Rehearing Wins Institution of Inter Partes Review

PTAB ALERT By Christopher Lacenere, Ph.D.. A member of our Patent Practice Group

In a rare move, the Patent Trial and Appeal Board (“the Board”) granted the institution of an inter partes review (“IPR”) upon a request for rehearing after initially denying its institution.  IPR2017-00731 Paper No. 29.  However, don’t expect such reversals to become commonplace.  This case involved a panel of administrative patent judges who were not sufficiently familiar with negative limitations in a patent claim. Consequently, upon being denied institution, the petitioner needed a rehearing to educate the judges on how to correctly interpret such limitations.

Hospira, Inc. (“Petitioner”) filed a petition requesting that claims 1-14 of U.S. Patent No. 7,846,441 (“‘441 patent”), owned by Genentech, Inc. (“Patent Owner”), be reviewed as being obvious over the prior art.  The ‘441 patent relates to the treatment of disorders, such as breast cancer, characterized by the overexpression of ErbB2, a transmembrane protein related to the epidermal growth factor receptor. Claim 1 recites a method of treating a cancer patient with an anti-ErbB2 antibody and a taxoid, “in the absence of an anthracycline derivative.”

Petitioner argued that claims 1-14 of the ‘441 patent were unpatentable as being obvious over Baselga 1996 and Baselga 1994.  Baselga 1994 teaches that ErbB2-overexpressing tumors grown in mice resulted in 35% growth inhibition following a treatment with either the 4D5 anti-ErbB2 antibody or paclitaxel (a taxoid) alone, and a 93% growth inhibition following treatment with a combination therapy of the antibody and paclitaxel.  A combination treatment of the antibody and doxorubicin (an anthracycline derivative) resulted in 70% growth inhibition.

The Board initially declined to institute an IPR.  Although it acknowledged that Baselga 1994 teaches the combined treatment of an anti-ErbB2 antibody with either a taxoid or with an anthracycline, but not with both, the Board nonetheless reasoned that nothing in Baselga 1994 or Baselga 1996 suggests that a person of ordinary skill in the art would have avoided anthracyclines in pursuing a combination therapy with an anti-ErbB2 antibody and a taxoid.  Without additional evidence or argument that a skilled artisan would have avoided anthracyclines, the Board concluded that Petitioner had not established a reasonable likelihood it would prevail in showing that the challenged claims would have been obvious over Baselga 1994 and Baselga 1996. More...

Federal Circuit Tells Patent Office: Rejecting Claims for Obviousness Must Be Better Supported

By Thomas Tuytschaevers. A member of our Patent Practice Group

The Court of Appeals for the Federal Circuit had recent occasion to remind the U.S. Patent and Trademark Office (“USPTO”) to be rigorous in its examination of patent applications. Patent practitioners should take note of In Re: Stepan Company and use its teachings to rebut improper rejections.

Stepan had filed a patent application claiming a water-based herbicidal concentrate including an herbicide (glyphosate salt) in solution with a surfactant system having a “cloud point” above at least 70°C.  Surfactants are known to enhance glyphosate’s herbicidal efficacy by providing better adherence to plant leaves, and a high cloud point (the temperature below which a solution becomes cloudy due to the surfactants becoming insoluble) facilitates production of the herbicidal concentrate.

Stepan attributed its desirable cloud point to the unexpected synergy of three ingredients of its surfactant system and their specified quantitative ranges.

The patent examiner rejected Stepan’s application as obvious over a previous patent to Pallas, even though Pallas does not teach a formulation with the same ingredients or claimed quantitative ranges, and fails to teach a cloud point above 70ºC.

The examiner took a shortcut familiar to many patent practitioners: Rather than finding Stepan’s invention in the prior art, the examiner concluded that it would be “routine optimization” to select and adjust the surfactants to the claimed range since (a) Pallas teaches that the surfactant component comprises “any combination of surfactants,” and (b) achieving a cloud point above 70ºC would be a simple matter of optimizing such a formulation since Pallas teaches that the ideal cloud point should be above 60ºC.

The Patent Trial and Appeal Board (“Board”) affirmed the rejection by adopting the examiner’s argument and determining that Stepan failed to rebut the examiner’s prima facie case of obviousness.

The Federal Circuit disagreed, vacated the Board’s decision, and remanded, finding that “the Board failed to adequately articulate its reasoning . . . and improperly shifted to Stepan the burden of proving patentability.”  The opinion makes several noteworthy points.

First, even when an obviousness rejection combines multiple embodiments from a single prior art reference, the rejection still requires a motivation to make the combination and a reasonable expectation that such a combination would be successful.  More...

By Thomas Carey. Chair of our Business Practice Group

The America Invents Act contemplates the possibility of multiple inter partes review (IPR) challenges to the same patent.  However, it authorizes the Patent and Trademark Office, in considering whether to institute an IPR, to take into account whether the same or substantially the same prior art or arguments were presented to the PTO in an earlier petition and to reject the later petition on the grounds of this redundancy.

This language, from 35 USC §325(d), could be read as providing a single, narrow basis for rejecting a request for an IPR that challenges a patent that was previously the subject of an IPR petition.  If so, doesn’t it follow that, if the petitioner raises different prior art from before, or presents a new argument, this provision requires the PTO to initiate the IPR?

In September 2017, the Patent Trial and Appeal Board (PTAB), an administrative law body of the PTO, rejected that contention.  It pointed to a separate provision of the America Invents Act, 35 USC §314(a), which makes the decision of whether or not to initiate an IPR a matter of the PTO’s discretion.  According to the PTAB, this general rule applies in the case of follow-on petitions as well as initial petitions.  In October 2017, the PTAB designated its September 2017 opinion as precedential.

In that case, a PTAB judge had denied the request of General Plastic Industrial Co., Ltd. that the PTAB commence an IPR. The petitioner requested a rehearing.  A panel of seven PTAB judges, including the Chief Administrative Patent Judge, denied this request.

The opinion does more than assert the PTO’s right to reject IPR petitions in its discretion.  It also listed factors that it will consider when faced with a follow-on petition asserted by the same party that asserted the first petition.  Here are the factors:

1. Whether the same petitioner previously filed a petition directed to the same claims of the same patent;
2. Whether at the time the first petition was filed the petitioner knew or should have known of the prior art asserted in the second petition;
3. Whether at the time the second petition was filed the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition;
4. The length of time that elapsed between the time the petitioner learned of the prior art asserted in the second petition and the filing of the second petition;
5. Whether the petitioner provides adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent;
6. The finite resources of the PTAB; and
7. The requirement under 35 U.S.C. § 316(a)(11) to issue a final determination not later than one year after the date on which the Director formally institutes the IPR. More...