Board Denies IPR Challenge Based on Insufficient Chemical Range Overlap

13278506_sDespite a long history of precedence, chemical “range” cases still generate contested issues and inter partes review proceedings are no different. The Board considered an issue relative to an overlap of ranges in E Ink Corporation v. Research Frontiers Incorporated, IPR2014-00422, involving US Pat. No. 6,606,185. Because the prior art cited by Petitioner did not disclose, with sufficient specificity, ranges that overlapped with the claimed ranges of the ‘185 invention, the Petition seeking IPR was denied.

The ‘453 patent relates generally to films comprising heat-reflective particles, and key limitations of the claimed invention recite ranges for particular particle sizes. Of relevance to the range issue of this article, claim 1 of the challenged patent requires “particles hav[ing] an average length in a range between about 1 micron and about 50 nanometers.”

Both Patent Owner and Petitioner acknowledged that the art cited by Petitioner described particle size ranges that overlapped with the ranges claimed in the ‘185 patent.  Specifically, the prior art disclosed “anisometric particles having an average particle size of about 0.2 microns or less, preferably about 0.1 microns or less.” Despite this overlap, Patent Owner argued that (1) the cited art failed to recognize the importance of the claimed lower limit of the ‘185 particle size range; and (2) that the overlap between the art-described ranges and the ‘185 claimed ranges were insufficient for anticipation.

The Board agreed, finding that the cited art did not disclose a lower limit to a particle size range, as required by the ‘185 patent.  The Board also found that the lower limit of the particle size range was key to the ‘185 invention, as Patent Owner emphasized that particle sizes smaller than the lower limit could lead to problems with the invention.  Therefore, because of lack of disclosure of a lower limit to the particle size range, and because the cited art’s range was larger than the ‘185 patent, the Board found that there was no anticipation of the ‘185 claims.

Accordingly, the Board was unpersuaded by Patent Challenger’s range-based anticipation arguments, and denied the petition for inter partes review.

Attorney Argument in Preliminary Response Continues to be Trumped by Expert Evidence from Petition

DroppingChallenging two patents with a common parent application, Butamax Advanced Biofuels was able to get 28 challenged claims of one Gevo patent and 18 challenged claims of a second into separate trials for inter partes review, in cases styled as Butamax Advanced Biofuels LLC v. Gevo, Inc. (IPR2013-00214 and IPR2013-00215), involving U.S. Pat. Nos. 8,304,588 and 8,283,505.

The duo of patents both relate to a “method for recovering C3-C6 alcohols, including isobutanol, from dilute aqueous solutions, such as fermentation broths.”

The Board in both cases dealt with a handful of preliminary issues before delving into the analysis. The first issue regarded whether DuPont should have been named as a real party-in-interest by Patent Challenger. The Board rejected Patent Owner’s argument that inter partes review should be barred because of this issue, reasoning that the mere fact that DuPont and Butamax (who have board of directors’ members in common, among other tangential ties) share a common interest in the two patents does not necessarily make DuPont a real party-in-interest.  The real party-in-interest inquiry is “fact-dependent” and Patent Challenger simply had not set forth persuasive evidence of DuPont’s ability to fund or direct the proceeding.  IPR2013-00214 Order at 4.  This issue is, of course, challenging for a Patent Challenger to prove in light of the Board’s high burden to obtain “additional discovery” that would help provide the persuasive facts for this fact-dependent inquiry.

The Board then rejected Patent Owner’s argument that inter partes review should be barred because the references relied upon and the arguments utilized were previously considered by the Examiner. In discounting Patent Owner’s argument, the Board simply stated that Patent Challenger’s arguments had merit. IPR2013-00214 Order at 5.

To conclude the preliminary matters, the Board rejected Patent Owner’s argument that expert testimony should be discredited because it was provided by an expert with a business relationship with DuPont (an alleged unnamed real party-in-interest), citing the expert’s qualifications and persuasive testimony. IPR2013-00214 Order at 6.

The Board’s analysis of the merits of the petitions contained a few interesting points.  For example, in the 214 proceeding, the Board deemed the preambles of the challenged claims limiting, especially given that a portion of the preamble provided antecedent basis support for certain of the dependent claims. IPR2013-00214 Order at 9.

In the 215 proceeding, the Board considered Patent Owner’s argument that, by modifying one prior art reference’s disclosed process by including as step from another reference, the fundamental principles of operation of the process would be changed.  Thus, per Patent Owner, the proposed modification would render the prior art invention inoperable.  IPR2013-00214 Order at 11.  The Board discounted this argument based on the rational that Patent Owner’s “argument improperly is based on what each reference teaches separately, and not on the teachings of the combined references.”  Id.  More specifically, the Board relied on the Federal Circuit’s decision in In re Keller, 642 F.2d 413, 425 (CCPA 1981) to not require “bodily incorporation” of a secondary reference into a primary reference.

This decision shows why there is a growing trend in IPR practice to waive the Patent Owner Preliminary Response or, at the least, to not focus on the merits of, for example, an obviousness analysis.  Time and again in the Board’s decision, it discounted the attorney argument of Patent Owner and referred, instead, to the declaration testimony of Patent Challenger’s expert.  Clearly, expert evidence, if properly presented, is provided great weight, as compared to mere attorney argument (and no expert testimony is, of course, allowed in such a Preliminary Response).  As such, Patent Owners are reconsidering the forecast of arguments that could be made in the formal response to the petition, when expert testimony may be provided, given that the Board is not giving much weight to those arguments in the Preliminary Response.

27 for 28: Expert Witness Provides Deciding Testimony in Grant of Two Inter Partes Review Trials

eyedroppersApotex has successfully forced two Alcon Pharmaceuticals patents into inter partes review trials (HERE and HERE), in cases styled as Apotex Inc. v. Alcon Pharmaceuticals, Ltd. (IPR2013-00012 and IPR2013-00015), involving US Patent Nos. 6,716,830 and 7,671,070. In each case, all challenged claims were put into trial.

The technology involved in the ‘830 and ‘070 patents involves compositions containing a “new” class of antibiotics (e.g., moxifloxacin) to treat ophthalmic, otic, and nasal conditions, or for prophylactic use, by topically applying the compositions to affected tissues. The claims at issue were specifically directed to ophthalmic conditions.

Both decisions are based on the same underlying facts and arguments and are, as such, treated together herein.

The most relevant claim construction dispute between the parties was the term “pharmaceutically acceptable vehicle.” Rejecting Patent Challenger’s construction, the Board determined the broadest reasonable interpretation to be a vehicle that is acceptable for use as a topical ophthalmic pharmaceutical composition, i.e., any excipient(s) that can be safely used in the eye, such as saline.  Order at 7.

The Patent Challenger’s expert witness declaration played a key role in the these cases, as the Board cited to the declaration on more than one occasion to explain the understanding of a person of ordinary skill in the art, for both discussion of the prior art references and the obviousness analysis. It is also interesting to review the qualifications that the Board found persuasive in the Expert’s declaration, including educational background, scientific investigations in the relevant art, publication history, etc.  Order at 8, n.2.  Based on the opinions proffered by the expert, the Board concluded that Patent Challenger demonstrated a reasonable likelihood of prevailing that at least claim 1 was obvious.

In so concluding, the Board discarded Patent Owner’s arguments that the prior art references taught away from using moxifloxacin topical ophthalmic compositions, including an argument that moxifloxacin presented a risk of toxicity. The Board again found Patent Challenger’s expert opinion to be credible; specifically, that moxifloxacin was safe and effective for ophthalmic use and the prior art as a whole would not have discouraged a skilled artisan from producing a topical ophthalmic moxifloxacin pharmaceutical composition. Patent Owner also tried to argue additional objective indicia of nonobviousness, including unexpected results, meeting a long-felt need, commercial success, and skepticism by experts, but the Board was not persuaded by any of those arguments.

The Board did however deny Patent Challenger’s anticipation challenge because the prior art range of 0.5 to 95 wt. % was sufficiently different than the 0.1-1.0 wt. % limitation of the claims of the ‘830 and ‘070 patents. The teachings of the prior art were also not expressly tied together in a meaningful manner, because the reference did not specifically relate the formulation concentration to moxifloxacin or relate its teaching to ophthalmological formulations. The Board cited Finisaar Corp. v. DirecTV Group, Inc., 523 F.3d 1323 (Fed. Cir. 2008), that while a prior art reference does not necessarily have to provide an example of the claimed invention, the teachings in the reference relied upon by Patent Challenger were unconnected to the extent that they did not anticipate the claims of the ‘080 and ‘071 patents.

In summary, the Board granted both trials on all claims based on one challenge ground of obviousness. Interestingly, the board denied all other obviousness challenge grounds as cumulative without specifically addressing them, furthering the debate about how these ‘cumulative’ grounds will be treated in the future if the granted grounds prove unsuccessful.

14 for 15: Another Inter Partes Review Trial Instituted

SONY DSCSuddenly, the 92% rate at which the Patent Office granted petitions seeking inter partes reexamination seems kind of low.  While the standard for initiating an inter partes review is ostensibly higher (reasonable likelihood) than the standard that was required to institute an inter partes reexamination (substantial new question), the rate at which inter partes review trials are being instituted does not reflect any such difference.  The Board instituted the fourteenth out of fifteen trials in Ranbaxy Labs, Ltd. v. Vertex Pharm., Inc. (IPR2013-00024), involving US Patent No. 5,436,989.  The Board initiated this trial based on two of the four proposed grounds and against all twelve of the challenged claims.

The subject matter of the ‘989 patent includes prodrugs of HIV aspartyl protease inhibitors, including pharmaceutical compositions and methods of treatment.  In general, the advantages of the prodrugs of the ‘989 patent included higher aqueous solubility, higher oral bioavailability, and decreased pill burden/increased patient compliance.

The first chemical trial instituted by the Board, Ranbaxy also is an outlier because it is one of the few decisions by the Board instituting a trial wherein claim construction was not a central part of the Board’s decision.  Perhaps the Patent Owner was simply saving a claim construction dispute for later in the proceeding, but the Board remarked that “the terms recited in the claims of the ‘989 Patent do not appear to be in dispute.”  Order at 4.

Instead, the Board’s decision turned on the issue of whether the claimed chemical compound was obvious, and used the test for obviousness in a chemical case articulated in Otsuka Pharma. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012).  More specifically, the correct inquiry was articulated as “whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.”  Order at 7.

Starting with the “Reason to Modify” prong of the Otsuka test, the Board undertook a detailed analysis of the state of the art at the time the ‘989 patent was filed and determined that a shortcoming of protease inhibitors, low solubility, was well-known in the art. The Board gained this perspective from a review of the art of record in this inter partes review.  Because one of the prior art references taught the addition of a solubilizing group known to improve solubility of a low solubility compound, the Board found sufficient “reason to modify.”

Turning to the “Reasonable Expectation of Success” prong, the Board found that the prior art discloses a prodrug similar to the claimed compound.  Further, the Board cited to the ‘989 patent description to support its finding that there was merely insignificant differences between the prior art and claimed methods.  As such, the Board found that the similar structure and disclosure of similar solubility problems associated with that structure would have provided a reasonable expectation of success in improving solubility using the methods taught in the prior art.  Order at 13.

The Board relied upon Patent Challenger’s expert’s testimony in coming to its conclusions.  It being improper, of course, for Patent Owner to introduce any counter-testimony at this stage, there was no evidence to dispute the expert’s conclusion.  Patent Owner’s day, in that regard, will come.  In any event, the two Otsuka prongs having been met, the Board instituted the trial against all challenged claims.

Finally, it is worth noting an interesting point raised by the Board regarding the qualifications of Patent Challenger’s expert.  Specifically, the Board stated that “Patent Owner had not directed us to any reason to doubt Dr. Fisher’s qualifications to testify as an expert in the field of HIV aspartyl protease inhibitors.”  Order at 6.  The remark is interesting because the Board has previously shown a reluctance to consider evidentiary issues at this stage of the proceeding and because an expert’s qualifications are not among the items listed in the Trial Practice Guide as proper subject of a Patent Owner Preliminary Response.