This article is written by Aayushi Gupta of Rajiv Gandhi National University of Law, Punjab. This is an exhaustive article on the patent-eligibility subject matter after the landmark case of Mayo v. Prometheus in the US. It also discusses the pre-Mayo case and the implications of the case on the patent-eligibility matters.
The law of patents in the US continues to evolve. The case of Mayo had a profound impact on the patent-eligibility of the method claims and radically altered the US § 101 on Patent Law’s jurisprudence. This decision radically changed the method of evaluation of a patent eligibility claim and this standard of evaluation is harder to clear and needs to be kept in mind while filing a patent application. The US Supreme Court’s decision in this case immediately evoked strong praise and equally strong criticism from across the medical and scientific communities. Some people assert that this decision is at the root of all problems facing the industry relative to patent eligibility and will only discourage advances in such fields.
What was the case before Mayo?
Patent law and related cases in the US create a wide realm of the patent-eligible subject matter. Although several cases have been decided on patent-eligibility earlier, some cases like Mayo v. Prometheus have a more lasting and profound effect than others. This case was considered to be potential enough to change the patent laws and the United States Code § 101 of the Patent Act’s jurisprudence. This case changed the analysis of patent eligibility of method claim under Title 35 USC § 101.
The US Constitution bestows Congress with the power to advance useful arts and technologies by granting the inventors exclusive right to their discoveries for a limited period of time. These exclusive rights are codified under the patent laws of Title 35 of the United States Code. The inventions eligible for these rights are described in § 101 as any invention or discovery that involves a new and useful process, the composition of matter, the machine, or manufacture, or any new and useful improvement can be granted the right to patent, subject to requirements and conditions of the Title. This brief statutory text has been expounded to mean that anything under the sun that is made by man is patentable, which acts as a limitation to this otherwise sweeping statute. However, the US courts have long recognized that abstract ideas, the law of nature, or natural phenomena are exceptions to patent eligibility. These exceptions envelop concepts that are part of the warehouse of knowledge, free for everyone and exclusively reserved for none. However, claims to these exceptions are not patent-eligible, an application of one of the aforementioned principles is patent-eligible. It was held in Mayo v. Prometheus that all inventions, at some level, use, embody or reflect abstract ideas, laws of nature, or natural phenomena. So an invention or discovery involving applications of one of these exceptions may be patent-eligible.
The US Supreme Court has decided many cases on patent eligibility, some of them were decided even before the patent legislation was drafted. Several of these cases involved patentability in new technological fields, and since developments in the field of technology could not have been foreseen by the Congress when it was drafting the patent legislation, so there is uncertainty regarding the application of patent laws in this field.
The 1972 Gottschalk v. Benson’s case was the first foray by the US Supreme Court into the patent eligibility of computer software. The claims, in this case, were directed to a process of conversion of binary code decimal numerals into pure binary numbers using a series of mathematical steps. The claims were not constrained to any particular machine or field; it involved any use of the method in any type of computer. The court decided that the claims were not patent-eligible since they were based on an abstract idea involving mathematical formula and algorithm. They held that the formula didn’t have any practical application except its connection with the computer, so a patent on the claimed method would only intend to strike the mathematical formula and would, in fact, be patent on the algorithm itself.
The US Supreme Court decided another case on the patent-eligibility of computer software in Parker v. Flook in 1978. The defendant asserted a method of calculating alarm limits using a new algorithm. The court held that the claim at hand is not patent-eligible, not because it contained an algorithm, but it didn’t contain some other inventive concept. The court held that the Flook’s contribution was that of a mere algorithm and that is not sufficient to create a patent-eligible invention. Instead, an inventive application of that algorithm would have made it patent-eligible. Flook argued that the post-solution activity, i.e., the adjustment of the alarm limits in accordance with the numbers computed by the algorithm met the eligibility standard. The court denied its notion and held that post-solution activity can transform an unpatentable principle into a patentable matter, but in this case, the post-solution activity didn’t include an inventive concept beyond the unpatentable algorithms and was rather conventional and obvious.
In 1981, in Diamond v. Diehr case, the Supreme Court held the computer software claims patent-eligible for the first time. The claimants claimed the process for moulding and curing synthetic rubber. The process involved steps like constantly measuring the temperature inside the mould, sending measurements to the computer which would calculate the cure time using the Arrhenius equation and when the recalculated cure time was equal to the actual time the rubber has been curing, it signalled to open the mould. The Supreme Court decided that the process was patent-eligible because it transformed an article to a different thing or state. Unlike Flook, the claimants here were not trying to patent the equation or prevent the use of it by others but wanted to preclude the use of the equation in combination with all of the steps involved in the claimed process. The inclusion of a mathematical equation or a computer didn’t affect the patentability. Hence, the application of an unpatentable abstract idea was made patent-eligible.
In 1980, the court dealt with patent eligibility of another new technology involving genetic engineering in Diamond v. Chakrabarty. This claim addressed the patent-eligibility of genetically engineered living organisms. Chakrabarty, in this case, claimed the bacterium had been engineered with two plasmids, giving it the ability to break down crude oils. The court decided that the bacterium was patent-eligible since it was not naturally occurring. The court held that, with respect to patent-eligibility, Congress made a distinction between products of nature, whether living or not and human-made inventions and not between animate and inanimate objects. Since the bacterium didn’t occur in nature, it was patent-eligible.
The Supreme Court also dealt with a new type of technology-business method- in 2010 in Bilski v. Kappos. The claims were related to risk hedging in competitive markets. The court decided that the claims, in this case, were unpatentable abstract ideas. Because the court identified that the claims were a mere attempt to patent the concept of hedging risk and its application in the market. The former is an unpatentable abstract idea while the latter involves a limited application of the concept and the limited application of the abstract idea to one field of use doesn’t make it patentable.
Until Mayo v. Prometheus in March 2012, the court dealt with only one case of patent eligibility in the life sciences field, in Funk Brothers Seed Co. v. Kalo Inoculant Co in 1948. Like the aforementioned case of Chakrabarty, this case also dealt with bacteria. The patentee asserted the injection of mixed species of root nodule bacteria. These bacteria specifically infect legumes, but each bacteria species will infect only a specified and limited group of legumes. So the farmer growing different varieties of legumes needed more than one species of bacteria. The previous attempts to combine bacteria species were unsuccessful as the bacteria was inhibitory in nature. But the patentee discovered and combined bacteria species that were not inhibitory.
The court held that the claimed bacteria inoculate was not patent-eligible because it was merely a discovery of the work of nature. Each species of bacteria in the mixed inoculate had the same characteristics when they were alone and they infected the same group of plants with the same level of efficacy. Unlike Chakrabarty, the claimed bacteria in Funk Brothers was already a handiwork of nature, rendering it patent-ineligible. Although the court has lumped this case, it is stated that this case predates the 1952 Patent Act and thus predates 35 USC § 101, but it is described as an obviousness case under 35 USC § 103.
The cornerstone of diagnostics is the recognition of the relationship between a level of a chemical and its efficacy. For long, the recognition of A correlated with B was patent-eligible. Thus, the administering or determining steps were added to claims to demonstrate a transformation or manipulation of a sample. The transformation or manipulation was proof that there was a physical application of the natural laws and, thus, patent-eligible. Many diagnostic methods were considered to be applications of the laws of nature. An assay transforms the material from one state to another. For instance, the administration of a vaccine transforms the patient from a susceptible state to an immuned state. An assay could have manipulated a substance to effect a change in the substance in the furtherance of the methods. These manipulations and transformations were active steps and, thus, patent-eligible.
In Mayo v. Prometheus, the claims at issue involved a testing method that provided information regarding treatment. The method involved administering a drug into a patient’s body, checking his or her metabolite levels and determining, whether the dosage was ineffective or highly toxic. Twice it was held patent-eligible. Administering a drug into a patient transformed him from one state to another and likewise, the determining step manipulated the sample in a way that was not natural. So the method claim was patent-eligible. But the Supreme Court was of the view that it was a reiteration of natural laws and determining steps were obvious and conventional. This landmark case had the most profound lasting effect on the patent-eligibility of a method claim.
Mayo Collaborative Services v. Prometheus Laboratories Inc.
Prometheus Labs is a San-Diego based company which focuses on gastroenterological and oncological therapeutics. It also used several markers to diagnose these gastrointestinal disorders and to monitor and predict treatment outcomes, which is also known as personalized medicine.
One of these diagnostic tools is a test for the physicians to adjust the correct dosage of thiopurine drugs for patients. Thiopurine drugs are used to treat immune-mediated gastrointestinal disorders which include inflammatory bowel diseases like ulcerative colitis, Crohn’s disease, etc. When these drugs are ingested, the body breaks down the drugs into metabolites and their respective nucleotides in the bloodstream. Patients metabolize these drugs differently so the doctors find it really difficult to decide whether a particular patient’s dose is too low, proving to be ineffective or too high, risking harmful side effects. Researchers and clinicians knew that the measurement of these metabolites can help determine the toxicity or efficacy of the drugs, but the exact measurement of metabolites that correlate with toxicity and efficacy has been unknown. Two researchers in Montreal, Canada discovered these concentrations and correlations and filed for patent applications and several patents have since then been issued.
Prometheus is the sole and exclusive licensee of two of the patents: US Patent Nos. 6,355,623 (‘623) and 6,680,302 (‘302). Most of the claims in these patents embody researchers’ findings that identify the correlations between metabolite levels and likely toxicity or efficacy of the ingested drug with precision. Each claim involves:
- An administering step- Instructing the doctor to administer the drug to the patient;
- A determining step- Doctor measuring the resulting metabolite levels in the patient’s blood; and
- A wherein step- Describing the metabolite concentration above which the drug proved to be toxic and below which it proved to be ineffective and metabolite concentrations above and below these parameters indicate a need to decrease or increase the dosage, respectively.
Prometheus marketed a thiopurine test based on these patents. Petitioners Mayo Collaborative Services and Mayo Clinic Rochester bought and used the diagnostic tests which were based on the respondent’s patents. Later, in 2004, Mayo announced that it wishes to sell and market its own diagnostic test which measures the same metabolites but slightly different levels as indicative of drug toxicity. Prometheus sued Mayo claiming that it infringed its patents.
District court’s decision
After Mayo’s proclamation of its own diagnostic test, Prometheus sued Mayo for the infringement of the ‘623 and ‘302 Patents. The US District Court for the Southern District of California granted the summary judgment in favour of Prometheus, stating that Mayo’s alleged thiopurine metabolite test infringed the claims in Prometheus’ patents. Despite its initial finding of infringement in favour of Prometheus, the District Court, subsequently, granted summary judgment in favour of Mayo’s motion of invalidity of the patents under 35 USC § 101. The court held that the steps claimed in the patented method embodied only the correlations between metabolites levels and the likely efficacy or toxicity of thiopurine drugs and the correlations are a natural phenomenon. They also stated that the claims wholly prevent the use of that phenomenon in such a manner that it seems a patent on the whole phenomenon itself, which is impermissible under US § 101’s jurisprudence.
Federal circuit’s first and second decision
Prometheus appealed the District Court’s holding of invalidity of his patents to the US Court of Appeals for the Federal Circuit in May 2008. The Federal Circuit reversed the District Court’s decision, basing its decision on the then patent-eligibility test, which stated that a claimed process is surely patent-eligible if it’s tied to an apparatus or a machine, or if it transforms a particular article from one state to another. This Machine or Transformation Test (MOT) also required that the transformation of an article or use of a machine must inflict meaningful limits on the claim’s scope and the inclusion of the machine or the transformation must be principal to the claimed method or at least must not be some insignificant extra solution or data-gathering activity.
The Federal Circuit held that Prometheus’ claim falls well within the scope of 35 USC § 101. Both the administering and determining steps transformed the article from one state to another and the transformation was primary to the subject of the claimed process. When drugs are administered, the human body undergoes a transformation from a susceptible state to an immune state, which is the reason why drugs are administered. Even though the administered drug is metabolized via natural processes but the administering step is still patentable because every transformation of any physical matter is carried out by natural processes and here, in this case, the drug is administered to transform the subject which is itself not a natural process.
The Federal Circuit held that the determining step is also patentable because it is also transformative and central to the claimed process. It is transformative in the sense that, since metabolite levels can be determined through a simple inspection, therefore, manipulation is necessary to extract the metabolites from the bodily sample and determine their concentration. It is central because measuring metabolite levels is what indicates the need to adjust the dosage of thiopurine drugs.
Although the court found that the wherein step of the claimed process was an unpatentable mental step, that alone didn’t negate the transformative nature of the previous steps. In the end, the Federal Circuit held that since the claims meet the MOT, they don’t forestall a fundamental principle and are, therefore, patent-eligible. The Federal Circuit reversed the District Court’s decision and remanded the case with instructions to deny Mayo’s motion for summary judgment of Prometheus’ patent-ineligibility. Since Mayo’s motion was denied, it appealed to the Supreme Court.
Meanwhile, another 35 USC § 101 cases sought its way to the Supreme Court. In Bilski v. Kappos, it was held that the MOT was not the sole test for the patent eligibility claim under 35 USC § 101, but was instead a useful and important clue. In this case, the Federal Circuit heavily depended on its definitive MOT for analyzing the eligibility of Prometheus’ claims. The day following Bilski’s decision, the Supreme Court granted Mayo’s petition for a writ of certiorari, remanded the case for further consideration in lieu of Mayo’s claim.
On remand from the Supreme Court, the Federal Circuit applied the same analysis as it had applied before Bilski and decided that the Prometheus’s claims are still patent-eligible. Prometheus’ claims were a patent-eligible application of naturally occurring correlations between metabolite levels and its likely toxicity or efficacy and don’t wholly prevent all uses of the correlations. And the claimed methods of treatment satisfy the transformation and central prong of the MOT. Thus, the Federal Circuit again reversed and remanded the case. Mayo appealed to the Supreme Court again and was granted certiorari in June 2011. This time, the Supreme Court heard the case on its merits.
US Supreme court’s decision
Justice Stephen Breyer delivered the opinion for a unanimous Supreme Court, stating that the claims at issue are not covered under patent-eligibility subject matter under 35 USC § 101. The court found that the claims at issue are covering natural laws as they are describing the correlation between the metabolites and its therapeutic toxicity or efficacy. The correlations are natural laws as they completely rely on natural processes of the body metabolizing these drugs. As established in previous cases, the natural laws are not patent-eligible but the application of laws of nature may be. So, the question before the court was whether the method claims add significantly more than simply reiterating the natural laws, i.e., do the patent claims add enough to their statements of correlations to allow the processes they claim become patent-eligible for its application of natural laws.
The court held that the claims didn’t add enough to the laws of nature covered therein. They said that, even outside the ambit of laws of nature, the method claimed was a conventional, well-understood, routine activity. Researchers, at the time when the correlations were discovered, were aware that the metabolic is associated with therapeutic toxicity or efficacy, but its precise correlations were not discovered.
Laws of nature are not patent-eligible and neither are the processes that recite the law of nature, but if the processes give a practical assurance that they are more than a mere attempt to monopolize the laws of nature, then that process can become patent-eligible. The court tried to find additional features that would transform the process from an unpatentable application to a patent-eligible one but were unable to find any.
The court held that:
- Firstly, the administering step referred only to the relevant audience which included doctors who have been using thiopurine drugs to treat patients for a very long time.
- Secondly, the determining step was considered to be a well-understood conventional activity which simply tells the doctor to engage in measurement of metabolite levels after the injection of the drug. This activity is the measurement of metabolite levels, but it is not restricted to any particular method and methods of ascertainment of metabolite levels were already known to the researchers at the time of claimed invention. This was the first time that the court introduced the concept of novelty and obviousness in the patent-eligibility claims. Under § 102 and § 103, novelty and nonobviousness are standards for claims to be patentable. They have always been treated as separate determinants. But in this case, the court held that the use of conventional methods didn’t impart patent eligibility to natural law.
- Thirdly, the wherein clause at the end simply tells a doctor about relevant natural laws and at best reminds them to keep these natural laws in mind while treating patients.
- Lastly, the court found nothing additional when it considered these steps in combination. It said that it was targeted to a relevant audience which included a routine and conventional activity and added nothing significant beyond the sum of their parts when viewed in combination.
After reviewing previous cases on USC § 101, the court held that the method claimed, in this case, was weaker than the patent-eligible in Diamond v. Diehr and no stronger than the unpatentable method in Parker v. Flook. Like Flook, the present claims say nothing more than measuring something and is a mere reiteration of natural laws and there was no practical proof that would have transformed it into a patent-eligible subject matter. The court said that the claimed steps were patent-ineligible, however, it failed to mention whether less conventional steps would have rendered it eligible for a patent. They reversed the Federal Circuit’s decision and were of the view that processes that allegedly helped physicians to determine proper dosage levels of thiopurine drugs used to cure autoimmune diseases are not patent-eligible subject-matter under 35 USC § 101.
Mayo v. Prometheus is considered a lawless decision which has continued to wreak havoc on the system of patent protection. It is even thought that seeking patent protection for cutting edge software, genetics, biotech is relatively easier in countries like Europe, Canada, and even in China. This decision had indeed made it hard for biopharmaceutical diagnostic patent claims that don’t have a very novel aspect attached to its testing method. Usually, new diagnostics are a result of an understanding of a new biological relationship that doesn’t necessarily depend on a new testing method. It was, however, decided in Mayo that discovering a new biological relationship with no new testing method is a mere reiteration of natural laws and, thus, not patentable. It is considered that Mayo is at the root of all the problems facing that industry of patent-eligibility. The new patent-eligibility analysis adopted in this case has narrowed the breadth of eligibility.
The Prometheus already had an impact- though a temporary one- on the highly controversial Association for Molecular Pathology v. Myriad Genetics Inc. case. Each human gene is coded by DNA, which consists of two nucleotides. These sequences of DNA containing nucleotides provide information necessary to produce amino acids which are further used to build proteins. The nucleotides that code for amino acids are known as exons and those who do not are known as introns. Scientists can isolate several segments of DNA to study. And they can also create exons-only strands of nucleotides, called complementary-DNA or cDNA.
Myriad Genetics obtained several patents after discovering the precise location of BRCA1 and BRCA2 genes, mutations of which can increase the risk of breast and ovarian cancer. This allowed them to determine the gene’s typical nucleotide sequence, which enabled them to generate medical tests to detect the mutations and analyze the patient’s health risk. If patents are valid, it would give Myriad the exclusive right to isolate BRCA1 and BRCA2 genes and also the exclusive right to synthetically create BRCA cDNA. The plaintiffs sought a declaratory judgment claiming that 15 claims in seven patents allotted to Myriad are invalid under 35 USC § 101. The claims can be categorized as following: (a) composition of matter claims to isolated DNA; (b) drug screening claims; and (c) methods of analyzing BRCA gene sequences and comparing them with cancer mutations.
The case was first heard in the Southern District Court of New York and the court gave summary judgment in favour of petitioners stating that all of the challenged claims were patent-ineligible as they covered laws of nature. Myriad appealed to the US Court of Appeals for the Federal Circuit and the court held that isolated DNA that doesn’t exist alone in nature is patentable and so does the drug screening claims but Myriad’s diagnostic claims were unpatentable. On appeal, the Supreme Court remanded the case and advised the Federal Circuit to reconsider the case in lieu of Prometheus. The Federal Circuit was firm in its decision and Prometheus didn’t affect the case. They found that the steps comparing breast cancer DNA sequences with controlled DNA sequences were similar to administering and determining steps involved in Mayo. The Public Patent Foundation filed for a writ of certiorari and it was granted. Then, the Supreme Court unanimously invalidated Myriad’s claims to isolated genes stating that merely isolating DNA that already exists in nature is not patentable. With this, the Supreme Court reversed 30 years of US Patent Office practice to grant patents for isolated nucleic acid sequences. However, it was held that non-naturally occurring DNA like cDNA is patentable.
In Myriad, the Supreme Court ruled that the claims covered subject matter that doesn’t exist in nature and on the other hand, the Supreme Court ruled that the claims were patent-ineligible under the law of nature doctrine. There is a serious flaw in this decision. It can be seen in this case that claims can be patent-ineligible under judicially doctrine law of nature while it doesn’t even come under the ambit of the law of nature in practicality. The Supreme Court established a two-prong test for patent-eligibility. Firstly, is the claim directed to a judicial exception, and secondly, if yes, is there any element in the claim that sufficiently proves that it is significantly more than the judicial exception.
Also, the case of eBay v. MercExchange comes close to Mayo in terms of damage to the patent system. Petitioner Ebay operated a popular Internet website that allowed private sellers to list the goods they wish to sell. Petitioner half.com, a subsidiary of eBay, also operated a similar website. Respondent MercExchange sought to license its business method patent to the petitioners, but they failed to reach an agreement. Consequently, the respondent sued them for patent infringement.
The case was first heard in the US District Court of Virginia, where a jury found that the patent was valid and the petitioners had infringed it and damages were appropriate. Based on the jury’s decision, the District Court denied the relief of permanent injunction. The Court of Appeals for the Federal Circuit reversed the decision of the District Court and held by a general rule that permanent injunction must be provided for patent infringement absent exceptional circumstances.
But the Supreme Court vacated the judgment or rendered it void. It stated that, in disputes arising under Patent Act, a plaintiff seeking a permanent injunction must prove that (a) an irreparable injury has been caused to him; (b) that the monetary or other damages are inadequate; (c) taking into consideration the balance of hardships between plaintiff and defendant and ensuring that remedy in equity is warranted, and (d) public interest is not disserved by the injunction. The Supreme Court held that injunctive relief should be in accordance with the principles of equity. And in the case at bar, neither the District Court nor the Federal Circuit applied these traditional equitable principles in deciding for the injunctive relief. The Federal Circuit’s general rule went against the four traditional principles, therefore, the Supreme Court reversed the Circuit’s decision and granted MercExchange the relief of permanent injunction.
Here, in eBay, the Supreme Court ignored the factual reality that patent is in itself an exclusive right and also the truth that the victorious patent owner is worse off having won because before winning injunction, he had the right to exclude. Infringement stop moving forward is supposed to stop based on the exclusive right under patents, so a permanent injunction only obviates the need to file a brand new patent infringement suit against the repeated infringer.
Despite these very serious errors in Myriad and eBay, the decision in Mayo was far worse. The claims in Mayo clearly passed the threshold under 35 USC § 101, but the Supreme Court declared it patent-ineligible based on judicially created exceptions. It seems that it is a lawless decision that intentionally seems to ignore the statute. Under the patent space, the US Supreme Court doesn’t seem to be an equal counterpart of the US government. The real problem here is that it did what was considered forbidden in Diamond v. Diehr. In Diehr, it was held that in determining the eligibility of a method claim for patent protection under §101, the claims must be considered as a whole. It is impertinent to divide the claims into old and new elements, because the new combination of steps in a process may be patent-eligible while the constituent steps may be conventional and already known. It is also urged that novelty should be considered as a constituent while analyzing the claim under § 101. § 101 says that an invention may be patent-eligible subject to the conditions of the title. In Mayo, the court did what was forbidden, it dissected the elements into new and old when making a patent-eligibility decision. The Supreme Court’s decision in Mayo ignored the statute and its precedent and made patentability into a one-part inquiry. Thanks to Mayo, it allows the claims to be deemed conventional and thus, patent-eligible without even applying the single piece of prior art or references or precedents.
The Supreme Court in Mayo case considered and rejected arguments in favour of patentability. The Federal Circuit was of the view that the administering and determining steps were transformative of the human body and the bodily sample. But the court discarded the relevance of transformation altogether. They thought that these transformations were irrelevant and unnecessary because a different system for determining metabolite levels may be developed which wouldn’t require such transformation. Even the US government argued that the Court should take a permissive stance on patent-eligibility claims under § 101 and leave the rest of the determination of patentability to other provisions like § 102 (novelty), § 103 (obviousness), § 112 (written determination) and § 112 (enablement). But the court was of the view that this would render the law of nature exception like a dead letter with greater legal uncertainty.
In Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit invalidated the claims for non-invasive methods of detecting paternally inherited cell-free fetal DNA (cffDNA). The Court viewed that the only subject matter new and useful in this case was the presence of cffDNA in the mother’s plasma. Judge Linn said that just because he was bound by the language of Mayo, such a meritorious invention is kept out of patent protection. Other judges were also of the view that it was unsound to have a rule that prevents such inventions to get patents but they are bound by the Supreme Court precedent.
The two-prong test established by the Supreme Court can be passed if the patent owner seems to address the first prong that a claim is not even directed to a judicial exception rather than the second prong saying that the claim adds significantly more than the judicial exception. In the case McRo Inc. v. Bandai Namco Games America Inc., the claims were directed to generating automated lip-sync and facial expression for 3D animated characters to improve computer animation. The District Court was of the view that the claims were directed to the patent-eligible subject matter while the Circuit held that they were not even directed to judicial exceptions. The Federal Circuit held that the claims were directed to a patentable, technological technique which tends to bring over improvement in the existing animation field.
Following the lead of Mayo v. Prometheus, there were several claims invalidated which were directed to diagnostic methods. For instance, in the case of Endo Pharmaceuticals v. Actavis Inc., the claims were directed to treating patients diagnosed with renal impairment by measuring the creatine clearance rate and adjusting the oxymorphone dosage based on the rate. The court found the claim ineligible because the only new step involved was advising the doctors to adjust the dosage level in accordance with natural law. No creative steps were involved besides the discovery of natural law.
In these cases, it was noted that, prior to suing a patent infringer, one must consider whether the defence of patent-ineligibility can be raised. A patent owner considering enforcing a patent must now take into account revised and expanded post-grant procedures in the US Patent and Trademarks Office (USPTO) established by America Invents Act, that can be used to invalidate the patent. One such procedure is Inter Partes Review (IPR), in which a trial proceeding is held and the Patent Appeal and Review Board reviews whether the patent is ineligible due to lack of novelty, non-obviousness or is unconventional. The final decision is given after 12-18 months after an IPR is instituted. These developments highlight the difficulty in obtaining and enforcing patents for diagnostic tests and personalized medicine. David Kappos, the head of USPTO has demanded to repeal § 101 of the Patent Act.
Also, in the case of Smartgene Inc v. Advanced Biological Laboratories, it was held that the patents regarding systems, methods and computer programs for guiding the selection of therapeutic regimes for treatments are not patent-eligible. It took into account all the precedents to form a judgment similar to that of Prometheus.
Alice Corporation v. CLS Bank International is an important case in this regard. Alice is an Australian Company that owns several patents, all of which have to do so with a computerized program that deals with financial transactions in which a third party settles obligation in case of a dispute. In 2007, the CLS Bank sued the petitioners claiming non-infringement and invalidation of patents. Alice countersued and claimed that CLS infringed its patents. The summary judgment was granted in favour of CLS and the District Court held that the patents were invalid as they were directed to an abstract idea which preempts the use of a neutral intermediary to settle the differences. The Federal Court reaffirmed. The unanimous court believed that the use of a third party to eliminate settlement risk is already a prevalent practice, and is essentially the building block of the modern-day economy. The court held that Alice did no more than require a generic computer to perform the abstract idea of settlement by performing generic functions, which is not enough to transform it into a patent-eligible matter.
In 2018, the Mayo-Alice framework was first used by the Federal Circuit in the case of Vanda Pharmaceuticals v. West-Ward Pharmaceuticals International. The Federal Circuit analyzed claims directed to the method for treating schizophrenia, and it was determined that it was not directed to natural law or phenomenon and hence it is patent-eligible. Many practitioners view this as a milestone decision and USPTO updated its internal guidance for patent-eligibility in lieu of the court’s decision, focusing that methods of treatment could be patent-eligible. The issue here is the application of the Mayo-Alice two-step framework in deciding the case. In the first step, they concluded that the claims were directed to a specific method for specific patients using a specific compound at specific doses to achieve a particular outcome. The Federal Circuit held that the claims in Mayo were not directed to the application of a drug to treat a particular disease. They held that the claims, in this case, were not directed to the patent-ineligible subject matter, therefore, no step two inquiry is needed. In addition, they also held that the claims in Mayo were not directed to a novel method instead it was directed to a diagnostic method based on the relationship between the concentration of metabolites and its likely toxicity or efficacy. One of the defendants appealed the decision and it’s pending in the US Supreme Court. It is to be seen whether the Supreme Court will let the majority ruling stand or take the case under its ambit and add it in the Mayo-Alice progeny.
The case of Athena Diagnostics Inc. v. Mayo Collaborative Services provides an example for cases where the Federal Circuit’s decision was inconsistent with several post-Mayo analyses of method claims. It was a patent-eligibility case directed to diagnostic testing methods. The claims at issue, in this case, are directed to methods for diagnosing neurological diseases by detecting antibodies. At step one of Mayo-Alice analysis, the Court held that the claims involve the discovery of natural law and the additional recited steps only apply conventional techniques to detect that law. The majority was satisfied with Athena’s claim that the additional recited steps used a man-made molecule to detect antibodies. They also found that the claims in Athena were a mere recitation of natural laws and uses conventional methods to detect it while Vanda involved the application of natural law, which is patent-eligible. At Mayo-Alice step two, they found that the recited steps require only standard techniques to be applied in a standard way. So, they held that since it fails to provide an inventive concept, it is thus patent-ineligible. But Judge Newman dissented with the unanimous opinion and said that the claim was patent-eligible in the first step itself as the method as a whole is not a law of nature but involves man-made chemical biomedical procedure.
Implications of Mayo v. Prometheus
The Supreme Court’s decision in Mayo prompted strong criticism as well as a strong appraisal from the medical and scientific communities. Everyone appreciates the medical advances but they are critical of the fact that patents like those involved in Mayo and more importantly, the court’s analysis of such patent claims will promote or discourage such advances. Some observers believe that it will significantly impact research in the biotechnological and personalized medicine field in the US. It is also believed that claiming patents for diagnostic methods would eventually become difficult in the future. On the other hand, some commentators also believe that Mayo follows established legal procedures and aptly maintains critical scientific and medical data within the public domain.
The decision, in this case, raised speculation regarding the future of testing method patents and personalized medicine, similar to that of Prometheus. For instance, the patent eligibility of classical methods of administering drugs to treat a patient may be vulnerable after the Mayo judgment. Even when the drug has been known in the art, a new non-obvious method of using it has been eligible to be granted patent protection for long. But the recent judgment in Mayo holds the view that the administration of a drug to treat patients is a routine and conventional activity. It also considers the pre-existing and target audience that administers the drug to patients. It also held that the ability of a drug to cure patients is a natural phenomenon as it is carried out by natural processes. The court also held in this case that the transformation of the human body and the bodily sample is irrelevant. This decision surely had a profound impact on the recent court decisions on the biopharmaceutical industries.
Prometheus highlights the challenge of protecting various applications of systems medicines. Diamond v. Diehr held that the application of a law of nature may be patent-eligible and in Gottschalk v. Benson, it was held that the application must be inventive. But in the Prometheus judgment, it was stated that to transform an unpatentable law of nature into a patentable subject matter, one must do more than simply reiterating the law of nature while adding the words “apply it”. It was concluded that mere application of law will not become patent-eligible unless the application is unconventional and not a well-routine activity. It makes it difficult for claimants who don’t have a novel aspect to their testing methods. But the recent guidelines of the USPTO states that the transformation need not be “novel and non-obvious” to carry the claim across the threshold of patentability.
This decision has caused concern in the life sciences industry and diagnostic methods of treatment claims must be drafted with care. The claimant should seek that the opposing party can take the defence of invalidity of patents. The challenge for them is to draft a physical transformation step which is not a mere correlation mechanism, and such a step needn’t necessarily be novel but should render the whole method claimed novel and non-obvious.
However, Prometheus doesn’t necessarily pose a threat to the application of patenting of systems medicine, rather it provides a holistic approach to protecting innovation. This case emphasized a concern that permitting patents on a certain subject matter may render it unusable to others.
Patent law is quintessential for maintaining and sustaining the market, as well as safeguarding both the inventor and the exploiter. An interpretation detrimental to even one of these could harm the general interest of the genuine public and will, in some way, inhibit the development of such technologies. The Prometheus judgment has stunned the patent community and has continued to destroy the genuine patent claims and has left them unprotected.
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