Source: https://www.patentdocs.org/2016/12/index.html
Timestamp: 2019-04-18 10:37:52+00:00

Document:
In an order issued last week, Judge Vince Chhabria of the U.S. District Court for the Northern District of California denied a motion to stay filed by Defendant Shortbus Flashers, LLC. Shortbus Flashers sought the stay because it had filed a request for an ex parte reexamination of the patent being asserted in the litigation by Plaintiff Pro-Troll, Inc. While the District Court noted that the decision whether to stay the case during the ex parte reexamination was discretionary, the Court also noted that factors to be considered in deciding whether to stay a case for patent reexamination or review include: whether discovery is complete and a trial date has been set, whether a stay will simplify the issues in the case, and whether a stay would unduly prejudice or present a clear tactical disadvantage to the nonmoving party.
In the instant case, the District Court noted that Shortbus Flashers had the choice of requesting ex parte reexamination or petitioning for inter partes review and that the Defendant's choice of patent review was relevant to the Court's decision to deny the motion to stay. In particular, the Court indicated that "[t]he choice of ex parte reexamination was strategically advantageous to Shortbus Flashers because the result of the reexamination will have no estoppel effect on Shortbus Flashers's arguments here," explaining that "even if the PTO decided not to invalidate the patent after reexamination, Shortbus Flashers could continue to press an invalidity argument here." The District Court also noted that "the ex parte reexamination process is much less likely to advance the ball in this case," and would prevent Pro-Troll, which the Court pointed out was Shortbus Flashers' direct competitor, from asserting its patent rights in court "for as long as two years," "with Shortbus Flashers having effectively pressed the pause button on the litigation while hardly needing to lift a finger."
In a footnote, the District Court hinted that the result may have been different had Shortbus Flashers argued that it had chosen ex parte reexamination over inter partes review because of limited resources (especially given its participation in the ongoing district court litigation), and that those limited resources justified the stay of the litigation pending the results of the reexamination. However, the Court stated that "Shortbus Flashers did not argue that here; indeed, it indicated at oral argument that it isn't an issue in this case."
In a notice published in the Federal Register last week (81 Fed. Reg. 93669), the U.S. Patent and Trademark Office announced that the Extended Missing Parts Pilot Program that was implemented on January 8, 2010 would be extended for another year. The pilot program allows applicants to request a twelve-month extension to pay the search fee, examination fee, any excess claim fees, and surcharge for late submission of the search and examination fees in a nonprovisional application. The notice indicates that the pilot program benefits applicants by providing additional time to determine if patent protection should be sought and focus on commercialization efforts, benefits the public by adding publications to the prior art, and benefits the Office by removing nonprovisional applications that applicants decline to pursue from its workload. In last week's notice, the Office noted that while it "has not yet completed its evaluation of the program, the number of participants in the program over the past several years indicates that there may be sufficient benefits to the patent community." The pilot program has been extended through January 2, 2018.
The Office implemented the Extended Missing Parts Pilot Program six years ago, noting that it would "effectively provide a 12-month extension to the existing 12-month provisional application period, providing applicants additional time to find financial help, evaluate a product's worth in the marketplace or further develop the invention for commercialization" (see "USPTO Implements Pilot Program Extending Provisional Application Period"). The Office initially sought comments regarding the program in April 2010 (see "USPTO Seeks to Effectively Double Provisional Application Period"). Under the pilot program as originally implemented, the Office modified its missing parts practice -- which at the time permitted an applicant to pay the filing fees and submit an executed oath or declaration after the filing of a nonprovisional application within a two-month time period that is extendable for an additional five months on payment of extension of time fees -- such that applicants would file a nonprovisional application with at least one claim within the 12-month statutory period after the provisional application was filed (as well as pay the basic filing fee, submit an executed oath or declaration, and not file a nonpublication request) and then be given a 12-month period within which to decide whether the nonprovisional application should be completed by paying the required surcharge and the search, examination, and any excess claim fees.
(4) the applicant must not have filed a nonpublication request.
[C]autions all applicants that, in order to claim the benefit of a prior provisional application, the statute requires a nonprovisional application filed under 35 U.S.C. 111(a) to be filed within twelve months after the date on which the corresponding provisional application was filed. See 35 U.S.C. 119(e). It is essential that applicants understand that the Extended Missing Parts Pilot Program cannot and does not change this statutory requirement.
[I]f a nonprovisional application is filed outside the 12 month period from the date on which the corresponding provisional application was filed, the nonprovisional application is not eligible for participation in the Extended Missing Parts Pilot Program, even though the applicant may be able to restore the benefit of the provisional application by submitting a petition under 37 CFR 1.78(b).
The latest notice regarding the pilot program also notes that while "an application (other than an application for a design patent) filed on or after December 18, 2013, is not required to include a claim to be entitled to a filing date," under the PLT and PLTIA, and the Office of Patent Application Processing will issue a notice giving the applicant a two-month, extendable time period within which to submit at least one claim in order to avoid abandonment of the application, "[t]he Extended Missing Parts Pilot Program does not change this time period."
In addition, under the pilot program, nonprovisional applications are still published according to the existing eighteen-month publication provisions. As a result, applications participating in the pilot program still must be in condition for publication. The notice indicates in order for a nonprovisional application to be in condition for publication, Applicants must have submitted the following: (1) the basic filing fee; (2) the executed inventor's oath or declaration in compliance with 37 CFR 1.63 or an application data sheet containing the information specified in 37 CFR 1.63(b); (3) a specification in compliance with 37 CFR 1.52; (4) an abstract in compliance with 37 CFR 1.72(b); (5) drawings in compliance with 37 CFR 1.84 (if applicable); (6) any application size fee required under 37 CFR 1.16(s); (7) any English translation required by 37 CFR 1.52(d); and (8) a sequence listing in compliance with 37 CFR 1.821–1.825 (if applicable). Applicants must satisfy any compact disc requirements and provide an English translation of any provisional application that was filed in a non-English language.
[T]he extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property (Paris Convention). Accordingly, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.
In the Office's most recent notice regarding the pilot program, the Office reiterates that applications that are not filed electronically will still be assessed a $400 additional fee (or $200 for small entities) pursuant to the AIA, that this fee will be due within the two-month (extendable) time period to reply to the Notice to File Missing Parts of Nonprovisional Application, and that applicants will not be given the 12-month time period under the pilot program to pay this fee.
Petitioners, KAYAK Software Corp., OpenTable, Inc., Priceline.com LLC, and The Priceline Group Inc. filed a Petition requesting a covered business method (CBM) patent review of claims 1–9 and 12–17 of U.S. Patent No. 5,796,967. International Business Machines Corp. (IBM), the Patent Owner, filed a Preliminary Response. The Board issued a decision denying institution of the CBM patent review of any of the challenged claims because the Petitioner had not established that the challenged patent qualifies as a CBM patent. This decision comes after the Federal Circuit's recent decision in Unwired Planet v. Google Inc., in which the Federal Circuit criticized the PTAB for allowing broad interpretation of the AIA statute. The Board here followed the Federal Circuit's instructions for a strict application of the statute with respect to what patents qualify for CBM patent review.
The '967 patent relates to a method for presenting applications in an interactive service featuring steps for generating screen displays of the service applications at the reception systems of the respective users. This method of presentation involves storing and processing applications or parts of applications at a user's local personal computer rather than at a remote server. This helps avoid possible server bandwidth issues that can be caused by the server being required to serve too much data to multiple users simultaneously. The '967 patent lists many applications that can take advantage of this method of presentation, including games, news, weather, movie reviews, banking, investments, home shopping, messaging, and advertising.
Of the challenged claims, claim 1 is independent and is reproduced below.
c. generating concurrently with the first partition at least a second partition for presenting a plurality of command functions, the command functions including at least a first group which are selectable to permit movement between applications.
Section 18 of the AIA provides for the creation of a transitional program for reviewing covered business method patents. A "[c]overed business method patent" is a patent that "claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions." AIA § 18(d)(1); see 37 C.F.R. § 42.301(a). For purposes of determining whether a patent is eligible for a covered business method patent review, the focus is on the claims.
Petitioner identified three claims (claims 1, 13, and 16) that it contended satisfy the financial-product-or-service requirement on the basis of their claim language.
Patent Owner argued, however, that neither claim 13 nor claim 16 may provide the basis for eligibility for covered business method patent review ("CBM eligibility"), because each of these claims has been disclaimed pursuant to 35 U.S.C. § 253(a) and 37 C.F.R. § 1.321(a).
A patent subject to a disclaimer under § 253(a) is treated as though the disclaimed claims never existed. Accordingly, even though claims 13 and 16 of the '967 patent existed at the time the Petition here was filed, we must now treat the '967 patent as if it had never included those claims. Under this legal rubric, claims 13 and 16 cannot provide the basis for the '967 patent's CBM eligibility.
With respect to the claims of the '967 patent left after Patent Owner's statutory disclaimer, Petitioner presented CBM eligibility arguments only as to claim 1. Specifically, Petitioner argued that, because claim 1 recites a "method for presenting interactive applications" and "generating at least a first partition for presenting applications," and because those applications may be financial in nature, claim 1 is financial in nature.
However, the Board noted that it is not enough that a claim of general applicability has some scope that may be described as finance-related. Rather, to find CBM eligibility, the Board should focus on the claim language at issue and determine whether there is anything explicitly or inherently financial in the construed claim language. Under Unwired Planet and Blue Calypso, LLC v. Groupon, Inc., to provide CBM eligibility, a claim must be limited, explicitly or inherently, to "a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service." AIA § 18(d)(1). The fact that a claim is broad enough to encompass a finance-related activity does not necessarily mean that the claim, as a whole, is limited to that finance-related activity.
The Board noted that the Example depicted in Figure 3b of the patent is financial in nature, since it gives the user the option to purchase apples and that it is described as presenting advertising to the user. But the presence of a financial application in the specification of the '967 patent does not limit the claims of the '967 patent to financial applications. As noted above, the Board must examine the language of the claims, not merely the specification, for any explicit or inherent limitation to finance-related activity.
Claim 1 contains limitations that recite "[a] method for presenting interactive applications" and "generating at least a first partition for presenting applications." As demonstrated by the application depicted in Figure 3b of the '967 patent and discussed above, the "applications" in question may be financial. But the question that Blue Calypso requires the Board to answer is not whether the applications may be financial, but rather whether they must be financial.
Here, the record demonstrates that the "applications" recited in claim 1 may be non-financial. First, the specification of the '967 patent describes several non-financial applications in addition to the financial application depicted in Figure 3b. These other applications include the display of information such as "movie reviews" and "the latest news." Other types of information that can be displayed by applications include "hobbies and cultural interests," as well as "weather".
In addition, the applications that claim 1 recites displaying are not limited to those that have financial purposes or operate in a financial context. As noted, "provid[ing] requested information" can constitute providing information about news, weather, movie reviews, and hobbies and cultural interests, none of which has been shown by Petitioner to be either explicitly or inherently financial. Given the failure of Petitioner to establish that any claim of the '967 patent is explicitly or inherently limited to financial contexts, the Board concluded that the claims of the '967 patent are claims of general utility.
The Board noted that several earlier non-binding Board decisions have determined that a patent is not CBM eligible when it has only claims of general utility with no explicit or inherent finance-related terminology or limitations.
Thus, claims of general utility are not converted into finance-related claims merely because the specification of the challenged patent suggests that the scope of the claims is broad enough to encompass some finance-related activities.
Here, other than the disclaimed claims discussed above, Petitioner has not alleged that any claim of the '967 patent is anything other than a claim of general utility, so the mere fact that the specification contains some discussion of financial activities is of little moment.
The Board noted that if the specification were to make clear that the claims should be interpreted as limited to finance-related contexts, the presence of general-utility claim language would not preclude a finding of CBM eligibility. Because the claims are of general utility with no explicit or inherent finance-related terminology or limitations, the Board concluded that Petitioner has not established that the '967 patent is a covered business method patent under AIA § 18(d)(1).
Earlier this month, in Garfum.com Corp. v. Reflections by Ruth d/b/a Bytephoto.com, Chief Judge Jerome B. Simandle of the U.S. District Court for the District of New Jersey issued an opinion granting Plaintiff Garfum.com Corporation's motion for reconsideration of the Court's earlier finding that the case was exceptional under 35 U.S.C. § 285, and determined that no award of attorneys' fees and costs would be made to Defendant Reflections by Ruth d/b/a Bytephoto.com. In its motion for reconsideration, Garfum.com had requested that the Court reconsider its finding of exceptionality in light of new evidence and new caselaw regarding 35 U.S.C. § 101.
After Garfum.com filed suit against the Defendant, Bytephoto.com responded by filing a motion to dismiss Garfum.com's infringement action, on the grounds that Garfum.com's patent was directed to unpatentable subject matter under 35 U.S.C. § 101. Garfum.com then executed a covenant not to sue, and filed a motion to voluntarily dismiss the complaint and counterclaims, which the District Court granted. Bytephoto.com countered with a motion for attorneys' fees under 35 U.S.C. § 285, asserting that Garfum.com's arguments against its motion to dismiss were meritless under § 101 and contrary to the text of the asserted patent, and that Garfum.com's litigation conduct was unreasonable. The Court granted Bytephoto.com's motion for attorneys' fees, finding that Garfum.com's case "did not have substantive strength since it 'should have been obvious' that its claims did not have an inventive concept in a post-Alice environment under 35 U.S.C. § 101," and that Garfum.com "'propound[ed] unreasonable [litigation] positions in support of validity under § 101, and then dismiss[ed] the case to avoid a decision on the merits.'" In finding the case to be exceptional, the District Court rejected Garfum.com's argument that the U.S. Patent and Trademark's allowance of a continuation application of the asserted patent demonstrated that its case had substantive strength and was litigated reasonably, stating that the allowance of the continuation application could not "provide cover" for Garfum.com's litigation positions "without any mention of 35 U.S.C. ¶ 101 in the notice of allowance."
Following the parties' briefing on Bytephoto.com's motion for attorneys' fees, Garfum.com filed a second Request for Continued Examination and an Information Disclosure Statement in the continuation application, citing all of the § 101 briefings from the instant case. The USPTO issued a third Notice of Allowance less than two weeks before the District Court issued its opinion granting Bytephoto.com's motion for attorneys' fees.
In granting Garfum.com's motion for reconsideration, the District Court noted that Garfum.com's motion was "not a mere disagreement with the Court's initial decision, but a good faith effort to present evidence to the Court that was either not previously available or overlooked at the time of the March 2016 Opinion." The Court explained that it had "overlooked the substantive strength of Plaintiff's litigation position because of the uncertainty of the state of the law regarding 35 U.S.C. § 101." The Court agreed with Garfum.com's argument that the USPTO's allowance of the continuation application of the asserted patent, which contained "nearly identical claims," countered the Court's prior finding that it "should have been obvious" to Garfum.com that there was no inventive concept in the asserted claims.
The Court also noted that Garfum.com had submitted several persuasive intervening cases in support of its motion for reconsideration, including YYZ, LLC v. Pegasystems, Inc., No. 13-581, 2016 WL 1761955, at *1 (D. Del. May 2, 2016) (stating that "the § 101 analysis is an evolving state of the law and a difficult exercise, which does not lend itself to, e.g., shifting fees pursuant to 35 U.S.C. § 285"); Papst Licensing Gmbh & Co. KG v. Xilinx Inc., No. 16-925, 2016 WL 4398376, at *2-*4 (N.D. Cal. Aug. 18, 2016); Device Enhancement LLC. v. Amazon.com., Inc., No. 15-762, 2016 WL 2899246, at *7 (D. Del. May 17, 2016); Clarilogic, Inc. v. FormFree Holdings Corp., No. 15-41 (S.D. Cal. Apr. 27, 2016); Credit Card Fraud Control Corp. v. Maxmind, Inc., No. 14-3262, 2016 WL 3355163 at *2 (N.D. Tex. Apr. 7, 2016); and EON Corp. IP Holdings, LLC v. FLO TV Inc., No. 10-812, 2014 WL 2196418, at *2 (D. Del. May 27, 2014). The District Court also noted that since issuing an opinion in DDR Holdings, LLC v. Hotels.com, the Federal Circuit had "opined in three additional instances on § 101 since briefing was completed in this case, furthering the uncertainty in this area of jurisprudence." The three cases referred to by the District Court are Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016), BASCOM Global Internet Services v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016), and McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed Cir. 2016).
In looking at the district court decisions cited by Garfum.com and the additional Federal Circuit decisions, the District Court noted that "while this Court had stated that it should have been obvious to Plaintiff that it did not have a § 101 case in a post-Alice environment, the law has since sufficiently evolved so that Plaintiff may have had an arguable or plausible inventive concept under § 101." The District Court also indicated that "[a]fter a thorough review and upon further reflection, the Court concludes that Plaintiff's conduct in this case was not unreasonable -- this is not one of the rare patent cases in which attorneys' fees are warranted by the manner of litigation." The Court concluded that "under the totality of the circumstances, Plaintiff's case was not 'exceptional' under § 285," adding that "[i]n light of the unsettled legal landscape regarding patentability under § 101 after Alice, coupled with the PTO's allowance of nearly identical claims, '[t]his is one of the rare instances where reconsideration is appropriate.'"
• A Closer Look at the "Patent Dance"
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• Will the Cuozzo decision in an IPR context be extended to PGR and CBM AIA reviews?
• How will the district courts apply the new standard for enhanced damages?
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About the PTAB Life Sciences Report: Each month (or more frequently) we will report on developments at the PTAB involving life sciences patents.
Merial, Inc. v. Fidopharm, Inc.
PTAB Petition: IPR2016-01182; filed June 10, 2016.
PTAB Trial Instituted Document filed November 7, 2016.
Patent at Issue: U.S. Patent No. 8,829,038 ("Parasiticidal formulation," issued September 9, 2014) claims a parasiticidal formulation comprising: Fipronil, or a veterinarily acceptable derivative thereof; at least one C1-C6 alcohol co-solvent, wherein the total amount of C1-C6 alcohol is up to 8% by weight of the formulation; at least one organic solvent which is not the C1-C6 alcohol co-solvent; and at least one crystallization inhibitor, wherein the total amount of crystallization inhibitor is from 2 to 20% by weight of the formulation.
Petitioner Merial, Inc. is challenging the '038 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 3, and 6) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 4, and 5). View the petition here. Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Robert A. Pollock (author) issued a decision instituting inter partes review of claims 1-3 and 7-21 of the '038 patent under 35 U.S.C. § 103(a) as being obvious over Etchegaray (Ground 4a) and as being obvious over Frontline Top Spot references (Ground 4b); claims 4-6 of the '038 patent under 35 U.S.C. § 103(a) as being obvious over Etchegaray in view of Maddison, Jeannin, or Young (Ground 5); and claims 1-3, 9, and 18-19 of the '038 patent under 35 U.S.C. § 102(b) as being anticipated by Pan (Ground 6). Grounds 1-3 were all denied institution.
Related Matters: According to the petition, the '038 patent is not involved in any related matters.
Mylan Pharmaceuticals, Inc. v. Shire Laboratories, Inc.
PTAB Petition: IPR2016-01033; filed May 12, 2016.
PTAB Trial Instituted Document filed November 17, 2016.
Patent at Issue: U.S. Patent No. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) claims a pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising: (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes.
Petitioner Mylan Pharmaceuticals, Inc. is challenging the '096 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Toni R. Scheiner (author), Lora M. Green, and Sheridan K. Snedden issued a decision instituting inter partes review of claims 18–25 of the '096 patent under 35 U.S.C. § 103 as being obvious in view of Mehta, PDR 1997, Brown, and Amidon.
Related Matters: According to the petition, the '096 patent is currently (or was) the subject, as the parent patent or current reissue form, of the following litigations: Shire LLC v. Amerigen Pharms. Ltd., 14-cv-6095 (D.N.J); Shire LLC v. Corepharma, LLC, 14-05694 (D.N.J); Shire LLC v. Par Pharm., Inc., 15-cv-01454 (D.N.J); Shire Labs., Inc. v. Impax Labs, Inc., 03-cv-1164 (D. Del.); Shire LLC v. Sandoz, Inc., 07-cv- 197 (D. Colo.); Shire Labs., Inc. v. Barr Labs., Inc., 03-cv-1219,-6632 (SDNY); Shire LLC v. Watson Pharms., Inc., 11-cv-2340 (SDNY); Shire LLC v. Neos Therapeutics, Inc., 13-cv-1452 (N.D. Tx.); Shire LLC v. Colony, Pharms. Inc., 1:07-cv-00718 (D. Md.); Shire Labs., Inc. v. Andrx Pharms. LLC, 07-cv-22201 (S.D. Fla.); and Shire Llc v. Abhai LLC, 15-cv-13909 (D. Mass.). Also, the '096 patent is currently the subject of Inter Partes Review IPR2015-02009 (Amerigen Pharms. Ltd. v. Shire LLC; Petitioner Amerigen Pharmaceuticals; filed 10/01/2015; instituted 04/18/2016).
Alkermes Pharma Ireland Ltd. and Alkermes, Inc. v. Otsuka Pharmaceutical Co., Ltd.
PTAB Petition: IPR2017-00287; filed November 17, 2016.
Patent at Issue: U.S. Patent No. 9,125,939 ("Carbostyril derivatives and mood stabilizers for treating mood disorders," issued August 2, 2006) claims a method of treating bipolar disorder in a patient partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt thereof monotherapy comprising: administering an amount of a composition comprising aripiprazole, and lithium or a salt thereof in a pharmaceutically acceptable carrier, wherein the amount of lithium is about 0.01 to 500 parts by weight and the amount of aripiprazole is about 1 part by weight, wherein the bipolar disorder is chosen from bipolar disorder I, bipolar disorder II, bipolar disorder with or without psychotic features, mania, acute mania, bipolar depression, and mixed episodes.
Petitioners Alkermes Pharma Ireland Ltd. and Alkermes, Inc. are challenging the '939 patent on six grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '939 patent is not the subject of any pending litigations or post-grant reviews. However, the '939 patent was the subject of a litigation in the District of New Jersey captioned Otsuka Pharmaceutical Co., LTD. v. Stason Industrial Corp., et al., No. 1:16-cv-00557-JBS-KMW.
PTAB Petition: IPR2016-01337; filed June 30, 2016.
PTAB Petition: IPR2016-01335; filed June 30, 2016.
PTAB Petition: IPR2016-01393; filed July 8, 2016.
PTAB Trial Instituted Document filed November 18, 2016 (IPR2016-01337 and IPR2016-01335).
PTAB Trial Instituted Document filed November 21, 2016 (IPR2016-01393).
Patent at Issue: U.S. Patent No. 7,772,209 ("Antifolate combination therapies," issued August 10, 2010) claims a method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.
Petitioner Wockhardt Bio AG is challenging the '209 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition for IPR2016-01335 here, the petition for IPR2016-01337 here, and the petition for IPR2016-01393 here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued decisions (IPR2016-01337, IPR2016-01335, and IPR2016-01393) instituting inter partes review of claims 1–22 of the '209 patent under 35 U.S.C. § 103 as being obvious in view of Rusthoven, EP 0,595,005 A1, and the knowledge of one of ordinary skill in the art. The Panel also granted Petitioner's Motion for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22–42.122(b), joining the instant proceeding with IPR2016-00240, and terminating the instant proceeding under 37 C.F.R. § 42.72.
Related Matters: According to the petition, the '209 Patent has been the subject of the following lawsuits in the Southern District of Indiana: Eli Lilly and Company v. Biocon Ltd., 1:16-cv-00469; Eli Lilly and Company v. Dr. Reddy's Laboratories, Ltd. et al., 1:16-cv-00308; Eli Lilly and Company v. Fresenius Kabi USA, LLC, 1:15-cv-00096; Eli Lilly and Company v. Sandoz Inc., 1:14-cv-02008; Eli Lilly and Company et al. v. Nang Kuang Pharm. Co., Ltd. et al., 1:14-cv- 01647; Eli Lilly and Company v. Glenmark Pharm. Ltd. et al., 1:14-cv-00104; Eli Lilly and Company v. Sun Pharm. Global FZE et al., 1:13-cv-01469; Eli Lilly and Company v. Accord Healthcare, Inc., USA, 1:13-cv- 00335; Eli Lilly and Company v. Apotex, Inc. et al., 1:12-cv-00499; Eli Lilly and Company v. Accord Healthcare, Inc., USA, 1:12-cv-00086; Eli Lilly and Company v. App Pharm., LLC, 1:11-cv-00942; and Eli Lilly and Company v. Teva Parental Medicines, Inc., et al., 1:10-cv-01376. Also, the '209 patent is involved in IPR2013-00356 (Petitioner, Accord Healthcare, Inc.; filed 06/14/2013; denied institution 10/01/2013); IPR2016-00318 (Petitioner, Sandoz Inc.; filed Dec. 14, 2015; instituted 06/16/2016); IPR2016-00237 (Petitioner Neptune Generics, LLC; filed Nov. 24, 2015; instituted 06/03/2016); and IPR2016-00240 (Petitioner Neptune Generics, LLC; filed Nov. 24, 2015; instituted 06/03/2016).
OmniActive Health Technologies, Inc. v. Kemin Industries, Inc.
PTAB Petition: IPR2017-00305; filed November 21, 2016.
Patent at Issue: U.S. Patent No. 8,815,955 ("Method of treating ocular disorders," issued August 26, 2014) claims a method of treating the increased age-related macular degeneration present in a subject having age-related macular degeneration and either hyperopia or astigmatism, relative to the age-related macular degeneration present in a subject having age-related macular degeneration but neither hyperopia nor astigmatism, comprising administering to the subject having the macular degeneration and either the hyperopia or astigmatism a composition comprising a therapeutically effective amount of one or more ocular antioxidants.
Petitioner OmniActive Health Technologies, Inc. is challenging the '995 patent on three grounds as being obviousness under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '955 patent is the subject of a complaint under 19 U.S.C. § 1337 against Petitioner in the International Trade Commission (ITC), captioned Certain Food Supplements and Vitamins, Including Ocular Antioxidants and Components Thereof and Products Containing the Same, Inv. No. 337-TA-3177. Also, the '955 patent is the subject of a litigation in the District of New Jersey captioned OmniActive Health Technologies, Inc. v. Kemin Industries, Inc., No. 1:16-cv-4988.
Mylan Pharmaceuticals Inc. v. ICOS Corp.
PTAB Petition: IPR2017-00323; filed November 22, 2016.
Patent at Issue: U.S. Patent No. 6,943,166 ("Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction," issued September 13, 2005) claims method of treating sexual dysfunction in a patient in need thereof comprising orally administering one or more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, of a compound.
Petitioner Mylan Pharmaceuticals Inc. is challenging the '166 patent on one ground as being obviousness under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '166 patent is the subject of several litigations in the Eastern District of Virginia: Eli Lilly and Company et al v. Mylan Pharmaceuticals Inc., No. 1:16-cv-01122; Eli Lilly & Co. et al. v. Alembic Pharmaceuticals Ltd. et al., No. 16-cv-01120; Eli Lilly & Co. et al. v. Zydus Pharmaceuticals, No. 16-cv-01170; Eli Lilly & Co. et al. v. Teva Pharmaceuticals USA Inc., No. 16-cv-01169; Eli Lilly & Co. et al. v. Aurobindo Pharma Ltd. et al., No. 16-cv-01121; Eli Lilly & Co. et al. v. Sun Pharmaceutical Indus., Ltd. et al., No. 16-cv-01168; Eli Lilly & Co. et al. v. Actavis Labs. UT, Inc., No. 16-cv-01119; Eli Lilly & Co. et al. v. Cipla USA, Inc., No. 16-cv-01208; Eli Lilly & Co. et al. v. Accord Healthcare, Inc., No. 16-cv-01352. Also, the '166 patent was involved in IPR2016-00678 (IntelGenX Corp.; filed 02/26/2016; denied 09/01/2016).
PTAB Petition: IPR2017-00046; filed October 7, 2016.
Patent at Issue: U.S. Patent No. 6,685,730 ("Optically-absorbing nanoparticles for enhanced tissue repair," issued February 3, 2004) claims methods involving localized induction of hyperthermia in tissue or materials by delivering nanoparticles to the tissue or materials and exposing the nanoparticles to an excitation source under conditions wherein they emit heat and the use thereof for the repair of tissue.
Petitioner Sienna Biopharmaceuticals, Inc. is challenging the '730 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 2, and 3) or obviousness under 35 U.S.C. § 103(a) (grounds 4, 5, and 6). View the petition here.
Related Matters: According to the petition, the '730 patent is not involved in any litigation or administrative proceeding.
PTAB Petition: IPR2017-00047; filed October 11, 2016.
Patent at Issue: U.S. Patent No. 6,331,415 ("Methods of producing immunoglobulins, vectors and transformed host cells for use therein," issued December 18, 2001) claims a process for producing an immunoglobulin or an immunologically functional immunoglobulin fragment containing at least the variable domains of the immunoglobulin heavy and light chains. The processes can use one or more vectors which produce both the heavy and light chains or fragments thereof in a single cell.
Petitioner Merck Sharp & Dohme Corp. is challenging the '415 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '415 patent is involved IPR2015-01624 (Sanofi-Aventis US LLC v. Genentech, Inc. and City of Hope; Petitioners Sanofi-Aventis US LLC; filed on 07/27/2015; instituted on 02/05/2016; and terminated 09/02/2016 through settlement). The petition also indicates that the '415 patent is involved in IPR2016-00383 (Petitioner Genzyme Corporation; filed on 12/30/2015; Institution denied 06/23/2016); IPR2016-00460 (Petitioner Genzyme Corp.; filed on 01/15/2016; Instituted 06/08/2016; terminated 09/02/2016); IPR2016-00710 (Petitioner Mylan Pharmaceuticals Inc.; filed on 03/03/2016; Instituted 09/08/2016; pending); and IPR2016-01373 (Petitioner Merck Sharp & Dohme Corp.; filed on 07/07/2016; pending).
Thermo Fisher Scientific Inc. v. Bio-Rad Laboratories, Inc.
PTAB Petition: IPR2017-00054; filed October 14, 2016.
Patent at Issue: U.S. Patent No. 8,236,504 ("Systems and methods for fluorescence detection with a movable detection module," issued August 7, 2012) claims a fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler and methods of use are provided. In one embodiment, the apparatus includes a support structure attachable to the thermal cycler and a detection module movably mountable on the support structure.
Petitioner Thermo Fisher Scientific Inc. is challenging the '504 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, 4, and 5). View the petition here.
Related Matters: According to the petition, the '504 patent is involved in litigation in the District of Delaware, captioned Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc., C.A. No. 16-358.
PTAB Petition: IPR2017-00055; filed October 14, 2016.
Petitioner Thermo Fisher Scientific Inc. is challenging the '504 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
OSI Pharmaceuticals, LLC. and Genentech, Inc. v. Arch Development Corp. and Dana-Farber Cancer Institute, Inc.
PTAB Petition: IPR2016-01034; filed May 13, 2016.
PTAB Trial Instituted Document filed October 18, 2016.
Patent at Issue: U.S. Patent No. 7,838,512 ("DNA damaging agents in combination with tyrosine kinase inhibitors," issued November 23, 2010) claims a method of improving chemotherapeutic intervention in a patient comprising: (a) administering a DNA damaging agent to the patient; (b) administering a therapeutically effective amount of a low molecular weight tyrosine kinase inhibitor to the patient, wherein the low molecular weight inhibitor binds intracellularly to inhibit the activity of more than one tyrosine kinase protein, and wherein the agent and the inhibitor act in combination by effecting a series of intracellular events to enhance cell death, thereby improving chemotherapeutic intervention.
Petitioners OSI Pharmaceuticals, LLC. and Genentech, Inc are challenging the '512 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Robert A. Pollock (author), issued a decision instituting review of claims 1–3, 5, and 6 of the '512 patent under 35 U.S.C. § 103(b) as being obvious over the combination of Honma, the knowledge of a person of ordinary skill in the art, Honma 1992, and McGahon; and claims 1–3, 5, and 6 of the '512 patent under 35 U.S.C. § 103(b) as being obvious over the combination of Akinaga, the knowledge of a person of ordinary skill in the art, Seynaeve, Tam, and Friedman.
Related Matters: According to the petition, the '512 patent is the subject of litigation in the Northern District of Illinois captioned Arch Development Corp. et al. v. Genentech, Inc. et al., No. 1:15-cv-6597.
PTAB Petition: IPR2017-00109; filed October 19, 2016.
Patent at Issue: U.S. Patent No. RE45,725 ("Method and apparatus for spin-echo-train MR imaging using prescribed signal evolutions," issued October 6, 2015) claims a magnetic resonance imaging "MRI" method and apparatus for lengthening the usable echo-train duration and reducing the power deposition for imaging.
Petitioner General Electric Co. is challenging the '725 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, and 4). View the petition here.
Related Matters: According to the petition, the '725 patent is involved in litigation in the Western District of Virginia, captioned UVAPF v. General Electric Co., No. 3:14-cv-00051-nkm. The petition also indicates that the '725 patent is a continuation of U.S. Patent No. RE44,644 which is involved in IPR2016-00357 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/22/2016); IPR2016-00358 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/23/2016); and IPR2016-00359 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/24/2016).
PTAB Petition: IPR2017-00115; filed October 20, 2016.
Patent at Issue: U.S. Patent No. 9,216,025 ("Joint arthroplasty devices and surgical tools," issued December 22, 2015) claims a surgical system including an articular repair system and a patient-specific surgical tool for use in surgically repairing a joint of a patient.
Petitioner Smith & Nephew, Inc. is challenging the '025 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '025 patent is involved in litigation in the District of Massachusetts, captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT.
PTAB Petition: IPR2016-01117; filed June 2, 2016.
PTAB Trial Instituted Document filed October 21, 2016.
Patent at Issue: U.S. Patent No. RE44,186 ("Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method," issued April 30, 2013) claims compounds said to inhibit the enzyme dipeptidyl peptidase IV.
Petitioner Aurobindo Pharma USA, Inc. is challenging the '186 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Rama G. Elluru (author), and Christopher G. Paulraj issued a decision instituting review of claims 1, 2, 4, 6–11, 25–28, 32–35, and 40 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag and Hanessian; claims 12-16, 29, 30, 36, 37, 41 and 42 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the GLUCOPHAGE Label; claims 12, 17, 18 and 22 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the XENICAL Label; and claims 12 and 19-21 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the MEVACOR Label. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC , Mylan Pharms., Inc.; filed 06/04/2015; instituted 05/02/2016), adding Aurobindo as a petitioner to IPR2015-01340 and terminating IPR2016-01117 under 37 C.F.R. § 42.72.
Related Matters: According to the petition, the '186 patent is the subject of several litigations, including AstraZeneca AB v. Mylan Pharmaceuticals Inc., 14- cv-00696 (D. Del. 2014); AstraZeneca AB v. Mylan Pharms. Inc., 14-cv-00094 (D.W. Va. 2014); AstraZeneca AB v. Aurobindo Pharma Ltd. et al., 14-cv-014696 and 14-cv-00664 (D. Del. 2014); AstraZeneca AB v. Actavis Labs. FL, Inc., 14-cv-01356 (D. Del. 2014); AstraZeneca AB v. Watson Labs. Inc., 14-cv-01051 (D. Del. 2014); AstraZeneca AB v. Sun Pharma Global FZE et al., 14-cv-00694 (D. Del. 2014); AstraZeneca AB v. Amneal Pharms. LLC., 14-cv-00697 (D. Del. 2014); and AstraZeneca AB v. Wockhardt Bio AG et al., 14-cv-00696 (D. Del. 2014). The '186 patent also has been challenged in the following instituted inter partes reviews IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC, Mylan Pharms., Inc.; filed 06/04/2015; Instituted 05/02/2016); IPR2016-01122 (Teva Pharmaceuticals USA, Inc. v. AstraZeneca AB, LLC, Teva Pharms., Inc. filed 06/01/2016; joined to IPR2016-01122 09/23/2016); and IPR2016-01209 (Wockhardt BIO AG v. AstraZeneca AB, LLC, Wockhardt BIO AG, filed 05/11/2016; joined to IPR2016-01122 08/23/2016).
Alembic Pharmaceuticals, Ltd. v. Research Corp. Technologies, Inc.
PTAB Petition: IPR2016-01101; filed May 25, 2016.
PTAB Petition: IPR2016-01242; filed June 21, 2016.
PTAB Petition: IPR2016-01245; filed June 22, 2016.
PTAB Trial Instituted Document filed October 24, 2016.
Patent at Issue: U.S. Patent No. RE38,551 ("Anticonvulsant enantiomeric amino acid derivatives," issued July 6, 2004) claims compounds in the R configuration about the asymmetric carbon and pharmaceutical compositions containing same and the use of such compounds in treating CNS disorders in animals.
Petitioners, Mylan Pharmaceuticals (IPR2016-01101), Breckenridge Pharmaceutical, Inc. (IPR2016-01242), and Alembic Pharmaceuticals, Ltd. (IPR2016-01245), are challenging the '551 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, and 4). View the petition for IPR2016-0110 here, the petition for IPR2016-01242 here, and the petition for IPR2016-01245 here. Administrative Patent Judges Francisco C. Prats, Jacqueline Wright Bonilla (author), and Christopher G. Paulraj issued a decision instituting review of claims 1-9 as being obvious under 35 U.S.C. § 103(a) over Kohn 1991 and Silverman; and claims 10-13 as obvious under 35 U.S.C. § 103(a) over Kohn 1991, Silverman, and the '729 patent. The panel also grants Petitioners' Motions under 37 C.F.R. § 42.122 for Joinder to IPR2016-00204 (Argentum Pharmaceuticals LLC. v. Research Corporation Technologies, Inc., Argentum Pharmaceuticals, LLC; filed 06/04/2015; instituted 05/02/2016), adding Mylan, Breckenridge, and Alembic as petitioners to IPR2015-01340 and terminating IPR2016-01101, IPR2016-01242, and IPR2016-01245 under 37 C.F.R. § 42.72.
Related Matters: According to the petitions, the '551 patent is the subject of several litigations, most of which have been consolidated with UCB, Inc. v. Accord Healthcare Inc., 1:13-cv-01206 (D. Del. Jul. 10, 2013). IPR2014-01126 (Petitioner Actavis, Inc.; filed 07/10/2014; denied 01/09/2015) is also identified as a related matter where a panel previously denied inter partes review challenging the same claims (1-13) of the '551 patent.
The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions. However, some commentators have suggested that antibodies are regarded as a special case by the EPO when evaluating inventive step / obviousness. It is implied that the EPO sets a higher patentability threshold for inventions in this field as compared to, for example, small molecule therapeutics.
This perception likely reflects no more than the crowded nature of the antibody field, which has matured rapidly in recent years. As a result, EPO Examiners are able to make a large (and increasing) number of assumptions regarding the background knowledge of the skilled person. For example, in the absence of evidence to the contrary, the EPO considers it to be routine to raise an antibody to a known target. The EPO also considers it to be routine to optimise certain characteristics of an antibody, such as affinity or immunogenicity.
Although it is not unique to the field, the approach of the EPO can present significant challenges to applicants seeking to pursue claims to antibodies, particularly antibodies to known targets. We have set out below our suggestions for how grant of antibody claims at the EPO might nonetheless be achieved in different factual scenarios. We have also set out the types of supporting evidence that may be required in each case. Figure 1 provided at the end of this briefing summarises the suggestions in the form of a decision tree, which may help to guide you to the most appropriate strategy at different stages in an antibody development project.
"An antibody which specifically binds to <target>"
"An antibody which specifically binds to <target> for use in a method of treating <new disease or condition>".
These two basic scenarios are discussed in more detail below.
The extensive mapping of genomes and proteomes means that truly "new" targets are increasingly rare. However, an applicant who identifies, for example, a new polypeptide (potentially including new mutant forms of a known polypeptide) can expect to obtain broad claims to any antibody that specifically binds to the new polypeptide. It is not typically necessary to provide evidence that an antibody has actually been produced if the target is susceptible to routine methods of antibody production.
An applicant who develops a method allowing an antibody to be raised for a known target which was not susceptible to routine methods can also expect to obtain broad claims. The EPO effectively views such a target as a special category of new target -- it is "newly available" for antibody production. Inventions of this type are though increasingly rare. Methods of antibody production have developed such that few targets are not now susceptible to them, and overcoming technical difficulties is frequently seen as routine. If the EPO can be persuaded otherwise for a particular case, the patent application will need to include clear evidence that an antibody to the target has indeed been raised, as well as sufficient information to allow this to be repeated.
For antibodies to such newly-identified targets or difficult targets, medical use claims may be allowable even without direct evidence of a clinically-relevant functional effect.
Where a known target molecule is found to have a previously unappreciated role in a disease, it may be possible to obtain claims directed to any antibody that specifically binds to the target for use in a particular method of treatment. In a typical scenario of this type, the target has a known association with one disease, but is subsequently found to have a role in a different (new) disease that was not previously appreciated. Under such circumstances the claims will be limited to an antibody for use in a method of treating the new disease, but will cover any anti-target antibody for the said use.
It will be necessary to establish that the new medical use is not obvious from any previous disclosure regarding the target or existing antibodies that bind to it. It will also be necessary to establish that it is at least plausible that an antibody binding to the target will have a therapeutic effect. At present this is a relatively low threshold at the EPO and in vitro functional data will likely be sufficient, particularly if it derives from a disease model or other assay relevant to the indication. In vivo data from animal models is helpful but not required. It is not normally expected that a patent application will include in vivo data from human clinical trials.
Similar considerations may apply if it was previously thought that the only antibodies that could be produced to a target were pharmaceutically irrelevant (for example due to low affinity), but it is subsequently found that they have a therapeutic effect1. In such cases a claim to a pharmaceutical composition comprising any antibody specific for the target may be possible.
It is unlikely that broad antibody claims will be available if both the target and associated medical uses are known. However, grant of narrower claims may still be possible. Such claims will likely need to incorporate limitations from either or both of the following categories.
Limitations to specific functional characteristics of the antibody, such as a required level of affinity or a down-stream functional effect, likely also with at least some structural (sequence) characteristics.
Limitations to specific aspects of the medical use, such as a particular patient group or a dosing/administration regime.
Both categories are discussed in more detail in the following section. The categories are not mutually exclusive, and claims including both should be pursued wherever possible as part of a comprehensive filing strategy (see additional comments on filing strategy in the separate section below). However, in our experience, at any given stage in development a particular antibody project is likely to favour limitations from one category over the other.
Examples of the types of functional characteristic that applicants may seek to rely upon are described in more detail below. These examples should not be viewed as exhaustive or mutually exclusive. In practice a combination of these and other characteristics may well provide the best route to allowable claims.
Irrespective of the characteristic(s) relied upon, pursuit of this approach will likely require that applicants have provided a significant amount of structural information (primary amino acid sequences) in the patent application. Whether a particular antibody is claimed directly or is recited as a reference antibody, the EPO often insists that structural detail be provided at a level at least sufficient to define the target binding region of an antibody. It may alternatively be possible to meet these requirements by reference to a biological deposit of, for example, a hybridoma, provided the deposit is made in accordance with the Budapest Treaty.
Historically, the EPO has accepted structural definitions of antibodies which refer only to one or two CDR sequences. However, EPO Examiners are likely now to insist upon all six CDRs as a minimum requirement, unless data is available to show that any characteristic relied upon is achieved with fewer CDRs. There is though an increasing appreciation of the relevance of framework regions to target binding, and so there is a trend towards requiring that the heavy and light chain variable region sequences be recited in full. In some cases it may even be necessary to specify the isotype of the constant region if this is relevant to the characteristic(s) relied upon.
By contrast to its approach for small molecule therapeutics, the EPO does not in general consider that a unique structure can confer inventive step on an antibody to a known target. Thus, whilst an antibody comprising a unique primary sequence will be considered to be novel, structural non-obviousness arguments are unlikely to be accepted even when both variable region sequences are recited in full.
This means that applicants will generally be unable to rely upon, for example, the determination of unique CDR and framework sequences to provide an inventive step.
Instead, the EPO has developed a requirement that a new antibody to a known target must demonstrate "an unexpected effect" relative to pre-existing antibodies to the same target2 in order for inventive step to be acknowledged. It will therefore generally be necessary to demonstrate that the antibody as claimed possesses a functional characteristic (or combination of characteristics) which could not reasonably have been predicted from the prior art.
Ideally, at least some direct experimental evidence of the characteristic(s) relied upon will be provided in the patent application, for at least one exemplary antibody.
Under some circumstances it may be possible to rely upon supplementary data filed later, but there must be a connection to the characteristic(s) shown in the application. The characteristic(s) relied upon must be at least plausible at the filing date3.
This test has been applied very strictly by the EPO on at least one occasion. In a specific case4 the Board of Appeal held that a particular effect relied upon by an applicant to support inventive step could not be derived from the patent application itself, even though an arguably related effect was explicitly demonstrated in the Examples. Accordingly the effect relied upon was considered to have been demonstrated only after the filing date of the application, and was not taken into account when assessing inventive step.
If the EPO is persuaded that "an unexpected effect" is present and plausible, the breadth of claim that is allowed will depend upon the circumstances of each case -- in particular the state of the prior art and the data available.
"An antibody which binds specifically to <target> and which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."
"An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>."
"An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>, wherein the antibody competes for binding to <target> with an antibody which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."
As mentioned above, the following examples should not be viewed as exhaustive or mutually exclusive. In practice a combination of these and other characteristics may well provide the best route to allowable claims. The goal is to establish that there is a technical effect or characteristic (or multiple such effects or characteristics) which can be shown to have been unexpected based on the relevant prior art.
The EPO considers the generation of an antibody with nanomolar affinity to be achievable by routine methods for the vast majority of targets. Whilst there may be exceptions for particularly difficult targets, high affinity alone is now unlikely to be sufficient to establish an inventive step. However, high affinity in combination with another advantageous characteristic is nonetheless likely to be helpful.
The EPO tends to view high specificity for target to be an inherent characteristic of all antibodies and so an increase in specificity alone is unlikely to be sufficient to establish an inventive step. However, an increase in specificity which gives rise to an unexpected technical advantage, or which was previously thought to be difficult to achieve, may be enough. For example if a new antibody is able to distinguish between closely-related targets to a greater extent than was previously possible.
An antibody which can bind to an epitope in a target that was previously unrecognised and/or previously considered to be inaccessible is likely to be viewed as inventive. Under certain circumstances this may even be seen as a sub-category of the "Newly-identified or difficult target" scenario described above. If binding to the particular epitope also provides a functional advantage (e.g. enhanced specificity) this is likely to be helpful.
Routine optimisation for improved solubility etc is unlikely to be viewed as inventive. However, there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected. For example, if a surprising increase in affinity or specificity occurs.
Humanisation of antibodies to reduce anti-isotypic or idiotypic responses is now largely viewed as routine, as is the production of fully human antibodies. However, as with manufacturability there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected.
The Board of Appeal has held in one case5 that particular point mutations to introduce human sequences in the framework regions of a specific mouse antibody were sufficient to acknowledge inventive step for that antibody. The evidence in that case persuaded the Board that the skilled person could not reasonably have expected that those specific mutations would reduce immunogenicity without significantly reducing affinity.
Any improvement in down-stream function is likely to be helpful when seeking to establish an inventive step. However, adaptations of an antibody to enhance down-stream functions such as ADCC are unlikely to be viewed as inventive where they rely upon known phenomena such as altered glycosylation of Fc regions.
It seems it is becoming ever more challenging to persuade the EPO that a new or improved characteristic of an antibody is enough alone to establish inventive step. However, in our experience antibody inventions are treated no differently to other therapeutics when assessing further developments of a known medical use, in which a new and unexpected technical effect can be demonstrated.
The scope of claim that may be available via this route will depend upon the data produced, since it will be necessary to show that the effect relied upon is achieved across substantially the whole scope claimed. This may require limitation to an antibody defined by a complete structural definition (including constant regions), if the EPO do not accept that the effect relied upon applies more generally, for example to all antibodies possessing the same six CDRs.
Ideally the data showing the effect should be present in the patent application. However, data generated post-filing may be used to supplement arguments later in prosecution, provided the effect relied upon is plausible at the filing date6.
Any form of therapy which combines an antibody with another functionality may give rise to allowable claims. Examples include a combination with another binding functionality in the same molecule (a bispecific molecule), a combination with another effector functionality in the same molecule (a drug/toxin conjugate), or the co-administration of the antibody with another therapeutic (combination or co-administration), or any combination of these types. In each case, as with any combination of known therapeutics, it will be necessary to establish that the combination results in a technical effect (typically an advantage) which was not obvious from the prior art (e.g. synergistic increase in efficacy). It will likely be necessary to include experimental evidence of the technical effect in the patent application.
The Enlarged Board of Appeal of the EPO has established7 that claims to second/further medical uses of a substance may be based not only on the treatment of a different disease, but also on the treatment of the same disease by a method which differs for example in the dosage, formulation, administration regime, group of subjects or route of administration. In each case, as with any known therapeutic, it will be necessary to establish that the difference gives rise to a technical effect (typically an advantage) which was not obvious from the prior art (e.g. surprisingly enhanced efficacy for topical versus parenteral administration). It will likely be necessary to include experimental evidence of the technical effect in the patent application.
An invention which relates to a new type of antibody may give rise to broad claims which are not limited to a specific antibody or target. Examples of possible inventions in this category could include a novel and inventive arrangement of the binding domains (a new antibody "format"), a novel and inventive effector region (such as a modified Fc domain), or an entirely different class of antibody molecule isolated from a newly-discovered species.
For inventions of this type, the assumptions that the EPO would otherwise make regarding production and optimisation of known antibody types should largely be negated. The EPO should treat such inventions in the same way as any other technology, since normal considerations of novelty, inventive step and sufficiency of disclosure should apply. As such the assessment of each case will depend upon its merits.
A typical antibody development project will pass through different stages, and at each stage it may correspond more closely to one or the other of the scenarios outlined above. This briefing is intended to provide some suggestions as to how patentable claims may be achieved in each scenario. These suggestions are also summarised in Figure 1.
However, the scenarios that are described are not mutually exclusive. As with any therapeutic invention, a comprehensive filing strategy should seek to explore all of the available options for patent protection throughout the lifespan of the project and beyond. For example, an initial broad filing to a new medical indication should be followed with multiple narrower filings to antibodies with improved characteristics and/or developments of the treatment methodology.
1 Board of Appeal decision T601/05: claims to a pharmaceutical composition comprising human anti-TNFα antibodies were found to be inventive. At the time only low affinity human antibodies to the target could be generated, and it was thought that these were not suitable for pharmaceutical use.
A contentious patent battle has continued to rage between the Broad Institute at Harvard/MIT and the University of California ("UC"). UC is challenging thirteen patents related to CRISPR gene editing technology that are currently held by the Broad Institute. The basis of the challenge lies in explaining the potential influence that the work of Jennifer Doudna (UC Berkeley) and Emanuelle Charpentier (then at Umeå University) had on Feng Zhang's (Broad Institute) later work, and whether his work was an obvious development beyond that of Doudna/Charpentier, or whether it has the earliest priority claim. Although the patent battle remains active with an uncertain outcome, Doudna, Charpentier, and Zhang remain key players with regards to both the patents and research advances/startup companies related to the technology.
As the patent battle for CRISPR gene editing technology wages on, it has been easy to overlook other clinical and therapeutic advances that these companies are researching and pioneering at a rapid pace. Although early investigations have focused primarily on oncology/cancer treatments, many expect the field of CRISPR-based therapeutics to progress into treating rare and orphan diseases, many of which have well-understood pathologies and disease mechanisms, but that currently lack effective treatments. With regard to these diseases, there is huge promise for a lifelong cure after just a single treatment. Understandably, this is extremely attractive to patients. The development of novel treatments and therapeutic approaches promises to reveal clear opportunities for patent-eligible therapeutics and other related findings, even in light of the current CRISPR patent landscape.
In assessing the current landscape of patents in this area, it is readily apparent that the space is largely dominated by the initial patents that were filed for CRISPR technologies by Jennifer Doudna, Emmanuelle Charpentier, and Feng Zhang, and that research being done by the previously mentioned companies and others has been governed by the granting of both exclusive and non-exclusive licenses. As the patent battle for CRISPR technologies continues, we eagerly anticipate inventors being required to approach the subject of patent-eligibility with regards to CRISPR in a new light -- one that not only allows for the patenting of novel therapeutics, methodologies, and advances, but also remains flexible in light of the pending ruling on the current Broad Institute/UC Berkeley case.
Apotex Inc. and Apotex Corp. v. Alcon Research, Ltd.
PTAB Petition: IPR2016-01640; filed August 18, 2016.
PTAB Trial Instituted Document filed October 5, 2016.
Patent at Issue: U.S. Patent No. 8,791,154 ("High concentration olopatadine ophthalmic composition," issued July 29, 2014) claims an ophthalmic aqueous solution containing relatively high concentrations of olopatadine solubilized within the solution where the composition is preferably capable of providing enhanced relief from symptoms of ocular allergic conjunctivitis, particularly late phase symptoms of ocular allergic conjunctivitis.
Petitioners Apotex Inc. and Apotex Corp. are challenging the '154 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Jennifer Meyer Chagnon, Christopher M. Kaiser (author), and Christopher G. Paulraj issued a decision instituting review of claims 1–4, 8, 12, 13, 21, and 22 as obvious under 35 U.S.C. § 103(a) over Bhowmick, Yanni, and Castillo; and claims 1–4, 8, 12, 13, 21, and 22 as obvious under 35 U.S.C. § 103(a) over Schneider, Hayakawa, Bhowmick, and Castillo. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00544 (Argentum Pharmaceuticals v. Alcon Research, Ltd, Argentum Pharmaceuticals; filed 02/02/2016; Instituted 07/18/2016), adding Apotex Inc. and Apotex Corp. as petitioners to IPR2016-00544 and terminating IPR2016-01640 under 37 C.F.R. § 42.72.
Related Matters: According to the petition, the '154 patent is the subject of two litigations in the District of Delaware captioned Alcon Research, Ltd. v. Watson Laboratories, Inc., Case No. 1-15-cv-01159-SLR, and Alcon Research, Ltd. v. Lupin Ltd., Case No. 1-16-cv-00195.
PTAB Petition: IPR2016-000927; filed April 21, 2016.
Patent at Issue: U.S. Patent No. 8,198,092 ("Digital sampling apparatus and methods for sorting particles," issued June 12, 2012) claims a system and method for sorting a mixture of stained particles including a digital signal processor for analyzing and classifying the digital information generated from the particles and providing a sorting signal to a sorting system as a function of the analyzed and classified digital information.
Petitioner ABS Global, Inc. is challenging the '092 patent on three grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Kristina M. Kalan (author), and Christopher M. Kaiser issued a decision instituting review of claims 1–3, 5–9, 11–13, 16, 18–19, 21, 28, 32, 40–41, and 43–46 as obvious under 35 U.S.C. § 103 over Godavarti and Leary; claims 4, 26–27, 42, and 49 as obvious under 35 U.S.C. § 103 over Godavarti, Leary, and Johnson; and claim 10 as obvious under 35 U.S.C. § 103 over Godavarti, Leary, and Piper.
Related Matters: According to the petition, the '092 patent is involved in litigation in the Western District of Wisconsin captioned ABS Global, Inc. v. Inguran, LLC, Case No. 3:14-cv-00503-wmc.
PTAB Petition: IPR2016-01341; filed July 1, 2016.
PTAB Trial Instituted Document filed October 6, 2016.
Patent at Issue: U.S. Patent No. 7,772,209 ("Antifolate combination therapies," issued August 10, 2010) claims a method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.
Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00237 (Neptune Generics, LLC. v. Eli Lilly & Compnay, Petitioners GKC General Partner II, LLC; GKC Partners II, LLC; Gerchen Keller Capital, LLC; and Neptune Generics, LLC; filed 11/24/2015; Instituted 06/03/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00237, and terminating IPR2016-01341 under 37 C.F.R. § 42.72.
Related Matters: According to the petition, the '209 patent is the subject of litigation in the Southern District of Indiana, including Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Case No. 1:10-cv-1376.
The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune and IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01190 (Apotex) and IPR2016-01335 (Wockhardt) seek to join IPR2016-00237. Also, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva) seek to join IPR2016-00240. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt), and IPR2016-01340 (Teva) seek to join IPR2016-00318.
PTAB Petition: IPR2016-01343; filed July 1, 2016.
Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00240 (Neptune Generics, LLC. v. Eli Lilly & Compnay, Petitioners GKC General Partner II, LLC; GKC Partners II, LLC; Gerchen Keller Capital, LLC; and Neptune Generics, LLC; filed 11/24/2015; Instituted 06/03/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00240, and terminating IPR2016-01343 under 37 C.F.R. § 42.72.
The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune and IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-001191 (Apotex) and IPR2016-01337 (Wockhardt) seek to join IPR2016-00240. Also, IPR2016-01190 (Apotex), IPR2016-01335 (Wockhardt), and IPR2016-01341 (Teva) seek to join IPR2016-00237. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt), and IPR2016-01340 (Teva) seek to join IPR2016-00318.
PTAB Petition: IPR2016-01340; filed July 1, 2016.
Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00318 (Sandoz Inc. v. Eli Lilly & Compnay, Sandoz; filed 12/14/2015; Instituted 06/16/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00318 and terminating IPR2016-01340 under 37 C.F.R. § 42.72.
The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune Generics, LLC and IPR2016-00318 by Sandoz. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01393 (Wockhardt) and IPR2016-01429 (Apotex et al.) seek to join IPR2016-00318. Also, IPR2016-01190 (Apotex), IPR2016-01335 (Wockhardt), and IPR2016-01341 (Teva) seek to join IPR2016-00237. Additionally, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva) seek to join IPR2016-00240.
Minerva Surgical, Inc. v. Hologic, Inc.
PTAB Petition: IPR2016-00868; filed April 11, 2016.
Patent at Issue: U.S. Patent No. 6,872,183 ("System and method for detecting perforations in a body cavity," issued March 29, 2005) claims a method and system for detecting perforations in a body cavity, where a fluid (liquid or gas) is delivered into a body cavity to slightly pressurize the cavity. A pressure sensing system monitors the pressure within the cavity for a predetermined test period. If cavity pressure is not substantially sustained during the test period, the physician is alerted to further assess the cavity for perforations before initiating treatment within the cavity.
Petitioner Minerva Surgical, Inc. is challenging the '183 patent on seven grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Meredith C. Petravick (author), Mitchell G. Weatherly, and Timothy J. Goodson issued a decision instituting review of claims 1, 4, 6, 7, 9, 11–13, and 15 as obvious under 35 U.S.C. § 103 over Masterson and Bolduc; claim 14 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Isaacson; claim 5 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Himmelstein; claims 8 and 10 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Benaron; claims 1–4, 6, 7, 9, and 11–15 as obvious under 35 U.S.C. § 103 over Isaacson and Goldrath; claim 5 as obvious under 35 U.S.C. § 103 over Isaacson, Goldrath, and Himmelstein; and claims 8 and 10 as obvious under 35 U.S.C. § 103 over Isaacson, Goldrath, and Benaron.
Related Matters: According to the petition, the '183 patent is the subject of litigation in the District of Delaware captioned Hologic, Inc. v. Minerva Surgical, Inc., Case No. 1:15-cv-01031-SLR.
Patent at Issue: U.S. Patent No. 7,157,456 ("Substituted oxazolidinones and their use in the field of blood coagulation," issued January 27, 2007) claims oxazolidinone derivatives, the processes for their preparation and the use of such oxazolidinone derivatives as active compounds in medicaments.
Petitioner Mylan Pharmaceuticals, Inc. is challenging the '456 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '456 patent is involved in litigation in the District of Delaware, captioned Bayer Intellectual Property GmbH et al v. Aurobindo Pharma Limited et al, 1:15-cv-00902-SLR; Bayer GmbH v. Breckenridge Pharmaceutical, Inc., 1:16-cv-00628, District of Delaware; and Bayer GmbH v. InvaGen Pharmaceutical Inc., 1:16-cv-00064, in the District of Delaware.
Patent at Issue: U.S. Patent No. 7,585,860 ("Substituted oxazolidinones and their use in the field of blood coagulation," issued September 8, 2009) claims oxazolidinone derivatives, the processes for their preparation and the use of such oxazolidinone derivatives as active compounds in medicaments.
Petitioner Mylan Pharmaceuticals, Inc. is challenging the '860 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '860 patent is involved in litigation in the District of Delaware, captioned Bayer Intellectual Property GmbH et al v. Aurobindo Pharma Limited et al, 1:15-cv-00902-SLR; Bayer GmbH v. Breckenridge Pharmaceutical, Inc., 1:16-cv-00628, District of Delaware; and Bayer GmbH v. InvaGen Pharmaceutical Inc., 1:16-cv-00064, District of Delaware.
Patent at Issue: U.S. Patent No. 6,530,944 ("Optically-active nanoparticles for use in therapeutic and diagnostic methods," issued March 11, 2003) claims a method for inducing localized hyperthermia in a cell or tissue comprising the steps of delivering nanoparticles to said cell or tissue and exposing said nanoparticles to infrared radiation under conditions wherein said nanoparticles emit heat upon exposure to said infrared radiation.
Petitioner Sienna Biopharmaceuticals, Inc. is challenging the '944 patent on seven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 2, 3, and 4) or obviousness under 35 U.S.C. § 103(a) (grounds 5, 6, and 7). View the petition here.

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