In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s reasoning in this opinion is troubling, and the non-obvious result may be difficult to extrapolate to other cases, but this case illustrates the value of including a variety of claims that focus on different aspects of the same invention.Continue reading this entry
In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court and held that Bayer’s patent covering its Yaz® birth control pill product is invalid as obvious. The court found a strong prima facie case of obviousness, and rejected each of Bayer’s arguments relating to secondary indicia of non-obviousness.
In Mintz v. Diets & Watson, Inc., the Federal Circuit vacated the district court’s determination that the claims at issue were obvious. In so doing, the court discussed several steps in an obviousness analysis that can guard against the improper use of hindsight. The court’s emphasis on the importance of objective evidence of non-obviousness is a reminder of the potential value of developing a strong factual record to support patentability.
In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a “lead compound” approach to the obviousness determinations. This case reaffirms the applicability of the “lead compound” analytical framework, and highlights subtle differences in its application to questions of obviousness and obviousness-type double patenting. Continue reading this entry
In ClearValue, Inc. v. Pearl River Polymers, Inc., the Federal Circuit found that a jury verdict of validity was not supported by substantial evidence, and so reversed the district court’s decision denying Pearl River’s motion for judgment as a matter of law (JMOL). This case is interesting because it explains when a broad range may or may not anticipate a narrower range. Continue reading this entry
In Celsis In Vitro, Inc. v. Cellzdirect, Inc., the Federal Circuit upheld the district court’s grant of a preliminary injunction based on a finding that Celsis had shown a likelihood of success against an obviousness challenge. While the opinion of the court (authored by Chief Judge Rader and joined by Judge Prost) did not strike me as unusual, Judge Gajarsa’s dissent certainly got my attention.Continue reading this entry
The Federal Circuit decision in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc. is interesting in several respects. In this article, I look at the court’s decision to permit unexpected results discovered after the patent applications at issue were filed to support non-obviousness.
In In re Klein, the Federal Circuit reversed an obviousness rejection because the cited references were found to be non-analogous art. This case is an important reminder that questioning the relevance of the cited references can be an important first step to overcoming an obviousness rejection.
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit affirmed the district court’s finding that product claims reciting a specific dose of temazepam were obvious in view of an entry in a medical reference book. Although Tyco tried to overcome the disclosure with evidence of unexpected results and commercial success, its arguments were unavailing.
The recent Federal Circuit decision in In re Huai-Hung Kao addressed obviousness rejections in three separate patent applications assigned to Endo Pharmaceuticals, Inc. The court affirmed the Board’s rejections in two of the applications, but vacated and remanded in the other application. This article looks at the court’s finding in that application that the rejection was “based . . . on factual findings lacking in substantial evidence,” and also discusses the court’s commentary on the “nexus” requirement for secondary evidence of non-obviousness, including unexpected results and commercial success.
The difference between patentability and freedom to operate took the forefront in Siemens Medical Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc. The Federal Circuit upheld the district court’s denial of JMOL after a jury found that Saint-Gobain was liable for infringing Siemens’ patent under the doctrine of equivalents, even though Saint-Gobain’s product was covered by a separate (and later) patent.
The Federal Circuit decision in Tokai Corp. v. Easton Enterprises, Inc. touches on several “hot” issues in patent law. While the case involved a mechanical invention, the principles are applicable across the board, and may arise in the context of pharmaceutical and biotech patent challenges.
The Patents At Issue
As summarized by the Federal Circuit and illustrated in these figures from the ’775 patent, the lighters have a trigger (120) and a safety device that includes a locking member (125) and a spring (26). To operate the lighter, the user depresses the locking member against the force of the spring and pulls the trigger. When the user releases the locking member, the spring automatically returns the locking member to its initial position, where the trigger is blocked from inadvertent actuation.
(It’s good to know how these work. I usually end up pushing and squeezing various parts of our lighter to no avail, and then give up and ask my (teenage) son to light the grill.)
Burden of Proof
The asserted prior art included a combination of references that had been considered by the USPTO during examination and newly cited references. Tokai argued that an “enhanced burden” should apply because “some of the asserted prior art references were considered during prosecution.”
The Federal Circuit acknowledged the principle that an “enhanced burden” can apply if the invalidity challenge “relies on the same prior art as considered during examination,” but noted that the principle does not apply when “not all of the asserted prior art was considered by the PTO.”
(The Federal Circuit noted that the “clear and convincing” standard of proof would apply either way. In Microsoft Corp. v. i4i Limited Partnership, the Supreme Court will consider whether a lower burden of proof—preponderance of the evidence—should apply when none of the prior art was considered by the USPTO.)
Post-KSR Obviousness Analysis
There was no dispute that all elements of the claimed lighting rods could be found in the prior art. Although several of the safety features were found in prior art cigarette lighters rather than prior art lighting rods, the parties had agreed that cigarette lighters were in an analogous art. Additionally, Tokai had acknowledged that the safety devices involved “simple mechanical parts.” Thus, there was no question that the cigarette lighter safety features could be incorporated in lighting rods.
The “reason” to combine was found “in the nature of the problem to be solved.” It was “undisputed” that “a need for safer utility lighters was recognized in the art as of the priority date.” Thus, the Federal Circuit agreed with district court that the skilled artisan would have combined features of cigarette lighters with lighting rods in an effort to design safer lighting rods.
The Federal Circuit summarized the obviousness determination as follows:
[T]he undisputed facts in this case—including the state of the prior art, the simplicity and availability of the components making up the claimed invention, and an explicit need in the prior art for safer utility lighters—compel a conclusion of obviousness as to the subject matter of each of the asserted claims.
Tokai presented evidence of commercial success, but it was not probative because no “nexus” was shown between the commercial success and the claimed invention. For example, although Tokai’s corporate representative discussed the “marketing and sales of Tokai’s utility lighters,” he did “not once” discuss the automatic locking feature that purportedly distinguished the claimed invention from prior art utility lighters.
Moreover, the Federal Circuit noted that even if a nexus had been shown, the evidence might not overcome “the strong showing of prima facie obviousness.”
(Compare this decision to In re Glatt Air Techniques, where the Federal Circuit reversed a Board decision that had found that the evidence of commercial success was not sufficiently commensurate with the scope of the claims.)
Tokai’s Take Home Message
As someone who practices in the pharmaceutical and biotech space, the most striking aspect of the Federal Circuit’s decision in Tokai is the idea that a prima facie case of obviousness can be so strong that it cannot be overcome with evidence supporting secondary considerations of non-obviousness. Perhaps the court would not apply this reasoning if the evidence related to unpredictability or unexpected results, but it is not always possible or practical to provide such evidence (such as comparative data) that is “commensurate” with the full scope of the desired claims.
In In re Glatt Air Techniques, Inc., the Federal Circuit reversed a decision of the U.S. Board of Patent Appeals and Interferences that held a claim obvious. The decision is remarkable in that it overturned the Board under the deferential "substantial evidence" standard, and found that the USPTO had not even established a prima facie case of obviousness. The court also criticized the Board for dismissing the applicant’s evidence of commercial success because it only related to one embodiment of the claims.
The claim at issue originally was granted as claim 5 of U.S. 5,236,503. That patent underwent ex parte reexamination, which led to the obviousness rejection.
The invention relates to fluidized bed coaters for applying a coating to particles, such as pharmaceutical ingredients. In so-called Wurster coaters, the particles are introduced into a chamber where they circulate in the path of the coating material which is sprayed from nozzle. Figure 1 of the ’503 patent is reproduced below.
The invention addressed the problem of particle agglomeration that "occurs because the circulating particles prematurely enter the stream of coating spray before the spray pattern has fully developed." The invention solves this problem by "shielding the coating spray nozzle to prevent the particles from entering the spray prematurely."
Claim 5 recites the invention in "Jepson" format, with the preamble defining the prior art:
5. In a fluidized bed coater having a product container opening upwardly into an expansion chamber and downwardly into a lower plenum chamber through an air distribution plate/screen having openings formed therethrough for upward air flow from said lower plenum chamber into said product container, said product container including a substantially cylindrical partition spaced above said air distribution plate/screen for defining an inner upbed area and an outer downbed area, and an upwardly discharging spray nozzle mounted substantially centrally within said cylindrical partition, the improvement comprising shielding means positioned adjacent said spray nozzle for shielding the initial spray pattern developed by said nozzle against the entrance of particles moving upwardly through the upbed.
The claim uses "means-plus-function" language to recite the novel aspect of the invention. Thus, in accordance with 35 USC § 112, ¶6, this claim element is construed with reference to the specification of the ’503 patent, which teaches that a "cylindrical partition" or "air wall or stream" can perform the shielding function.
The Obviousness Rejection
During the reexamination proceeding, claim 5 was rejected as being obvious in view of the prior art recited in the preamble of the claim (the non-bolded portion above) and German Patent DE 3323418 (Naunapper). An English translation of Naunapper was made of record during the reexamination proceeding.
Naunapper describes fluidized bed coaters with sensors that monitor gas flow to detect particle agglomeration. Naunapper teaches that agglomerates can be removed by "blowing through" with increased air flow.
The examiner asserted that Naunapper’s air flow read on the "shielding means" of claim 5.
The Federal Circuit summarized the Board’s grounds for affirmance:
[The Board] found that Naunapper "plainly teaches an arrangement that can provide . . . an air wall or stream surrounding the [coating spray] nozzle to address the same or similar problem discussed in the ’503 Patent,” and concluded that the arrangement described in Naunapper “would inherently or necessarily be capable of performing the same function recited for the claimed ‘shielding means.’”
The Substantial Evidence Standard
The Federal Circuit reviews the Board’s factual findings—such as its interpretation of a prior art reference—under the "substantial evidence" standard. This is a rather deferential standard that requires the court to consider the evidence on both sides and uphold the finding "if a reasonable mind might accept the evidence as adequate to support the Board’s factual conclusions."
The Non-Obvious Difference Between Prevention and Cure
The Federal Circuit agreed with the Board’s finding that "Naunapper teaches modulating gas flow in the coating apparatus to control particle agglomeration," but noted that "[i]t is readily apparent . . . that this technique does not shield circulating particles from entering the initial spray pattern."
The court recognized a distinction between Naunapper’s "way to remedy the blockage caused by particle agglomeration using bursts of air" and Glatt’s invention, which "prevents the agglomeration from occurring in the first place. The court found:
Naunapper’s air source can be used to (1) circulate particles and (2) clear blockages. The air source cannot perform both of these functions simultaneously, and more importantly, neither of these functions constitutes shielding.
The Federal Circuit therefore determined that the Board’s factual finding that Naunapper taught a "shielding means" was "not supported by substantial evidence." As such, the USPTO had "failed to make a proper prima facie case of obviousness."
The Evidence of Commercial Success
During the reexamination proceeding and Board appeal, the applicant cited evidence of commercial success to rebut the asserted obviousness rejection. The evidence pertained to the applicant’s commercial embodiment, which used a physical shield for the "shielding means."
Both the examiner and the Board rejected the evidence as being "not commensurate with in scope with claim 5," because the claim also encompassed embodiments where the shielding means was an air wall. The Federal Circuit rejected the USPTO’s position:
To the extent the PTO asserts that Glatt needed to submit commercial success evidence from multiple embodiments for that evidence to be commensurate in scope with claim 5, this position is not consistent with our precedent.
The court reasoned:
It seems unlikely that a company would sell a product containing multiple, redundant embodiments of a patented invention. The fact that Glatt’s commercial products only contain one type of shielding means does not make its commercial success evidence irrelevant.
Citing earlier Federal Circuit precedent, the court explained:
Commercial success evidence should be considered “so long as what was sold was within the scope of the claims.”
Could This Appeal Have Been Prevented?
I imagine that Glatt is satisfied with this decision, but I’m sure that it would rather not have had to pursue its appeal all the way to the Federal Circuit. When the court finds that it is "readily apparent" that the prior art does not teach what the USPTO says it taught, what more can or should the applicant have done during prosecution? Here, Glatt even submitted declaration evidence explaining Naunapper and the contribution of the invention, but the USPTO was not convinced.
The USPTO is developing and implementing new ways to measure and improve patent quality. Still, as long as rejections like this can make it past experienced examiners and the Board, it is applicants who bear the ultimate burden and expense of ensuring that patents that should be granted are granted.
The Federal Circuit’s recent decision in Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd. is a nice example of a thorough analysis of the patentability of a new chemical entity by the "lead compound" approach to obviousness. The case emphasizes the perspective of the "medicinal chemist of ordinary skill" and illustrates how evidence on multiple aspects of non-obviousness can insulate a patent from obviousness challenges.
On September 1, 2010 the USPTO issued an update to the Obviousness Examination Guidelines that were promulgated after the Supreme Court’s 2007 KSR decision. The new Guidelines are intended to supplement, not replace, the 2007 Guidelines, and extract teaching points from Federal Circuit decisions addressing obviousness in the wake of KSR. I was surprised by the number of pharmaceutical cases discussed in the Guidelines—out of 24 decisions, 13 relate to chemical, biotech or pharmaceutical inventions.