Consentia on Multidisciplinary Research

MAYO V. PROMETHEUS : A POTENTIAL GAME CHANGER IN U.S.A.

ABSTRACT

In  this  work  we have  tried  to  explore  how  Mayo  is  a  game  changer  in  the  field  of  patent when it is to be evaluated whether a claim is patent eligible or not.  we  have  first  presented  a  brief  view  of  the  basic  principles,  the  patent  eligible  law,  specifically  the  process  patents  and  the  trinity  of  exceptions  regarding  the  patent  eligibility  of  a  claim.  Second,  we  have  shed  some  light  on  the  journey  of  patent  eligibility  till  Mayo  and  the  summary  of  Mayo.  Third,  the  essay  gives  a  detailed  analysis  of  the  judgment  in six segments and the inquiry whether a claim is patent eligible is exemplified. Finally, it  Myriad,  which  followed  Mayo is discussed.  This  essay  tries  to  portray  how  a  change  is  brought  in  the  range  of  patent  eligible  subject  matter  after  Mayo.  The  claims for patent involving  diagnostic  methods,  DNA,  etc.  are  largely  affected,  but  they  still  have  other  options  which  this  essay tries to  explore. The essay supports this change brought by Mayo as it is beneficial to society at large.

INTRODUCTION

Dr. Jonas Salk, the developer of the polio vaccine, was once asked by Edward R. Murrow in a 1954 interview, whether he owned the patent on it. Salk famously replied in disbelief by asking, “Could you patent the sun?”  He said such things must belong to “the people.”[1]

            Intellect is a resource which if utilised on the right track can result in wonders. Intellectual property law regulates the creation, use and exploitation of mental and creative labour.[2] There exist men of superior intellect who are apt to invent and discover ingenious devices. Due to existence of patent laws for their inventions and discoveries, others cannot not build them, due to this benefit more men apply their intellect and genius discover and build devices for great utility. Abraham Lincoln extolled patent law and  said,

“The patent system ….., secured to the inventor for a limited time exclusive use of his inventions, and thereby added the fuel of interest to the fire of genius in the discovery and production of new and useful things.” [3]

            Such law inspire many minds to discover the genius in them and use their mental labour to invent or discover something which is patent eligible. But nowadays it is observed that this law instead inspires to patent the inventions, which do not majorly involve an invention but merely law of natural. The present era is in short of men who promise immense benefit to mankind without considering the money making aspect, e.g. 20% of the genes are  claimed as private property. [4] So it is important to regulate the patent eligible matter.

            In 2010, the Supreme Court of the United States had addressed the patent eligibility in Bilski v. Kappos[5] in which it reiterated the patent ineligibility of abstract ideas. Thereafter, in 2012 Mayo v. Prometheus[6] dealt with the patent eligibility of inventions that invoke a purported natural law and brought a change in the range of it. This case has been recently followed in Association for Molecular Pathology v. Myriad Genetics Inc.[7]                                            

NOTHING ENDURES BUT CHANGE: A CHANGE IS BROUGHT BY MAYO IN THE RANGE OF PATENT ELIGIBLE MATTER

Change is the only constant[8] and this is felt in everyday life. This is even depicted in the opinion of the Supreme Court.  The law has gone through many changes and then it has become what it is today. In the matter at point the Supreme Court has from the case of Mayo slightly modified the criteria for evaluating patent eligibility of subject matter.[9] Laws of nature, natural phenomenon and abstract ideas are not patentable subject matter and this case throws light on when can the process involving unpatentable law of nature can be transformed into a patentable one. The test already laid down in prior case to evaluate the patent eligibility of the subject matter is observed to be ‘not definitive’[10]. The Supreme Court did not accept the process[11] in question to be patent eligible because the process “adds nothing to the laws of nature that is not already present.”[12]

BASIC PRINCIPLES

The Court in Mayo has first of all dealt with the basic principles. The law stated in 35 U.S.C. §101,[13] looks after the patent eligible matter, but along with it other principles also govern it. These have been laid down in various Supreme Court judgments. In short these may be pointed out as follows:

  1. The three implicit exceptions- laws of nature, natural phenomenon and abstract ideas, are not patentable. [14]
  2. Phenomena of nature, mental processes and abstract intellectual concepts are basic tools of scientific and technological work hence cannot be patented,[15]
  3. The interpretation of the above exclusionary principle should not be too broad,[16]
  4. Novel and useful structure created with the aid of knowledge of scientific truth may be patentable,[17]
  5. If there is to be an invention from a discovery of a law of nature, it must come from the application of the law of nature to a new and useful end.[18]
  6. One must do more than simply state the law of nature while adding the words “apply it.”[19]

            If a claim involves the above stated exception then the basic principles should be considered. This should not be broadly interpreted because all the inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract idea.[20]

 ‘PATENT ELIGIBLE MATTER’ ACCORDING TO 35 U. S. C. §101

To understand what Mayo reflects it is of utmost importance to throw light on what is patent eligible matter according to the existing law.

            Patentable subject matter is defined in  §101 of the Patent Act. It says:

“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 therefore, subject to the conditions and requirements of this title.” [21]

            The courts have taken an expansive view of statutory subject matter; indeed, Chief Justice Burger famously wrote that “Congress intended statutory subject matter to include anything under the sun that is made by man.”[22] This is indubitably supported by the legislative history of the Act.[23] According to this notion genetic material such as DNA sequences, protein software and business methods are eligible subject matters.[24] The laws of nature, physical phenomenon and abstract ideas have not been held patent eligible.[25]

            This section enumerates the types of inventions that can be patented in the United States. There are four categories, viz. process, machine, manufacture, or composition of matter.

  • A process, in patent parlance, is synonymous with a method, and is merely a series of steps for carrying out a given task. Process patents have been granted for a method of making a “stuffed-crust” pizza,[26] and to the Internet bookseller Amazon.com for its method of “one-click” online ordering of merchandise.[27]
  • A machine is synonymous with an apparatus, and generally has moving parts, such as an internal combustion engine.
  • A composition of matter includes chemical compositions and mixture of substances such as metallic alloys.
  • Lastly, a manufacture is the “catch-all” category for human made subject matter without moving parts, such as a helically grooved foam football[28] or the Java Jacket insulating sleeve for hot drink cups.[29]

 

THE FIRST STATUTORY CATEGORY: PROCESS

This part is devoted to ‘process patents’ because  Mayo involved process claims.

            The age of patenting of process is the same as patent law itself. Often, the process is a novel and nonobvious method of making some end product. The process can be such which is of utility, an easily understandable example is a method of preparing a pizza wherein the cheese and pizza sauce are prevented from blending with one another prior to consumption of the pizza by the consumer[30] is as follows:

  1. forming a pizza shell,
  2. applying a predetermined quantity of pizza sauce
  3. cooking the pizza base for a X time period at a first  A temperature and subsequently cooling the pizza base
  4. once cooled, a P quantity of pizza toppings are placed on the moist sauce including other toppings
  5. it can be refrigerated for future use or further heated for Y time period at B temperature and subsequently served to the consumer.

            The independent patentability of new processes for making known products reflects the importance to society of stimulating new process innovation. Consider, for example the societal benefit achieved through the invention of new processes to make insulin, a well known protein needed by the people with diabetes. Insulin is now easily obtained in large quantities through DNA cloning technique. This recombinant process is much more efficient than the conventional method of extracting insulin from the pancreas of hogs.[31] Patent system calls forth new and non obvious ways to make existing products.[32]

THE TRINITY:  THE THREE EXCEPTIONS

In Mayo the Court has recognised “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.”[33]

            What is the reason behind the concept that one may not patent a principle, abstract ideas or law or product of nature (e.g. law of gravity by Newton, Einstein’s Relativity  theory or a naturally occurring mineral or plant) – Public policy dictates that there are some things that are so fundamental to the advancement of technology that they must remain in the public domain. Also, laws or products of nature, for example, do not constitute a machine, composition of matter, or manufacture; that is there is no invention or human intervention, only discovery. Moreover, allowing patent protection on abstract ideas and laws of nature would lead to excessive rent seeking and extremely high transaction cost.[34]

Justice Breyer had this to say about the prohibition:

           “The reason for the exclusion is that sometimes too much patent protection can impede rather than promote the Progress of Science and useful Arts, the constitutional objective of patent and copyright protection.”[35]

 JOURNEY OF PATENT ELIGIBILITY BEFORE THE COMING OF MAYO

Rothstein J.A.’s assertion is that “the language of patent law is broad and general and is to be given wide scope because inventions are, necessarily, unanticipated and unforeseeable.” It does not follow that all proposed inventions are patentable. Only those should get patent which deserve to be. A check has to be maintained to regulate the patenting of the claims and this has been reflected in the judgments of Supreme Court by keeping a check on the patent eligibility of matter. Following cases had some important rulings laid down by the Supreme Court regarding process patents:

  1. Gottschalk v. Benson[36]– MOT test, i.e., transformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.
  2. Parker v. Flook[37]Benson[38]analysis was taken further. In case that a claim uses a known mathematical formula and “even if the solution is for a specific purpose, the claimed method is non statutory” and an inventor cannot circumvent patenting abstract ideas “by attempting to limit the use of the formula to a particular technological environment.
  3. Diamond v. Diehr[39]– a known mathematical formula is not patentable, however, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”

 Recently, patent eligibility has been discussed in the following cases:

  1. Bilski v. Kappos[40]– rejected the notion that the MOT test was the “sole and exclusive” test for deciding whether a patent was eligible under §101.
  2. Mayo [41]– affirmed Bilskiholding that the MOT test was not the definitive test. In fact, the Supreme Court found that the claims of the patent in Prometheus passed the MOT test because they were “transformative.” However, the court held the claims were unpatentable because they added “nothing of significance to the natural laws themselves.”

 

Mayo is recently followed inAssociation For Molecular Pathology Et Al. v. Myriad Genetics, Inc., Et Al[42]

“laws of nature, natural phenomena, and abstract ideas”“ ‘are basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection.[43]

SUMMARY OF MAYO

Facts of the case:

The body metabolizes thiopurine drugs when they are ingested. This produces metabolites in the bloodstream and this differs from patient to patient. The respondents identified correlations between an individual’s blood levels of thiopurine metabolites after drug administration and also the effectiveness and harmfulness of the dose. Prometheus Laboratories, Inc. (Prometheus), is the sole and exclusive licensee of the two patents at issue. This concern the use of thiopurine drugs to treat autoimmune diseases. These diagnostic tests based on Prometheus’ pa­tents were bought and used by Mayo Collaborative Services and Mayo Clinic Rochester (Mayo). Mayo made an announcement in 2004 that it intended to sell and mar­ket its own, somewhat different, diagnostic test.  Mayo was sued by Prometheus contending that Mayo’s test infringed its patents.

            The District Court dismissed on summary judgment to Mayo, reasoning that the processes claimed by the pa­tents effectively claim natural laws or natural phenomena[44] and therefore are not patentable. The Federal Circuit reversed, finding the processes to be patent eligi­ble under the Circuit’s “MOT test.” Supreme Court remanded for reconsideration in light of Bilski v. Kappos,[45] which clarified that the “machine or transformation test” is not a definitive test of patent eligibility. The Federal Circuit reaffirmed its earlier conclusion leading to Mayo again petitioned for certiorari.[46]

The claimed ‘Process’:

Each claim recites;

  1. an “administering” step—instructing a doctor to ad­minister the drug to his patient
  2. a “determining” step—telling the doctor to measure the resulting metabolite levels in the patient’s blood
  3. a “wherein” step—describing the metabolite concen­trations above which there is a likelihood of harmful side-effects and below which it is likely that the drug dosage is ineffective, and in­forming the doctor that metabolite concentrations above or below these thresholds “indicate a need” to decrease or increase the drug dosage.’

Issues:

  1. Whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws?
  2. Whether the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?[47]

Holding:

Prometheus’ process is not patent eligible.

Ratio:

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. The steps in the claimed processes  involving well-understood, routine, conventional activity previously engaged in by researchers in the field would not be patent eligible. Moreover, these exceptions are basic tools in development.

Obiter dicta:

            In evaluating the significance of additional steps, the patent-eligibility inquiry        and, say, the § 102 novelty inquiry might sometimes overlap.

ANALYSIS OF THE JUDGMENT

The judgment delivered by Justice Breyer is of paramount importance today . Being patent eligible is the primary step which should be passed in order to consider other factors for a claim to be granted a patent.

            The Judgment can be analysed in six segments. This is derived in accordance with the opinion given by the Court.

i. Conditions Laid Down In Precedents

These conditions are:

  • The  patent eligibility should not depend simply on the draftsman’s art without reference to the principles underlying the prohibition against patents for natural laws. [48]
  • There is warning against upholding patents that claim processes that too broadly pre-empt the use of a natural law.[49]
  • A process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. [50]

This reflects that the Court did not go against many of the precedents. For this reason these are still applicable and have to be followed while deciding claims of such nature involved.

            The Court observed that the steps in the claimed processes involve well-understood, routine, conventional activity previously engaged in by researchers in the field.[51] This is the central reason why patent was not granted and this encroaches on patentability.

ii. The Court did not rely on the MOT Test

The Federal Circuit Court observed that the process explained, involve the transformation of the human body, satisfying the Circuit’s MOT test. The court thought sufficient to “confine the patent monopoly within rather definite bounds.” [52]

            When the case was remanded in the light of Bilski, it thought that the MOT test, understood merely as an important and useful clue, nonetheless led to the “clear and compelling conclusion . . .that the . . . claims . . . do not encompass laws of nature or pre-empt natural correlations.” [53]

            Granting of certiorari by the Court draws attention on the fact that the Supreme Court upheld Bilski. This means that this test is no more very appropriate to be used to determine the patent eligibility in matters influenced largely by law of nature.

iii. ‘Adds Nothing To The Laws Of Nature’

Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.[54]

            The question raised by the Court was do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?[55]

            The answer of the Court was in negative. 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.

            The words ‘additional’ and ‘add’ have been used by the Court repeatedly to express that the process should do something more than just stating the natural law.

            “These additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.”[56]

            The Court has emphasised on these words. The process should add something more to the unpatentable matter in order to make it patentable. Here it sets a little confusion as it has not expressly described as to how to identify whether there have been sufficient additions.

iv. Controlling Precedents

In Diehr, the Court pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole.

In Flook, the Court characterized the claimed process as doing nothing other than “providing an unpatentable formula for computing an updated alarm limit.” [57] Unlike the process in Diehr, it did not “explain how the variables used in the formula were to be selected, nor did the claim contain any disclosure relating to chemical processes at work.” In Flook, the Court observed that there was no “inventive concept” in the claimed application of the formula.[58]

            The claim in Mayo tells doctors to measure the current level of the relevant metabolite, use laws of nature to calculate the current toxicity/inefficacy limits, and reconsider the drug dosage in light of the law. These instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.[59]

Patentability And Patent Eligibility Not In Water Tight Compartments

The judgment demonstrates that patentability and patent eligibility are not in water tight compartments. The Court required that the steps should be something more than well-understood, routine, conventional activity previously engaged in by researchers in the field, rather than something “purely ‘conventional or obvious.’” The Court “recognized that, in evaluating the significance of additional steps, the patent-eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap.”[60] The observation claims did not add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws embody the patentability field.

v. Supportive English Case Law

The English court in Neilson,[61] which had a similar problem as here in the Court, concluded that the claimed process did more than simply instruct users to use the principle.

            The court has stressed on ‘more than’ simply instructing the users. Mayo, to an extent endorses this ratio. In all due fairness, it can be said that they should do more than or add more to the natural law or principle claiming.

vi. Patent law should not inhibit further discovery

There exists a danger  of inhibiting further innovation if patented process amounts to no more than an instruction to “apply the natural law.”[62]

            The court here looks very concerned about the fact that there should be no such patents which hinder the future research and development. Every coin has two sides.  The more grant of patent shall on one hand encourage others to invent and discover, but on the other hand the patents if include the natural laws and phenomenon related to it, then it would be a disadvantage to others. But here chances of latter are higher.

             “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.”[63]

            As a result after Mayo the claims which invoke exception will be patent eligible only if they follow the basic principles plus what is laid down in Mayo.[64]

             It is observed that what has been laid down by the Court is to an extent vague. It has not clearly laid down any method or formula. The point to be focussed is whether it “adds” something more. This is not hitting at any particular way but leaves it on the Judges to decide in the respective cases.

AN INQUIRY OF PATENT ELIGIBILITY OF A CLAIM[65]

 This part is to exemplify as to how to inquire whether a claim is patent eligible according to Mayo.  A person’s mood is affected  by  white light due to change in neuronal activity. When white light strikes a person’s photoreceptors, it elicits a chemical reaction that starts an electrical response in the receptor cells modulating neuronal circuitry. Suppose the claim is for a method treating a psychiatric behavioral disorder of a patient. The disorder is associated with a level of neuronal activity in a neural circuit within a brain of the patient. The method is:

a)      providing a light source that emits white light;

b)      filtering the ultra-violet (UV) rays from the white light;

c)      positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the brain of the patient to the filtered white light to mitigate the behavioural disorder.

Analysis:

1: The claim is a process claim.

2: The claim focuses on the use of a law of nature.

3: It has sufficient steps that reflects the claim is significantly more than a law of nature + “apply it”. The additional step is positioning the patient. This establishes conditions that limit the application of the principle to exposure under certain specifically defined conditions. These precise conditions are not necessary to apply the law of nature because a person situated outside such that their photoreceptors are exposed to the sun’s rays would experience the effect on the neuronal circuitry. Considering the process as whole shows that it does not substantial practical application of the law of nature.

MAYO FOLLOWED IN MYRIAD

When Runi Limary was just 28 she got a shocking news: breast cancer. Her first decision was removal of right breast. She had her left breast removed after two years. Limary’s third decision has proved harder. Though she wanted a second, independent opinion before taking the preventive measure of having her ovaries removed, she didn’t have that option because one company, Myriad Genetics, held patents on isolated forms of the two genes in question.[66]

            But after Myriad judgment such people wouldn’t have this kind of problem because the tests would be much cheaper. Myriad’s DNA claim falls within the law of nature exception and this is why it was held not to be patent eligible. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes.  However cDNA is not a “product of nature,” so it is patent eligible under §101.

            The ruling followedMayo. Natural laws, Justice Breyer wrote for the court, may not be patented standing alone or in connection with processes that involve well-understood, routine, conventional activity.

What Can Be Claimed?

The Supreme Court provided notable dicta in Myriad on what is not implicated by Myriad decision. Following claims can withstand patent eligibility:

  1. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments,
  2. Method claims an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes,
  3. Applications for the knowledge developed in discovering underlying ineligible information, and
  4. Court implicitly blessed patent claims addressing breakthroughs regarding products of nature or abstract ideas where the claims somehow manipulate that knowledge through a method or application.[67]

CONCLUSION

The claim is not patent eligible if  it involves a natural law, it had well-understood, routine, conventional activity previously engaged in by researchers in the field and did not add much to it. Even a narrow law of nature can inhibit the further innovation.  Following this came the Myriad Judgment which held DNA not to be patent eligible, the basis of which was Mayo. These cases are a setback to the persons claiming patent in diagnostic method, DNA and even in business methods.  But they are boon to the people as they can gain more benefit out of such inventions. The society at large will benefit. These judgments have profoundly laid down legal points rather than benefit of the society. But it is to be noted that it did not perfectly established method to determine as to how a claim involving a natural law is to be judged as whether it is patent eligible. It is vague but it clearly favours the society at large. Justice Sotomayor in Myriad observed “I can bake a chocolate-chip cookie using natural ingredients — salt, flour, eggs, butter,” she said. “And if I combust those in some new way, I can get a patent on that. But I can’t imagine getting a patent simply on the basic items of salt, flour and eggs.” DNA falls under the category of law of nature exceptions, which according to Myriad is not patent eligible, and hence DNA is unpatentable. Mayo proved to be a game changer. The interpretation of the things changed the scenario.

[1] MARY CROSS, 100 PEOPLE WHO CHANGED 20TH-CENTURY AMERICA (ABC-CLIO, 2013).

[2] B LIONEL & S BRAD, INTELLECTUAL PROPERTY LAW 1(3rd edn Oxford University Press 2009).

[3] Lecture ‘Discoveries, Inventions and Improvements’ (22 Feb 1860) in J G NICOLAY & J HAY (eds.) COMPLETE WORKS OF ABRAHAM LINCOLN (1894), Vol. 5, 113. In E C GERHART QUOTE IT COMPLETELY! (1998) 802.

[4] Jonathan Turley, Myriad Genetics raises significant Moral And Legal Issues, USA Today, April 16, 2013, available at <http://www.usatoday.com/story/opinion/2013/04/15/gene-patents-supreme-court myriad/2074893/>.

[5] 130 S.Ct. 3218 (2010).

[6]Hereinafter referred to as Mayo.

[7] 569 U. S. (2013), No. 12–398 (June 13, 2013).

[8] Quote by Heraclitus of Ephesus(c.535 BC475 BC). He was a Greek philosopher, known for his doctrine of change being central to the universe, and for establishing the termLogos  in Western philosophy as meaning both the source and fundamental order of theCosmos.

[9] As per 35 U. S. C. §101.

[10] In the case of Bilski.

[11] The patent claims here set forth processes embody­ing researchers’ findings that identify correlations between metabo­lite levels and likely harm or ineffectiveness with precision.

[12] 132 S.Ct. 1289 (2012).

[13]This is discussed in detail in the next segment.

[14] Dia­mond v. Diehr, 450 U.S. 175, 185 (1981); see also Bilski v. Kappos, 561 U.S. (2010) (slip op., at 5); Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980); Le Roy v. Tat­ham, 14 How. 156, 175 (1853); O’Reilly v. Morse, 15 How. 62, 112–120 (1854); C.f. Neilson v. Harford, Webster’s Patent Cases 295, 371 (1841) (English case discussing same).

[15] Gottschalk v. Benson , 409 U.S. 63, 67 (1972).

[16] Dia­mond v. Diehr 450 U.S. 175 (1981); Parker v. Flook 437 U.S. 584, 590 (1978).

[17] Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86, 94 (1939).

[18] Funk Brothers Seed Co. v. Kalo Inoculant Co,. 333 U.S. 127, 130 (1948).

[19] Benson, supra note 16, at71–72.

[20] Mayo, supra note 1, at 6.

[21] 35 U.S.C. §101.

[22]Chakrabarty, supra note 15, at 303.

[23]Committee Reports accompanying the 1952 Act; Chakrabarty, supra note 15, at 309.

[24]According to the recent judgment in Association For Molecular Pathology Et Al. v. Myriad Genetics, Inc., Et Al, DNA is not held to be patent eligible.

[25] Parker v. Flook; Gottschalk v. Benson; Funk Brothers Seed Co. v. Kalo Inoculant Co.; Le Roy v. Tatham.

[26] See, “Method for making stuffed crust pizza crust,” U.S. Patent No. 6,048,556( Issued April 11, 2000).

[27] See, “ Method and system for placing a purchase order via a communications network,” U.S. Patent No. 5,960,411 (Issued September 28, 1999).

[28] See, U.S. Patent No. Re. 33,449 (reissued Nov. 20, 1990).

[29] The Java Jacket patent, U.S. Patent No. 5,425,497 (issued June 20, 1995).

[30] See, US Patent No. 6753025 (issued June 22, 2004).

[31] K DRLICA, UNDERSTANDING DNA AND GENE CLONING: A GUIDE FOR THE CURIOUS,14 (3rd edn 1997).

[32] J M MUELLER, PATENT LAW 259(3rd edn Aspen Publishers 2009).

[33] Quoting Benson, supra note 16, at 67.

[34] WM LANDES & RA POSNER, THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW 305-06 (2004).(noting transaction costs would be “enormous because the scope” of protection “often is extremely difficult to pin down, and this would make it difficult for newcomers to now when they needed to get a license”).

[35] Laboratory Corp. of America Holdings v. Metabolite Labs. Inc., 548 U.S. 124, 126-27 (2006) (J. Breyer, dissenting)

[36] 409 U.S. 63 (1972).

[37] 437 U.S. 584 (1978).

[38] To transform an unpatentable law of nature into a patent ­eligible application of such a law, a patent must do more than simply state the law of nature while adding the words “apply it.”  Gottschalk v. Benson, supra note 37, at71–72.

[39] 450 U.S. 175 (1981).

[40] Bilski .supra note 6.

[41] Mayo, supra note 1.

[42] 569 U. S. (2013) No. 12-398.

[43]Mayo, supra note 1.

[44] Namely, the correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drugs.

[45] 130 S.Ct. 3218 (2010).

[46]The Court granted and hence this Judgment.

[47] Mayo, supra note 1.

[48] Flook, supra note17, at 593.

[49] O’Reilly v. Morse 15 How. 62, 114–115;  Benson, supra note 16, at 71–72

[50] Flook, supra note 17, at 594; Bilski, supra note 6, at 14.

[51] Mayo, supra note 1, at 8.

[52] 581 F. 3d 1336, 1345, 1346–1347 (2009).

[53] 628 F. 3d 1347, 1355 (2010).

[54] Mayo, supra note 1, at 7.

[55] Mayo, supra note 1, at 8.

[56] Mayo, supra note 1, at 8.

[57] Flook, supra note 17, at 586.

[58] Flook, supra note 17, at 594.

[59] Mayo, supra note 1, at 8. (quoting Parker v. Flook, 437 U.S. 584, 590 (1978))

[60] Mayo, supra note 1, at 13.

[61]Nielson, supra note 15.

[62]See, LEMLEY, RISCH, SICHELMAN, & WAGNER, LIFE AFTER BILSKI 63 STAN. L. REV. 1315  (2011) (arguing that §101 reflects this kind of concern); see also C. BOHANNAN & H. HOVENKAMP, CREATION WITHOUT RESTRAINT: PROMOTING LIBERTY AND RIVALRY IN INNOVATION 112 (2012).

[63] Mayo, supra note 1, at 12.

[64]These have been mention under the ratio of judgment in ‘Summary of Mayo’.

[65]Memorandum- 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature, UNITED STATES PATENT AND TRADEMARK OFFICE (July 3, 2012).

[66] Richard Wolf, Can human genes be patented , USA Today, April 10, 2013, available at <http://www.usatoday.com/story/news/nation/2013/04/10/can-human-genes-be-patented/2071275/>; Limary is among the original plaintiffs in a legal tussle that has been fought for four years, with mixed results (Myriad).

[67] Skadden, Arps, Slate, Meagher & Flom LLP, Patent Eligibility Considerations Following the Supreme Court’s Myriad Ruling , June 17, 2013, available at <http://www.skadden.com/insights/patent-eligibility-considerations-following-supreme-courts-myriad-ruling>.

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