Recombinant BCG: tuberculosis vaccine Patented in accordance with 35 USCS § 101


The Bacille Calmette-Guerin (BCG) vaccine is a great example of an entity derived from nature being used in a new and resourceful way. I have written a  research paper on TB and after re-reading it, I realized how much the recombination of M. bovis relates to the 35 USCS § 101, especially because it was successfully patented. ( The information below is from the United States Code of Service and my research paper respectively.

The Law:

“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 therefor, subject to the conditions and requirements of this title [35 USCS §§ 1 et seq.].”

Background on Mycobacterium tuberculosis:

Mycobaceterium tuberculosis (MTB) is a species that belongs to the family Mycobacteriaceae, and the  genus Mycobacterium, which is actually the only genus in the Mycobacteriaceae family. There are about 71 known species of Mycobacterium and they are divided into categories based on their colony morphology, biochemical properties, and growth rate. Growth rate is the property used to divide these species into two populations: slow and rapid growers. Rapid growth is defined as colony presentation within 7 days. Interestingly, slow growers tend to be more pathogenic for humans than the rapid growers are. Some of the species that are categorized as slow growers are: M.leprae, M. ulcerans, M. avium and M. tuberculosis. Although these species differ in many ways, all members of the Mycobacterium genus are gram positive, rod-shaped and non-motile.

Antibiotic Resistance:

Mycobacteria are particularly resistant to beta-lactam antibiotics such as penicillin and ampicillin, which target peptidoglycan cell wall synthesis. This resistance is not only attributed to the impermeability of the mycobacteria cell membrane but also to beta-lactamases that are intrinsically encoded for in the bacterial chromosome. However, drugs such as streptomycin, isoniazid, and rifampin have been shown to be quite effective against this microbe. Streptomycin is an antibiotic that inhibits protein synthesis. Rifampin inhibits nucleic acid synthesis and isoniazid, which is also known as isonicotinylhydrazine (INH) is an organic molecule that is activated by the microbe and inhibits the production of mycolic acid, an essential component of its bacterial cell wall.Although this has led to advancements in TB treatment, widespread use of these antibiotics has worsened antibiotic resistance. However, MTB drug resistance is not a new occurrence. On the contrary, it has been an issue for almost seventy years.

History of Resistance:

In the 1940s it was found that after just a few months of streptomycin treatment four-fifths of the patients were experiencing antibiotic resistance. A decade later, “combination therapy” was the new method of treatment. This therapy entailed the use of three drugs. This three-drug regimen was quite pragmatic. Theoretically, the probability of the bacterium developing resistance against all three different antibiotics is much lower than the probability that the bacterium will develop resistance against just one antibiotic. A nine-month combinatorial treatment of rifampin, streptomycin and isoniazid was shown to cure nearly all the patients treated.These results demonstrate the effectiveness of combination therapy. However, drug therapy can be just as quickly rendered ineffective, at it can effective. Unfortunately, multidrug-resistant MTB (Mdr) has already arisen, particularly against rifampin and isoniazid. Yet, there is a silver lining; the rediscovery of a drug called Pyrazinamide (PZA) in the 1980s reduced the period of treatment time for TB from nine-months, to six-months making patient compliance a bit easier. PZA may also help combat moderately dormant forms of TB by acting as an artificial analog to a compound known as nicotinamide. Nicotinamide is a vitamin that is needed for many important biological processes, particularly NAD synthesis. Exactly how PZA inhibits bacterial growth is poorly understood.

Treatment Today (BCG):

Unfortunately, due to the risk of resistance with antibiotic treatment, other means of treatment must coincide with antibiotic use. Scientists have developed an attenuated vaccine in order to treat/prevent PTB.  When creating an attenuated vaccine one takes a pathogen and infects a different host with it until the fitness of the pathogen is no longer optimal in the vaccinated host. Once this occurs, the virus can no longer cause disease. In this case M.bovis, a bacterium that causes bovine TB and can also cause disease in humans, is the attenuated strain used to prevent TB infection. The vaccine used for TB treatment is known as BCG, which stands for Bacille Calmette-Guerin after the two scientists who created it in 1921. An M. bovis isolate was taken from a cow suffering from mastitis, which is inflammation of breast tissue, and then the isolate was attenuated for about 13 years, ensuring that the strain was no longer virulent in the host.This vaccine has been shown to be clinically effective against the primary progression of  PTB.

The Vaccine’s Drawbacks:

However, there are some drawbacks associated with use of this vaccine. The polymorphism involved in M. bovis gene expression may result in varying degrees of efficacy against TB. For example, during a study done by the World Health Organization (WHO) in 1993 (out of 129 cases)  infants were vaccinated with either the “Paris-type” vaccine or the “Glaxo” vaccine. Those that received the Paris-type vaccine were 40% less likely to contract TB. Both vaccines contained M.bovis but because of the slight differences in gene expression one was less effective than the other. This can be problematic when trying to consistently treat TB worldwide. Another caveat is exposure to environmental mycobacteria or UV light can render the BCG vaccine ineffective. Currently, steps are being made to develop a new TB vaccine that will be more consistent and effective.


  •  Brogden, Kim A., Minion, F.C., et al.(2007). Virulence Mechanisms of Bacterial Pathogens. Washington, DC: ASM Press
  • Koneman, E., Procop G. et al (2006). Koneman’s Color Atlas and Textbook of  Diagnostic Microbiology (6th e.d.). Philadelphia: Lipincott Williams & Wilkins. 4. Novartis Foundation.(1998). Genetics and Tuberculosis. Chichester, England: John Wiley & Sons.
  • Ratledge, Colin., Dale, Jeremy.(1999). Mycobacteria: Molecular Biology and Virulence. Malen, MA: Blackwell Science.
  • Tibayrenc, Michel.(2007). Encyclopedia of Infectious Diseases. Hoboken, New Jersey: John Wiley & Sons.

Patent Infringement, Senate Amendment to 35 USCS § 217, and Claim Construction Illustration

So we now know as scientists that we can patent microbes that are unlike any microbes found in nature, and cDNA and/or genetically modified DNA/RNA not found in nature. So, let’s say your invention is patentable under 35 USCS § 101. How do you protect the patent that you were awarded? What new or amended laws is the legislature proposing? How are courts interpreting patents in order to determine patent infringement? All of these questions will be answered in this post. First, patent infringement will be defined and broken down into its elements, Second, a bill that the Senate has proposed that modifies the patent infringement statute will be addressed, and third an example of the court interpreting language in the patent will be shown. Enjoy!

The infringement of a patent is a tort. A tort is a wrongdoing that the court offers compensation for if all the elements of the tort are met. These are the elements of patent infringement as provided in 35 USCS § 271:

(1) Whoever without authority

(2)  makes, uses, offers to sell, or sells any patented invention,

(3) within the United States or imports into the United States any patented invention

(4) during the term of the patent

therefor, infringes the patent.

Each one of these elements must be met, in order for the inventor to be awarded damages against the patent infringer. If even one of these elements are not met, you will not receive compensation for the alleged infringement.

NEXT, the bill.

There is pending legislation regarding patent infringement. This is language from a bill (113 S. 504) that the Senate introduced March 7, 2013 and it is an amendment to this patent infringement statute:

d)  No patent owner otherwise entitled to relief for infringement or contributory infringement of a patent shall be denied relief or deemed guilty of misuse or illegal extension of the patent right by reason of his having done one or more of the following: (1) derived revenue from acts which if performed by another without his consent would constitute contributory infringement of the patent; (2) licensed or authorized another to perform acts which if performed without his consent would constitute contributory infringement of the patent; (3) sought to enforce his patent rights against infringement or contributory infringement; (4) refused to license or use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.

  • (e) 
    • (1)  It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.


(b)  Infringement of Patent.– Section 271(e) of title 35, United States Code, is amended by adding at the end the following:

  • “(7)
    The exclusive remedy under this section for an infringement of a patent for which the Secretary of Health and Human Services has published information pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act shall be an action brought under this subsection within the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal Food, Drug, and Cosmetic Act.”

This means that redress for the patent infringement suit is brought under this statute, 35 USCS § 271 within 45 days.


Lastly, claim construction: the court’s interpretation of specific language found in patent 901.

“Determining whether accused device infringes patent requires two-step analysis: (1) claims of patent must be construed to determine proper scope; and (2) determination must be made as to whether properly construed claims read on accused device and first step of claim construction is question of law for court, only those terms in controversy need be construed, and only to extent necessary to resolve controversy.” Glaxo Group, Ltd. v Apotex, Inc. (2003, ND Ill) 268 F Supp 2d 1013

The following is the specific language in an actual patent, interpreted in Schering Corp. v. Amgen Inc., by the United States District Court for the District of Delaware in 1998:

“A recombinant DNA molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells” is interpreted by the court in Schering:

  • A ²recombinant DNA molecule² is a molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and they have the capacity to infect some host cell and being maintained therein.
  • ²Consisting of² in Claim indicates the claim is closed and no elements not recited in the claim may be included.
  • Segments of DNA from different genomes² refer to DNA segment or DNA sequences in genomes of cells or viruses which may be both naturally occurring and non-naturally occurring.
  • ²Joined end-to-end outside of living cells² is a structural limitation which may encompass identical  products made by different processes.

“Which have the capacity to infect some host and to be maintained therein, and the progeny thereof” interpreted by the court as requiring that the recombinant DNA segments infect the progeny of the host cells, but not necessarily maintained in the host cells.

“A substantially pure DNA sequence . . .said DNA sequences coding on expression for only a single polypeptide chain” is interpreted by the court as well:

Substantially pure DNA . . . coding on expression for only a single polypeptide chain² refers to “a naturally occurring or non-naturally occurring DNA sequence independent of any plasmid DNA in a host cell, which codes on expression for an immature, fused, and/or incomplete form of a naturally occurring, human leukocyte interferon protein, subsequently labeled IFN-a-1.”

18 F. Supp. 2d 372, *400; 1998 U.S. Dist. LEXIS 13421, **85

Thank you for reading my blog today. If I see that there a number of people interested in a particular topic regarding science and patents I will address it on subsequent posts. Happy Saturday!


Virology 101

What are viruses?

Viruses are acellular pathogens, meaning they are not cells and they are not made up of cells, and they have the ability to cause disease. Minimally, every virus has nucleic acid and a protein coat.

Viruses are unique for the following reasons:

  1. No Metabolism, viruses have no ability to make energy on their own
  2. Some viruses can use RNA as their genomic material
  3. Viruses are made from small repetitive subunits that cannot grow in size (no organelles)
  4. Viruses have no ability to make their own proteins (all bacteria do)

Historical Background:

The 1800’s were the golden Era of Bacteriology/Microbiology due to Louis Pasteur’s swan neck flask experiment that disproved spontaneous generation. Moreover, all research and experiments in the scientific world, up to the1930’s were based on preconceived notions that everything that caused disease was a bacterium. For example, back then scientists tried to make all disease-causing microbes fit “Koch’s Postulates.”

Koch’s Postulates:

  1. Disease causing organism should be found in every case there is disease
  2. *Should be able to isolate it and grow it in pure culture
  3. Should be able to put it back in new host and cause disease
  4. Should be able to re-isolate pathogen

Unknown to the scientists of the time viruses do not work that way. Sometimes the virus cannot be found because it is latent (which we will discuss later). Sometimes the virus cannot be isolated or grown in pure culture.

It wasn’t until the 1890’s that the first virus was discovered, the Tobacco Mosaic Virus (TMV). The discovery of this virus was driven by economical concerns. Tobacco was a staple crop and if the tobacco was being diminished by TMV, it was bad for business. Furthermore the virus was costing the government a lot of money so the government funded the research that led to this discovery.

How the first virus was discovered:

The research involved grinding up leaves and making liquid extract. The liquid extract could cause disease in another tobacco plant. The liquid extract caused the disease to be contagious. Additionally, a scientist conducted a filtration experiment in which he would continually filter the liquid extract to see if it still caused disease. After filtering the liquid, he found that the filtered extract was still disease-causing. This was the first sign that the disease was not bacterial. Although they were not aware of very small bacteria back then, in general bacteria are filterable. Critics stated that the tobacco plant’s disease was caused by a bacterial toxin. However, if it were a toxin, after the toxin had been diluted out to a certain point it could no longer cause disease. However a virus can re-concentrate disease power. Contrarily, toxins cannot be spontaneously created but a virus can proliferate. This is known as the “Re-concentration experiment.”

The first animal virus discovered:

First animal virus discovered was the “Foot and mouth” virus. This virus was discovered the same way that TMV was discovered. Scientists found that they could re-amplify diluted stock in cattle, it could not be grown in culture, and it was filterable.

The first human virus discovered:

The first human virus discovered is the Yellow Fever virus. The discovery of this virus, like the discovery of TMV was influenced by  economic concerns. This virus was a major problem for the United States because it interfered with the country’s ability to build the Panama Canal. When scientists were able to find a cure to yellow fever, America became an even bigger international power and isolationism ended.

The discovery of viruses was one of the most important progressions made in scientific history. When the electron microscope was created in the early 1930’s the virus was viewable (because viruses are so small, you would not be able to see them with a  compound microscope). Because the electron microscope allowed scientists to see what a virus actually looked like, viruses became more than a filterable aliquot of a contagion. Now, scientists realize that there is something other than bacteria out there.

But is it profitable?

There is power in technology. The world embraces it. Although we haven’t advanced as quickly as the creators of “The Jetsons” had hoped and there are no flying saucers hovering above ground it is evident that we as a society are making strides towards a more technologically advanced existence. Computers are getting smaller and smaller everyday and wires fewer and fewer. Indeed, the more we know the less we need.

With such progression it may seem rather prehistoric, discussing microorganisms that have been here for billions of years. Virtually every American has used some form of technology on a day to day basis but how many have streaked agar plates for isolation of a bacterial species? How many have amplified microbial DNA using the Polymerase Chain Reaction (PCR)? Not many. Microbiology unlike technology does not provide a basis for commonality for the average modern man. Why is a basis for commonality important? It allows for profit.

For example, which album would sale the most records today, one entitled “Bach’s Greatest Hits” or one entitled “Beyoncé’s Greatest Hits?” One does not have to be an economist to realize that Beyoncé would out sale Bach. Yes, Bach is brilliant, yes Bach is legendary but Beyoncé is the queen of pop culture. She comes with shiny ribbons and irresistible hooks. Bach is for connoisseurs and Beyoncé is for the common man or woman. 

Analogously technological inventions trump microbiological inventions in the eyes of the public. The average person is only concerned with a virus or a bacterium if it can get him or her sick.  That is why most companies have focused their energies on antimicrobials. Yes, antimicrobials are important but they are even more important because most individuals think they are important.

Yet, it is true that one of the most impressive and lucrative microbiological patents involved Psuedomonas putida, the genetically modified “oil-eating” bacteria invented by Ananda Chakrabarty  who acquired fame in the scientific world in the 1980’s. On the other hand, Chakrabarty is less known than Bill Gates, the world’s wealthiest man. It is no coincidence that Gates’ invention was Microsoft, a computer company.  

In the end patenting microorganisms involves more than just the criteria that the U.S. Supreme Court set out in Diamond v. Chakrabarty . The inventions must appeal to the public as well for economical reasons. After all who would profit the most from the “Advertisement of invention” provision of 35 USCS § 101, Chakrabarty or Gates?

Before patent grant, inventor has right to sell product of invention, and to advertise it, but not right to misrepresent it; after patent grant, patentee has right to sell article and to advertise it, but not right to misrepresent it; patent does not cover advertising



Recombinant DNA, Patenting, and Claim Construction

When I took “Metabolic and Biochemical Processes of Microorganisms” at UT Austin my professor Dr. Marvin Whiteley lectured on blue/white screening. In its fundamental form, the concept involved mutated E. coli that could no longer breakdown lactose because its “lacZ” gene was removed.

The bottom line is that DNA would be inserted into the mutated bacterial genome via transformation. Ultimately, mutated E.coli once the lacZ gene was inserted, would be able to produce the enzyme beta-galactosidase (responsible for the lactose breakdown). The enzymatic activity could be detected by using an organic compound known as “X-gal.” If the cells are grown in the presence of X-gal when the lacZ gene is translated into the beta-galactosidase the enzyme will catabolically cleave the X-gal, resulting in a blue colored cell. If the cells did not produce the enzyme, then the cells would be white. This classic experiment is sine quo non to the understanding of recombinant DNA.

In 1998, in the case Schering Corp. v. Amgen Inc. the United States District Court for the District of Delaware  interpreted a patent regarding recombinant DNA. Dr. Charles Weissmann used recombinant DNA technology to amplify human-extracted interferon- [alpha]. When a white blood cell is exposed to a virus, the blood cell makes interferon, a protein that kills viruses. This protein also has anti-tumor activity. However, the human body does not create a large enough amount of the interferon so Dr. Weissmann sought to produce the interferon in higher quantity by amplifying the genetic code of the polypeptide using bacteria through DNA recombinant technology. Dr. Weissmann was the first person to identify and isolate the interferon- [alpha] genetic code. He filed for the 901 Patent for each DNA segment that coded for interferon- [alpha], the sequences that he himself identified and isolated.

The corporation the doctor worked for alleged that  the defendant, Amgen Inc. infringed on its 901 Patent. Although the plaintiff claimed that Amgen infringed on its patent, Amgen claimed that the patent was invalid. The court was left to interpret the patent.

In a patent infringement case the court uses a two step analysis. First, the court must interpret the meaning of the patent, this is known as “claim construction.” Second, the court must compare the claim to the “accused product.” The court construed some of the words in favor the plaintiff, and others in favor of the defendant.

The significance of this case in the world of “Mircobiolawgical” is that it applies the concept of claim construction in a patent infringement case. Here, it is apparent that the way the patent is worded may affect how protected the discovery or invention will be.

For example, one of the issues was whether the term “consisting of” should be afforded a limited special meaning. The court found that words were inconsequential, and merely transitional. The court then did a step-by-step analysis of significant word listed in each claim.

Plato and Patentability

The soul has been born often and has seen all things…there is nothing which it has not learned.- Meno by Plato.

Plato, in his story about Socrates and a slave boy, philosophized that we as human beings know all things, and that “learning” is merely a recollection of past knowledge. When I heard of this in school it sounded like philosophical “jibber-jabber.” I was too busy jotting down arrows to illustrate the flow of electrons in a nucleophilic attack. 

Yet, as I studied the Inventions Patentable statute today Plato’s words resonated throughout my mind as I read: “Idea of itself is not patentable.” 35 USC § 101, 38. Idea as a basis for patent. I began to think that knowledge, in the form of ideas is not new, as Plato suggested.

Furthermore the statute cites, Diamond v. Chakrabarty  “…issuance of patents does not embrace every discovery…laws of nature, physical phenomena and abstract ideas are not patentable; discoveries that are manifestation of nature free to all men and reserved exclusively to none are not patentable.” 35 USC §101 (quoting Diamond v. Chakrabarty.). Interestingly, the Court placed abstract idea in the same list as physical phenomenon and laws of nature as if it were related to the two.

Again, Plato was on to something. Perhaps ideas are free in human nature, like natural phenomenon are free in physical nature. Perhaps Plato was right in that, knowledge is not novel but it is a mere re-discovery.

Indeed, unless manifested into a process, an idea is merely naked for “[p]atent system is not concerned with quality of inventor’s mind, but with quality of his product.” 35 USC § 101(quoting Associated Plastics Cos. v. Gits Molding Corp.).

Process is much more important. Patentability of process seems to be an area fertile for litigation, especially regarding alleged patent infringement. However, what is “process” exactly, and which cases illustrate its importance? There are some very interesting cases that involve alleged infringement of patented process, in particular Schering Corp. v. Amgen Inc. discussed the very detailed process of amplifying human-extracted interferons in E.coli. In this case the court interprets the patent and goes through the process associated with such patent. The “product-by-process” claim will be discussed in the next post in further detail.

Until next time,



Drugs, Microbes, and 35 U.S.C. § 101, Oh my!

Drugs. What is a drug? Any chemical that alters a functional living system is a drug. However, a drug in itself does not have an effect without binding to a receptor. Receptors are macromolecular components found in the cell membrane. Drugs typically bind to receptors through chemical bonds such ionic bonds, covalent bonds (strong), Van der Waals forces (weak), and hydrophilic or lipophilic interactions. Why does any of this matter? The nature of the bond between the drug and the receptor is that drug’s affinity and affinity is one of the two most important qualities of an agonist (a drug that binds to a receptor). The other most important quality is efficacy. Efficacy is the agonist’s ability to activate the receptor and “effect” the living system, producing a response.

An example is caffeine. Caffeine binds to adenosine receptors and acts as antagonist (competes with adenosine and prevents the substance from binding). When adenosine is inhibited I feel more wakeful, for a longer amount of time.The caffeine has altered my system. Although this is the basis of what I got out of Vertebrate Neurobiology class in college my short lesson in Pharmacology unexpectedly answered my question to patents and microbes.

It seems like a frivolous question with an obvious answer but what IS the difference between a drug and a microbe? Microbes can bind to receptors and alter a living system like drugs can. However, microbes are not chemicals. A chemical is defined as “a compound or substance that has been purified or prepared, especially artificially.”  Purify is defined as the removal of contaminants. A contaminant pollutes or adulterates the substance. Is this just semantics? No. This analysis slowly creeps to the heart of why there are so many drugs that are patented day after day and why seeking to patent a microbe could lead to years of litigation. Drugs are a deliberate composition of substances that are for the most part, artificially made. This is why Penicillin could no longer be patented. It was not artificially made, it is derived from mold.

If something is artificial, it is man-made and not made from nature. So where do we draw the line? For example you cannot patent a microbe found in nature but you can patent the process of purifying the microbe like you could patent a purified chemical substance.  35 U.S.C. § 101, provision 43 “Product of nature,” (citing In re Ridgeway). According to the § 101 it is all about process, newness, and usefulness. You have a microbial invention? You want to patent it? Show the court that your invention has a unique process that is not of nature but applies nature in some essence. Show the court that your invention is new and useful. Then you have reached patentable territory because in so many ways your microbe has become a drug.  

Bacterial Inventions

More ways inventions involving bacteria are used today. Here are some articles about it:

1. Bacteria are being used to make sunscreen more effective

2. Bacteria are now powering light bulbs. The invention is known as a “Biobulb.”

3. Scientists create rechargeable bacteria batteries


Curing Thrush with Patented Probiotics?

Scientists in Italy have used two strains of lactobacilli to fight vaginal thrush. Thrush is a fungal infection caused by Candida albicans, a usually harmless fungus in the vaginal microflora. The  interesting thing about this experiment is that these scientists were able to patent the two lactobacilli strains, Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, also known as SYNBIO®. How can we reconcile this with the Supreme Court’s Decision in Diamond v. Chakrabarty and Funk Bros. Seed Co. Kalo Inoculant Co.

For the full article:

A U.S. Supreme Court decision could affect the patentability of viruses

The most recent case that U.S. Supreme Court decided regarding patenting things derived from nature is Ass’n for Molecular Pathology v. Myriad Genetics Inc. The controversy in this case was whether DNA and cDNA could be patented.

DNA (deoxyribonucleic acids) makes up the genetic code of organisms. “Genes” are basically sequences of phosphorylated sugars connected by hydrogen bonds. These phosphorylated sugars are called “nucleotides.” There are four nucleotides in DNA: thymine, adenine, guanine, and cytosine.

In Ass’n for Molecular Pathology, Myriad found two genes that cause breast and ovarian cancer, BRCA1 and BRCA2. Ass’n for Molecular Pathology v. Myriad Genetics,  Inc., 133 S. Ct. 2107, 2111  (2013). After finding the precise location and genetic sequences of the genes, Myriad sought to patent its discovery.  The Court addressed two issues. Id. 1. Whether a DNA segment found in nature is patentable based on its location, and 2. whether “synthetic” DNA, known as complementary DNA (“cDNA”) is patentable. Id. The Court held that DNA is a product of nature and is therefore not patentable but cDNA does not naturally occur and is patentable. Id. The Court also found that mere isolation of genetic material is insufficient to warrant patentability. Id at 2120. During the analysis, Justice Thomas cited 35 USC § 101, and Diamond v. Chakrabarty (among other cases) to support the Court’s decision. (The Court’s opinion in the case will be discussed in further detail in later posts in the context of bacterial patenting.)

So what does this have to do with viruses?

Well viruses are basically “bags” of DNA or RNA. David Baltimore, a renowned virologist, divided viruses into four categories based on genetic material. Viruses either have single-stranded RNA (“ssRNA”), double-stranded RNA (“dsRNA”), single-stranded DNA (“ssDNA”) or double-stranded DNA (“dsDNA”). This is known as the “Baltimore classification.” Baltimore also divided the viruses even further by method of replication.

Viruses are generally not considered living things, but they are found in nature. Hypothetically speaking, if a scientist sought to patent a virus that could benefit the world in some way I believe the Ass’n for Molecular Pathology case could affect whether or not the virus was patent eligible because the case rules on patenting genetic material. However, the extent to which the case would affect virus patentability would depend on the facts.

I believe that patenting entities that derive from nature is not merely determined by a bright line rule. On the contrary, the Court takes an ample amount of time discussing the facts of each case before ruling on patentability. Arguably, the controversy could be settled with one question: is this “thing” a part of nature or not? However, Justice Thomas in his opinion cites the Court in Mayo Collaborative Servs. v. Prometheus Labs, stating that ” [t]he rule against patents on naturally occurring things is not without limits, however, for ‘all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas’ and ‘too broad an interpretation of this exclusionary principle could eviscerate patent law.'” This means that the rule does not exclude all things derived from nature. To do so would impair discovery and inventions. So perhaps the Court uses a rule of reason instead?