On March 21, 2017, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”). Three days later, on March 24, 2017, Celltrion filed two additional IPR petitions for U.S. Patent Nos. 6,626,196 (“the ‘196 patent”) and 7,371,379 (“the ‘379 patent”).  All four of these patents are related to Genentech’s Herceptin® (trastuzumab). Last month, Celltrion filed a petition with the Patent Trial and Appeal Board (“PTAB”) challenging certain claims of Genentech’s Patent No. 8,591,897, which is also related to Herceptin® as reported in this post.

Celltrion announced that its trastuzumab application had been received for review by the European Medicines Agency (“EMA”) in October of last year, and the company is planning to submit an application to the FDA during the first half of 2017.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceedings are IPR2017-01121 (involving the ’441 patent); IPR2017-01122 (involving the ‘549 patent); IPR2017-01139 (involving the ‘196 patent); and IPR2017-01140 (involving the ‘379 patent). The real parties-in-interest identified for Petitioner are Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH.

The challenged claims of the ’441 patent are directed to a method of treating cancers linked to the overexpression of the human ErbB2 protein by administering an anti-ErbB2 antibody that binds to epitope 4D5 and a taxoid chemotherapeutic agent in the absence of an anthracycline derivative.  The challenged claims of the ’549 patent are directed to a method of treating cancers characterized by the overexpression of ErbB2 by administering a combination of an anti-ErbB2 antibody, a taxoid chemotherapeutic agent, and another therapeutic agent which may be another antibody, a growth inhibitory agent, or a cytokine.  The challenged claims of the ’196 and ’379 patents are generally directed to methods of treating cancers characterized by the overexpression of ErbB2 by administering an effective amount of an anti-ErbB2 antibody using a dosage regimen that provides a large initial dose, followed by the subsequent administration of additional dosages in amounts that are the same as or less than the initial dosage spaced two to three weeks apart (referred to in the specification as “front loading”).  Hospira has also filed IPR petitions challenging claims of the ’441, ’549, ‘196 and ‘379 patents, as we reported here in January 2017.

Hospira  filed a petition on which trial has been instituted at the PTAB on a fifth patent related to Herceptin® (as reported here). A complete list of IPRs related to trastuzumab and other proposed biosimilar products can be found in RFEM’s IPR Dashboard.

Mylan is also seeking approval of a trastuzumab biosimilar. Mylan recently withdrew two IPR petitions and announced that Mylan and Biocon have reached a global settlement and licensing agreement with Genentech and Roche regarding Mylan’s trastuzmab biosimilar as discussed in this post.

Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. (collectively “Plaintiffs”) filed a Complaint in the United States District Court for the District of Massachusetts seeking a declaratory judgment from the Court that the development, manufacturing, sale, and promotion of Dupixent® (dupilumab) does not infringe U.S. Patent No. 8,679,487 (“the ’487 patent”).  The ‘487 patent, entitled “Anti-interleukin-4 receptor antibodies,” issued on March 25, 2014, with a total of 17 claims.  The ’487 patent is assigned to Immunex Corporation (“Immunex”), which was acquired by Amgen in 2002.

Dupilumab is a monoclonal antibody intended to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines believed to be the drivers of type 2 helper T-cell (Th2)-mediated inflammation.  Regeneron submitted a biologics license application (“BLA”) for dupilumab to the FDA on July 29, 2016, seeking approval of the product for the treatment of moderate to severe atopic dermatitis in adults.  Atopic dermatitis, the most common form of eczema, is a chronic inflammatory skin disease.  FDA accepted the application for review in September 2016 and granted the dupilumab application priority status, reducing the target goal for approval from the standard ten months after acceptance to just six months.  The PDUFA (FDA goal) date for the dupilumab application is March 29, 2017.

Plaintiffs state in the Complaint that Amgen had previously attempted to develop a monoclonal antibody treatment for asthma (AMG-317) that inhibited the activity of interleukin 4 (IL-4) and interleukin 13 (IL-13) and further allege that Amgen “abandoned” its development efforts after the product showed “disappointing” results in Phase II clinical trials.  The Complaint acknowledges that Amgen’s development efforts resulted in a number of patents, including the ’487 patent.  According to the Complaint, counsel for Regeneron and Sanofi learned just days ago that “Amgen has hired litigation counsel to prosecute a patent infringement litigation related to Amgen’s work on antibodies to the IL-4 receptor and is in the process of retaining experts.”  The Complaint further states that Amgen “has a long history of aggressively enforcing its patents against competitors” and notes that Amgen is “currently engaged in an unrelated patent litigation concerning Sanofi and Regeneron’s product Praluent®”.

The case is Civ. No. 17-cv-10465 and has been assigned to Judge Woodlock.  Amgen has not yet filed an Answer to the Complaint, and Amgen and has not filed a suit accusing Sanofi and Regeneron of infringing the ’487 patent.  A threshold question for the Court to consider will likely be whether the Complaint sets forth facts sufficient to establish the existence of an “actual controversy” between the parties regarding infringement of the ’487 patent.

Federal Courts are prohibited from issuing advisory opinions.  To establish jurisdiction under the Declaratory Judgment Act, it is necessary for the Plaintiff to demonstrate “that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant” relief.  See Medimmune, Inc. v. Genentech, 549 U.S. 118 (2007); see also 28 U.S.C. §§ 2201-2202.

We will continue to provide updates as the litigation continues.

Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 9, 2016, for inter partes review (“IPR”) of U.S. Patent No. 7,622,115 (“the ’115 patent”) related to Genentech’s Avastin® (bevacizumab).  Interestingly, Genentech elected not to file a preliminary response.  On March 16, 2017, the PTAB issued a decision instituting review of claims 1-5 of the ’115 patent.  The claims of the ’115 patent are generally directed to methods of treating cancer in a patient by administering an effective amount of bevacizumab and assessing the patient for gastrointestinal perforation during treatment.

Bevacizumab is an anti-vascular endothelial growth factor A (Anti-VEGF) specific monoclonal antibody that inhibits formation of new blood vessels and is used to slow the growth of tumors related to several types of cancers.  Avastin® is indicated for treatment of conditions related to metastatic colon cancer, lung cancer, glioblastoma, ovarian cancer, and cervical cancer.

The proceeding is IPR2016-01771. The real party-in-interest identified for Petitioner is Hospira. Petitioner also identified Pfizer Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. The only real party-in-interest identified for Patent Owner is Genentech, Inc. (“Genentech”).

Hospira and Genentech are also involved in several IPR proceedings concerning Genentech’s patents for trastuzumab (Herceptin®). The PTAB has instituted one of those proceedings as reported in this post and Institution decisions on Hospira’s other trastuzumab patent petitions are expected in July and August of this year.  A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.

Earlier this year, Genentech filed litigation against Amgen in the United States District Court for the District of Delaware accusing Amgen of failing to comply with the disclosure requirements of section (l)(2)(A) of the BPCIA during the first step of the “patent dance” for Amgen’s proposed bevacizumab biosimilar as discussed in this post.   Judge Sleet dismissed that complaint exactly two weeks after it was filed, as reported here, but the dismissal was without prejudice, permitting Genetech to file an Amended Complaint.

Celltrion, Inc. (“Celltrion”) filed three new petitions with the Patent Trial and Appeal Board (“PTAB”) on March 15, 2017 for inter partes review (“IPR”) of Biogen’s U.S. Patent Nos. 8,329,172 (“the ’172 patent”), 8,557,244 (“the ’244 patent”), and 9,296,821 (“the ’821 patent”) related to rituximab.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.

The proceedings are IPR2017-01093 (the ’172 patent), IPR2017-1094 (the’244 patent), and IPR2017-1095 (the ’821 patent). The real parties-in-interest identified for Petitioner are Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH.

The sole claim of the ’172 patent is directed to a method of treating low-grade B-cell non-Hodgkin’s lymphoma (“NHL”) by administering a well-known chemotherapy regimen of cyclophosphamide, vincristine, and prednisone (“CVP”), followed by rituximab maintenance therapy administered in four weekly doses of 375 mg/m2 every six months for two years.  The ’244 patent has two claims.  Claim 1 of the ’244 patent is directed to a method of treating a patient with diffuse large cell lymphoma (a subset of Non-Hodgkin’s Lymphoma) by administering a combination of an unlabeled chimeric anti-CD20 antibody and chemotherapy (the chemotherapy consisting of cyclophosphamide, hydroxydaunorubicin/doxorubicin, vincristine, and prednisone/prednisolonew).  The treatment claimed in the ’244 patent is specific to a patient who is greater than 60 years old, has bulky disease, and has a tumor greater than 10 cm in diameter. Claim 2 of the ’244 patent further limits the chimeric anti-CD20 antibody to rituximab.  The ’821 patent has six claim which are generally directed to methods for treating low-grade or follicular NHL by administering rituximab during a chemotherapy regimen of CVP.

The PTAB recently issued institution decisions on two other patents related to rituximab.  On February 24, 2017, the PTAB instituted review of certain claims of U.S. Patent No. 7,820,161 (“the ’161 patent”) based on a petition filed by Celltrion in IPR2016-01614 as we reported here, and on March 2, 2017, the PTAB denied Celltrion’s request for inter partes review of U.S. Patent No. 7,976,838 in IPR2016-01667 as we reported here.

A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.  We will continue to provide updates as these cases progress.

Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,807,799 (“the ’799 patent”) related to Genentech’s Herceptin® (trastuzumab).  On March 15, 2017, the PTAB issued a decision instituting review of claims 1–3 and 5–11 of the ’799 patent.  The ’799 patent is generally directed to methods for reducing leaching of protein A during protein A affinity chromatography by reducing temperature or pH, or by adding protease inhibitors.  The challenged claims are specific to a method of purifying a protein that comprises a CH2/CH3 region, including an antibody, and certain claims specify a method of purifying trastuzumab.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceeding is IPR2016-01837. The real party-in-interest identified for Petitioner is Hospira. Petitioner also identified Pfizer Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. The real party-in-interest identified for Patent Owner is Genentech, Inc. (“Genentech”). Hospira has several petitions for IPR pending for other patents related to trastuzumab.  Institution decision on Hospira’s other petitions are expected in July and August.  A complete list of IPRs related to trastuzumab and other proposed biosimilars can be found in IPR Dashboard. We will continue to provide updates as these cases progress.

In related news, Mylan announced earlier this week that it reached a global settlement agreement with Roche and Genentech that will provide Mylan with global licenses for its trastuzumab biosimilar as reported in an update to this post on Monday.  According to the press release, Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand, and in the European Free Trade Association countries, and Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.  Mylan and Biocon announced in November 2016 that Mylan had submitted an application for a trastuzumab biosimilar to the FDA. The BSUFA date (FDA’s target goal) for Mylan’s trastuzumab application is September 3, 2017.

On March 10, 2017, the PTAB published a decision terminating the proceedings in IPR2016-1693 and IPR2016-1694 because the parties have reached a settlement.  Mylan filed two petitions requesting inter partes review (“IPR”) of certain 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”) issued to Carter, et al., entitled “Method for Making Humanized Antibodies.” Although the ’213 does not claim a specific product, Genentech has publicly stated that the technology claimed by the ’213 was used in the development of Herceptin® (trastuzumab), as well as several other products.

Mylan and Biocon announced in November 2016 that Mylan had submitted an application for a trastuzumab biosimilar product to the FDA.  Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The settlement was reached shortly before a decision on institution was expected from the PTAB.  Mylan filed both petitions on the ’213 patent on August 30, 2016.  The patent owner filed its preliminary responses on December 16, 2016, and the PTAB would have issued a decision on institution no later than March 16, 2017.

The real parties-in-interest identified for Petitioner are Mylan Pharmaceuticals Inc.,

Mylan Inc., Mylan GmbH and Biocon Ltd. Petitioner also identified Mylan N.V. out of an abundance of caution, but made no admission that Mylan N.V. is a real party-in-interest.  The only real party-in-interest identified for Patent Owner is Genentech, Inc.  Although these two IPRs have been terminated, there are several petitions pending on other patents related to Herceptin® (trastuzumab).  A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.

3-13-17 UPDATE:  Mylan announced on March 13, 2017 that the settlement of the ‘213 patent dispute is part of a broader settlement agreement with Roche and Genenetech that will provide Mylan with global licenses for its trastuzumab product.  As part of the settlement, Mylan will also withdraw its IPR challenge to U.S. Patent No. 6,331,415.

According to the press release, Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries, and Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.  The BSUFA date (FDA’s target goal ) for Mylan’s trastuzumab application is September 3, 2017.

Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.

On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once every two weeks by subcutaneous injection for the treatment of rheumatoid arthritis was obvious as of June 8, 2001 (the priority date awarded by the Court to European Patent No. 1406656) and that administration of 40mg of adalimumab subcutaneously every other week for the treatment of psoriasis and psoriatic arthritis was obvious and/or anticipated as of July 18, 2003 (the priority date of the European Patent No. 1944322).

The opinion notes that “Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$ 12.5 billion.”  The case was originally filed in March 2016.  During the course of the litigation, AbbVie revoked (abandoned) the ’656 and ’322 patents in Europe.  AbbVie also de-designated a third patent in the UK that was going to be added to the litigation, European Patent No. 2940044.  AbbVie offered to sign an undertaking in which it agreed, inter alia, “not to obtain patent protection in the UK that would be infringed by certain dosage regimens.”  AbbVie asserted that in view of its agreed undertakings, declaratory judgment from the Court “would serve no useful purpose.”

The Court disagreed with AbbVie, however, characterizing the language of the proposed undertakings as “complicated and very long,” and specifically pointing out that “they do not refer to anticipation or obviousness, and they do not acknowledge that the Claimants’ products were anticipated or obvious at the priority date(s).”  The Court further reasoned that “threats of worldwide litigation” by AbbVie’s CEO, Mr. Richard Gonzalez, “are intended to have, and are likely to have had, a chilling effect on competition from biosimilars, including on third-party suppliers.”  The Court accepted Claimant’s allegations that such threats were “likely to impede the Claimants’ ability to market successfully their products in the United Kingdom.”  Therefore, the Court found that under the circumstances, the grant of declaration from the Court “would serve a useful purpose.”

Justice Carr’s opinion included additional, “[s]pecial reasons for or against the grant of the declarations,” where the Court stated that:

[O]n the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.

The Court provided its conclusions at the end a 99-page opinion in which it separately addressed the facts and evidence in support of the request for declaratory relief, the priority dates, and the merits of the technical case.

The UK Court’s ruling does not have any direct legal effect in the United States.  However, there is litigation pending before Judge Robinson in the United States District Court of Delaware involving ten of AbbVie’s patents and Amgen’s proposed biosimilar adalimumab product.  See AbbVie v. Amgen, Civ. No. 1:16-cv-666, (D. Del.)(SLR).  Several patents related to Humira® are currently being challenged in post-grant proceedings before the PTAB.  A summary of IPR proceedings on patents related to Humira® can be found in the RFEM Biologics IPR Dashboard.

 

On March 2, 2017, the PTAB issued a decision denying Celltrion, Inc.’s (“Celltrion”) request for inter partes review (“IPR”) of claims 1-14 of U.S. Patent No. 7,976,838 related to Genentech’s Rituxan® (rituximab).  This denial comes less than a week after the PTAB instituted IPR of U.S. Patent No.     7,820,161, related to the same product, in response to a separate petition filed by Celltrion as discussed in this post.  

The challenged claims of the ’838 patent are generally directed to methods of treating rheumatoid arthritis in a patient who experiences an inadequate response to a TNFα-inhibitor by administering an anti-CD20 antibody, such as rituxan, intravenously at certain dosages.  Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.

The Board denied institution in proceeding IPR2016-01667 filed on August 25, 2016. The real parties-in-interest identified for Petitioner are Celltrion, Celltrion Healthcare Co. Ltd. (“CTHC”), and Teva Pharmaceuticals International GmbH (“Teva”).  The only real party-in-interest identified for Patent Owner is Genentech, Inc.  The PTAB previously instituted an IPR for certain claims of the ’838 patent on a petition filed by Boehringer Ingelheim. That proceeding (IPR2015-00417) was terminated on October 1, 2015, following a Request for Adverse Judgment by Petitioner. Celltrion also previously filed a petition challenging certain claims of the ’838 patent, IPR2015-01733, on August 14, 2015.  Celltrion filed a motion seeking to join that proceeding with IPR2015-0417, but when IPR2015-00417 was terminated by Boehringer Ingelheim (before an institution decision on Celltrion’s petition), Celltrion moved to dismiss the petition in IPR2015-01733 without prejudice.

A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.

Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint without prejudice on March 1, 2017 for lack of subject matter jurisdiction in light of Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).  As discussed in our earlier post (which raised the question of whether Genentech had stated a claim on which relief could be granted), the Complaint for Declaratory Judgment filed by Genentech on February 15, 2017, alleged that Amgen failed to comply with the disclosure requirements of section (l)(2)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) in the “patent dance” involving Amgen’s bevacizumab product, a proposed biosimilar to Genentech’s Avastin®.

The whirlwind began on February 22, 2017—a week after the complaint was filed—with Genentech requesting a “speedy hearing” pursuant to Federal Rule of Civil Procedure 57.  Genentech sought a quick resolution because Genentech itself alleges that it faces a statutory deadline of March 24, 2017 to provide Amgen with its patent list under section (l)(3)(A) of the BPCIA.  Judge Sleet scheduled a teleconference with the parties on the morning of February 24, 2017 and then held follow-up teleconferences later that same day.  The Court ordered the parties to submit 3-page letter briefs on February 27 and 28, 2017, respectively, and scheduled a hearing for March 1, 2017.

Amgen argued that although it disagreed with the Federal Circuit’s interpretation of 42 U.S.C. § 262(l)(2)(A) in Amgen v. Sandoz, the Federal Circuit’s decision in that case mandated that the only course of action provided by the BPCIA for non-compliance with the disclosure requirements of section (l)(2)(A) is a declaratory judgment action for patent infringement, and therefore the relief sought by Genentech’s declaratory judgment complaint was procedurally improper.

Genentech countered that “the Federal Circuit did not (and did not purport to) foreclose declaratory judgment actions to determine whether an applicant complied with its statutory obligations” in Amgen v. Sandoz and that “it is only after [the] dispute regarding Amgen’s compliance is resolved that Sandoz’s guidance on remedies even becomes relevant.” Genentech argued that Amgen was simply seeking to defer resolution and force Genentech’s hand into a potential procedural default because if Genentech files a declaratory judgment action for infringement, Amgen will then move to dismiss that action under § 262(l)(9)(A).

Section (l)(9)(C) of the BPCIA provides that if an applicant “fails to provide the application and information required under paragraph (2)(A),” then the reference product sponsor (but not the applicant) may bring a declaratory judgment action for infringement of “any patent that claims the biological product or a use of the biological product.”  See 42 U.S.C. § 262(l)(9)(C).   On the other hand, section (l)(9)(A) of the BPCIA expressly states that if the applicant “provides the application and information required under paragraph (2)(A),” the reference product sponsor may not bring a declaratory judgement for infringement of any patent that is described in clauses (8)(b)(i) and (ii), prior to the date notice of commercial marketing is received.  Therefore, as explained in our earlier post, if Amgen has not provided sufficient information to satisfy the disclosure requirement of section (l)(2)(A), then Genentech is permitted to bring a claim for patent infringement, validity, or enforceability pursuant to section (l)(9)(C).  But, if Amgen has satisfied the disclosure requirements of section (l)(2)(A), then Genentech is prohibited from bringing a declaratory judgment claim for patent infringement until after the notice of commercial marketing is received.

For now, Judge Sleet has agreed with Amgen and dismissed the suit in light of the existing Federal Circuit precedent (which is currently on appeal to the Supreme Court as discussed here).  However, the order of dismissal expressly provides that the Complaint is being dismissed without prejudice, with leave to amend within forty-five days. While this case is dismissed for the moment, the dispute is surely not at an end.

This decision leaves for another day the answer to the question of what information, if any, in addition to the application, an applicant must provide to the reference product sponsor to satisfy the second clause of section (l)(2)(A).  Stay tuned.

Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”).  An IPR provides a mechanism for challenging the patentability of one or more claims of an issued patent through an administrative “trial” conducted by three Administrative Patent Judges from the United States Patent and Trademark Office’s Patent Trial and Appeal Board (“PTAB” or “Board”).  An IPR is available for any patent regardless of the issue date, but for patents examined under the AIA (those filed on or after March 16, 2013), an IPR petition may not be filed until nine months after the patent issues.  Additionally, if a petition for a post-grant review (“PGR”) has been instituted for the patent, the PGR must be concluded before an IPR petition can be filed.

IPRs were intended to provide a faster, more efficient, and less expensive means for challenging patents compared to traditional litigation.  The potential benefits of IPR over federal court litigation include:  a lower burden of proof, the absence of a presumption of validity, and a broader standard for claim construction.  An IPR may also be available earlier than litigation on biosimilar products (because it is not necessary to wait until a BLA has been filed and accepted for review by FDA before filing an IPR petition), and an IPR may provide faster resolution than litigation because of the short statutory deadlines imposed on the proceeding.

On the other hand, the grounds that can be asserted in an IPR are limited to challenges under 35 U.S.C. §§ 102 and 103 (anticipation and obviousness) based on patents and printed publications.  Another difference is that although discovery is permitted in an IPR, the scope of discovery is much narrower than in district court litigation.  Also, the direct testimony of expert witnesses is submitted in form of written declarations and cross-examination of experts is conducted by deposition.  Therefore, the only live testimony presented to the Board is generally attorney argument at the oral hearing, which is often limited to an hour or less per side (rather than the multi-day or multi-week trials held by district courts).  One should also be aware of the potential for estoppel under 35 U.S.C. § 315(e), as discussed in a post on RFEM’s PTAB website here.  Finally, each individual petition for IPR may only address one patent, so challenges to more than one patent require multiple IPR petitions.  Thus, IPRs may be a particularly useful alternative for biosimilar product manufacturers and developers to challenge individual patents or a small set of key patents outside of BPCIA litigation.

The preliminary portion of an IPR proceeding begins with the filing of a petition by a third party.  The patent owner has three months to file a preliminary response, and the PTAB will make a determination on whether to “institute” review within six months of the filing date of the petition.  The Board will institute an IPR if the petitioner has demonstrated “a reasonable likelihood that it will prevail with respect to at least one of the challenged claims.”  If the IPR is instituted, the “trial” portion of the proceeding will begin, and the Board will issue a final written decision within one year of the institution decision.  The one year statutory deadline may be extended by up to six months for good cause shown.

Petitions for IPR have been filed on many patents related to proposed biosimilar products.  A complete summary of IPR proceedings for patents related to proposed biosimilar products is provided in RFEM’s Biosimilars IPR Dashboard.

RFEM has an extensive PTAB practice.  For more information about our practice and other useful information about recent decisions from the PTAB, visit our PTAB site at www.ptablaw.com.