During the week of November 26, 2018, the Patent Trial and Appeal Board (“the Board”) issued seven decisions in TC 1600, one denying institution of inter partes review (“IPR”), one termination decision, and five final written decisions.  Summaries of the decisions follow:

Willowood USA, LLC (“Willowood”) v. BASF SE (“BASF”), IPR2018-01096 (Decision Denying Institution Entered November 29, 2018).

In its petition, Willowood challenged claims 1-17 of U.S. Patent No. 7,816,392 (“the ’392 patent”), which is directed to novel crystalline modifications of pyraclostrobin, preparation processes, and to their use for preparing compositions for crop protection.

Willowood challenged the claims as anticipated by Australian Pesticides and Veterinary Medicines Authority (“APR”) and obvious based on APR and references by Vogel and Beckmann.  As an initial matter, the Board construed the claim term “crystalline modification IV of pyraclostrobin” to be:

a crystalline structure of pyraclostrobin having a specific X-ray diffraction pattern at 25°C showing at least three of the following reflexes: d=6.02 ± 0.01 Å, d=4.78 ± 0.01 Å, d=4.01 ± 0.01 Å, d=3.55 ± 0.01 Å, d=3.01 ± 0.01 Å and a heat of fusion of about 72 to 78 J/g.

The Board declined to include melting point language, as reasoned by Willowood, when construing the relevant claims.  The Board was further not persuaded by Willowood’s argument that APR necessarily disclosed the claimed crystalline polymorph in part because references cited by BASF supported that melting point alone is insufficient evidence of the crystalline structure, including art authored by and seemingly contradicting Willowood’s own technical expert.  Because the Board concluded that, at best, the pyraclostrobin disclosed in APR may be the claimed crystalline polymorph, there was insufficient evidence to establish inherency.  The Board further held that Vogel and Beckmann failed to resolve the deficiencies of APR and therefore Willowood had not demonstrated a reasonable likelihood the challenged claim would have been obvious over the cited references.  As such, the Board denied institution of inter partes review of the ’392 patent.

 

Micro Labs Limited and Micro Labs USA Inc. (“Micro Labs”) v. Santen Pharmaceuticals Co., Ltd. and Asahi Glass Co., Ltd. (“Santen”), IPR2017-01434 (Termination Decision with Respect to Petitioner and Final Written Decision Entered November 27, 2018).

In its petition, Micro Labs challenged claims 1-14 of U.S. Patent No. 5,886,035 (“the ’035 patent”), directed to fluorine-containing prostaglandin derivatives and salts thereof and their use in treating or preventing eye diseases.

Two days prior to the statutory deadline for filing a final written decision, the parties reached a settlement agreement and filed a joint motion to terminate the proceedings and a joint request that the settlement agreement be kept confidential, which the Board granted-in-part and granted, respectively.  In light of the advanced stage of the proceeding, the Board proceeded to a final written decision, terminating the proceeding with respect to Micro Labs, but not with respect to SantenSee Paper 52 of IPR2017-01434.

Micro Labs challenged claims 1-14 of the ’035 patent as obvious over the combined teachings of: (1) Klimko, Kishi, and Ueno and/or (2) Klimko, Kishi, Bezuglov 1982 and/or Bezuglov 1986, and Ueno.  The challenged claims are directed to fluorine-containing prostaglandin derivatives having two fluorine atoms at the 15-position, or salts thereof, and medicines containing the compounds as the active ingredient.  In particular, the compound 16-phenoxy-15-deoxy-15,15-difluoro-17,18,19,20-tetranorprostaglandin F (“tafluprost”) was the focus of the petition.  Tafluprost and the other claimed derivatives are considered superior to known naturally occurring prostaglandins for long lasting effects of lowering intraocular pressure, while mitigating irritation to the eyes.

Micro Labs argued that it would have been obvious to start with “Compound C” of Klimko, to recognize the hydroxyl group at the C-15 position as the cause of negative side effects, and to replace the hydroxyl with two fluorine atoms to arrive at the claimed compound, tafluprost.  See figure below, from page 17 of Paper 52, the Final Written Decision.

The Board agreed with Santen that even if one of skill in the art selected Compound C, Micro Labs failed to show the prior art suggested making the required modifications to arrive at tafluprost.  Santen also argued that the view in the art at the time of the invention was, in fact, that the C-15 position was particularly important for allowing the reduction in intraocular pressure.  Thus, the Board concluded that even if one were motivated to remove the C-15 hydroxyl group from Compound C, Micro Labs had not presented sufficient support to conclude one would have also been motivated to difluorinate the C-15 position with a reasonable expectation of success at retaining the intraocular pressure effects.

The Board found that Micro Labs “attempt[ed] to imbue one of ordinary skill in the art with knowledge of tafluprost and its properties, when no prior art reference, references of record, or other evidence conveys or suggests that knowledge” and that the “proposed rationale relies upon general and conclusory statements from [the expert].”  See page 34 of Paper 52, the Final Written Opinion.

As such, the Board concluded that Micro Labs failed to demonstrate by a preponderance of the evidence that claims 1-14 the ’035 patent would have been obvious.

 

Pfizer, Inc. (“Pfizer”) v. Chugai Pharmaceutical Co. Ltd. (“Chugai”), IPR2017-01358 (Final Written Decision Entered November 28, 2018).

In its petition, Pfizer challenged claims 1-7, 12, and 13 of U.S. Patent No. 7,927,815 (“the ’815 patent”), which is directed to protein purification methods, specifically methods for removing contaminant DNA in a sample using an acidic aqueous solution of low conductivity and neutralizing the resulting sample by adjusting the pH to a neutral level.

Independent claim 1 is representative and recites:

A method for removing contaminant DNA in a sample containing a physiologically active protein, which comprises the following steps:

1) converting the sample containing a physiologically active protein into an acidic aqueous solution of low conductivity of 300 mS/m or less and having a molarity of 100 mM or less at pH of 1.5 to 3.9;

2) adjusting the pH of the resulting sample from step (1) to pH of 4 to 8 to form particles, wherein the molarity of the adjusted sample is 100 mM or less; and

3) removing the particles thereby to remove contaminant DNA in the sample.

The claims were challenged on one ground of anticipation and one ground of obviousness over Shadle.  At the outset, and despite Pfizer’s assertion otherwise in its petition and at oral argument, the claim term “molarity” was interpreted as the “the total concentration of solute present in the solution,” rather than the concentration of one particular solute.

The Board found that because Pfizer did not account for the contribution to the molarity of the eluate of any solute other than citrate, as required under the Board’s interpretation of the term “molarity,” Pfizer’s arguments as to any express or inherent teachings of Shadle were unpersuasive.  Notably, the Board pointed out that in IPR proceedings, unlike district court litigation, parties have an obligation to make their case in their petition and to show with particularity why the challenged claims are unpatentable.  As such, the Board held Pfizer’s inherency arguments, absent from the petition, to be impermissible and even if timely, insufficient to support a finding of anticipation.

The Board also found that Pfizer’s petition and subsequent reply addressed obviousness with mere conclusory assertions.  In view of these deficiencies, the Board held Pfizer had not established, by a preponderance of the evidence, that the challenged claims would have been obvious in view of Shadle.

As such, the Board concluded that Pfizer failed to demonstrate by a preponderance of the evidence that claims 1-7, 12, and 13 of the ’815 patent were unpatentable.

 

Pfizer, Inc. (“Pfizer”) v. Chugai Pharmaceutical Co. Ltd. (“Chugai”), IPR2017-01357 (Final Written Decision Entered November 28, 2018).

In its petition, Pfizer challenged claims 1-8 and 13 of U.S. Patent No. 7,332,289 (“the ’289 patent”), which is directed to protein purification methods, specifically methods for removing contaminant DNA in an antibody-containing sample using an acidic aqueous solution of low conductivity and neutralizing the resulting sample by adjusting the pH to a neutral level.

Independent claim 1 is representative and recites:

A method for removing contaminant DNA in an antibody-containing sample, which comprises the followings steps:

1) applying the antibody-containing sample to affinity chromatography on Protein A or Protein G;

2) eluting the antibody with an acidic aqueous solution of low conductivity having a molarity of 100 mM or less;

3) neutralizing the eluate from step (2) to form particles by addition of a buffer to raise the pH to 4 to 8, wherein the molarity of the neutralized eluate is 100 mM or less; and

4) removing the particles to thereby remove contaminant DNA from the antibody-containing sample.

The claims were challenged on one ground of anticipation and one ground of obviousness over Shadle.  At the outset, and despite Pfizer’s assertion otherwise in its petition and at oral argument, the claim term “molarity” was interpreted as the “the total concentration of solute present in the solution,” rather than the concentration of one particular solute.

The Board found, for reasons nearly identical to those discussed above regarding IPR2017-01358, Pfizer’s inherency arguments, absent from the petition, to be impermissible and even if timely, insufficient to support a finding of anticipation.  Similarly, the Board found that Pfizer’s petition and subsequent reply addressed obviousness with mere conclusory assertions.  In view of these deficiencies, the Board held Pfizer had not established, by a preponderance of the evidence, that the challenged claims would have been obvious in view of Shadle.

As such, the Board concluded that Pfizer failed to demonstrate by a preponderance of the evidence that claims 1-8 and 13 of the ’289 patent were unpatentable.

 

Celltrion, Inc. (“Celltrion”) v. Genentech, Inc. (“Genentech”), IPR2017-01374 (Final Written Decision Entered November 29, 2018).

In its petition, Celltrion challenged claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (“the ’213 patent”), which is directed to methods for the preparation and use of variant antibodies, in particular, for use in immunology and cancer.  The ’213 patent provides methods for rationalizing the selection of substitution sites for deriving humanized antibodies having increased efficacy.  Notably, the ’213 patent is the subject of nine IPR proceedings, five of which are currently pending.  The claims were challenged under two novelty and six obviousness grounds.

At the outset, Genentech convinced the Board that two of the cited references did not qualify as prior art under § 102(b) as to certain claims that were determined to have a priority date less than one year before the publication dates of the references.  In addition, the Board was not persuaded by Celltrion’s arguments regarding the credibility of the inventor’s testimony or insufficient evidence of corroboration.  As such, the Board concluded that Genentech had sufficiently demonstrated reduction to practice of two humanized antibodies prior to the publication of two of the cited references and therefore held that Celltrion had failed to establish any of claims 12, 42, 60, 65, 71, 72-77, and 79 were unpatentable.

Second, Genentech expressly waived its defenses with respect to claims 1, 2, 25, 29, 80, and 81.  In view thereof, the Board interpreted such decision as a request for adverse judgment as to those claims or, in the alternative, held the those claims unpatentable as anticipated and obvious in view of the cited references.

The Board then held claims 63, 66, 72, and 78 to be anticipated by a prior art reference that inherently arrived at the claimed invention, particularly the substitutions of residues within the Markush groups of the challenged claims.  However, claims 75 and 76 were found to not be anticipated because they require at least two substitutions and the art provided little guidance as to which substitutions to use, which would have amounted to improper picking and choosing.  The Board further held that a second reference taught each and every element, in particular, the “consensus human variable domain,” limitation of claims 4, 62, and 64.

The Board further agreed with Celltrion that an ordinary artisan would have had reason to combine the teachings of the prior art references, to choose framework region substitutions having improved binding to arrive at the claimed invention, and that these would have been routine optimization for one of skill in the art.  Genentech also argued the claims were not obvious based on evidence of unexpected results and commercial success.  However, the Board determined Genentech had not provided adequate evidence that was commensurate in scope with the breadth of the challenged claims.  Even with respect to claims 30, 31, and 33, which were determined to embody Herceptin®, on balance the Board concluded Celltrion had demonstrated by preponderance of the evidence that claims 30, 31, and 33 were obvious over the cited references.

In sum, the Board found Celltrion had demonstrated by a preponderance of the evidence that claims 1, 2, 4, 25, 29, 30, 31, 33, 62-64, 66, 67, 69, 72, 78, 80, and 81 were unpatentable, but did not make the required showing with respect to claims 12, 42, 60, 65, 71, 72-77, and 79.

 

Pfizer, Inc. and Samsung Bioepis Co., Ltd. (“Pfizer”) v. Genentech, Inc. (“Genentech”), IPR2017-01488 (Final Written Decision Entered November 29, 2018).

In its petition, Pfizer challenged claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (“the ’213 patent”).  The disclosure of the ’213 patent is summarized above.  Samsung Bioepis (“Bioepis”) timely submitted a petition with substantially the same challenges along with a request for joinder which was granted.  The claims were challenged under similar novelty and obviousness grounds as summarized above for IPR2017-01374, and for nearly identical reasons, the Board found Pfizer had demonstrated by a preponderance of the evidence that claims 1, 2, 4, 25, 29, 30, 31, 33, 62-64, 66, 67, 69, 72, 76, 78, 80, and 81 were unpatentable, but did not make the required showing with respect to claims 12, 42, 60, 65, 71, 73-75, and 79.