As with any news platform focused on the patent world, we keep a close eye on the major court cases in the US, particularly those that have a direct impact on IP value creation. Key decisions from district courts, the Court of Appeals for the Federal Circuit (CAFC) and the Supreme Court, ripple throughout the IP world and so it’s important to know the cases that are coming which are likely to have repercussions for our readers. With all that in mind, we asked former CAFC Chief Judge Paul Michel to cast his eye over the Federal Circuit’s docket to identify what he believes we’re likely to be talking (and writing) about in 2018. Here are his top five.
(1) Regents of the University of California et al v The Broad Institute Inc et al; CAFC no 2017-1907
This may be the case of the year in 2018. This is an appeal of an interference decision that the patented inventions of The Broad Institute are non-obvious over the earlier-developed application claims of the University of California. Therefore, there was, the Patent Trial and Appeal Board ruled, no interference-in-fact, for the inventions were separately patentable. Hence, the Board dissolved the interference provoked by the University. This meant the University's applications will likely mature into patents and The Broad's issued patents stand.
The inventions of the University concerned development of gene editing technology called CRISPR CAS-9 in prokaryotic cells (eg, bacteria); those of The Broad related to technology for adapting such systems for use in Eukaryotic (plant and mammalian, eg human) cells. The adaptations were necessary because single-cell organisms function very differently from multi-cell organisms, whose cells are far more complex and present many more challenges to efforts to slice and splice selected, mutant portions of the DNA with the CAS-9 enzyme.
The CRISPR technologies represent perhaps the greatest breakthrough in biological science, ever. Nobel prizes may well await the various inventors of the two groups or teams. Already they have received many prizes and awards, most recently from the Intellectual Property Owners Association as 2017 "Inventors of the Year". The technology patented by The Broad enables mutant strands of DNA to be excised from the patient's cells, which could prevent or cure vast varieties of serious illnesses. But the University invented the foundational methods, so, although separately patentable, would-be practitioners might need to obtain licenses from both groups. Commercial companies affiliated with each group have attracted enormous investments and are beginning to commercialise the methods for correcting DNA abnormalities. Along with vast improvements in human health, these developments will likely lead, at least eventually, to vast revenues for these companies and the patent owners themselves. Accordingly, the dispute has attracted extensive commentary in the general press as well as in the scientific and legal publications.
The appeal raises questions about the application of basic obviousness precedents and their attendant doctrinal standards and analytic methodologies. Because obviousness lies at the heart of nearly every patent application and litigation, both in the Patent and Trademark Office and the courts, the Federal Circuit's decision could affect all technologies, not only CRISPR, great though it surely is. Specific issues raised that concern such basic standards include:
- How specific must the instructions of the prior art be in order to support a conclusion of obviousness?
- What nature and level of certainty is required to establish a "reasonable expectation of success"?
- How to assess" independent" and/or nearly "simultaneous" invention by others, and exactly what do these terms mean?
- How to determine what sort or amount of experimentation constitutes "undue experimentation", and hence leads to a conclusion of non-obviousness?
Unsurprisingly given the nature of the case, both sides are represented by large teams of the very best litigators. The appeal will no doubt receive intense attention by the court as well as being followed by patent practitioners everywhere.
(2) FWP IP APS v Biogen MA Inc; CAFC No 2017-2109
In this appeal from the Patent Trial and Appeal Board Interference decision invalidating the patent of Forward Pharma for inadequate Written Description, appellant raises the issues of when "blaze marks" are required and when a disclosure depicts the "invention as a whole", obviating the need for them. And, whether they are required merely because the specification discloses unclaimed inventions and embodiments. Appellant points out that in Novozymes A/S v DuPont Nutrition Biosciences APS, 723 F3d 1336,1347, the court held that such marks are not required where the claimed inventions is disclosed as "one of several possibilities" or "as useful separately or in various combinations”. Thus, the high-level question is whether the Board correctly understands the court's key precedents on written description and can correctly apply them. In addition to Novozymes, the board's use of Snitzer v Etzel, 426 F2d 889 (CCPA 1972) and ScriptPro LLC v Innovation Associates Inc, 833 F3d 1336 (Fed Cir 2016) are challenged, again on the basis that the Board misunderstood them and hence misapplied them.
The invention concerned administration of a particular daily dose of a particular chemical known as DMF to treat multiple sclerosis. The exact dosage was disclosed both in original claims and the specification. The composition was well known in the art as effective to treat this disease. In addition, the specification listed it as one of several useful dosages in a table and listed MS as one of the diseases to be treated.
The Board nevertheless applied Novozymes, which held “blaze marks” are required "where a patent's written description disclosed certain subject matter in terms of a broad genus but its claims specified a particular subgenus or species contained therein", even though the patent in issue in the Interference did not present a genus-species situation. The Novozymes court noted that the original application there failed to convey possession because it had disclosed no enzyme "that actually satisfies the claims”. The court further noted that the application contained neither a single species that falls within the claims nor any "blaze marks" leading the artisan to such a species "among a slew of competing possibilities”. Thus, the application provided "only generalized guidance listing several variables that might, in some combination, lead to a useful result”. But, somehow, the Board concluded that Novozymes applied in the situation of Forward's patent.
As to Snitzer, the Board misunderstood or modified its holding, according to Forward, because it characterised Snitzer as a "small species case" when there was nothing in Snitzer to support such an interpretation. It thereby distinguished Snitzer in order to impose a “blaze marks” requirement when Snitzer overturned a Board decision finding inadequate written description and held the description was sufficient.
As to ScriptPro, the board based its decision on a finding that the Forward application had a "focus" on a controlled release formulation, while also claiming non-controlled release formulations, when there the court held that: "A patent's focus on one particular embodiment or purpose cannot limit the described invention where that specification expressly contemplates other embodiments or purposes."
This appeal thus raises fundamental questions of the true meaning of several major Federal Circuit decisions on Written Description and whether the board correctly understands them. All practitioners should be interested in seeing the expected clarification.
(3) Acorda Therapeutics Inc et al v Roxane Laboratories Inc et al; CAFC Nos 2017-2078, -2134
In his obviousness conclusion in the District Court for the District of Delaware, the judge relied on a particular view of the "obvious to try" standard as articulated in KSR International Co v Teleflex Inc, 550 US 398 (2007) and an extension of the "blocking patent" doctrine in Merck & Co v Teva Pharmaceuticals Inc, 395 F3d 1364 (Fed Cir 2005). Appellant Acorda challenges both interpretations as legally erroneous and reflecting a misunderstanding of each doctrine as intended by the two courts. The Federal Circuit's disposition of these issues bodes well to clarify both points, which would be a boon to practitioners.
Pre-KSR case law suggested that something that was merely obvious to try was not thereby shown to be obvious. But in KSR, the Supreme Court indicated that obvious to try could establish obviousness if the invention is merely "the predictable use of prior art elements according to their established functions". Thus, the combination constituting the invention is obvious to try and hence obvious if the combination is one of a "finite number of identified, predictable solutions". What constituted a finite number was not stated. But, the solutions clearly had to be predictable. The district court, however, equated "predictable" with "plausible", which appellants charge as an error. Second, Acorda asserted that, per KSR, the entire invention must be obvious to try, while the district court applied that standard to just one limitation, the dosage amount.
Because obviousness is at the centre of nearly every examination and litigation, clarifying these issues is extremely important. The standards analysed in the appeal briefs are often dispositive and are of widespread importance, potentially applicable to virtually all patent matters. Moreover, the decision in KSR may have reflected the simple mechanical technology there and may not translate easily to unpredictable arts like the method of treating walking speed in MS patients at issue in this case, or indeed to pharmaceutical cases generally. Finally, the proper application of various broad statements in KSR is subject to doubt and confusion which the decision in this appeal may resolve. Therefore, it should be of interest to all patent prosecutors and litigators.
The Merck decision held that an earlier dominating patent combined with exclusive FDA marketing approval to "block" all competitors and hence destroy the non-obviousness implication otherwise to be afforded to the various objective indicia. Here, however, there was no FDA ruling excluding others, yet the district court ruled that all such indicia were negated. And, the court ignored that foreigners could have tried and did try to develop the invention since the US patent cannot block them. Therefore, long felt and unmet needs and the failure of others should remain potent indicia even if commercial success is negated by a true blocking patent. Accordingly, Acorda charged the district court with wrongly extending Merck. The proper application of Merck was partly clarified by a further appeal, Merck II., but much uncertainty remains.
This appeal should eliminate such confusion and therefore be of interest and value to many patent attorneys. Even more importantly, it should explain the limits of KSR's "obvious to try" test.
(4) Sumitomo Dainippon Pharma Co Ltd et al v Emcure Pharmaceuticals Limited, et al; CAFC Nos 2017-1798, -1799, -1800
This appeal, like many, turns on whether the district court's claim construction was correct and was correctly reached. The central issue was whether this chemical compound claim was to a genus of related compounds and included a preferred embodiment, or, as urged by the generic defendants, was limited to a particular racemic mixture of two compounds. The district court relied heavily on the specification as well as the claims and the prosecution history--the intrinsic record, while the defendants relied primarily on extrinsic evidence of a short-hand graphic commonly used by artisans to indicate such a mixture in other contexts which appeared in the disclosure here. The court concluded that the claim had broad scope.
The court recognised that the contextual setting is particularly important when extrinsic evidence is offered to alter the meaning or scope a claim would otherwise be deemed to have. Although, generally speaking, the primacy of intrinsic evidence over extrinsic evidence is well established, as is the notion that preferred embodiments are normally within claim scope, this appeal tests the limits of these doctrines. They often control, but not always. The appeal therefore may result in an opinion that will meaningfully clarify these standards.
Claim scope, of course, is critical to most infringement cases. It is always important and usually dispositive since the nature of the accused product or process is seldom seriously contested. Ideally, once claim scope is defined, the issue of infringement, vel non, should become easy to decide, often suitable for summary judgement. That means, of course, that claim construction often decides the entire case. And it can do so regarding validity as well as infringement. Although 11 years after Markman, one might think all aspects of claim construction would have been settled definitively, that has not proven not to be so. Therefore, all claim construction cases are important despite the particular facts because they often reveal the detailed contours of basic principles.
This appeal looks likely to be such a case and therefore should be of interest to all patent attorneys, not only those litigating pharmaceutical cases.
(5) Wisconsin Alumni Research Foundation v Apple Inc; CAFC Nos 2017-2265, -2332, -2380, -2400
Like the CRISPR appeal, this one is famous among patent lawyers; here due to the prominence of the parties, the smartphone technology involved and the eye-popping damages award. Its ultimate doctrinal importance, however, may arise from the issues of vicarious liability it presents so squarely as to require resolution. WARF prevailed on all of the many, many issues decided that led to the enormous award.
In its appeal Apple argues, among other alleged errors, that the vicarious liability judgement (the basis for about half the award) must be reversed because: "No reasonable jury could find Apple liable as a direct infringer for Samsung's wafer manufacturing in Texas." Apple bases its argument on three grounds: First, the wafers as made there are not reasonably capable of infringing; second, Samsung is not Apple's agent; and third, Apple does not control or direct that Samsung manufacture wafers in the United States. Alternatively, Apple argues that a new trial is required because of an erroneous jury instruction, namely that such liability only required that Apple "control or direct" Samsung, rather than requiring a principal-agent relationship.
The first ground involves the fact that as made in Texas, the wafers cannot function until certain structural modifications are introduced in Korea where they are sent for further processing. This ground is essentially a matter of technology and proof. The second ground, however, is purely legal, as is the third.
Like the law of indirect infringement, i.e., either contributory or induced infringement, the law of vicarious, direct infringement is unsatisfactory and unsettled. Yet, these issues arise frequently in today's world of global supply chains. Although some recent decisions have begun to clarify matters, there is much more to be done. Centillion Data Systems LLC v Quest Communications International, 631 F3d 1279(Fed Cir 2011), for example, suggests that one cannot normally be liable for another's infringement unless the other acted as its agent. But the point is open to doubt. WARF v Apple may finally settle the issue.
Over Apple's objections, the trial court declined to instruct the jury that agency had to be proven. Rather, the court instructed that Apple could be held vicariously liable as a direct infringer under Section 271(a) "if Samsung performed an act of infringement under Apple's control or direction". Although the court relied on statements in Akamai, it is argued they were not correctly understood. As this issue is too important to remain under a cloud of uncertainty, the Federal Circuit may finally clarify the law. And, since the jury instruction is purely legal and not fact-driven, it may feel compelled to do so. Therefore, IAM readers should follow this appeal for that reason as well as others.