Over the course of 2012, on at least three occasions the Federal Circuit has found anticipation in a situation in which previously the invention would have merely been viewed as obvious:(1) where the prior art merely proposes the steps of the method, without knowledge of whether those method steps will achieve any result, much less the result claimed in the therapeutic method; (2) where the prior art discloses a broader range without providing a “pattern of preference” for a later-claimed narrower range; and (3) where the prior art discloses lists of potential components, where one has to pick from a large list of optional ingredients and a large list of possible compounds for each of those ingredients. This recent metamorphosis of obviousness rejections to anticipation rejections is not a question of mere academic interest. A whole arsenal of tools is available for overcoming an obviousness rejection, including showing that a reference teaches away from an invention or showing that the invention gives rise to one of the so-called secondary considerations, such as unexpected results, commercial success, failure of others and long-felt need. However, none of these tools is available for an applicant or patentee to overcome an anticipatory reference.

Federal Circuit Expands Doctrine of Anticipation to Cover Situations in Which the Prior Art Merely Proposes a Claimed Pharmaceutical Method Without Knowing if it Will Even Work

In In re Montgomery (Fed. Cir. 2012), the court reviewed the patentability of a claim that recited “[a] method for the treatment or prevention of stroke or its recurrence,” which comprised “administering to a patient diagnosed as in need of such treatment or prevention, an inhibitor of the renin angiotensin system,” such as ramipril.

The only reference ultimately relied upon by the Federal Circuit described the design of a larger trial of ramipril to prevent myocardial infarction, stroke or cardiovascular death for a group of patients at high risk for cardiovascular events such as myocardial infarction and stroke.

Although the study ultimately found that patients receiving ramipril had a statistically significant reduction in the risk of stroke, these results were irrelevant to an anticipation analysis because they were not published until after Montgomery’s priority date. The only actual administration of ramipril reported in the reference used a dose of ramipril below the therapeutic dose as part of an initial patient “randomization” carried out before the actual trial.

The question as framed by the court was whether a showing of effectiveness was necessary for inherent anticipation of Montgomery’s method.  The Patent Office Board of Appeals and Interferences rejected Montgomery’s argument that none of the references demonstrated that ramipril actually treats or prevents stroke, noting that ramipril inherently treats or prevents stroke, and “[i]t matters not that those of ordinary skill theretofore may not have recognized these inherent characteristics.”

Finding that “there is no question here that treating stroke-prone patients with ramipril does in fact inevitably treat or prevent stroke,” the Federal Circuit affirmed the board’s rejection based on inherent anticipation. Referring to its decision in Bristol-Myers Squibb*, the court noted that “[w]e have repeatedly held that ‘[n]ewly discovered results of known processes directed to the  same purpose are not patentable because such results are inherent.’ … As we stated in  Cruciferous Sprout, 301 F.3d at 1350*2, ‘[i]t matters not that those of ordinary skill heretofore may not have recognized the[] inherent characteristics of the [prior art].’”[2] The court also cited King v. Eon Labs3*3 where a claim directed to increasing the bioavailability of a drug by taking it with food was found to be inherently anticipated by a prior art taking the same drug with food to reduce stomach distress. 

Read in a vacuum, the court’s rationale seems rather straightforward: (1) the prior art proposes administering ramipril to patients prone to cardiovascular disorders such as high blood pressure and stroke; (2) when ramipril is in fact administered to such patients, it will treat or prevent stroke; (3) our inherency case law makes clear that it matters not whether one of ordinary skill in the art would have appreciated this effect at the time of the invention, so long as that effect is indeed the necessary result of the process.

The problem here is that the court’s premise — that administration of ramipril is a “newly discovered result of a known process directed to the same purpose” — appears to represent a newly minted judicial expansion of what is meant by “known.” In particular, is a process “known” if it is merely proposed and if one does not even know if it will work at all, much less for the purposes recited in the claim? In this regard, earlier inherency cases cited by the court are inapposite, because in those cases, the processes were specifically known to work and the patentee merely recognized an additional inherent benefit of those processes.

For example, in Cruciferous, the claim recited “[a] method of preparing a food product rich in glucosinolates, comprising germinated cruciferous seeds … and harvesting sprouts prior to the 2-leaf stage, to form a food product comprising a plurality of sprouts.” However, it was undisputed that such sprouts were already being grown, harvested and consumed in the prior art for nutritional purposes and it did not matter whether the grower/harvester/consumer knew that it was a food product rich in glucosinolates that was being grown/harvested/consumed.

Likewise, in King, the claim recited “[a] method of increasing the bioavailability of metaxalone to a patient receiving metaxalone therapy” by administering “a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” Again, it was undisputed that patients were already taking metaxalone with food, albeit to reduce stomach upset, and it did not matter whether such patients appreciated that they were enhancing the bioavailability of the drug while they did so.

So in both cases, in the course of achieving one effect with a process known to be effective, another unappreciated effect was inevitably also achieved. This is classic inherency. Here, however, there did not already exist in the prior art a process known to achieve a first effect that was later discovered to achieve a second effect previously unappreciated.

The distinction lost on the majority is the difference between appreciating an additional benefit to a process already known to work for a particular purpose, as in both Cruciferous and King, versus knowing whether a process will work at all for any purpose, as in Montgomery.

The court also sought to justify its holding based on a purported admission by Montgomery’s counsel that the prior reference would in its own right have been sufficient to support a patent.  This is particularly interesting for a couple of reasons.

First, as the dissent pointed out, the prior art reference ended up having to alter its study before it would be accepted for publication. Second, Judge Timothy Dyk, who wrote the Montgomery decision, authored the In re ‘318 litigation decision, in which he specifically held that an invention directed to a method of treating Alzheimer’s was not enabled because it was based on an unproved hypothesis, even though that hypothesis proved to be correct. (“[T]he specification,

even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”)

It is difficult here not to conclude that there is a double standard at play, since speculation that proved to be correct did not entitle an inventor to a patent in ‘318, yet similar speculation in a prior art article was enough to constitute an inherent anticipation. Judge Alan Lourie summed it up well in his dissent in stating that “a mere description of a

process that, if it had been carried out, might yield a particular undisclosed result is not an inherent anticipation of that result.”

In ClearValue Inc. v. Pearl River Polymers Inc. (Fed. Cir. 2012), the court reviewed the validity of a claim, reciting “[a] process for clarification of water of raw alkalinity less than or equal to 50 ppm by chemical treatment” comprising adding and blending with the water both a particular high molecular weight aluminum chlorohydrate (ACH) polymer and a particular high molecular weight quaternized ammonium polymer (DADMAC) “in an amount sufficient to form a flocculated suspension in the water and to remove turbidity from the water.” The district court found that ClearValue’s patent was both valid and infringed.

On appeal, the Federal Circuit reviewed whether ClearValue’s claims were anticipated over prior art generally teaching treatment of water with an alkalinity of 150 ppm or less and providing a specific example showing the same combination of DADMAC and ACH to clarify water, but with an alkalinity of between 60 and 70 ppm. ClearValue argued that the prior art’s teaching of clarifying water with alkalinity of 150 ppm or less is too broad to anticipate the 50 ppm or less limitation of its claim.

The question thus addressed by the court was whether a prior art disclosure of a genus of less than 150 ppm anticipated a claim setting forth a species of less than 50 ppm. ClearValue cited Atofina v. Great Lakes Chemical Corp., 441 F.3d 991, 78 USPQ2d 1417 (Fed. Cir. 2006), for the proposition that a broader genus does not anticipate a narrower species. The court in Atofina found that a temperature range of 100 to 500 degrees Celsius in the prior art did not anticipate a claimed range of 330–450° C in a method of synthesizing difluoromethane, “[[g]iven the considerable difference between the claimed range and the range in the prior art” such that “no reasonable fact finder could conclude that the prior art describes the claimed range with sufficient specificity to anticipate this limitation of the claim.”

Interestingly, although the Atofina decision cited the lack of “sufficient specificity” as its rationale, the panel in ClearValue went in a completely different direction, relying on the fact that Atofina’s patent states that “only a narrow temperature range enables” the process “to operate as claimed,” and that problems occur when operating the reaction either below 330 degrees Celsius or above 400 degrees Celsius. The court thus concluded that “[i]n Atofina, the

evidence showed that one of ordinary skill would have expected the synthesis process to operate differently outside the claimed temperature range, which the patentee described as ‘critical’ to enable the process to operate effectively.”

By contrast, “ClearValue has not argued that the 50 ppm limitation in claim 1 is ‘critical,’ or that the claimed method works differently at different points within the prior art range of 150 ppm or less. Nor does ClearValue argue that the Hassick reference fails to teach one of ordinary skill in the art how to use the claimed invention, i.e., that Hassick is not enabled to the extent required to practice claim 1 of the ’690 patent.”

There are several very disturbing aspects to the court’s holding. First, the most applicable precedent, Atofina, said nothing in its holding about the claimed range being critical to enable the invention to operate as claimed but simply relied on the fact that the prior art range was so much broader than the claimed range.

Second, to the extent the new coin of the realm for avoiding anticipation of a narrower species in view of a broader prior art genus is intrinsic evidence of criticality of the narrower range, then ClearValue seems to meet that test as well as Atofina did. In particular, the patent at issue in ClearValue indeed did disclose a critical difference between its claimed range of under 50 versus the prior art range of under 150; (“[i]t is well known that significantly greater chemical dosages

are needed for clarification of water with low alkalinity [less than 60 ppm] than for clarification of water with high alkalinity … . [W]ater having a low alkalinity and a low turbidity is very difficult to clean.”)

So in fact, ClearValue’s specification did establish criticality at an alkalinity under 50 and the prior art fell squarely in the definition of those systems having alkalinity higher than 60.

This case also conflates well-entrenched differences between obviousness and anticipation. In particular, when a claim is obvious over the prior art, one can rely on a teaching away or secondary considerations such as unexpected results. By contrast, when a claim is anticipated, a teaching away or an unexpected result is legally irrelevant. By this holding, the court creates a new hybrid animal, where one looks to factors relevant to obviousness, such as criticality of a claimed range, to determine whether a claim is anticipated.

So in essence, this court now wants you to rebut anticipation by providing it with evidence, such as criticality, which it heretofore held was irrelevant to anticipation!

In WM Wrigley Company v. Cadbury Adams (Fed. Cir. 2012), the court reviewed the validity of Wrigley’s claim directed to a gum including as flavor components menthol and a N-2,3-trimethyl-2-isopropylbutanamide, which goes by the trade name “WS-23.” The district court concluded that the gum was anticipated by the Shahidi patent.

The Shahidi reference broadly disclosed oral compositions including toothpastes, mouth rinses, liquid dentifrices, lozenges and gums containing as essential components xylitol and copper bisglycinate.

The reference also disclosed 14 different optional components, one of which is cooling agent(s) including those described in five different patents, and three preferred compounds identified as WS-3, WS-23 and TK-10, and the other of which is a flavoring agent, including as “the most suitable” 23 different agents, one of which is menthol.

On review, the court acknowledged, as argued by Wrigley, that “[f]or a prior art reference to anticipate a claim, it must disclose all of the limitations of the claim ‘arranged or combined in the same way as in the claim.’” Nonetheless, the court concluded that “[t]his is not a case in which the prior art discloses a genus and the claim at issue recites a species of that genus” and where the issue of anticipation therefore “turns on whether the genus was of such a defined and limited class that one of ordinary skill in the art could ‘at once envisage’ each member of the genus,” citing Eli Lilly & Co. v. Zenith Goldline Pharm. Inc.

Rather, in this case, “Shahidi envisions using WS-23 and menthol in a single product. While Shahidi discloses a number of different combinations of cooling and flavoring elements, one of them is the combination of menthol, which Shahidi identifies as one of the ‘most suitable’ flavoring agents, with WS-23, which Shahidi identifies along with WS-3 as among a group of three ‘particularly preferred cooling agents.’ Based on the disclosure of the combination of those

components, we agree with the district court that Shahidi anticipates [the claim].”

The court noted that “the number of categories and components in Shahidi” was not “so large that the combination of W-23 and menthol would not be immediately apparent to one of ordinary skill in the art.” The court found in particular that “Shahidi specifically discloses the use of both WS-23 and menthol in chewing gum.” Relying on the fact that the patent under review had as its objective the obtaining of a cooling flavor composition that will contribute a long-lasting cooling

sensation, the court noted that “the Shahidi reference clearly identifies the combination of WS-23 … and menthol.”

There are two somewhat questionable aspects to the court’s logic. First, the court appears to have impermissibly relied on Wrigley’s own specification to support selection of a cooling agent and a flavoring agent; (“[g]iven the objective of the [Wrigley] patent, to obtain ‘a cooling flavor composition that will contribute a long-lasting cooling sensation’ and a chewing gum with a ‘clean, high-quality flavor … with a good cooling effect,’ the Shahidi reference clearly identifies the combination of WS-23 … and menthol”).

Second, though the court was technically correct when it noted that the prior art characterized menthol as one of the “most suitable” for use in the invention, the court conveniently omitted from its discussion that all the other listed flavoring agents (more than 20 others) were similarly characterized as being “the most suitable.”

Thus, in Wrigley, one had to choose to use (1) a gum (1/6); (2) one of the optional components (1/2); (3) the particular combination of cooling agent and flavoring agent (1/14)(1/14); (4) WS-23 as the cooling agent (1/3); and (5) menthol and the flavoring agent (1/23), for a total likelihood of 1 out of 162,288 possible combinations. This, according to the Federal Circuit, was “immediately apparent.”

Conclusion

Whether your viewpoint tends to lean pro-patent or anti-patent, the above cases are disturbing to the extent that they thwart settled case law and expectations of practitioners. It is of little surprise that there were vigorous dissents in two of the three cases.

Each case is troubling in its own way. Montgomery concludes that a therapeutic method is the inherent or necessary result of a prior art method that is merely proposed and may or may not work. This is new law. ClearValue concludes that a smaller range within a larger range is anticipated even without an example or a pattern of preferences directing one of ordinary skill in the art to that narrower range. This is new law. Wrigley holds that selection of optional components from multiple lists is an “immediately apparent” anticipation even where there is less than a 1 in 100,000 chance of selecting such components. This is new law.