Focusing Questions of Software Patent Eligibility on the Specific Technological Solution and Specific Technological Problem Being SolvedThe U.S. Supreme Court presented a two-step framework for determining whether a claim contains patentable subject matter under the abstract idea exception to 35 U.S.C. § 101 in Alice Corp. Pty. Ltd. v. CLS Bank Int’l. According to the framework erected in Alice, one must first “determine whether the claims at issue are directed to one of those patent-ineligible concepts,” such as an abstract idea. Then, if so, one must determine whether “additional elements transform the nature of the claim into a patent-eligible application.” Despite the Supreme Court’s Alice decision, Alice and its progeny have yet to provide a consistent and specific definition and/or test for what exactly is an abstraction under 35 U.S.C. § 101. As a result, the Federal Circuit has struggled to consistently apply Alice to computer software, and the law continues to be in flux.

Ancora Technologies, Inc. vs. HTC America, Inc. appears to be an attempt by the Federal Circuit to provide a test to determine whether the claimed computer-related subject matter is an abstraction. As noted by the Federal Circuit at page 11 of Ancora, the test provided in Ancora relates to step one of the Alice analysis. In short, Ancora requires that software claims identify the specific technological technique being used to solve a specific technological problem. Under this analysis, the Federal Circuit in Ancora held that the claims in the Ancora Technologies’ U.S. Patent 6,411,941 (the “‘941 patent”) were specific enough to pass step one of the Alice test. The Federal Circuit thus reversed the United States District Court for the Western District of Washington’s ruling that the claims of the ‘941 patent were directed to patent ineligible subject matter under Alice.

Claims of 941 and Technological Background

Ancora Technologies, Inc.’s ‘941 patent describes and claims methods of preventing a computer from running unauthorized software. Specifically, claim 1 of the ‘941 patent recites:

  1. A method of restricting software operation within a license for use with a computer including an erasable, non-volatile memory area of a BIOS of the computer, and a volatile memory area; the method comprising the steps of:

selecting a program residing in the volatile memory,

using an agent to set up a verification structure in the erasable, non-volatile memory of the BIOS, the verification structure accommodating data that includes at least one license record,

verifying the program using at least the verification structure from the erasable non-volatile memory of the BIOS, and

acting on the program according to the verification.

Of particular importance to the Federal Circuit’s analysis in Ancora is the verification structure stored in the erasable, non-volatile memory of the BIOS. BIOS memory is typically utilized to store start-up programs in a computer. However, this is not how the BIOS memory is being used in the ‘941 patent. Instead, the ‘941 patent teaches using the BIOS memory to store a verification structure that can be used to determine whether the program stored in volatile memory is licensed to run on that computer. The innovation taught by the ‘941 patent thus lies in the interaction between the verification structure stored in BIOS memory and the program that is stored in another memory structure to check for permission to run the program. This was a new and specific use of the BIOS memory. According to the ‘941 patent, using the BIOS memory instead of other computer memory makes it much harder to hack the verification structure because successfully hacking the BIOS memory would render the computer inoperable. The teachings of the ‘941 patent therefore solved a particular technological problem.

Federal Circuit’s Analysis

The Federal Circuit’s analysis is interesting in that it attempts to synthesize many of the Federal Circuit’s post-Alice computer-related decisions. The Federal Circuit focuses the question of abstraction in computer-related technologies by stating:

In cases involving software innovations, this inquiry often turns on whether the claims focus on ‘the specific asserted improvement in computer capabilities . . . or, instead, on a process that qualifies as an ‘abstract idea’ for which computers are invoked merely as a tool.’ Ancora at pg. 8 (citing Finjan, Inc. v. Blue Coat System, Inc., 879 F.3d 1299, 1303 (Fed. Cir. 2018) (external citations omitted)).

The Federal Circuit begins its analysis by characterizing its holding in Enfish. The Federal Circuit in Ancora describes Enfish as holding that the patent claims at issue were not directed to an abstract idea. According to Ancora, the claimed self-referential tables in Enfish improved the way that computers operated and handled data, which enabled programmers to construct databases in new ways and with less configuration prior to launch.

The Federal Circuit then moves onto its holding in Visual Memory LLC v. NVIDIA Corp. According to the Federal Circuit in Ancora, the claims in Visual Memory were directed to an improved memory system that configured operational characteristics of a computer’s cache memory to accommodate different types of processors without compromising performance. Thus, the patent in Visual Memory was characterized by the Federal Circuit as being specifically directed to an improved computer memory system, not to the abstract idea of categorical data storage.

Next, the Federal Circuit characterizes its holding in Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc. The claims in Core Wireless were directed to a method for making websites easier to navigate on a small-screen device. According to the Federal Circuit in Ancora, the claims were not directed to the abstract idea of indexing information but rather directed to a specific type of index for a specific type of user and thus were not abstract.

Finally, the Federal Circuit discusses its holding in Data Engine Technologies LLC v. Google LLC. According to the Federal Circuit in Ancora, the claims in Data Engine were a specific technological solution in the art of electronic spreadsheets. The claimed method in Data Engine solved the navigation difficulties of prior art spreadsheets by providing a highly intuitive, user-friendly interface with familiar notebook tabs for navigating the three-dimensional worksheet environment. In Data Engine, the court distinguished other cases in which the claims were held to be directed to abstract subject matter, such as displaying a graphical user interface, or collecting, manipulating and organizing information. According to the court in Ancora, the claims in Data Engine recited a specific structure of notebook tabs within a spreadsheet display that performs the specific function of navigating within a three-dimensional spreadsheet. This provided the specificity required to find that the claims were patent eligible.

The Federal Circuit in Ancora then asserts that claim 1 of the ‘941 patent is not directed to an abstract idea based on the precedents of the aforementioned cases. According to the Federal Circuit, preventing a computer from using a program without authorization is not abstract “if done by a specific technique that departs from earlier approaches to solve a specific computer problem” (Ancora at pg. 10). Claim 1 of the ‘941 patent specifically identifies how a functionality improvement is effectuated. More specifically, claim 1 recites a structure containing a license record (i.e., verification structure) stored in a particular modifiable portion of the computer’s BIOS memory and that structure is used for verification by interacting with the distinct computer memory that contains the computer program to be verified. The technological problem solved is the vulnerability of license-authorization software to hacking. The Federal Circuit in Ancora thus concludes that claim 1 of the ‘941 patent is not abstract under step 1 of Alice because “[i]n short, claim 1 of the ‘941 patent is directed to a solution to a computer-functionality problem: an improvement in computer functionality that has ‘the specificity required to transform a claim from one claiming only a result to one claiming a way of achieving it’” (Ancora at pg. 11, quoting SAP America, Inc. vs. InvestPic, LLC).

Key Takeaway

The court’s holding in Ancora is a reminder to patent prosecutors that vague and generic software claims are unlikely to pass the Alice test. Whenever writing a software patent, patent counsel should be able to identify the specific technological technique being used and the particular technological problem being solved by the technique. The specific technological technique should be worked into the claims, and the particular technological problem being solved should be discussed in the specification in detail. Certainly, identifying the electronic components and working these electronic components into the claims will go a long way to ensure patent eligibility. If not, the claims should at least identify the virtual “structures” produced by the software in order to solve the particular technological problem, like in Data Engine. Software claims that merely recite actions (e.g., the processing of information) performed by a computer are not likely to pass step one of the Alice test under Ancora.

Patenting Diagnostics and Biomarkers Six Years After <i>Mayo</i>In 2012, the U.S. Supreme Court decided the landmark case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which was hailed by some as banning patents on methods of medical diagnosis. It appeared to be the end of the road for the development of personalized medicine for profit, at least in the United States. However, in the years since the lower courts have interpreted Mayo to still allow inventors to patent certain diagnostics and biomarkers, but only to a limited extent. 2018 has been a very active year for judicial decisions on this topic (there were at least four significant decisions this year).

THE PRE-2018 LANDSCAPE

The U.S. Court of Appeals for the Federal Circuit (CAFC) is the highest court that decides patent questions below the Supreme Court.  Like the Supreme Court, the CAFC interprets diagnostics inventions to concern three types of subject matter that cannot be patented: natural laws (such as the relationship between an analyte and a disease), natural phenomena (such as genes), and abstract mental steps (such as reaching diagnoses based on observations). The CAFC made two critical decisions that have controlled their later decisions: Ariosa Diagnostics, Inc. v. Sequenom, Inc. in 2015 and Classen Immunotherapies, Inc. v. Biogen Idec in 2011 (before Mayo but after the Supreme Court’s decision in Bilski v. Kappos).

In Classen the invention was a method of designing a schedule of immunizations to reduce the occurrence of side effects, coupled with administering the immunizations according to the schedule. Although calculating the schedule was held to be an unpatentable abstract mental step based on an unpatentable natural law, but because immunizing patients was a concrete step and following the inventive schedule was neither conventional nor well-understood, the court decided that it added an “inventive concept” to the understanding of the natural law underlying the relationship between the immunization schedule and the side effects. Therefore the invention could be patented.

In Sequenom the invention was a method of fetal genetic testing by amplifying free paternal DNA from the mother’s blood. There was no evidence that anyone had ever conceived of testing a pregnant woman’s blood for fetal DNA (paternal or otherwise) for any purpose. No abstract steps were involved. The ability to amplify paternal DNA was considered to be nothing more than a recognition of a natural phenomenon: that fetal DNA is present in the mother’s bloodstream. The CAFC decided that additional limitations, such as the use of the polymerase chain reaction (PCR), were too well known and conventional to add any inventive concept to the recognition of the natural phenomenon. Although the CAFC recognized that the invention in question was quite brilliant and highly useful, replacing the risky procedure of amniocentesis with a simple blood test, they famously repeated the Supreme Court’s commandment that “groundbreaking, innovative, or even brilliant” inventions do not necessarily involve an “inventive concept” under the law.

DEVELOPMENTS IN 2018

This year the CAFC built on its own decisions and the Supreme Court’s decisions in Roche Molecular Systems, Inc. v. Cepheid, Vanda Pharmaceuticals v. Aventisub, LLC, and Exergen Corp. v. Kas USA, Inc. In addition, the U.S. District Court for the District of Delaware rendered an interesting decision in Mallinckrodt Hospital Products IP Ltd. et al. v. Praxair Distribution, Inc. in December of 2017.

Vanda

Of these new decisions, Vanda is the most significant. It involved a patent for treating schizophrenia patients with iloperidone that is tied to genotyping the patient to determine the patient’s tolerance for iloperidone. More specifically, the inventors discovered certain cytochrome P450 2D6 genotypes that indicate poor metabolism of iloperidone that increases the patient’s risk of cardiac complications of iloperidone treatment for doses of about 12 mg/day. The claims comprised determining whether the patient had the poor metabolizer gene, administering 12 mg/day or less iloperidone if the patient has the poor metabolizer gene, but otherwise administering 12-24 mg/day iloperidone.

The CAFC found the claim to be patent eligible, essentially for the same reason that the immunization method in Classen was patent eligible: treating a patient according to a diagnosis is more than just the diagnosis itself. This decision squarely reaffirms Classen’s holding on methods of treating or preventing disease.

Roche v. Cepheid

On the other hand, in Roche v. Cepheid, the CAFC considered the opposite situation: a patent for a breakthrough test to detect the bacterium that causes tuberculosis and simultaneously determine the bacterium’s drug resistance, but that was not coupled to any form of treatment or intervention.  Specifically, the claims in Roche involved a PCR test for Mycobacterium tuberculosis that also reports certain mutations that confer rifampicin resistance, and specific primers for use in the test. The CAFC found that the primers themselves were “natural phenomena,” because the nucleotide sequence was identical to natural nucleotide sequences found in M. tuberculosis. The CAFC then found that using the primers in PCR to detect the bacterium did not add an inventive concept to the primers themselves, because PCR is a routine procedure in medical diagnostics. In the absence of any treatment step, the claims were found invalid.

You can read more about Roche v. Cepheid here.

Exergen

The invention in Exergen was slightly different: it involved a method of calculating body temperature by measuring the peak radiant heat over the skin of an artery, and an electronic thermometer configured to execute the method. An exemplary claim reads as follows:

A method of detecting human body temperature comprising making at least three radiation readings per second while moving a radiation detector to scan across a region of skin over an artery to electronically determine a body temperature approximation, distinct from skin surface temperature.

The CAFC found this method to be patent eligible. They found the claims were directed to the law of nature that physiologic core temperature is a function of skin temperature above an artery and ambient temperature; but also found that the specific method of measuring body temperature based on these two factors, combined with the unconventional method of measuring radiant heat at least three times per second, added an inventive concept to the application of the natural law. The invention was not only the discovery of the relationship between core temperature, air temperature, and skin temperature above an artery, but it was also a new and more accurate way of measuring the skin temperature.

You can read more about the Exergen decision here.

Mallinckrodt

A lower court made a decision at the end of 2017 that is inconsistent with Classen and Vanda in Mallinckrodt Hospital Products IP Ltd. et al. v. Praxair Distribution, Inc. In that case the inventors discovered that infants with impaired function of the left ventricle are at elevated risk for pulmonary edema if treated with nitric oxide (which is used to treat neonatal hypoxia). The U.S. District Court for the District of Delaware considered claims for treating hypoxic newborns using nitric oxide, if and only if an echocardiogram shows that the newborn is not also suffering from left ventricular dysfunction. The district court judge concluded that the claims were not eligible for patenting, because nitric oxide treatment is a conventional hypoxia treatment. Classen involved conventional immunizations, administered according to a new schedule. Vanda involved a conventional schizophrenia treatment, administered according to new criteria. The district court’s decision in Mallinckrodt does not seem readily reconcilable with these appellate court decisions, and could be reversed on appeal.

You can read more about the Mallinckrodt decision here.

HOW CAN DIAGNOSTICS AND BIOMARKERS BE PATENTED NOW?

Although the CAFC has created relative certainty in terms of what can be patented, it also introduces some serious complications to obtaining effective patent rights. There are a few apparent strategies for patenting diagnostics and biomarkers, but each has attendant drawbacks.

Methods of Treatment/Prevention Tied to the Test

As discussed above, Classen set a precedent that methods of treatment or prevention of disease tied to diagnostic methods are eligible for patenting. The USPTO recognizes this rule in their guidance documents (see Claims 5-6 in Example 29 in “Subject Matter Eligibility Examples: Life Sciences”). However, claims for such methods can be complicated to enforce. In order for patent infringement to occur, the patented method must either be performed by one person in its entirety, or performed by multiple parties all under the control or direction of a single party. When a patient is treated based on the result of a diagnostic test, often the diagnostic test is performed by a contract laboratory and the treatment is provided by a physician. Physicians are unattractive targets for patent infringement lawsuits, both because they are usually the customer base of the patented product (and nobody likes to sue their customers) and because they have limited immunity from patent infringement under 35 U.S.C. § 287(c). Even if the physician ordered the test (and so the test was performed under the physician’s direction and control), suing the physician might not be desirable or possible. It might be argued that the testing lab induced the physician to both order the test and administer the treatment, but such an argument failed in Cleveland Clinic Foundation v. True Health Diagnostics LLC.

In Cleveland Clinic, the Clinic had determined that lipid lowering drugs are particularly effective in patients with elevated myeloperoxidase (MPO) activity. Accordingly, their patent claimed testing a patient for MPO activity, then administering a lipid lowering drug if MPO activity was elevated. The CAFC found the claim to be patent eligible under the Classen rule, but found that the testing lab had not infringed. The doctor had performed the step of administering the drug, and the testing lab did not direct him to do so. This fact pattern is likely to come up in numerous situations. Accordingly, when using this approach, patents should be carefully drafted to attempt to include only steps that will be performed by one party.

Novel Way of Measuring the Analyte

As Exergen teaches, a novel way to measure a recognized property or analyte can still be patented, even if not tied to a diagnostic step (see Claims 3-4 in Example 29 in “Subject Matter Eligibility Examples: Life Sciences”). This includes new assays, reagents, protocols, and equipment. Claims to a specific way to measure the analyte have the inherent weakness that others can simply measure the analyte in some other way to evade patent infringement. This risk can be mitigated if the test requires FDA approval, as approval can be sought only by the patented method. This tactic will not work if another party seeks separate approval using another method, so it is not foolproof.

Measuring the Analyte Without a Diagnostic Step

The USPTO has taken the position that steps to measuring an analyte can be patented, in the absence of any diagnostic or other mental steps. In Claims 1 and 7 of the USPTO’s Example 29 in “Subject Matter Eligibility Examples: Life Sciences,” steps of determining the concentration of an imaginary analyte are recited without any treatment or diagnosis step. The USPTO’s analysis is that, without a diagnosis step, the claim does not involve a mental step or a natural phenomenon. So far no judicial opinions support or refute this position. Without judicial affirmation, this might be a useful secondary way to patent a diagnostic test. However, it will only be effective if the analyte has never been measured before in a patient, at least not in the manner as claimed. Otherwise the claim, although directed to patent eligible subject matter, will lack novelty. There is also significant risk that the courts might not adopt the USPTO’s analysis of the eligibility of this type of claim.

Look to Foreign Markets

The complex and vague constraints U.S. courts have placed on patents for diagnostics and biomarkers are unique to the United States. Most other developed nations allow diagnostic tests to be patented in some form or another. For example, in Europe diagnostics tests may be patented, so long as they are performed outside of the patient’s body. Therefore, when preparing patent applications for diagnostics tests, those hoping to enter the European market should make it clear if the test can be performed ex vivo. Other developed countries have their own conventions that must be considered. Overall, the difficulties of patenting diagnostic tests in the U.S. should guide the development of new tests to focus on the needs of developed countries apart from the U.S.

THE OUTLOOK FOR THE FUTURE

At present there is no immediate prospect for changes in U.S. law that would return us to the regime that was in place until the Mayo decision. Mayo and Myriad changed U.S. law in ways that have put us out of step with the rest of the world and in violation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Ironically, the United States expended significant diplomatic capital to create the TRIPS regime and other treaties to increase the international harmonization of patent law. Although several pro-inventor organizations have proposed legislative changes to return the U.S. to the original patent regime, none have been introduced in Congress so far. However, efforts have begun in Congress to strengthen America’s patent laws by reversing certain aspects of the America Invents Act of 2011. It is possible that amid these efforts proposals to improve patents for diagnostic tests and personalized medicine could be introduced. Of course, this blog will update the reader with news of any such developments.

In a decision issued by the Federal Circuit on October 24, 2018, the court affirmed a finding by the Patent Trial and Appeal Board (PTAB) that a multiple sclerosis (MS) treatment claimed in A Morass of Possible Combinations Does Not Satisfy the Written Description Requirement under 35 U.S.C. § 112an application owned by FWP IP APS (FWP) was not supported by adequate written description under 35 U.S.C. § 112. While the non-precedential nature of the decision might have indicated to some that the dispute was not all that important, the claims in dispute relate to Biogen’s blockbuster drug Tecfidera, which accounted for over a billion in sales for Biogen last year. As a result of the Federal Circuit’s ruling, Biogen’s patent for Tecfidera remains intact and FWP will not be able to realize its goal of collecting future royalty payments on sales of Tecfidera from Biogen. In addition, the opinion itself serves as a reminder for patent practitioners that laundry lists and kitchen sinks are better suited for households than patent applications.

Background

The case arises from an interference between the named parties, FWP and Biogen. Biogen owns U.S. Patent No. 8,399,514 (the ʼ514 patent), which describes and claims a specific method of treating MS with a daily dosage of 480 mg of fumaric acid esters (fumarates). Prior to the filing of Biogen’s application that issued as the ʼ514 patent, FWP filed a patent application (U.S. Application No. 11/576,871 (the ʼ871 application)) disclosing controlled-release compositions of fumarates. Upon issuance of Biogen’s ʼ514 patent, FWP canceled the then-pending claims in the ʼ871 application and added new claims that closely tracked to Biogen’s ʼ514 patent claims.  The PTAB declared an interference between FWP’s application and Biogen’s ʼ514 patent.

The PTAB distilled the interference count down to three main limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of dimethyl fumarate and/or monomethyl fumarate, at (3) a specific dosage of 480 mg per day. Biogen moved the PTAB for a judgment that FWP’s claims were not adequately supported by the ʼ871 application’s specification. The PTAB ruled in Biogen’s favor and held that, even though each of the claim limitations were generally mentioned in FWP’s specification, the specification did not disclose the claimed invention in a manner that adequately described the claimed MS treatment to a skilled artisan and thus, the ʼ871 application did not meet the written description requirement.  FWP appealed.

The Federal Circuit’s Decision

Not surprisingly, the Federal Circuit affirmed the PTAB’s decision. While the court agreed with the PTAB that the ʼ871 application identified dimethyl fumarate and/or monomethyl fumarate as useful for treating a large number of described conditions (including MS) and that a dosage of 480 mg per day was generally disclosed, the court held that the ʼ871 application did not adequately teach a specific treatment of MS at a dosage of 480 mg per day.

In addressing the treatment of MS, the court noted that the ʼ871 application merely states that the fumarates in general are “contemplated to be suitable to use in the treatment of one or more of the following conditions.” While the “following conditions” were further described to include over 20 diseases and conditions including, for example, psoriasis, psoriatic arthritis, inflammatory bowel disease, and autoimmune diseases (including MS as one of the 11 listed), the only conditions discussed in any detail in the ʼ871 application were psoriasis and conditions associated with psoriasis. The court determined that, based on the laundry list of diseases and conditions discussed and the wide variability of the pathophysiologies of each of those listed diseases and conditions, the inventors of the ʼ871 application had yet to definitively conclude at the time of invention that fumarates and, more specifically, dimethyl fumarate and/or monomethyl fumarate, were effective for treating all of the 20 diseases and conditions identified.

The court came to a similar conclusion with respect to the dosage requirement. FWP argued that a table in the ʼ871 application expressly discloses a dosage of 480 mg per day during the seventh week of a contemplated nine-week scale-up period and a skilled artisan would have recognized that all of the listed dosages in the table are therapeutically effective dosages for all of the conditions and diseases listed. However, the court disagreed and determined that FWP failed to provide any persuasive evidence why a skilled artisan would have understood that a dosage for only one of the weeks in the nine-week scale-up period would be therapeutically effective for treating MS. Rather, the court determined that the table was simply providing guidance on gradual dosing to help patients’ gastrointestinal systems acclimate to the side effects of fumarates.

Interestingly, in a last attempt to save the claims, FWP further argued that the original claims, which FWP canceled and replaced with new claims to provoke the interference, provided sufficient support for the claims in the interference. Like the PTAB, the court found that the large number of disease conditions, dosages, active ingredients, and pharmaceutical formulations covered in the original claims detracted from FWP’s argument that it possessed and invented the claimed, specific MS treatment. Moreover, the court took issue with the improper multiple dependent format in which the original claims were written, stating “[f]inding a treatment for MS with 480 mg of DMF and/or MMF per day in the morass of possible combinations of the impermissibly drafted original claims would … take ‘the patience of a yogi to decipher their meaning, as they stand.’”

In view of the lack of specificity in the ʼ871 application with regard to a treatment for MS with a precise dosage of 480 mg per day using specific fumarates, the Federal Circuit affirmed the PTAB’s finding that the claimed MS treatment was not supported by the application’s specification as required by 35 U.S.C. § 112.

Key Takeaway

The court’s holding serves as an important reminder that the written description requirement requires more than the mere mention of a claim limitation in the specification. While FWP’s patent application described the use of fumarates in a broad fashion across a variety of medical conditions, there was not sufficient detail in the disclosure such that a person of ordinary skill in the art would be able to appreciate any and all specific treatments that might be possible permutations (including the specific MS treatment claimed in Biogen’s patent). Had FWP’s application described MS in more detail and included one or more working examples of treating MS patients with dosages at or around 480 mg per day of fumarates, the outcome may have been different for FWP.