ELIGIBLE SUBJECT MATTER IN THE LIFE SCIENCES: Is the Conundrum Necessary - Lucas & Mercanti, LLP

ELIGIBLE SUBJECT MATTER IN THE LIFE SCIENCES:

Is the Conundrum Necessary

By Irv N. Feit, Ph.D., March 10, 2020

One of the most difficult and controversial areas of patent law is the judicially created doctrine (almost 150 years old) that abstract ideas and natural laws are not patentable. However, as many judges and scholars have noted, every invention is based, directly or indirectly, on natural laws or phenomena. And, although the courts and the US Patent & Trademark Office (USPTO) have attempted to delineate a hierarchical analysis, decisions still seem confusing and inconsistent. Below, I explain this conundrum, how it was created, and suggest what those of us involved in patent law might do to address it.}

BACKGROUND

What constitutes patent eligible subject matter under the patent laws of the United States is stated with simple, concise elegance in 35 USC §101:

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.

Clearly, the four categories of statutory patent-eligible subject matter set forth in §101 were intended to include any new thing that a human mind is capable of thinking of.  Thus:

a machine is any thing that has a moving part;

a manufacture is any thing that does not have a moving part

a composition of matter is a combination of things; and

a process is an act or a series of acts that convert a thing to a different thing.

The Supreme Court confirmed this universal scope of patent eligible subject matter forty years ago in its landmark decision in Diamond v. Chakrabarty, 447 US 303 (1980).  Before the Chakrabarty decision, living cells did not constitute eligible subject matter.

According to the Court, eligible subject matter “includes anything under the sun that is made by man.”  (Today, one expects the Court would probably have added the words “and woman”).  The Court reasoned that a cell can be considered to be a manufacture or a composition of matter, and nothing in § 101 renders a manufacture or a composition of matter ineligible merely because it is living.

Nevertheless, the Court felt compelled to add the following caveat:

This is not to suggest that § 101 has no limits, or that it embraces every discovery.  The laws of nature, physical phenomena, and abstract ideas have been held not patentable.  See Parker v. Flook, 437 U. S. 584 (1978); Gottschalk v. Benson, 409 U. S. 63, 409 U.S. 67 (1972); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 333 U. S. 130 (1948); O’Reilly v. Morse, 15 How. 62, 56 U.S. 112-121 (1854).  (Emphasis added.)

This quote from Chakrabarty is clearly dictum, and most unfortunate, as we shall see.

The caveat in Chakrabarty has led to a body of law regarding the scope of § 101 that has been the source of considerable controversy and criticism, particularly in the life science industry.  Research is critically important in this industry, and any reduction in IP incentives to conduct research is harmful to everyone.

The purpose of this article is to demonstrate that the caveat is not only harmful with respect to the health science industry, but also unnecessary.[1]  The article will conclude with suggestions for how to deal with the short-term and long-term consequences of the § 101 conundrum.

As he was writing this article, the author was reminded of the famous words of William Faulkner: “The past is never dead.  It’s not even past.”  As will be demonstrated below, this quote is apt to the § 101 conundrum.

THE GENESIS OF THE CONTROVERSY (THE PAST)

In particular, we start by re-visiting the nineteenth century case cited by the Supreme Court in Chakrabarty, namely O’Reilly v. Morse (see above).  Samuel Morse was deemed to be the original inventor of the electro-magnetic telegraph, at least in the United States.  Conceiving an invention in the United States was sufficient at that time for obtaining a U.S. patent, even if the invention was known elsewhere (which it was).

A patent was issued to Morse in 1840 and reissued in 1848 with eight claims.  The first seven claims were held to be valid.  The issue before the Supreme Court was in regard to the eighth claim, which stated:

I do not propose to limit myself to the specific machinery or parts of machinery described in the foregoing specification and claims; the essence of my invention being the use of the motive power of the electric or galvanic current, which I call electromagnetism, however developed, for making or printing intelligible characters, signs or letters at any distances, being a new application of that power, of which I claim to be the first inventor or discoverer.  56 U.S. 112. (Emphasis added.)

The Supreme Court held that Morse:

… claims an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe when he obtained his patent. The court is of opinion that the claim is too broad, and not warranted by law. (Emphasis added, 56 US 113.)

Writing for the Court, the infamous Chief Justice Roger Taney[2] explained that:

… Professor Morse has not discovered that the electric or galvanic current will always print at a distance, no matter what may be the form of the machinery or mechanical contrivances through which it passes. You may use electro-magnetism as a motive power and yet not produce the described effect. (Emphasis added, 56 US 117.)

From the underlined words in this quote, it is apparent that the Supreme Court doubted that Morse’s eighth claim was enabled over its entire scope.  Under today’s law, therefore, the claim would have been held to be invalid under both the written description and enablement prongs of 35 U.S.C. § 112.[3]

The outcome of the other case mentioned in Chakrabarty that was not related to software and business methods, namely the much-criticized 1948 Supreme Court decision in Funk Brothers Seed v. Kalo Inoculant (see above) was similar.  In Funk Brothers, the invention related to a mixed culture of naturally occurring, nitrogen-fixing Rhizobia bacteria that are capable of inoculating the seeds of plants belonging to several cross-inoculation groups.  Unlike previous mixed cultures, however, the mixed culture of bacteria at issue in Funk Brothers was not mutually inhibitory.  Justice William Douglas, writing for the Court, stated:

The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are 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. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.  (Emphasis added, 333 U.S. 131.)

Laws of nature are literally as old as the universe.  From the underlined phrases in the above quote, it is apparent that the Funk Brothers v. Kalo Inoculant case could have been decided under what would be considered today to be anticipation (i.e., § 102).

In other words, it was, and still is, not necessary to invoke § 101 in considering the validity of the claims in either Morse v. O’Reilly or Funk Brothers v. Kalo Inoculant.

THE ORIGIN OF THE MODERN CONTROVERSY (“THE PAST IS NEVER DEAD”)

The subject matter in the other two cases mentioned in Chakrabarty, namely Parker v. Flook and Gottschalk v. Benson, related to algorithms and computer software.  The USPTO has struggled with the patentability of this type of subject matter since it began to appear in claims starting in the early 1970s.  The struggle was especially intense in the case of claims directed to business methods.  In 1996, for example, MPEP § 706.03(a) acknowledged that: “Office personnel have had difficulty in properly treating claims directed to methods of doing business.”  This ”difficulty” in the USPTO metastasized to the health care industry in the 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs, 132 S. Ct. 1289.  The claims involved in the Mayo case recited the following three elements:

(1) administering a thiopurine drug;

(2) determining the resulting metabolite levels in the patient’s blood; and

(3) a “wherein” clause—describing a range of effective and safe metabolite concentrations.

The Supreme Court reasoned that the correlation between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drugs is a law of nature.  The Court held that a diagnostic method based on a law of nature, without more, does not constitute patentable subject matter under § 101.  The Supreme Court explained that the administering step “… simply helps to pick out the group of individuals who are likely interested in applying the law of nature.”

The Supreme Court in Mayo cautioned that its decision should not be misapplied to cases in which claims were written with clearer practical applications of the laws of nature on which they are based.  The Court stated:

The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.

The Supreme Court’s warning, unfortunately, has not always been heeded by the Federal Circuit or, for that matter, by the Supreme Court itself in later decisions.  Shortly after its Mayo decision, for example, the Supreme Court further muddied the waters with regard to subject matter eligibility in its decision in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013).  The issue in Myriad was the patentability of DNA.

Myriad had discovered the precise location of mutations in certain genes that dramatically increase a woman’s risk of developing breast and ovarian cancer.  From the precise location, Myriad was able to determine the sequence of the genes, which are now known as the BRCA1 and BRCA2 genes.

Because of its discovery, Myriad was able to develop medical tests that are useful for assessing whether a woman has an increased risk of cancer.  The Supreme Court acknowledged that Myriad’s discovery constituted a “medical breakthrough.”  133 S. Ct. 2112, 2113.

Claim 1 of the Myriad patent recited an isolated DNA molecule having the entire sequence of the BRCA1 gene, i.e., both exons and introns.  This gene exists in nature as part of a cell’s genome. The BRCA1 gene does not, however, exist in nature in isolated form.

Writing for a unanimous Court, Justice Thomas, citing Funk Brothers, held that Myriad’s “… discovery, by itself, does not render the BRCA genes new … composition[s] of matter. § 101.”  Therefore, the Court held that the subject matter of claim 1 was not patent eligible.

The Court acknowledged that the BRCA1 gene had not been isolated before.  Nevertheless, the Court held that “that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”

The Court rationalized its decision by pointing out that an isolated gene has the same function as a gene in its natural genome surroundings.[4]  It did not, however, explain why the isolation of a newly discovered gene was not new.  Nor could it; it had never been isolated before.

A more rational decision in Myriad could have been arrived at by considering whether the isolation of the BRCA1 gene was obvious under § 103.  Resolution of that issue would have involved an investigation of how much effort was required to locate the gene and how much motivation existed to isolate it.  The USPTO and the courts have a large body of settled law to rely on in resolving obviousness issues.  Instead, the Court chose the chaotic and unsettled precedents of patent eligibility law under § 101 to arrive at its unfortunate decision.

RECENT CASE LAW (“… IT ISN’T EVEN PAST”)

Three recent cases illustrate the continued confusion caused by the chaotic past history of the subject matter eligibility controversy under § 101.  They are discussed below.

Rapid Litigation Management V. CellzDirect, Inc., 827 F.3d 1042, 1048 (Fed. Cir. 2016)

The invention involved in CellzDirect was based on the discovery that hepatocytes, i.e., liver cells, can be freeze-dried more than once without destroying the cells.  Before this discovery, it was not believed to be possible to do so.

The discovery was significant, because it made multi-donor hepatocyte pools possible.  Multi-donor pools are more representative of normal liver cells than single donor samples.  As a result, the pools constitute superior controls for comparing the liver cells of a patient

Claim 1 recited a method of producing multi-cryopreserved hepatocytes capable of being frozen and thawed at least two times.  The steps of the method included: (A) fractionating hepatocytes that have been frozen and thawed in order to separate viable hepatocytes from nonviable hepatocytes, (B) recovering the viable hepatocytes, and (C) cryopreserving the viable hepatocytes.

At trial, the district court considered the ability of hepatocytes to survive multiple freeze-thaw cycles to constitute a law of nature.  Therefore, the claims were said to be “directed to” a judicial exception of subject matter eligibility, and therefore unpatentable under § 101.

The Federal Circuit disagreed and held that claim 1 is not directed merely to a law of nature.  In doing so, the court distinguished a claim’s “reciting” a law of nature from a claim’s being “directed to” a law of nature.  According to the court, most inventions are based on, and often “recite,” laws of nature; but that does not necessarily mean they are “directed to” a law of nature.

According to the Federal Circuit, claim 1 recited, but was not directed to, the law of nature identified by the district court.  Rather, claim 1 was said to be directed to an application of the law of nature, i.e., “a new and useful laboratory technique for preserving hepatocytes.”  Consequently, claim 1 was held to be eligible under § 101.

Claim 5 required the additional step of pooling hepatocytes from multiple donors.  The court had an easier time holding claim 5 to be eligible under § 101.  According to the court:

… because the claimed process involves both multiple freeze-thaw cycles and pooling cells from various donors, it results in a preparation that is both new and vastly more useful for research than hepatocyte preparations made by conventional methods.

The Federal Circuit’s CellzDirect decision is of particular interest because of the interpretation the USPTO gave it.  This interpretation will be discussed below.

Vanda Pharm. v. West-Ward Pharm., 887 F.3d 1117 (Fed. Cir. 2018).

The preamble of the first claim announces what the invention relates to, namely: “A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia … .”  The invention is based on the appreciation that schizophrenia patients who metabolize iloperidone poorly are pre-disposed to suffer from certain side effects, such as serious cardiac problems.

The first step in the claimed method is to determine whether the patient is a poor metabolizer of iloperidone.  In accordance with the invention, such poor metabolizers are treated more safely by administering a lower dose of the drug than would be administered to a person who are normal metabolizers of iloperidone.  The second step is to determine if the patient has a poor metabolizer genotype.

Significantly, the last step is to administer iloperidone to the patient.  If the patient is a poor metabolizer, the dose of iloperidone is 12 mg/day or less; if the patient is a normal metabolizer, the dose 12 to 24 mg/day.  The Federal Circuit affirmed the lower court that the claims involved in Vanda constitute patentable subject matter.

Citing CellzDirect, the Federal Circuit reasoned that:

… it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is directed to. If the claims are not directed to a patent ineligible concept at step one, we need not address step two of the inquiry. (Emphasis added; citation and inner quotes deleted.)

The court distinguished the claims in Vanda from those in Mayo by pointing out that the claims in Mayo were directed to a diagnostic method based on the 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.  According to the court, this relationship is a consequence of the biological process by which thiopurine compounds are metabolized by the body.  Therefore, the court held the process to be based entirely on a natural law.  (See above.)

By contrast, the claims in Vanda require actually treating a disease by administering a drug at either a low dose or a high dose depending on the result of a genotyping assay. Thus, the court characterized the Vanda claims as a new way of using an existing drug that is safer because it reduces the risk of side effects.

The Cellzdirect and Vanda decisions suggested a more enlightened attitude toward § 101 issues.  But it was two steps forward and one step backwards, as we shall see in the next case discussed.

Am. Axle & Mfg v. Neapco Holdings, 939 F.3d 1355 (Fed. Cir. 2019).

The claimed invention at issue in American Axle was a method of manufacturing driveline propeller shafts (“propshafts”) for automotive vehicles.  In the method, a liner is tuned to attenuate at least two types of vibrations transmitted through the shaft member.  The tuned liner is then positioned in the propshaft such that the liner is configured to damp two modes of vibration.  According to the Federal Circuit, however, “neither the claims nor the specification describes how to achieve such tuning.”

Tuning the liner is accomplished using Hooke’s law, which is an equation that describes the relationship between an object’s mass, its stiffness, and the frequency at which the object vibrates. The court concluded that “… the claims’ general instruction to tune a liner amounts to no more than a directive to use one’s knowledge of Hooke’s law, and possibly other natural laws, to engage in an ad hoc trial-and-error process of changing the characteristics of a liner until a desired result is achieved.”

Therefore, according to the court, “… the problem is that the claims’ instruction to tune a liner essentially amounts to the sort of directive prohibited by the Supreme Court in Mayo—i.e. “simply stat[ing] a law of nature while adding the words ‘apply it.’ ”  The claims were held not to constitute eligible subject matter.

Judge Moore vigorously (and persuasively) dissented.  She wrote:

Whether this disclosure combined with the knowledge of a skilled artisan would permit that skilled artisan to tune a liner to a given propshaft in order to reduce bending mode vibrations without undue experimentation is exactly and precisely the enablement test pursuant to § 112.  A patentee’s failure to enable his invention renders the claims invalid under § 112, it does not, however, render the claims ineligible under § 101.

Amen, Judge Moore.

See also strong support for this view in the dissenting opinion of Judge Newman in Athena Diagnostics v. Mayo Collaborative Servs., 915 F.3d 743 (Fed. Cir. 2019) as well as the concurring opinions of Judges Lourie, Hughes, Dyk, and Chen and the dissenting opinions of Judges Moore, Newman, Stoll, and O’Malley regarding the order on July 3, 2019 of the Federal Circuit denying the subsequent petition for en banc rehearing of the Athena case.

The Current Regimen for Determining Subject Matter Eligibility

After the Supreme Court decisions in Mayo and in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), the USPTO developed a “two-step” regimen for determining subject matter eligibility for claims that fall into one of the four categories of inventions listed in § 101.  The first step asks whether the claims are “directed to” a law of nature, natural phenomenon, or abstract idea. If not, the invention is patent eligible.

If the claims are directed to an ineligible category, the second step of the regimen asks whether the claims contain elements that transform the nature of the claim into a patent-eligible application of the ineligible concept, so that the claim amounts, in practice, to something “significantly more” than a patent on the ineligible concept itself.  If the invention fails the second step of the Alice/Mayo regimen, then it is patent-ineligible.

The USPTO illustrated its regimen for conducting the Alice/Mayo test in the MPEP, and described it as having two steps.  In fact, as can be seen in the diagram, the regimen actually has three steps.  They are, however, designated 1, 2A, and 2B.

In the January Guidance , the USPTO “streamlined” step 2A by dividing it into two prongs.  Accordingly, the “two step” Alice/Mayo test now has four steps, designated step 1; step 2A prong 1, step 2A prong 2; and step 2B.  See the article by Jay Pattumudi regarding these steps.

Why does the USPTO feel constrained to insist that its test for patent eligibility has two steps?  Possibly because the Federal Circuit and the Supreme Court have referred to a “two-step framework” for determining patent eligibility.[5]  Whatever the reason, the unnecessary and complex designation of the steps of the new § 101 regimen is an appropriate metaphor for the new regimen itself, which, as explained above, is also unnecessary and complex.  It is likely that the USPTO does not want to be admonished again by the Supreme Court for ruling in ways inconsistent with its precedent (i.e., that the eligibility test has two steps).[6]

Harm Caused by the Current Regimen for Determining Subject Matter Eligibility

The patent community has had almost seventy years of experience and precedents in dealing with those sections of the patent act that typically determine the patentability of an invention, namely § 102 (novelty), § 103 (obviousness), and § 112 (written description and enablement).  Consequently, there is a measure of predictability regarding the patentability of an invention in a field that is inherently subjective. The addition of a new regimen for determining patentability causes harm in at least two ways.

For claims that are found to be ineligible under the new § 101 regimen, but that would have been declared unpatentable under one or more of §§ 102, 103, and 112, the addition of the new regimen to determine patentability necessarily increases the uncertainty in predicting patentability of an invention, and increases the cost of obtaining a patent.  Such predictability is critical in deciding whether to invest in a technology.

In addition, important inventions are unnecessarily declared unpatentable.  A good example is the decision in the Myriad case.  As mentioned above, the Supreme Court acknowledged that Myriad’s discovery of the precise location and the sequences of the BRCA genes, constituted a “medical breakthrough.”  Nevertheless, claims to the isolated BRCA genes and, more importantly, to fragments that make possible diagnostic tests that reveal a woman’s risk of developing breast and ovarian cancer, were held not to be patentable.

Myriad should at least have had the opportunity to argue that its claims were novel and unobvious in accordance with the well-established rules of §§ 102 and 103.  It was prevented from doing so because the Supreme Court truncated the analysis by holding that a claimed invention to a “medical breakthrough” of potentially life-saving utility did not constitute patentable subject matter in accordance with § 101.

SUGGESTIONS FOR DEALING WITH THE CURRENT REGIMEN FOR DETERMINING SUBJECT MATTER ELIGIBILITY

Dealing with the Regimen Short Term

Anyone who is interested in any aspect of intellectual property must deal, one way or another, with the issue of whether a patent claim is or is not subject matter eligible under § 101.  The USPTO provided some guidance in its “October 2019 Update: Subject Matter Eligibility.” (See 84 Fed. Reg. 55942; hereafter “October Update”).  The October Update “streamlined” its “2019 Revised Patent Subject Matter Eligibility Guidance,” which was published on January 7, 2019 (See 84 Fed. Reg. 50; hereafter “January Guidance”.)

As was mentioned above, the October Update “streamlined” step 2A of the January Guidance by referring to the original text of step 2A as prong one and adding a second prong.  The question whether a claim is “directed to” a judicial exception in Step 2A is now to be evaluated using a two-prong inquiry. The purpose of prong two of this inquiry is to emphasize that there is a distinction between “reciting” and being “directed to” a judicial exception (i.e., an abstract idea, law of nature, or natural phenomenon.)  This distinction was emphasized in the Cellzdirect decision.  See above.

According to prong one, the mere inclusion of a judicial exception in a claim means that the claim “recites” a judicial exception.  The mere recitation of a judicial exception, however, does not necessarily mean that the claim is “directed to” the judicial exception.

Under prong two, a claim that “recites” a judicial exception is not “directed to” the exception if the claim “integrates the recited judicial exception into a practical application of that exception.”  Accordingly, an important consideration regarding the patentability of a claim in a patent application or patent that recites a judicial exception is whether the claim integrates the exception into a practical application.

In an admirable attempt to mitigate the harmful effects of the Mayo decision on medical diagnostic research, the USPTO made it easier for examiners to find a practical application in Step 2A Prong 2 by stating:

[A] claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity.

See Section III(B) of the October Update.  Finding a practical application recited in a claim is important because it renders it patent eligible under § 101.

In support of this proposition, the USPTO interpreted the Federal Circuit’s CellzDirect decision in the October Update, as follows:

… the court [in CellzDirect] noted that a claimed process for preserving hepatocytes could be eligible [in § 101] as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.  (Emphasis added.)

This statement, although well-intentioned and welcome, appears to require a stretching of the actual facts of the CellzDirect decision, as well as of logic.  Thus, two facts in CellzDirect are:

  1. Claim 1 was held to be patent eligible simply because it integrated a law of nature into a practical application.
  2. The conclusion of eligibility of claim 1, according to the court, “applies even more so to claim 5,” which depends from claim 1, because it constituted an improvement, i.e.: “it results in a preparation that is … vastly more useful…”

Accordingly, the statement in the October Update that a claimed process may be patent eligible because it constitutes “an improvement to technology” is not consistent with a careful reading of CellzDirect.  Neither claim 1 nor claim 5 was held to be patent eligible because it constituted an improvement.  As mentioned above, claim 1 was said to be patent eligible because it was directed to a practical application of a law of nature.  Claim 5 was said to be more easily found to be patent eligible because it constituted a significant improvement of that application.

Nor is the statement in the October Update quoted above that “… a claimed process … could be eligible as an improvement to technology … , even though the claim is based on the discovery of something natural” consistent with logic.  If the invention is based on a law of nature, as was alleged in CellzDirect, is it not still a law of nature irrespective of how much it improves the relevant technology?

Something is clearly wrong when an attempt, however beneficial, to modify a harmful policy requires a justification that lacks factual and logical rigor. Most inventions improve a technology in some way.  What is and is not patent eligible should not depend on how much a patent examiner, the PTAB, or a court subjectively considers a claimed invention to constitute an improvement over the relevant technology.

Dealing with the Regimen Long Term

Long term, those of us who are interested in intellectual property should work to change the law.  Relying on the Supreme Court to re-visit this issue received a serious setback in January of 2020.  In that month alone, the Supreme Court refused to review eight cases that would have given it an opportunity to make changes in its § 101 jurisprudence; five on January 13, including the Athena and Vanda cases discussed above, and three more on January 27.[7]

The best, and probably only, way to change the law is to lobby Congress to amend § 101.[8]  The amendment should make clear that § 101 only adds a utility requirement to the other relevant sections of the U.S. patent code that specify the primary requirements for patentability, i.e., §§ 102 (new), 103 (unobvious), and 112 (clearly described and adequately enabled).  The amendment should also eliminate the redundant requirement in § 101 that the invention must be new.  There is, after all, a very long history of defining how an invention must be new in accordance with § 102.

There have already been many proposals to achieve this result.  Mine is to amend § 101:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may, without any further consideration or exceptions under this section, obtain a patent therefor, subject to the conditions and requirements of this title.

Irv N. Feit, Ph.D is a patent attorney specializing in chemical and biotech patent law, including drafting and prosecuting patent applications; post-patent procedures (e.g., reissues, reexaminations, interferences and appeals); providing opinions in matters relating to portfolio strength, infringement, and validity for a variety of large and small chemical and biotechnology companies, as well as for investment bankers. He also has extensive experience negotiating and drafting patent licenses and related (e.g., research and supply) agreements. He has also served as an expert witness during litigation.

[1] The harm is not limited to the life sciences.  For the detrimental effect of the caveat in Chakrabarty on business method patents, see Wen Xie, “USPTO Guidance Not Helpful for Method Patent Applicants, Law360, January 27, 2020.

[2] Infamous because he wrote the infamous Dred Scott decision in 1857.

[3] In a good illustration of this conclusion, the claims at issue before the Federal Circuit in In re Wright, 999 F.2d 1557 (1993), were directed to “any and all live, non-pathogenic vaccines, and processes for making such vaccines, which elicit immunoprotective activity in any animal toward any RNA virus.” These claims were held not to be enabled under § 112.  Writing for the court, Judge Rich held that: “… to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” Even Judge Newman, traditionally the most applicant-friendly Judge at the Federal Circuit since its inception, agreed.

[4] Claim 2 in Myriad’s application, by contrast, recited an isolated cDNA molecule having the sequence of only the exons of the BRCA1 gene. The Court found that cDNA molecules do not exist in nature.  Therefore, according to the Court: “… the lab technician unquestionably creates something new when cDNA is made.”  133 S. Ct. 2119.  Accordingly, claim 2 was held to constitute patentable subject matter.

[5] See, for example, Alice Corp. v. CLS Bank Int’l., 134 S. Ct. 2347, 2355 (2014), citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294, 1296-98 (2012).

[6] See, for example, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

[7] See Law360 January 24, 2020 and Law360 January 28, respectively for the impact of these decisions.

[8] Bipartisan efforts in Congress are, in fact, currently underway.  See Law360, February 12, 2020 for an update.

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