Earlier this month, Celltrion, Inc. (“Celltrion”) filed a copycat IPR petition directed against U.S. Patent No. 7,976,838 (“the ʼ838 patent”) that is essentially identical to a petition filed by Pfizer, Inc. (“Pfizer”).  The PTAB recently instituted review of the ʼ838 patent based on Pfizer’s petition in IPR2017-01923.  Celltrion’s copycat petition was accompanied by a motion for joinder with the currently pending Pfizer IPR.

Celltrion’s motion for joinder asserts that it contains identical grounds to those presented in the Pfizer petition, and thus would not create any additional burdens on the parties or impact the trial schedule.  Celltrion further explains that it conferred with Pfizer’s counsel and agreed to proceed in a limited “understudy” role, unless Pfizer is terminated from the proceedings.  As part of this understudy role, Celltrion agreed to not produce its own testifying witnesses, file any substantive papers (unless those papers do not affect Pfizer), or participate in the oral hearing.

This is the third time Celltrion has challenged the ʼ838 patent in an IPR.  Celltrion’s first challenge to the ʼ838 patent was via another copycat petition based on Boehringer Ingelheim’s (“Boehringer”) petition filed in IPR2015-00417.  Celltrion filed a motion for joinder in that case but while the motion was pending, Boehringer requested adverse judgment and the IPR was terminated.  Celltrion then requested dismissal of its copycat petition without prejudice, which the PTAB granted.  Celltrion subsequently filed its own IPR challenging the patentability of the ʼ838 patent, but the PTAB declined to institute review.

In Celltrion’s first copycat petition in the Boehringer IPR, Celltrion did not retain an expert of its own to support its petition.  Rather, Celltrion relied on the same exhibits and expert declaration that Boehringer submitted.  However, once Boehringer requested adverse judgment, Celltrion was no longer able to work with that expert.  Without an expert of its own, Celltrion could not proceed in the IPR.  Celltrion apparently learned from this experience, and supported its most recent copycat petition with expert declarations submitted by experts independent of those relied on by Pfizer.

The lesson here for parties filing copycat petitions is that they should consider submitting independent expert declaration(s), even if those declaration(s) are essentially identical to those supporting the petition being copied, to avoid any problem with continuing in the IPR if the first-filing party drops out of the proceeding.

Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter partes review of Abbvie’s patent, U.S. Patent No. 9,512,216 (“the ’216 patent”), directed to methods for treating moderate to severe chronic plaque psoriasis with a human anti-tumor necrosis factor α (TNFα) antibody.[1] The petition, filed on October 2, 2017, asserted that claims 1-16 of the ’216 patent were unpatentable under 35 U.S.C. § 103(a) as obvious over a Humira 2003 Label and a Humira 2002 Label, in combination with other references. The institution decision ultimately hinged on whether the labels constituted prior art “printed publications” under 35 U.S.C. § 102(b).

As the Board explained in its decision, the petitioner has the burden to establish a reasonable likelihood that it will prevail on the merits, which, inter alia, includes putting forth sufficient arguments and evidence to show that the petitioner would establish public accessibility of the reference by a preponderance of the evidence over the course of the trial.[2] Whether a reference qualifies as a “printed publication” is a case-specific inquiry, with the key factor being a satisfactory showing that the reference was “sufficiently accessible to the public interested in the art” before the filing date.[3] A reference is considered “publicly accessible” if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it.”[4]

In its petition, Sandoz identified the Humira 2002 Label and Humira 2003 Label as prior art under § 102(b), asserting merely that the labels were “prior art FDA-approval label[s]” and that the drugs were approved by the FDA in December 2002 and January 2003, respectively.[5] In the preliminary patent owner response, Abbvie argued that this showing was insufficient. Specifically, Abbvie pointed out that the issue dates on the face of the labels do not establish “public accessibility,” and although Sandoz attached exhibits which could support an argument that the labels were publicly accessible, including a screenshot of the Humira 2003 label from the WayBack Machine and affidavit from the Office Manager at the Internet Archive, neither was cited or discussed in the petition itself.

In response to the preliminary patent owner response, Sandoz sent an email to the Board requesting, in part, authorization to file a reply to address Abbvie’s arguments regarding the public availability of the Humira labels. The PTAB denied this request, explaining that Petitioner could have reasonably foreseen arguments regarding whether the Humira labels were publicly available before the priority date of the ʼ216 patent, given that a petitioner bears the initial burden of production to establish the existence of prior art that renders the claims unpatentable. The Board did, however, grant Sandoz’s request to file a reply in response to the Patent Owner’s arguments regarding §§ 314(a) and 325(d).

Despite the Board’s limited authorization regarding the scope of the reply, the background section of Sandoz’s reply included arguments addressing the public availability and “printed publication” status of the Humira labels, citing to the WayBack Machines screenshot and the affidavit of Christopher Butler, Office Manager at the Internet Archive, affirming that the 2003 Humira Label was publicly accessible and archived from www.fda.gov on March 31, 2003. This appears to have rubbed the Board the wrong way. In the decision denying institution, the PTAB noted that “Petitioner’s attempt in the Reply to meet its threshold showing that Humira 2003 Label is a printed publication is not only untimely, but also appears to circumvent our Order (Paper 11) denying Petitioner’s request to file a reply on that very issue.”[6]

The PTAB ultimately agreed with Abbvie’s arguments that the Humira labels were insufficient to establish public availability, such that the labels did not qualify as prior art under § 102(b), and the petition was thus denied. While this decision illustrates a hard lesson learned under the old adage “don’t bite the hand that feeds you,” it is also a testament to the need for petitioners to put forth sufficient evidence to establish that a reference relied upon is indeed a prior art “printed publication” in the petition itself. Merely including supporting evidence as an exhibit, without a citation or explanation in the petition, just won’t cut it for meeting the threshold showing of prior art status.

 

[1] Sandoz Inc. v. Abbvie Biotechnology Ltd., IPR2018-00002, Paper No. 13 (PTAB May 3, 2018).

[2] Id. at 6-8.

[3] Id. at 7 (citing In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009)).

[4] Id. (citing Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (citation and internal quotations marks omitted)).

[5] Petition at 24.

[6] Sandoz Inc. v. Abbvie Biotechnology Ltd., IPR2018-00002, Paper No. 13 at 12 (PTAB May 3, 2018).

 

Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.  The FDA also approved Retacrit for use before and after surgery to reduce the chance that red blood cell transfusions will be necessary due to blood loss during surgery. The FDA’s approval was granted to Hospira, which is now a Pfizer company by virtue of Pfizer’s acquisition of Hospira in 2015.

According to the FDA, approval “is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit.”  The FDA further noted that although Retacrit has been approved as a biosimilar, it has not been approved as interchangeable with Epogen®.

Retacrit is the first epoetin alfa biosimilar to be approved by the FDA, and just the tenth biosimilar approved overall.  In announcing the approval, Pfizer stated that “[a]s the first approved epoetin alfa biosimilar in the U.S., RETACRIT may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients.”  Pfizer also stated that “RETACRIT is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit.”

The FDA’s approval of Retacrit comes nearly a year after it issued a complete response letter (“CRL”) to Pfizer regarding the then pending application.  As we previously reported, Pfizer stated that the CRL did not specifically relate to the manufacture of Retacrit, but was in response to matters noted in a Warning Letter following a routine inspection of a manufacturing facility that was identified as a potential manufacturing site for its epoetin biosimilar.

Hospira and Amgen are currently involved in litigation over patents that Amgen has asserted over this biosimilar.  Last September, a jury in the District of Delaware found Hospira liable for infringing one of the two patents at issue and awarded Amgen 70 million dollars in damages.  However, post-trial motions filed by both Hospira and Amgen are still pending, and so the judgment is not final.  In addition, the patent that Hospira was found to infringe has now expired.

As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents relating to Herceptin® (trastuzumab) and Rituxan® (rituximab) are non-infringed, invalid, and/or unenforceable.  In response, Genentech filed a motion to dismiss in both cases arguing that the case was statutorily barred under the BPCIA.  On May 9, 2018, the Court granted both of the motions.

To better understand the parties’ positions and the Court’s ruling, a brief recap of the patent dance portion of the BPCIA is helpful.  Following the FDA’s acceptance of an abbreviated Biologic Licensing Application, the applicant (here, Celltrion) provides the reference product sponsor (here, Genentech) with a copy of that application.  After receipt of the application, the reference product sponsor provides the applicant with a list of patents that it believes to be infringed.  The applicant then sends the reference product sponsor a claim-by-claim analysis of why it believes the asserted patents are not infringed by the biosimilar product, are invalid, or are otherwise not enforceable.  The reference product sponsor then responds to the applicants arguments.  Once those exchanges are complete, the parties must negotiate in good faith to identify the patents that will be subject of immediate patent infringement litigation.  The parties have 15 days to complete these negotiations.  If an agreement cannot be reached, the applicant must identify the number of patents that it wishes to litigate, and that number sets the limit on the patents-in-suit.  The parties then exchange the lists of patents that each party believes should be litigated and the reference product sponsor may then bring suit.

The BPCIA also sets limits on the remedies available to an applicant in the event it does not comply with any of the various steps in the patent dance. For example, if the applicant does not provide a copy of its application to the reference product sponsor, then the applicant cannot bring a declaratory judgment action.  Similarly, the applicant is barred from bringing a declaratory judgment action if it does not serve the various required disclosures, e.g., the number of patents it wishes to litigate or the list of patents it believes should be litigated, on the reference product sponsor.

Returning to Genentech’s motion(s) to dismiss, the thrust of the motions was that Celltrion’s declaratory judgment actions were barred due to Celltrion failing to comply with its obligations during the “patent dance” portion of the BPCIA.  According to Genentech, Celltrion failed to engage in the required good faith negotiations that must occur following Genentech’s initial disclosure of the patents it believed Celltrion’s product would infringe.  Genentech alleged that although it initially identified 40 patents, it subsequently proposed reducing the number of patents it would assert based on Celltrion’s responses.  Genentech asserted that Celltrion responded by stating it wished to litigate all 40 patents and filing the declaratory judgment action.

Celltrion counters that although Genentech proposed narrowing the number of patents in suit, it purported to reserve its right to assert infringement of the other identified patents.  According to Celltrion, this “created unacceptable legal uncertainty” and for this reason, it wished to litigate all 40 patents.  Celltrion also explained that it provided Genentech with a notice of commercial marketing when it brought the declaratory judgment action.  According to Celltrion, service of a notice of commercial marketing triggers a new wave of the patent dance that allows either party to bring a declaratory judgment action to settle any patent disputes remaining at the time of the notice.

The Court disagreed with Celltrion, and found that the declaratory judgment suits were clearly barred by the BPCIA. In both suits, the Court noted that Celltrion failed to identify the number of patents it wished to litigate and failed to exchange a list of patents that it believed should have been in the suit with Genentech.  The Court found Celltrion’s explanation for its actions unavailing.  Celltrion argued that it notified Genentech that it wished to litigate all of the patents originally identified, and thereby simultaneously fulfilled its obligation to negotiate, set the number of the patents in dispute, and rendered a subsequent list exchange redundant.  However, the Court found that because the requirement to negotiate in good faith is in one section of the statute and the identification of the number of patents-in-suit/list of patents exchange is in another, “no single statement or gesture can satisfy the requirements of both sections simultaneously.”  The Court thus concluded that Celltrion had improperly conflated a number of discrete steps and exchanges that are mandated by the statutory framework.  The Court also found that even assuming Celltrion’s interpretation of the statute was correct, Celltrion had erred by presupposing disagreement during the negotiation phase gave it the power to unilaterally terminate the patent dance.  Moreover, the Court concluded that even if negotiations had not been fruitful, the statute requires the list exchange and empowers Genentech, and not Celltrion, to file suit.

The Court also disagreed that Celltrion’s service of a notice of commercial marketing permitted Celltrion to bring the declaratory judgment action.  According to the Court, the BPCIA contains three distinct statutory bars that each apply to a different factual circumstance where an applicant fails to comply with the statute.  Service of a notice of commercial marketing only lifts one of those statutory bars, i.e., where the parties have fully complied with all of the statutory steps.  If the list exchange step (among others spelled out in the statute) is not completed, then a separate bar applies, and the filing of a notice of commercial marketing cannot lift it.

In its order dismissing the case, the Court permitted Celltrion to file an amendment complaint.  However, the basis for the Court’s dismissal was that Celltrion did not comply with certain steps in the statute, and, notwithstanding Celltrion’s explanation of its actions, there does not appear to be a dispute between the parties as to what actions did and did not occur. Meanwhile, Genentech has filed patent infringement suits based on the same Celltrion abbreviated Biologic Licensing Applications in New Jersey and Delaware.

We will continue to keep you updated on future developments.

The Patent Trial and Appeal Board (“the Board”) has decided not to institute inter partes review (“IPR”) on two patents owned by Biogen and Genentech.  Pfizer, Inc. (“Pfizer”) filed two petitions asserting that the patents, U.S. Patent Nos. 8,206,711 (“the ’711 patent”) and 7,682,612 (“the ’612 patent”), were invalid as obvious in view of prior art. Both of these patents relate to Rituxan® (rituximab) and its use in the treatment of chronic lymphocytic leukemia (“CLL”).

Last month, the Board denied Pfizer’s IPR petition for the ’711 patent, finding that all of the claims were not obvious over the cited prior art. Pfizer, Inc. v. Biogen, Inc., IPR2017-02127 (PTAB Apr. 19, 2018) (Paper 10). The Board held that the cited prior art failed “to provide guidance concerning clinical endpoints, treatment parameters, or other information relating to how one would treat CLL with rituximab, or why one would reasonably expect such treatment to be successful.” Id.at 23.

This past week, the Board denied Pfizer’s other petition for the ’612 patent, again finding that the claims were not obvious over the prior art. Pfizer, Inc. v. Biogen, Inc., IPR2017-02126 (PTAB Apr. 30, 2018) (Paper 10). Pfizer argued that the prior art “would have provided an ordinarily skilled artisan with a reasonable expectation of success for methods of using rituximab to treat CLL patients at the claimed doses.” Id.at 11. However, the Board disagreed that the prior art demonstrated that “an ordinarily skilled artisan would have had a reasonable expectation of success in using any dosage of rituximab to treat CLL.” Id. at 10. Rather, the prior art suggested “a rationale for exploring the possibility of treating CLL with rituximab,” but such suggestion amounted “to no more than an invitation to experiment.” Id. at 10.

This is not the first challenge to these two Rituxan® patents. Celltrion, Inc. previously filed three IPR petitions challenging both patents, all of which were denied by the Board. See Celltrion, Inc. v. Biogen, Inc., IPR2017- 01227 (PTAB Oct. 23, 2017) (Paper 10); Celltrion, Inc. v. Biogen, Inc., IPR2017-01230 (PTAB Oct. 12, 2017) (Paper 12); Celltrion, Inc. v. Biogen, Inc., IPR2017-01229 (PTAB Oct. 23, 2017) (Paper 10).

Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab.  In the announcement, Sandoz stated that it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter.”  Sandoz further indicated that although disappointed, it “remains committed to further discussions with the FDA to bring this important medicine to US patients as soon as possible.”

Sandoz initially announced that the FDA accepted its application for its proposed rituximab biosimilar on September 12, 2017.  Sandoz’s licensing application to the United States FDA followed the approval of its rituximab biosimilar for all indications in Europe.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

We will continue to keep you updated on further developments.

  • European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars
  • FDA has not approved any biosimilar drug in 2018
  • Only three of nine approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales for the top nine branded biologic drugs were estimated to total $63 billion in 2016[1].  Competition in the heavily regulated marketplace for these blockbuster therapeutics is expected to substantially impact the pharmaceutical industry and national health systems.  To date, the U.S. has considerably lagged behind Europe’s expansion of biosimilar drug options.  The RAND Corporation estimates that biosimilar products can save the U.S. health system approximately $54 billion over the next decade, as discussed here.

Since 2005, the biosimilar regulatory framework in Europe has been implemented through the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).  The CHMP provides initial assessments for marketing authorization of new medicines that are ultimately approved centrally by the EMA.  Since Sandoz’s somatotropin biosimilar Omnitrope® was first authorized on April 12, 2006, an additional 39 out of 44 applications have been approved in Europe.  Three of the authorizations have been withdrawn post-approval by the marketing authorization holders (Table 1).

The U.S. did not implement a regulatory framework for biosimilar evaluation until after enactment of the Biologics Price Competition and Innovation Act (BPCIA) of 2009.  Given that the first U.S. biosimilar drug was approved almost a decade after the first in Europe, the number of authorized biosimilar drugs in Europe far exceeds the number of biosimilars approved in the United States.  Sandoz’s filgrastim biosimilar Zarxio® received the first U.S. approval in 2015, whereas nine filgrastim biosimilars have been approved in Europe dating back to multiple authorizations in 2008.  Zarxio® (in the U.S.) and Zarzio® (in Europe) are biosimilar to the reference product Neupogen® marketed by Amgen and originally licensed in 1991.   Subsequent to Zarxio®’s approval, only eight other biosimilar drugs have gained U.S. approval to date (Table 2).  As illustrated in the following graph, the EU’s significant head start led to the existent imbalance in the number of biosimilar drugs available in the respective markets.

Currently, sixteen biosimilar applications are under review by the EMA for marketing authorization (Table 3).  As an increasing number of U.S. patents expire on blockbuster biologic drugs, the number of abbreviated biologics license applications is also increasing.  Biosimilars for at least twelve different original biologics are currently navigating the FDA’s biosimilar pathway or are in late stage development (Table 4).  Interestingly, Neulasta® (pegfilgrastin) biosimilars have failed to gain approval in Europe and in the United States despite numerous attempts.  The FDA has rejected pegfilgrastim applications filed by Coherus, Mylan/Biocon, and Sandoz, and there are currently eight pending applications for pegfilgrastim pending in Europe.

On February 9, 2018, the EMA approved HerzumaTM, the second trastuzumab biosimilar to Roche’s Herceptin® in Europe.  The EMA previously approved Samsung Bioepis’ Ontruzant TM in November 2017.  Herzuma is the third biosimilar from Celltrion’s portfolio approved by the European Commission.

On April 23, 2018, Pfizer announced that the FDA had issued a Complete Response Letter (CRL) highlighting the need for additional information for its trastuzumab biosimilar referencing Herceptin®.   On April 5, 2018, Celltrion announced that the FDA had issued CRLs for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan®, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin®.  The FDA has not approved any biosimilars in 2018.

Given biosimilar applicant experience in navigating the EMA process and the EMA’s high authorization rate, the FDA will need to continue to provide useful guidance and streamline the approval process in order to reduce the imbalance.

Table 1. European Medicines Agency List of Approved Biosimilar Drugs (updated May 1, 2018).

Table 2. U.S. Food and Drug Administration List of Approved Biosimilar Drugs (CDER list of licensed biologics updated on April 17, 2018).

Table 3. European Medicines Agency List of Biosimilars Under Evaluation for Marketing Approval (Source: EMA list of applications for new human medicines updated on April 10, 2018).

Table 4. Biologics having already expired or nearing primary patent expiry in the U.S. that have biosimilars in the regulatory pipeline.

 

[1] Mullard, Asher. “Bracing for the biosimilar wave.” Nature Reviews Drug Discovery 16.3 (2017): 152-154.

Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent infringement case brought by Amgen Inc. and Amgen Manufacturing, Limited (collectively “Amgen”) against Coherus Biosciences, Inc. (“Coherus”). Judge Stark previously issued a Memorandum Order on March 26, 2018, adopting Magistrate Judge Burke’s Report and Recommendation (issued December 7, 2017) to grant Coherus’s motion to dismiss.

Amgen’s Complaint was filed on May 10, 2017, alleging infringement under the BPCIA due to Coherus’s submission of an abbreviated Biologic License Application seeking approval to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product.  In particular, Amgen alleged infringement of a single patent, U.S. Patent No. 8,273,707 (“the ʼ707 patent”), directed to a process for purifying proteins. Of particular relevance, the claimed process requires a combination of a first and second salt selected from the group consisting of citrate and sulfate, citrate and acetate, and sulfate and acetate.  Each salt must also be present within a particular concentration range.  In its Complaint, Amgen alleged that the Coherus process met this limitation through the use of a first and second salt that is the equivalent of one or more of the specified salt pairs.

On June 1, 2017, Coherus filed a motion to dismiss for failure to state a claim.  Coherus contended that it was entitled to dismissal because, as a matter of law, its accused manufacturing process does not infringe the ʼ707 patent.  In particular, Coherus argued that its process does not utilize one of the claimed salt pair, and does not utilize salts within the claimed concentration range.  Because the Court concluded that Coherus did not infringe based on the use of one of the claimed salt pairs, it did not address the second argument.

The Court initially noted that Amgen’s Complaint did not allege sufficient facts to support equivalence between the claimed salt pairs and the Coherus manufacturing process.  Instead, the Court explained that Amgen’s Complaint simply makes the legal conclusion that there is equivalence. Normally, Amgen would likely be permitted an opportunity to amend its Complaint to include facts sufficient to support its doctrine of equivalents theory.  However, Coherus argued there was no reason to allow Amgen to amend in this case because prosecution history estoppel barred Amgen’s theory of infringement.  Specifically, Coherus argued that during prosecution Amgen distinguished its claims from the cited prior art by emphasizing that the prior art did not teach or suggest the particular combinations of salts that were being claimed.  Accordingly, Coherus asserted that Amgen was estopped from asserting a different salt combination infringes the ʼ707 patent claims.

Following review of the prosecution history, the Court concluded that Amgen had clearly and unmistakably surrendered processes using a combination of salts that was different from the claimed combinations.  In particular, the Court took note of Amgen’s repeated emphasis that the cited reference did not teach that the “particular combination” of salts would increase the dynamic capacity of the column as required by the then pending claims.  Interestingly, the Court noted that if the prosecution history focused only on the fact that the pending claims required a combination of salts instead of the single salt disclosed in the prior art, there would not be an estoppel issue.

The Court also found it telling that Amgen did not substantively address the prosecution history argument made by Coherus.  Instead, it made three “peripheral” arguments that the Court did not find persuasive. First, Amgen argued that Coherus’s argument regarding the salt pair limitation should be taken up after claim construction and discovery.  However, the Court faulted Amgen for not explaining how either would “shed light on the objective inquiry regarding whether argument-based prosecution history estoppel applies here.”  Second, Amgen argued that prosecution history does not apply to so-called clarifying amendments.  Although the Court agreed with that principle, it noted that Amgen had not explained how the prosecution history statements Coherus relied on were clarifications as opposed to claim scope surrender.  Third, Amgen argued Coherus had not met the stringent standard for applying argument-based estoppel.  However, the Court dismissed this argument as being based on “wordplay [that] ignores the meat of Coherus’s position.”

It remains to be seen whether Amgen will appeal this ruling, although that seems likely.  In related news, Coherus recently announced that it anticipates a U.S. commercial launch of its pegfilgrastim product in the second half of 2018.

Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to commercialize a biosimilar to adalimumab developed by Fujifilm.  Under the terms of the agreement, Fujifilm grants Mylan an exclusive license to commercialize the biosimilar in Europe, and will receive an up-front fee in return.  In addition, Fujifilm is eligible to receive commercialization milestone payments and sales royalties.  Mylan is responsible for all sales activity of the product in Europe.  The parties are continuing to negotiate commercialization rights in other territories.

As we previously reported, Fujifilm’s medical marketing application for its adalimumab biosimilar was accepted for review by the European Medical Agency on May 18, 2017.  A decision from the EMA is expected in the second half of 2018.

We will continue to keep you updated on future developments.

On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab to treat psoriatic arthritis, it also instituted review of a second AbbVie patent directed to the use of adalimumab to treat chronic plaque psoriasis. More specifically, and once again at the urging of Sandoz Inc. (“Sandoz”), the PTAB instituted review of claims 1, 4, 7, 10, 13, 16, and 19 of U.S. Patent No. 9,090,689 (“the ʼ689 patent”), which is entitled “Use of TNFα Inhibitor for Treatment of Psoriasis.”

The challenged claims of the ʼ689 patent are directed to methods of administering adalimumab for the treatment of moderate to severe chronic plaque psoriasis.  The claims require filling adalimumab into vessels (syringes) and subcutaneously administering 40 mg of adalimumab to a patient every other week. Certain dependent claims also recite various efficacy limitations, e.g., achieving a score reduction for a particular psoriasis severity measurement.

The only claim construction dispute at issue in the Petition was whether the preambles of the independent claims (1 and 7) are statements of intended use.  If so, then Sandoz argued they are non-limiting. AbbVie did not respond to that position in its Preliminary Response, but reserved the right to do so if trial was instituted.  However, the PTAB determined that it was unnecessary to determine if the preambles are limiting at this stage.

Sandoz proposed two Grounds of unpatentability in its Petition, although both Grounds are substantively similar.  AbbVie did not contest that the cited references collectively disclose the claim limitations.  Instead, AbbVie disputed that a person of ordinary skill would have had a reasonable expectation of success in using adalimumab to treat chronic plaque psoriasis, or a reasonable expectation of success in using the claimed dosing regimen, i.e., 40 mg adalimumab administered every other week.

AbbVie’s arguments in this IPR were very similar to those it made in arguing that trial should not be instituted in the companion ʼ992 patent. Briefly, Sandoz asserted there was a reasonable expectation of success in using adalimumab (a TNF-α inhibitor) to treat chronic plaque psoriasis because the disease was known to be mediated by TNF-α, and other TNF-α inhibitors had been successfully used to treat it. Because of this known link, Sandoz alleged a prior art disclosure  in which adalimumab had been successfully used to treat rheumatoid arthritis (another TNF-α related disease) would have led a person of ordinary skill to believe it would also be effective to treat chronic plaque psoriasis.  AbbVie countered that none of the cited references actually disclose using adalimumab to treat chronic plaque psoriasis, and a disclosure that adalimumab can treat rheumatoid arthritis is not predictive of its ability to treat psoriasis. However, much like in the ʼ992 IPR, the PTAB was not persuaded by this argument based on the record currently before it.

AbbVie also asserted that two of the relied upon references do not teach treating chronic plaque psoriasis at all; rather, they teach treating “psoriasis.”  AbbVie contended that Sandoz did not establish that a disclosure of “psoriasis” teaches or suggests chronic plaque psoriasis. These arguments are part of a larger argument that AbbVie made regarding Sandoz’s failure to set forth an express construction of the term “moderate to severe chronic plaque psoriasis.”  However, the PTAB was once again not persuaded by this argument, and pointed out that Sandoz’s experts offered uncontested testimony that the term “psoriasis” is most commonly associated with chronic plaque psoriasis. Regardless, the PTAB pointed out that another reference that is common to both Grounds does teach treating chronic plaque psoriasis.

With respect to the claimed dosage regimen, Sandoz argued that numerous prior art references demonstrate the same dosage of a TNF-α inhibitor was successful in treating both rheumatoid arthritis and psoriasis. Thus, Sandoz alleged that the prior art disclosure of dosing adalimumab at 40 mg every other week to successfully treat rheumatoid arthritis would have provided a person of ordinary skill a reasonable expectation of success in using the same dosage to treat psoriasis. AbbVie responded by arguing that Sandoz’s cited prior art references used higher doses than those approved for rheumatoid arthritis to treat chronic plaque psoriasis. Thus, AbbVie contended that the prior art would have led a person of ordinary skill to use a higher dosage of adalimumab than what is claimed.  The PTAB disagreed, and pointed out that AbbVie assumed the FDA approved dosage is the only dosage relevant to the obviousness inquiry. The PTAB also found that Sandoz had submitted sufficient evidence showing that the same dose of adalimumab would have been effective to treat both rheumatoid arthritis and chronic plaque psoriasis.

With respect to the dependent claims, AbbVie contested only Sandoz’s allegations that the claimed efficacy requirements are the inherent result of administering the treatment.  The PTAB noted that AbbVie’s contentions implicate a claim interpretation for the clinical endpoints that neither party addressed in its papers to date. Consequently, the PTAB determined the best course was to institute and let the parties resolve the dispute during trial.

We will continue to keep you updated on future developments.