s head of sequencing solutions, Neil Gunn, said that Roche would announce a commercialization timeline in 2017.

It’s unclear how the lawsuit will impact that commercialization, but Mick Watson, director of ARK-Genomics at the Roslin Institute in the UK, speculated in a blog post that if the suit is decided in favor of UCSC, it could result in a very large settlement and potentially even the end of Genia.






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Interview with Bill Zurn, Scientist and Inventor in http://www.globalinnovationmagazine.com October 2016″

Reporter: Aviva Lev-Ari, PhD, RN


BILL ZURN’S drill bit & cylinder patent was issued on Oct 11, 2016. 

US Patent 9,464,487





Permission to Re-Publish Interview with Bill Zurn

“This interview was first featured in www.globalinnovationmagazine.com October 2016″.

From: clifford.thornton@gmail.com

Date: Fri, 14 Oct 2016 02:21:39 -0400

Subject: Fwd: Request permission to re-publish William Zurn Interview – Leaders in Pharmaceutical Business Intelligence (LPBI) Group

To: wilzur@msn.com

CC: avivalev-ari@alum.berkeley.edu; jamesoflynn@hotmail.com; clifford.thornton@gmail.com


Per James O’Flynn and his forwarded Email below, he is fine with you re-publishing the interview in LPBI.  He has granted you permission for that initiative. 

He has requested, as a condition of that permission, to note in the related LPBI publication/ re-publishing, “This interview was first featured in www.globalinnovationmagazine.com October 2016″.



———- Forwarded message ———-

From: james oflynn <jamesoflynn@hotmail.com>

Date: Fri, Oct 14, 2016 at 2:01 AM

Subject: Re: Request permission to re-publish William Zurn Interview – Leaders in Pharmaceutical Business Intelligence (LPBI) Group

To: Clifford Thornton <clifford.thornton@gmail.com>

That’s fine, I would like it noted in their publication though i.e. ‘This interview first featured in www.globalinnovationmagazine.com October 2016′



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Reporter: Aviva Lev-Ari, PhD, RN

Each year the recipient(s) of the Warren Alpert Foundation Prize are recognized at a scientific symposium hosted by Harvard Medical School.

OCTOBER 6, 2016 –

1:30PM TO 5:30PM


The CRISPR/Cas9 Revolution and Gene Editing

In honor of Rodolphe Barrangou, Emmanuelle Charpentier,  Jennifer Doudna, Philippe Horvath, Viginijus Siksnys for remarkable contributions to the understanding of the CRISPR bacterial defense system and the revolutionary discovery that it can be adapted for genome editing.

Harvard Medical School
The Joseph B.Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

RSVP: HMS_events@hms.harvard.edu
Seating available on a first-come first served basis

Opening Remarks

Barbara J McNeil, MD, PhD, Acting Dean, HMS

Warren Alpert a very prestiguos Prize for advancements in Medicine, Treatment of disease and alleviation of suffering

Clifford Tabin, MD, Prof. of Genetics at HMS

  • CRISPR as regulatory system

Featured Speakers include:

Rodolphe Barrangou, PhD
Todd R. Klaenhammer Distinguished Scholar in Probiotics Research
North Carolina State University
CRISPR-mediated immunity in bacteria: discovery and applications


Philippe Horvath, PhD
Senior Scientist
CRISPR-mediated immunity in bacteria: discovery and applications

  • CRISPR-Cas: basics, history, applications, future
  • cas1 (larger number of spacers) and Cas 2 almost universal
  • DNA repeate in preKariotes, 2002 Milk coagulation, dairy industry – lactic acid, bacteriaphaging – failure of fermentation


  • 2005 outstanding spacer polymorphism
  • CRISPR genotype – phase sensitivity & resistance correlation
  • CRISPR – Mechanism of Action
  • 8/2005 Patent of bacteriaphage – Eureka:comercialization in 1990 200 sequence resistance to phage – Anti Phaging Hypothesis
  • certain spacers in genome cross immunity against the phage –
  • Spacers: engineeringCRISPR-encoded immunity resistence against phaging: ad spacer gain resistence
  • cas9 disruption >> loss of phage resistence in dairy bacteria
  • csn2 disruption -.. no subsequence acquisition of spacers
  • no phenotypic resistance loss
  • RNSi – A putative RNA-interference-based immune system
  • Science 2007
  • Discovery of the CRISPR motif (PAM): resistence in Streptococcus Thermophilus
  • Immunity is mediated by small CRISPR RNAs (crRNAs)
  • CRISPR Immunity – DNA encoded in bacteria
  • CRISPR/Cas bacterial immune system cleaves bacteriaphage and plasmid DNA, Nature 11/2010
  1. Immunization
  2. Interference with expression of immunity – with invading nucleus by viral DNA infection

Applications for CRISPR

  1. Bacterial strain typing
  2. natural vaccination against phages: CRISPerization (cultivation, plating)
  3. Natural genetc tagging
  • signature in the genome – genetic tag
  • strain identification
  • Patent for phage genome editing in 2009
  • Lethal self-targegting in bacteria programmable antimicrobial is death
  • genotype of interest selected
  • Agriculture applications: contamination in food, starters probiotics

Perspective on last Decade  

  • phage resistance phenotype
  • In silico & predictions in vitro
  • success in Crops, Food, Animals
  • Matters: IP (file for Patent, convert, publish), PR, Reg

Emmanuelle Charpentier, PhD
Prof. Dr.; Scientific Member of the Max Planck Society, Max Planck Director
Professor, Umeå University
The transformative genome engineering CRISPR-Cas9 technology: lessons learned from bacteria

  • Non-infectious Disease: Cancer, Heart Genetic, Brain
  • Infectious Diseases: Transmiable & Comnunicative
  1. Bacteria
  2. Viruses
  3. funcgi
  4. parasites
  • Enzyme Cas9 S. Pyogenes: Group A Strep
  • spacer acquisition – crRNA expression and maturationng CRISPR-CAS evolved into 6 types
  • Human Bacterial host
  • An mRNA : Type II CRISPR -Cas locus: TracrRNA – pre-crRNA
  • Cas9 requires tracrRNA:crRNA to cleave DNA
  • Genome editing with sequence specific nucleatease
  • RNA -programmable CRISPR -Cas9
  • Applications of CRISPR-Cas9 in human medicine: sequencing of Human genome – gene therapy to an organ, genetic predisposition of diseases
  • trcrRNA is associated to Type II CRISPR-Cas
  • Interchangeability among dual-RNA-Cas9 orthologs
  • Cpf1 – Type V-A
  • Adaptive Immune system
  • Mechnism of maturation of CRISPR-RNA

Jennifer Doudna, PhD
Li Ka Shing Chancellor’s Chair in Biomedical and Health Sciences/HHMI Investigator
University of California, Berkeley
The Future of Genome Engineering: Biology, Technology and Ethics

  • Biology
  • Technology  – Gene Editing
  • Ethics


  • Adaptation – acquire and maintain genetic memory Prokaryotic cells
  • crRNA Biogenesis
  • Interference
  • Supercoiled plasmid target helps for the integration reaction
  • Integration preceeds via a 3′-OH nucleophilic attack, 3′ – PO4
  • What directs Cas1-Cas2 to the leader side of CRISPR Loci
  • Integration Host Factor (IHF): alpha and beta
  • IHF is required for spacer acquisition in vivo
  • mechanism of spacer integration for DNA repair and repeat replication
  • Harness integrase for genomic tagging


  • CAS9 is a dual-RNA guided DNA Endonuclease
  • Cas9 programmed by single chimeric RNA
  • Most CISPR systems target dsDNA
  • PAM binding drives DNA target recognition: protospacer — PAM– dsDNA
  • C2c2 is an RNA-activated RNase: cis Cleavage vs trans Cleavage – used to detect specific RNA


  • Chromatin search
  • DNA repair
  • RNA targeting


  • CRISPR based white mushrooms programmed to resist browning
  • human gene modification


Virginijus Siksnys, PhD
Professor and Chief Scientist/Department Head, Institute of Biotechnology
Vilnius University
From mechanisms of microbial immunity to novel genome editing tools

  • bacteria can absorb interference
  • superinfection survival
  • defense islands in genomes
  • CCGG-family: specificity of restriction enzymes that recognize different nucleotides
  • meganucleases: ZFN, TALEN
  • CRISPR-Cas are transportable: CRISPR3 was transferred to e-Coli and plasmid
  • isolate Cas9 protein – RNA-guided endonuclease – adaptive immunity in bacteria
  • generate Cas9 variants
  • Cas9 – restriction enzyme – targeting 2 sites on a pUC18 plasmid
  • Cas9 specificityis encoded by crRNA: REases
  • Cas9- versatilegenome editing tool: induce DNA breaks, gene editing of Human cells, animals plants
  • Cas target is composite – >1000 Cas9 orthologues are known: 20 nt protospacer PAM sequence PAM Assay: PAM depends on Cas9 concentration
  • RNP assembly Cas9
  • Type II-CCRISPR-Cas for B. laterosporus
  • PAM preference for Blat Cas9
  • Maze genome
  • Off-target cleavage: role of PAM, PAM contribute to cleavage at off-target site: Stringent PAM restriction on Cas9



Invited Speakers:

Luhan Yang, PhD
Chief Scientific Officer
Rewriting the pig genome to transform Xenotransplantation

  • Organ transplantation unmet needs
  • natural bioreactor for organ transplants manufacturing

Obstacles for Xenotransplantation

viral transmission

  • immunological Incompatibility
  • New tools: CRISPR-Cas9 multiplexible genome engineering
  • Infectivity of virus  – Infectivity is real: gRNA to destroy catalytic PERVs
  • Eridicate of PERVs activates in PK15 cells
  • generate viable PERV free embryo
  • Genotyping of Clone 40
  • viral transmission

immunological Incompatibility

  • a disruptive technology across tissue and organ types
  • therapeutic applications


  • write the Genome
  • Next Generation of Gene Editing Tools


Austin Burt, PhD
Professor of Evolutionary Genetics
Imperial College London
Developing CRISPR-based gene drive for malaria control

  • Genetically MODIFICATION of the mosquito strains that brings Malaria to Humans
  • Driving Y chromosom – convert all population of mosquitos to MALE: don’t bite, don’t transmit and do not contribute to next generation
  • Homing: natural process endonuclease genes in many microbes
  • Find Gene needed for female fertility: Ovary  expression : sterile non-sterile
  • gene needed for vector competence
  • target gene validation: number of Larvae
  • CRISPR-based homing at target gene – Frequency
  • Issues arising form this approach: Resistance, ecological and biodiversity, Governance and acceptance, step by step development pathway


Warren Alpert Foundation Prize Recipients


For remarkable contributions to the understanding of the CRISPR bacterial defense system and the revolutionary discovery that it can be adapted for genome editing.


For their pioneering discoveries in chemistry and parasitology, and personal commitments to translate these into effective chemotherapeutic and vaccine-based approaches to control malaria – their collective work will impact millions of lives globally particularly in the developing countries.


For seminal contributions to our understanding of neurotransmission and neurodegeneration.


For their seminal contributions to concepts and methods of creating a genetic map in the human, and of positional cloning, leading to the identification of thousands of human disease genes and ushering in the era of human genetics.


For the discovery, preclinical and clinical development of bortezomib to FDA approval and front line therapy for the treatment of patients with multiple myeloma.


In recognition of their extraordinary contributions to medicine and innovations in bioengineering.


For the expansion and differentiation of human keratinocyte stem cells for permanent skin restoration in victims of extensive burns.


For the discovery, characterization and implementation of laser panretinal photo-coagulation, which is used to treat proliferative diabetic retinopathy.


For work leading to the development of a vaccine against human papillomavirus.


For their contribution to the development of the breast cancer therapy Herceptin, the first target-directed cancer treatment for solid tumors.


For discovering angiogenesis and its relationship to disease, and for championing the concept of anti-angiogenic therapies.


For her seminal contributions to the understanding of how the antitumor agent Taxol kills cancer cells.


For their pioneering work on the purification, characterization, and cloning of human interferon-alpha.


For his pioneering work in understanding the role of vitamin A supplementation in preventing blindness and life-threatening infections in children in the developing world.


For their pioneering work in cardiovascular research which has dramatically reduced the mortality rate for heart attacks.


For their research that contributed to the development of a drug that effectively treats chronic megelogenous leukemia and other forms of cancer.


For their research in the development of statins which lower the level of cholesterol in the heart.


For elucidating the pathway forming the leukotrienes and their role in bronchial asthma.


For their discovery of human immune deficiency virus (HIV).


For their discoveries of molecules that regulate the growth and differentiation of bone marrow cells in health and disease.


For the development of the lung surfactant used for treating pulmonary hyaline membrane disease.


For identifying Helicobacter pylori as the organism that causes gastric and duodenal ulcers.


For developing a complete description of thalassemia at the molecular level.


For discovering the enzymatic basis of Gaucher’s disease leading to its effective treatment.


For designing a powerful new approach to the treatment of high blood pressure and congestive heart failure.


For pioneering the use of DNA in the diagnosis of congenital anemias.


For defining the genetic basis of muscular dystrophy.

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2016 Award Winners of the Lasker Foundation Awards in Physiology, Virology and Science Education

Reporter: Aviva Lev-Ari, PhD, RN

The Lasker Awards, among the most respected prizes in medicine, will go to six researchers who made major discoveries in physiology and virology, and to a scientist who has tirelessly promoted science education, the Albert and Mary Lasker Foundation announced on Tuesday.

The awards, honoring basic medical research, clinical research and special achievement, each come with a $250,000 prize and a nice omen: 87 Lasker laureates have also won Nobel Prizes.


2016 Award Winners


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Majority of mathematicians hail from just 24 scientific ‘families’

Reporter: Aviva Lev-Ari, PhD, RN


Majority of mathematicians hail from just 24 scientific ‘families’

Evolution of mathematics traced using unusually comprehensive genealogy database.

26 August 2016
Nature 537, 20–21 (01 September 2016) doi:10.1038/nature.2016.20491
  1. Leonhard Euler, via
  2. Joseph-Louis Lagrange; to
  3. Friedrich Leibniz, the father of the co-inventor of calculus; and to thirteenth-century Persian astronomer
  4. Shams ad-Din Al-Bukhari


Production of PhD in Math: Global Decline since 1970





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Patents in Immune Oncology – Inventor Yoram Reiter, PhD

Reporter: Aviva Lev- Ari, PhD, RN

Selected patents for generating TCRLs against Neoantigens and attaching a Toxin on the TCRL: For Linking a Toxin to TCRL

Antibody having a t-cell receptor-like specificity, yet higher affinity, and the use of same in the detection and treatment of cancer, viral infection and autoimmune disease
CA 2474782 A1


An isolated molecule which comprises an antibody specifically bindable with a binding affinity below 20 nanomolar, preferably below 10 nanomolar, to a human major histocompatibility complex (MHC) class I being complexed with a HLA-restricted antigen and optionally further comprises an identifiable or therapeutic moiety conjugated to the antibody.


For Generating Any TCRL against any neoantigen

Methods and pharmaceutical compositions for immune deception, particularly useful in the treatment of cancer

CA 2451353 A1


An immuno-molecule which comprises a soluble human MHC class I effector domain; and an antibody targeting domain which is linked to the soluble human MHC class I effector domain, methods of making same and uses thereof.

Single chain class i major histo-compatibility complexes, constructs encoding same and methods of generating same

CA 2404489 A1

Single chain class i major histocompatibility complexes, constructs encoding same and methods of generating same 

US 20090258393 A1



Methods of generating a functional mammalian single chain MHC class I complex in prokaryotic expression systems and a functional human single chain MHC
class I complex in eukaryotic or prokaryotic expression systems, which complexes are capable of presenting specific antigenic peptides restricted to specific CTL clones.


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How the ACLU Won the Fight Against Patenting Genes: Article and video on  the History of the Issue of Gene Patents

Curator: Stephen J. Williams, PhD


please see the TED talk below on how ACLU took on the Gene Patenting Industry:

Tania Simoncelli – How I took on the gene patent industry — and won – Ted Talks 2016

This fight started with the patenting of the BRCA1/2 gene mutants, which increase the risk of breast/ovarian cancer in women who harbor these mutation as well as their offspring, which would be the basis for genetic testing services offered by Myriad Genetics.

However, as seen below, these patent fights and the patenting of DNA has been around since the mid 1970’s, with the advent of cloning and other molecular biology techniques.


Robert Cook-Deegan and Christopher Heaney in Annu Rev Genomics Hum Genet. 2010 Sep 22; 11: 383–425.

In April 2009, the U.S. Patent and Trademark Office (USPTO) granted the 50,000th U.S. patent that entered the DNA Patent Database at Georgetown University. That database includes patents that make claims mentioning terms specific to nucleic acids (e.g., DNA, RNA, nucleotide, plasmid, etc.) (64). The specificity of many terms unique to nucleic acid structures makes it possible to monitor patents that correspond to and arise largely from research in genetics and genomics. Patents have been a part of the story of the rise of genetics and genomics since the 1970s, and not just because they can be counted but also because science and commerce have been deeply intertwined, one chapter in the story of modern biotechnology in medicine, agriculture, energy, environment, and other economic sectors. The first DNA patents were granted in the 1970s, but numbers surged in the mid-1990s as molecular genetic techniques began to produce patentable inventions.

This database (Delphion Patent Database) can be reached at (http://www.delphion.com).

From Cook-Deegan, R. and C. Heany. Annu Rev Genomics Hum Genet. 2010 Sep 22; 11: 383–425.

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U.S. Patents: DNA Patents and Patent Applications by Year, 1984–2008. The DNA Patent Database contains patents obtained by searching the Delphion Patent Database (http://www.delphion.com) with an algorithm posted on the DNA Patent Database website that searches for granted U.S. patents (since 1971) and published applications (since 2001) in U.S. patent classes related to genetics and genomics as well as claims that include words specific to nucleic acids, genetics, and genomics. The year 1984 is the first for which more than 100 granted patents are in the DNA Patent Database. Data from Reference 64.

The authors make several points concerning obtaining patents in the genomics field including:

  • Differences in patent practice can be important to scientists working in genetics and genomics. In the United States, a patent goes to the first inventor. If patents or patent applications overlap and the first person to invent is in dispute, then the patent office initiates what’s called an interference proceeding, with intricate rules about deciding priority of invention.
  • Interferences are more than twice as common in biotechnology patents than in any other patent class, six times higher than patents on average (140).
  • The United States also allows a year’s grace period from publication of information pertinent to a patent claim, whereas any public disclosure becomes “prior art” that can defeat patent claims in other jurisdictions.


International harmonization of DNA patents exist including:

  1. 1973 European Patent Convention created the European Patent Office (EPO). EPO can issue a patent valid in signatory countries
  2. 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement committed signatory countries to adopt patent standards mainly modeled on the developed-country model of strong patent protection
  3. 1998 Biotechnology Directive: the Directive became an important element of European patent law that binds national governments to comply with it
  4. Both the United States House and Senate of the 111th Congress are considering bills similar to one passed by the House of Representatives (but not the Senate) in the 110th Congress (2007–2008). Two provisions particularly relevant to genetic and genomic inventions are (a) shifting from the current “first to invent” U.S. standard to “first inventor to file,” as in the rest of the world; and (b) establishing a mechanism to challenge patent claims closer to the European opposition process.

top 30 institutions holding patents in the DNA Patent Database. Among them are

  1. Agribusiness and chemical companies (Monsanto and DuPont)
  2. U.S. Government (largely attributable to the large intramural research program at the National Institutes of Health)
  3. Public and private universities (Universities of California and Texas, Johns Hopkins, Harvard, Stanford, MIT, etc.)
  4. Pharmaceutical firms (Novartis, Glaxo SmithKline, Pfizer, Merck, SanofiAventis, Takeda, Bayer, Novo Nordisk, Lilly, etc.)
  5. Established biotechnology firms (Genentech, Amgen, Genzyme, ISIS, etc.)
  6. Firms created to exploit genomic technologies (Incyte, Human Genome Sciences, etc.)
  7. Instrumentation and DNA chip firms (LifeTechnologies, Affymetrix, Becton, Dickinson, etc.)
  8. Academic research institutes (Institut Pasteur, Salk, Scripps, and Ludwig Institutes, Cold Spring Harbor Laboratories, etc.)
  9. Hospitals with research units (e.g., Massachusetts General Hospital)







Top U.S. DNA patent holders. The authors compiled a list of assignees with at least 100 patents, combined different names for the same assignee, and updated names to reflect corporate mergers and acquisitions. Patent counts are from the Delphion Patent Database for U.S. patents granted as of October 26, 2009, using the DNA Patent Database algorithm (64). Data from Reference 64. From Cook-Deegan, R. and C. Heany. Annu Rev Genomics Hum Genet. 2010 Sep 22; 11: 383–425.

And an opinion article by Harvard Law School arguing against the patent-ability of natural products such as DNA:

DNA Sequences as Unpatentable Subject Matter

by  Victor Song & Prof. Peter Hutt

How Merck’s attempt to patent Vitamin B12 may have started a precedent:

In addition to Kuehmsted, the case most frequently cited to support the patentability of “purified and isolated” substances is Merck & Company v. Olin Mathieson Chemical Corporation [44] . In 1958, the United States Court of Appeals for the Fourth Circuit addressed the metes and bounds of the product of nature exception in Merck . The invention at the center of Merck was entitled, “Vitamin B(12)-Active Composition and Process of Preparing Same”.

Prior to the discovery claimed by the patent, vitamin B(12) was unknown to man. What had been known was that patients who had pernicious anemia could mitigate the effects of their condition by consuming cow liver. For years the scientific community analyzed cow liver to determine what in cow liver was the therapeutically active compound. For lack of a better term, scientists named this unknown therapeutic agent the “anti-pernicious anemia” compound.

After a considerable amount of chemical analysis, scientists at Merck isolated the “anti-pernicious anemia” compound in cow liver. They also discovered an alternate source of the “anti-pernicious anemia” compound. Merck scientists were able to harvest the “anti-pernicious anemia” compound from the fermenting eluent of certain microorganisms. After isolating and characterizing the structure of the newly found “anti-pernicious anemia” compound, the scientist renamed it vitamin B(12) for its chemical similarities to the vitamin B family.

Having discovered vitamin B(12), Merck filed for and obtained U.S. patent 2,703,302 (‘the ‘302 patent”) covering both the process of making vitamin B(12) and the actual chemical compound for vitamin B(12). Only the product claims were at issue in Merck [45] . A representative product claim reads:

A vitamin B(12)-active composition comprising recovered elaboration products of the fermentation of a vitamin B(12)-activity producing strain of Fungi selected from the class consisting of Schizomycetes, Torula, and Eremothecium, the L.L.D. activity of said composition being at least 440 L.L.D. units per milligram and less than 11 million L.L.D. units per milligram.[46]

Prior to the appeal, the district court had determined that the product claims were invalid as products of nature. The Court of Appeals for the Fourth Circuit reversed. In reversing the District Court, the Fourth Circuit followed a line of reasoning similar to Kuehmsted.The Court of Appeals reasoned that the product of nature was the unpurified fermenting eluent which had no therapeutic value. However, Merck’s purified fermenting eluent had therapeutic value. Thus, the court believed Merck’s purified product, which was essentially vitamin B(12), was a different from unpurified fermenting eluent. Since Merck’s purified product was different from the product of nature, the court reasoned that it could not be a product of nature.

The main weakness in the Merck decision is similar to weakness of the Kuehmsted decision. Can vitamin B(12) be considered “new” if it always existed in cow liver? In addition, is it necessary to grant Merck both product and process claims? Even without the product claims, Merck will still be able to profit handsomely from the process claims alone. In addition, Merck could have applied for a vitamin B(12) use patent. Merck could have patented the therapeutic use of their vitamin B(12) for treating pernicious anemia.

There are two interesting aspects of the courts decision in Merck . First, in coming to its conclusion that the purified fermentate was not a product of nature the court turned to the phrase “new and useful” contained in section 101. This was an appropriate focus of analysis for the court because it is from this phrase that the product of nature exception is derived. However, in interpreting the phrase “new and useful” the court substituted the patent terms “novelty and utility”.[47]

The threshold for meeting the utility requirement for patentability is very low. Nearly all inventions meet the utility requirement. It is the Fourth Circuit’s reliance on the patent requirement of novelty for the term “new” which is more interesting. The court’s reliance of the novelty standard presents an interesting interpretation because the product of nature exception is not premised solely on the novelty requirement.[48] The product of nature doctrine simply states that products of nature are not patentable because they are made by nature, not by man. Furthermore, since products of nature existed in nature prior to man’s discovery of them, they are not new and thus excluded from patentability.

The novelty standard requires a different analysis. Although the issue of novelty also addresses the question as to whether or not an invention is new, the question of novelty is answered by looking at the prior art. Roughly speaking, the prior art exemplifies man’s entire body of scientific knowledge at the time of invention. In order to be novel, an invention must not be recited in one piece of prior art. For example, to demonstrate a lack of novelty, a single scientific journal article must describe how to extract vitamin B(12) from a fungal fermenting eluent.

The problem with using the novelty requirement to interpret “new” with regard to product of nature purposes is that no product of nature would be found in the prior art before it was discovered. In effect, using the novelty standard eviscerates the product of nature exception. The novelty standard also circumvents the purpose of the product of nature doctrine which is to prevent man from claiming “manifestations of [the] laws of nature”.[49]

For illustrative purposes we can use vitamin B(12) as an example. According to the Fourth Circuit, in order for vitamin B(12) to be considered a product of nature it must lack novelty. To lack novelty, vitamin B(12) must be recited in a single prior art source. Before its discovery by Merck, vitamin B(12) was unknown and hence could not be found in any prior art source. However, vitamin B(12) has always existed as a naturally occurring substance in cow liver (i.e. a product of nature). Despite clear evidence that vitamin B(12) is a product of nature, the Fourth Circuit would permit a patent on vitamin B(12).

This approach nullifies the purpose of the product of nature doctrine. By using the novelty standard, the court never asks the question whether or not vitamin B(12) was made by man. The purpose of the product of nature doctrine is to prevent man from patenting what is made by nature and should thus be accessible to everyone. The Fourth Circuit’s novelty analysis does not consider this.

The second interesting point about Merck is the product claim itself. In claim 1 recited above, vitamin B(12) is claimed only as a product of fermentation. Merck did not claim the vitamin B(12)chemical formula. This is a significant distinction because competitors could design around Merck’s product claim if they could manufacture vitamin B(12) without utilizing the fermenting eluent of fungi. For example, a manufacturer who processed cow livers to obtain vitamin B(12) could sell its version of vitamin B(12) product without infringing Merck’s product claims[50] . With cases such as Kuehmsted and Merck on one side of the product of nature debate, there are several cases which fall on the other side of the debate[51] . In addition to Funk Brothers, General Electric Co. v. De Forest Radio Co. [52] is representative of a court decision upholding the product of nature exception. The invention at the center of General Electric was the chemical element tungsten (W). General Electric was assigned U.S. Patent 1,082,933 (the ‘933 patent) for tungsten.

Is DNA Patentable Subject Matter?

As the cases discussed indicate, it is not entirely clear whether or not DNA sequences are patentable subject matter. What is clear is that processes for isolating DNA sequences are permissible as are product claims that use DNA sequences (such as Chakrabarty’s genetically modified micro-organism). In addition, inventors could get patents for the therapeutic uses of their DNA sequence products.

The Supreme Court’s decision in Chakrabarty indicates an intention by the court to expand the scope of patentable subject matter, but the product of nature doctrine still remains. Whether or not the product of nature exception will apply to DNA sequences depends upon how the courts view DNA sequences. If the courts analogize isolated and purified DNA sequences to aspirin or vitamin B(12), then DNA sequences would be moved outside the product of nature exception and into the scope of patentable subject matter. On the other hand, if DNA sequences are comparable to tungsten or “manifestation of laws of nature” then the product of nature exception would apply.

As the law is currently interpreted by patent practitioners, the product of nature exception to patentable subject matter is considered a technical problem related to drafting DNA sequence product claims. For the patent attorney, all that is necessary to get around the product of nature exception is to not claim a DNA in its naturally occurring form. In order to resolve this technical problem, a patent attorney will claim DNA sequences in an “isolated and purified” form. For example, Amgen’s DNA sequence claim to EPO in United States Patent 4,703,008 reads, “A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin.”[57]

DNA sequences have been described as molecular strands of genetic information.[59] Information which is so fundamental that it is akin to the natural laws of science. This fundamental information, in the words of Funk Brothers , is “part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.”[60] As manifestations of the laws of nature, DNA sequences should be free to all men. By unlocking the hidden secrets of the genetic code, scientists will be able to produce new medical therapies to treat a wide range of illnesses. It is these new therapeutic inventions, their uses, and the processes for making them which should be patented, not the DNA sequences used to implement these inventions.

Although DNA sequences have been analogized to long polymer chains[65] and as a result should be treated similarly to synthesized polymers, this is not entirely correct. The analogy fails because an inventor’s ingenuity plays a part in designing a polymer chain. A chemist will manipulate reaction conditions to produce a polymer with certain characteristics such as strength, durability, and flexibility. This is not the case with DNA. The inventor’s ingenuity, once again, plays no part in designing the DNA sequence as this was the work of nature over thousands of years of evolution.

So the Harvard Law School article concludes:

  1. Patentable subject matter is statutorily defined in 35 U.S.C. Section 101 to include new and useful products (machines, manufactures, and compositions of matter) and processes. However, subject matter which fall outside the scope of Section 101 are products of nature.
  2. There are two general arguments for excluding products of nature from patentable subject matter. First, is that products of nature are the “manifestations of laws of nature”. As the building blocks of science, to grant ownership to these fundamental products would do more harm than good to scientific innovation. Second, is the patent system’s purpose in encouraging inventorship. An inherent aspect of inventorship is interaction of human ingenuity with the natural world. Products of nature are excluded from patentability because they would grant ownership rights to the natural world without any element of human ingenuity. These product of nature patents would reward inventors for nature’s work.

Man has played no part in creating DNA. What required man’s ingenuity was isolating, purifying, and sequencing the DNA. These inventions deserve patent protection.

Other articles on this Open Access Journal on Patents, Patent Fights and Intellectual Property include:

Top Twenty Universities on a list of the top 100 worldwide universities that received the most U.S. utility patents in 2014

The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

Innovators can exit with an idea: How to Monetizing Patents and ideas: yazamIP.com launches Idea Lab

RNA related IP Patents Awards

Linus Pauling: On Lipoprotein(a) Patents and On Vitamin C

Recent Patents on Biomarkers

Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method





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