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 While the non-precedential nature of the decision might have indicated to some that the dispute was not all that important, the claims in dispute relate to Biogen’s blockbuster drug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.

Federal Circuit Decision

Broadsoft, Inc. v. Callwave Communications, LLC, No. 2018-1124, 2018 WL 4999375, at *1 (Fed. Cir. Oct. 16, 2018) (per curiam) (affirming district court’s order finding claims invalid)

District Court Decision

Broadsoft, Inc. v. Callwave Commc’ns, LLC, 282 F. Supp. 3d 771 (D. Del. 2017)

Federal Circuit Affirms Decision Finding Telephone Dialing Claims IneligibleAdd internet telephony systems to the list of computer-related technologies considered for patent eligibility under 35 U.S.C. § 101. Under current law, among other requirements, in order to qualify as patent-eligible under § 101, a patent claim involving computer-related technology must be directed to something more than simply an abstract idea that fails to implement an inventive concept. A patent’s claims will fail this test if a court finds that they are simply directed to “method[s] of organizing human activity” or “a known idea” that “is routine and conventional.”

In Broadsoft, Inc. v. Callwave Communications, LLC, a three-judge Federal Circuit panel issued a per-curiam decision affirming the United States District Court for the District of Delaware’s grant of a motion for judgment on the pleadings as to patent ineligibility under 35 U.S.C. § 101. The trial court’s order examined claims in two patents assigned to Callwave Communications, U.S. Patent Nos. 8,351,591 and 7,822,188. The trial court found that the claims covered telephony methods involving conventional elements and lacking an inventive concept.

The Asserted Patents

The ’591 and ’188 patents have common specifications and are directed to techniques for placing internet telephone calls. The patents had two general types of claims: sequential dialing claims and single number outcall claims. Claim 40 of the ’188 patent was selected as an exemplary “sequential dialing” claim:

40. A method of processing calls, comprising:

receiving at a call processing system a message from an Internet protocol proxy regarding a first call from a caller;

determining if the first call is directed to a telephone address of a subscriber of services offered by the call processing system, wherein at least partly in response to determining that the telephone address is that of a subscriber:

accessing an account record associated with the subscriber, the account record including at least one subscriber instruction;

based at least in part on the subscriber instruction, placing a first outcall to a first communication device associated with the subscriber;

if the first outcall is not answered within a first number of rings or period of time, placing a second outcall to a second communication device associated with the subscriber; and [sic]

receiving a call connect instruction from the subscriber; and

instructing the call processing system to connect the first call to a third communication device.

Claim 1 of the ’591 Patent was selected as an exemplary “single number outcall” claim:

1. A method of processing calls, the method comprising:

storing in computer readable memory associated with a call processing system a first phone address associated with a first subscriber;

storing in computer readable memory a plurality of phone addresses for the first subscriber;

participating at the call processing system in a first call associated with the first subscriber, the first call associated with a second phone address different than the first phone address;

placing a first outcall from the call processing system to a first called party, wherein the call processing system inserts at least a portion of the first phone address in a callerlD field associated with signaling information associated with the first outcall;

causing the first call and the first outcall to be bridged;

participating at the call processing system in a second call associated with the first subscriber, the second call involving a subscriber communication device associated with a third phone address different than the first phone address;

placing a second outcall from the call processing system to a second called party, wherein the call processing system inserts at least a portion of the first phone address in a callerlD field associated with signaling information associated with the second outcall; and

causing the second call and the second outcall to be bridged.

The District Court Proceedings

Broadsoft filed a declaratory judgment action in the United States District Court for the District of Delaware seeking declaratory judgment that claims in Callwave’s patents were invalid. Callwave’s patents came under attack from Broadsoft after Callwave asserted those patents against Telovations, Inc., which had licensed accused software products from Broadsoft, and Bright House Networks, LLC, which had acquired Telovations. The software license agreement between Broadsoft and Telovations specified that Broadsoft owed an obligation to defend Telovations against patent infringement claims based on the software.

Broadsoft submitted motions seeking judgments that Callwave’s ’591 and ’188 patents were directed to patent ineligible subject matter under § 101. The motions also argued that the patents were invalid as anticipated under § 102 and obvious under 35 U.S.C. § 103.

Sequential Dialing Claims

Broadsoft argued that the idea of sequentially dialing a list of telephone numbers is an abstract idea that fails to provide any improvement to computer or technological processes. According to Broadsoft, the claims simply identify steps that automate the task of accessing a list of telephone numbers and sequentially dialing them, a task previously performed manually by a human. Callwave countered that the claims allow a call to be redirected without hanging up and redialing, a process impossible for a human operator who does not know any additional phone numbers for the party being called.

The court agreed with Broadsoft’s arguments, and found the sequential dialing claims were directed to an abstract idea. The court noted that the problem of callers receiving busy signals or being sent to voicemail rather than reaching the called party was a “human unavailability problem” that was not specific to telephone technology.

Broadsoft also argued that the sequential dialing claims lacked an inventive concept, partly because they simply use computer telephony to implement the idea of sequential dialing, and because no inventive concept is conveyed in claims that narrow an abstract idea to a particular technological application. Callwave cited McRo, Inc. v. Bandai Namco Games America, Inc., and argued that its claims did identify an inventive concept, focusing on three limitations addressing: 1) internet protocol proxy messaging for receiving or placing calls, 2) use of timing or number of rings to determine when to place a second call, and 3) use of a hybrid network to handle calls from different interfaces by converting call protocols.

The court found that none of the limitations Callwave identified represented an inventive concept. The court noted that the patent intended to solve the problem of calls ending in busy signals or voicemails, and failed to identify a technological solution for network interoperability, describing its call processing elements as “standard.” Use of timing rules to determine when to place a second call similarly failed to constitute an inventive concept because “there is nothing inventive about using a preset amount of time to determine when to initiate a particular step in a process, and it is difficult to imagine using in this system alternative rules not based on the passage of some period of time.” Unlike the decision in McRo, the sequential dialing claims did not require that the rules be obtained first. The patent lacked discussion about protocol conversion, leading the court to conclude that the process was just “routine.”

Single Number Outcall Claims

The single number outcall claims similarly identified an abstract idea and failed to include an inventive concept. The court found that exemplary claim 1 was essentially “directed to storing data in a database, looking up data from that database in response to the initiation of a phone call, and inserting at least a portion of that data in the already-existing callerID field,” and concluded that the “problem of being unable to reach a particular individual is a practical, human unavailability problem, not a technological one.” The court also noted that the claims could be practiced in an office setting by a human assistant. The court found no improvement to telephony technology or solution to a specific phone problem.

The court also agreed with Broadsoft regarding the lack of an inventive concept, stating that the call processing techniques of the claims were not directed to solving network interoperability problems, and that the patents “simply append[ ] conventional steps, specified at a high level of generality, [which is] not enough to supply an inventive concept.”

The Federal Circuit’s Decision

The Federal Circuit panel’s per curiam affirmance leaves Callwave with the option to request rehearing by the panel or the Federal Circuit as a whole en banc. Callwave has 30 days from the date of the opinion, or until November 16, 2018, to submit a petition for rehearing by the panel or rehearing en banc.

Impact on Current Law

The trial court’s decision occurred before Berkheimer v. HP, Inc., which generally states that factual issues may prevent a grant of judgment on the pleadings as to patent eligibility under § 101. But the Federal Circuit’s post-Berkheimer affirmance here indicates its agreement with the trial court’s conclusion that no such factual issues existed. Notably, the trial court’s decision finds absence of any factual issues as to whether an Internet Protocol proxy server, Session Internet Protocol proxy and computer telephony system are “conventional” elements. The trial court also determined that the problem the claims attempt to solve is that of a caller having to hang up and redial a new number if they get a busy signal or reach voicemail, which the court found is a “human unavailability problem,” not a technical one. Without contradictory evidence to consider, a court may find a lack of factual issues as to patent eligibility when the patent’s specification describes technology as “standard” or “conventional” and the claims identify a problem that can be solved by adding a human actor.

Rules for Patenting Genetic Biomarkers Are Updated in Roche v. CepeidAs the readers of this blog are no doubt aware, patenting DNA defined only by a naturally occurring nucleotide sequence was banned by the U.S. Supreme Court in the landmark case of Association for Molecular Pathology v. Myriad Genetics, Inc. The patentee in that case attempted to patent “isolated” DNA with the natural sequence of the BRCA1 breast cancer gene. The Supreme Court believed this was an attempt to claim the natural gene itself, which it believed to be an ineligible “natural phenomenon.” Prior to this decision, newly discovered DNA sequences could be patented, so long as they were claimed to be “isolated” from their original host organism.

However, the Supreme Court opinion specifically left open the possibility that artificial methods of using natural DNA could still be patented; some of Myriad’s claims were for such methods, and their eligibility for patenting was unchallenged, and thus not directly consider by the court.

The Supreme Court in Myriad also did not consider whether properties of artificial DNA other than its sequence could distinguish it from a natural product. The patentee in Myriad had simply relied on the magic word “isolated” to draw a distinction between its invention and what is natural, and the Supreme Court was not enchanted.

Questions have lingered over to what extent artificial processes using DNA can be patented, and to what extent DNA with a natural sequence but other artificial properties can be patented. The U.S. Court of Appeals answered both questions in the October 9 decision in Roche Molecular Systems, Inc. v. Cepheid.

The invention in Cepheid arose from the discovery of unique genetic biomarkers found in the pathogenic bacterium Mycobacterium tuberculosis. M. tuberculosis is the causative agent of tuberculosis, one of the most devastating diseases. Roche patented, among other things, primer sets for polymerase chain reaction (PCR) that are complementary to the biomarker sequences, and the process of detecting the biomarkers through use of PCR.

In the past the Federal Circuit has considered other patents that claim PCR primers having natural sequences, and the process of performing PCR with them, concluding they are not patent eligible. However, this case is different: In this case the natural DNA sequence is found on a circular DNA chromosome. M. tuberculosis, like all bacteria, has a single circular chromosome, unlike eukaryotes, which have linear chromosomes. In contrast, PCR primers must be linear, or they cannot function to prime DNA polymerization during PCR.

Therefore, Roche argued that the patent claims were directed to DNA that is not identical to the natural DNA in the bacterium, and so it is not a “product of nature.” The Federal Circuit disagreed. It cited In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. for the proposition that an abbreviated segment of a longer piece of natural DNA is no different from the natural DNA. Roche pointed out that the BRCA1 & BRCA2 case involved natural DNA on a linear molecule, not natural DNA on a circular molecule, as in the case at bar. The Federal Circuit found this structural distinction to be of no importance, opining “the subject matter eligibility inquiry of primer claims hinges on comparing a claimed primer to its corresponding DNA segment on the chromosome—not the whole chromosome” (emphasis from original). This would seem to be somewhat at odds with the statement elsewhere in the opinion that the presence of a free 3’ hydroxyl group on the claimed PCR primer does not distinguish the primer from the natural DNA, as this is a chemical difference with the corresponding DNA segment. The Federal Circuit’s position could be interpreted to mean that the nucleotide sequence of the natural DNA segment is the only thing that matters, to the exclusion of any other chemical or physical property of the molecule, because courts have interpreted the nucleotide sequence to embody the “information” that is the critical function of DNA. This line of reasoning could logically be extended to ban patenting of artificial polynucleotides such as locked nucleic acid and morpholinos (although to date no court has so held). Alternatively, the decision could be read to mean eligibility requires a difference between the natural and artificial DNA that affects the functioning of the invention – in this case the circularity of the entire genome hosting the natural sequence was of no consequence to the functionality of the sequence as a PCR primer.

For the first time this decision considered whether artificial DNA with an identical sequence to what is natural, but a different higher order of structure, can be patented. This decision reaffirms that PCR performed with a primers complementing a previously unknown, but naturally occurring nucleic acid sequence, cannot be patented, regardless of whether something about the gross structure of the natural genome could have prevented its use as a primer. The reason for this conclusion seems to be that the higher level structure of the natural DNA does not affect the functioning of the claimed primer, by itself or as used in PCR. It is possible that other chemical differences between a natural DNA molecule and an artificial DNA molecule with the same sequence could still distinguish the artificial DNA from its natural counterpart.

The Roche patent in this case was drafted many years before the Supreme Court’s Myriad ban went into effect, during which time it was unquestionably patent eligible subject matter. This may be why Roche’s arguments have the definite sound of post-hoc rationalizations, because the patent was not drafted with the goal of satisfying the Myriad standard. Those present patent applicants, with the luxury of being forewarned, should consider this case a lesson. Reliance on the differences in the gross structure of the chromosome in which a natural sequence is found and the claimed DNA may be misplaced. Instead, seek to rely on differences in the primary structure (nucleotide sequence), conjugation between natural nucleic acids (DNA and RNA) with synthetic moieties (such as fluorophores, etc.), or chemical differences in the nucleotides themselves (such as LNA or triplex molecules). Last but not least, remember that the Myriad ban is not the law in most major jurisdictions outside of the United States, and consider such foreign markets when planning your patenting strategy.