DC grant of SJ affirmed since covenant not to sue and exclusive license directed to different subject matter and not covered by merger clause

Molon Motor and Coil Corp. v. Nidec Motor Corp.
Docket No. 2019-1071
January 10, 2020

Brief Summary: DC grant to SJ barring Molon since there was no merger of two agreements affirmed.

Summary: Molon appealed DC grant of summary judgment (SJ) that Molon is barred from enforcing US 6,465,915 against Nidec by a convenant not to sue with Nidec’s predecessor (Merkle-Korff Industries (“MK”)) (“the 2006 Covenant”). Molon argued the 2006 Covenant was extinguished by “the 2007 settlement” as it included a “merger” or “integration” clause that merged the two agreements and left the 2006 Covenant “of no further force or effect.” The 2006 Covenant was entered into between Molon and MK regarding the ‘915 patent “with respect to any and all products previously or presently made, used or sold” by MK and dismissed litigation including the ‘915 patent, while litigation regarding Molon’s “’785 patent” continued. In the 2007 Settlement, Molon and MK agreed to dismiss all litigation and MK obtained an exclusive license to the ‘915 and ‘785 patents (as well as the “’726 patent”) in “a narrowly defined exclusive market” (the “Kinetek Exclusive Market”). The 2007 Settlement also granted MK “the right to exclude others from using the patents within the Kinetek Exclusive Market”, and included the merger/integration clause. MK and Nidec later merged, and in this suit Molon alleged “that Nidec is practicing and/or inducing others to practice the ‘915 patent outside the licensed Kinetek Exclusive Market.” The FC panel reviewed the DC grant of SJ de novo under IL Seventh Circuit law and the contracts were interpreted under IL law (choice of law provision in agreements; “four corners” rule; Volt Info., US 1989). Molon argued the merger/integration clause applied because “the two agreements concern the same subject matter” (i.e., “the right to practice the ‘915 patent”) and that the language of the agreements “is itself evidence of the parties’ intent to extinguish the 2006 Covenant.” But the FC panel agreed with Nidec that even though both agreements relate to the same patent, the 2006 Covenant “is equivalent to a nonexclusive or ‘bare’ license” (Ortho Pharm., FC 1995) that “impliedly reserves the right to grant similar nonexclusive licenses to other entities” (Intell. Prop. Dev., FC 2001; “non-exclusive licensee…merely enjoys freedom from suit” (Rite-Hite, FC 1995)), while the 2007 Settlement is an exclusive license (i.e., a “promise” to exclude any other besides the licensee from practicing the licensed patent (Textile Prods., FC 1998; Rite-Hite, FC 1995 (“We have characterized an exclusive license as ‘shar[ing] the property rights represented by a patent.”)) Since an exclusive license and a non-exclusive license do not “necessarily concern the same subject matter, even though both licenses include the same patent”, the FC panel concluded the 2007 Settlement language “did not expressly extinguish the 2006 Covenant.” The FC panel also found no evidence of an intent to merge the agreements (e.g., under the “merger doctrine” which neither party invoked) since the agreements “contain[] different terms” and granted different rights (no conflict of rights, 2006 Covenant terms not rendered “superfluous”). The DC grant of SJ was therefore affirmed. Judge Reyna’s dissent argued that the subject matter is the same (“the right to practice the ‘915 patent”) and that “the majority applies an unduly heightened standard for merger” (e.g., “no legal requirement that a party explicitly list prior agreements in a merger clause”).

Posted in Licensing, Uncategorized | Leave a comment

Genentech’s antibody purification claims correctly found anticipated or obviousness in IPR, Fed. Cir. decides

Genentech, Inc. v. Hospira, Inc. (United States, Intervenor)

Docket Nos. 2018-1933 (IPR2016-01837)
January 10, 2020

Brief Summary: Board’s IPR anticipation and obviousness findings affirmed.

Summary: Genentech appealed PTAB (“Board”) IPR final written decision (FWD) finding certain claims of US 7,807,799 directed to methods of purifying antibodies (“a protein which comprises CH2/CH3 region”) using “protein A affinity chromatography at a temperature in the range of from about 10oC to about 18oC” unpatentable as anticipated or obvious. The FC panel explained that prior art WO ‘389 (an alleged anticipatory reference) teaches use of temperature range of “room temperature (18-25oC)”, which “overlaps with the claimed range…regardless of the construction of ‘about 18oC’”, and that “[a] prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range” (Ineos, FC 2015). Once an overlapping range has been established, the FC panel wrote, the patentee must “establish[] that the claimed range is critical to the operability of the claimed invention” to overcome anticipation (Ineos; DuPont, FC 2018; Galderma, FC 2013), but Genentech did not argue this point. Genentech argued WO ‘389 “refers only to the temperature of the laboratory where each step was performed, and not to the temperature of the [cell culture] composition applied to the chromatography column” (e.g., “WO ‘389 discloses some ‘steps’ being carried out where the composition was cold or frozen”, expert testimony regarding cell culture being carried out at 37oC and no instructions in WO ‘389 to allow it to cool to RT). The FC concluded that substantial evidence supports the Board’s conclusion that WO ‘389 properly discloses the claimed temperature range (Board can “give more credibility to [one expert’s] testimony over [another’s]” (Yorkey, FC 2010); “missing limitation” reasonably understood or inferred (CRFD, FC 2017; Akamai, FC 2003; Genetech cited Nidec Motor, FC 2017 (Board cannot “fill in missing limitations simply because a skilled artisan would immediately envision them”)). On obviousness, the FC panel explained that “even a slight overlap in range establishes a prima facie case of obviousness…which the patentee may rebut…by showing ‘that there is something special or critical about the claimed range” (In re Peterson, FC 2003) or “by showing that a process parameter…was not recognized as ‘result-effective’” (DuPont, FC 2018; In re Antonie, CCPA 1977 (show “evidence…that the prior art recognized that [that] particular parameter affected the result”); In re Applied Materials, FC 2012 (“not inventive to discover the optimum or workable ranges by routine experimentation”)). Genentech’s arguments related to use of the claimed methods in “large-scale, industrial processes” but the Board was unpersuaded, and the FC panel found the Board’s conclusions to be supported by substantial evidence (e.g., “routine experimentation to explore the temperature dependence of protein A leaching”, “no evidence” a “presentation was selected due to the claimed method”). The FC panel also rejected Genetech’s “constitutional challenge” since the IPR was carried out “on grounds that were available…when the patent was issued and under the same burden of proof”. Judge Newman’s dissent argued the decision was based on hindsight (e.g., “experts on both sides agreed that the solution presented in the ‘799 patent was new to them”; Nidec, FC 2017; King, FC 2010 (anticipation only where “expressly or inherently” disclosed)).

Posted in Anticipation (35 USC 102), Inherency, Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations), Uncategorized | Leave a comment

“[R]esult that was inherent in the prior art” cannot overcome obviousness based on inherency

Hospira, Inc. v. Fresenius Kabi USA, LLC

Docket Nos. 2019-1329, -1367
January 9, 2020

Brief Summary: DC obviousness judgment of affirmed as “wherein” clause only describes “a result that was inherent in the prior art”.

Summary: Hospira appealed DC judgment finding claim 6 of US 8,648,106 relating to the Precedex Premix product (including the sedative dexmedetomidine; NDA N021038 also listing five other non-expired US patents (see FN1 re: ‘049 patent) invalid for obviousness. Sole independent ‘106 claim 1 is directed to “[a] ready to use liquid” dexmedetomidine in “a sealed glass container, wherein the liquid pharmaceutical composition when stored in the glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine.” Dependent ‘106 claim 6, at issue in this appeal, is dependent on claim 1 “wherein the dexmedetomidine…is at a concentration of about 4 [micrograms]/ml.” The FC panel explained that the ‘106 patent states “[t]he present invention is based in part on the discovery that” the “premixed formulation…does not require reconstitution or dilution prior to administration” and “remains stable and active after prolonged storage.” The DC concluded that at least one embodiment of ‘106 claim 6 was obvious based in part on its determination that the “about 2% limitation…is inherent” in prior art “expressly” teaching 4 [micrograms]/ml compositions and post-‘106 patent filing date “stability data for more than 20 tested samples” (e.g., DC found “Fresenius’s expert’s analysis…more reliable than that of Hospira’s expert”; citing In re Cuozzo, FC 2015 (“to prove that a claim covering multiple alternative embodiments is invalid, a defendant need only prove that one of the embodiments is invalid”); the DC noting that it was found not to be inherent in a separate decision (D. Del. 2018, aff’d Fed. Cir. 2019)). Hospira argued that the DC “incorrectly considered the inherency of the about 2% limitation in non-prior art embodiments rather than the allegedly obvious prior art combination” and “applied a lower ‘reasonable expectation of success standard’ rather than the higher ‘necessarily present’ standard to the inherency question.” Hospira argued that the tested samples were “manufactured using the…process described in Example 5 of the ‘106 patent, and thus the stability data…cannot suffice to prove that all samples of the allegedly obvious combination…would ‘necessarily’ meet the about 2% limitation.” The FC panel first explained that reliance on post-filing date data is acceptable (Monsanto, Fed. Cir. 2018), and that the claim is not a method or product-by-process claim so how the samples were manufactured is not relevant. The FC panel also found that although the DC “conflated the standards for inherency and reasonable expectation of success”, it was “harmless error” (Vanderbilt, Fed. Cir. 2010), and concluded the “wherein” clause only describes “a result that was inherent in the prior art” (Atlas Powder, FC 1999 (“unappreciated property”)); In re Kubin, FC 2009; Persion, FC 2019 (PK claims inherent); Alcon, FC 2012; In re Kao, FC 2011 (“‘food effect’ in an inherent property”); see also Schering, FC 2003 (“the prior art need not recognize the inherent property”)). The DC decision was therefore affirmed.

Posted in Inherency, Obviousness, Uncategorized | Leave a comment

Fed. Cir. reverses DC and finds Amneal’s Sensipar®-related product infringes Amgen ‘405 patent

Amgen Inc. v. Amneal Pharm., Pirimal, et al., Zydus Pharm., Cadila et al.

Docket Nos. 2018-2414, 2019-1086
January 7, 2020

Brief Summary: DC claim construction reversed (“composition comprising” not closed to other components); no infringement by Amneal reversed; no infringement by Pirimal affirmed; Amneal); infringement by Zydus affirmed.

Summary: Amgen appealed DC judgment that neither Amneal nor Pirimal infringes certain claims of US 9,375,405 relating to its Sensipar® product for secondary hyperparathyroidism (rapid dissolution cinacalcet hydrochloride, NDA 21688 which also lists US 7,829,595). Zydus and Cadila (“Zydus”) cross-appealed DC judgment that they do infringe certain ‘405 claims. Claim 1 of the ‘405 patent claims a “composition comprising:” a) about” 10-40% cinacalcet HCl (“about” 20-100 mg), b) “about” 45-85% by weight of selected diluents, c) “about” 1-5% by weight of “at least one” of the listed binders, and d) “about” 1-10% of “at least one” of the listed disintegrants. The FC panel explains that during prosecution Amgen added the “narrower” 20-100 mg limitation (and argument) in response to a prior art rejection (the “Cinacalcet Amendment”), which was followed by an Examiner’s Amendment that “revised the binder and disintegrant limitations into their current, Markush group format.” The claims were then allowed since “the closest prior art did not disclose or render obvious the ‘combination of components…in the amounts…set forth in claim 2” (‘405 claim 1). Amgen then filed multiple RCEs citing additional references and updates regarding revocation of a related European patent, including a “Preliminary Amendment” stating that the Examiner’s amendments “have not been made in response to a prior art rejection but rather to place the claims in proper format and to better define the claimed subject matter, including equivalents.” The DC found that Amneal and Piramal did not infringe because their products do “not meet the binder and disintegrant limitations” or “binder limitations”, respectively, which the DC construed as “closed” Markush groups (Multilayer Stretch, Fed. Cir. 2016 (“‘comprising,’ followed by ‘consisting of’ terminology”)) ((Amgen accepted the Examiner’s narrowing amendment; e.g., Amneal’s Opadry includes more than HPMC). The DC found Zydus infringed as its product included starch as a diluent which is in the ‘405 claimed diluent Markush group. In this appeal, Amgen argued its use of “‘comprising’…renders the claim open-ended” and “‘consisting of’…only applies to the group from which ‘at least one’ binding or disintegrant must be selected” and that the “at least one” language “would be meaningless if the groups are closed to additional binders and disintegrants” (as would “mixtures thereof”; citing Bitcon, Fed. Cir. 2006; Amneal et al. citing Shire, Fed. Cir. 2017 (“‘consisting of’ is closed to unrecited elements”)). The FC panel explained that this case asked “whether the ‘binder’ or ‘disintegrant’ limitations are written to preclude other binders and disintegrants”, and concluded “they are not” (unlike Multilayer or Shire which focused on one sub-limitation, not the “composition comprising” as here (Wis. Alumni, Fed. Cir. 2018; Multilayer). Based on its construction, the FC panel reversed the finding of no infringement by Amneal because “HPMC is present in Amneal’s formulation”. However, it found Amgen’s doctrine of equivalence arguments regarding Piramal’s product to be “barred by prosecution history estoppel” and therefore affirmed no infringement (e.g., Amgen accepted the Examiner’s Amendment and made the “to better define the” claims statement “over eight months” later; not tangential (Intervet, Fed. Cir. 2010). The FC panel also affirmed the DC decision that Zydus’s product infringed since “the pregelatinized starch in” it “functions as a diluent.”

Posted in Claim Construction, Generics / ANDA, Infringement | Leave a comment

IPR invalidity decision vacated and remanded due to erroneous claim construction

SIPCO, LLC v. Emerson Electric Co.

Docket Nos. 2018-1856 (IPR2016-01895)
December 20, 2019

Brief Summary: IPR invalidity decision vacated and remanded due to erroneous claim construction (e.g., different claim terms “presume[d]” to “have different meanings”).

Summary: SIPCO appeal PTAB IPR final written decision finding certain claims of SIPCO’s US 7,697,492 directed to a communication system unpatentable as anticipated and obvious based on construction of “scalable address” in the limitation “a receiver address comprising a scalable address of at least one remote device” as “an address that has a variable size based on the size and complexity of the system”, “varies in the size that the address occupies within a packet”, and “clarified” that it is “not limited to a single scalable unique address” (“does not mean each remote device’s unique address must be scalable”). The parties disputed “the Board’s clarifications of its construction”, and “SIPCO argued the Board’s construction “combines the terms ‘receiver address’ and ‘scalable address’, eliminating the separate requirement of a ‘scalable address of at least one remote device.’” The FC panel concluded “[t]he Board erred by construing the ‘scalable address’ as reading on the ‘to’ address in the specification…because the patentee chose to use different terms to define the ‘receiver address’ and the ‘scalable address” which are therefore “presume[d]” to “have different meanings” (Chicago Bd. Options Exch., Fed. Cir. 2012), as well as finding the Board’s construction to be inconsistent with the specification. The FC panel also found “[t]he Board…erred by ‘declin[ing] to construe ‘scalable address’ as including’ a requirement that ‘the address of the remote device…be scalable” since “[t]he claim language specifically contains such a requirement” (“The claim language uses the adjective ‘scalable’ to modify the phrase ‘address of at least one remote device.” Citing Appel, FC 2012 (“holding ‘each’ modified the phrase immediately following it”)). The FC panel agreed, however, “with the Board’s clarification that the ‘scalable address’ is not limited to a single unique address” but remanded the Board’s FWD for reconsideration under the correct claim construction.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Uncategorized | Leave a comment

Persion’s Zohydro ER claims invalid for obviousness and lack of written description (“inherently result in the claimed [PK] parameters”, functional limitations too broad)

Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.

Docket Nos. 2018-2361
December 27, 2019

Brief Summary: DC findings of invalidity of Persion’s hepatic insufficiency claims related to Zohydro ER for obviousness and no WD affirmed.

Summary: Persion appealed DC decision finding US 9,265,760 and 9,339,449 relating to methods for treating pain in a “patient having mild or moderate hepatic impairment” using “extended release hydrocodone” (Zohydro ER, two of 17 OB patents) invalid as obvious and lacking written description (WD). The ‘760 and ‘449 patents share a common written description and priority date. The FC panel explained that “the FDA required the owner” (of Zohydro) “to conduct a clinical study” regarding hepatic impairment which showed the drug “did not result in substantially higher concentrations of hydrocodone” in the blood of subjects with hepatic impairment, and led to the ‘760 and ‘449 patents, the claims of which “are not limited to the use of the Zohydro ER formulation but instead cover methods of using any extended-release formulation” of hydrocodone. The FC panel separated the ‘760 and ‘449 claims into “non-adjustment” and “pharmacokinetic” (“does not increase average hydrocodone AUC0-inf” or “Cmax” (PK claims)) categories. The DC concluded the ‘760 and ‘499 claims are invalid as obvious in view of the prior art references (Devane, Jain and the Vicodin and Lortab labels), and for WD as lacking “guidance as to whether other formulations would satisfy the functional limitations of the claims”. Persion argued the DC improperly relied on inherency in its obviousness conclusions for the PK claims, but the FC panel disagreed (the prior art “taught the combination of elements that inherently result in the claimed [PK] parameters” (PAR, FC 2012 (inherency where “limitation is ‘necessarily present,’ or is ‘the natural result’”); also citing Santarus, FC 2012 (“an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations”), In re Kao, FC 2011 (“inherent [PK] property…‘add[ed] nothing of patentable consequence’”), In re Kubin, FC 2009 (“a property necessarily present in [the claimed protein]”), and In re Wiseman, CCPA 1979 (“‘not the law’ that ‘a structure suggested by the prior art…is patentable…because it also possesses an [i]nherent, but hitherto unknown, function”)). The FC panel also found no error with the DC’s consideration of data regarding non-hepatically impaired patients. The FC panel also found no error with the DC’s reliance on the FDA’s finding that safety data regarding a hydrocodone/ibuprofen combination product as part of the Zohydro ER NDA was not sufficient to support use for hepatically impaired patients since “[t]he standard to find a motivation to combine is far below what is sufficient to prove safety and efficacy to the FDA”. The DC’s reliance on other data regarding other products was similarly not found to be erroneous. Persion also unsuccessfully argued the DC did not properly consider secondary consideration evidence, but the FC panel disagreed (“clear that it properly considered the totality of the obviousness evidence” (Leo Pharm., FC 2013; Cyclobenzaprine, FC 2012). The FC panel also found no inconsistency in the DC’s obviousness and no WD conclusions since the patent only supported the claims as to the Zohydro ER formulation, but claimed much more functionally. The DC decision was therefore affirmed.

Posted in Functional limitations, Inherency, Method claims, Obviousness, Obviousness (Secondary Considerations), Uncategorized, Written description | Leave a comment

Secondary consideration presumption of a nexus only where the product “is the invention disclosed and claimed”

Fox Factory Inc. v. SRAM LLC

Docket Nos. 2018-2024, -2025 (IPR2017-00118, -00472)
December 18, 2019

Brief Summary: Board IPR decision of no obviousness vacated and remanded for reevaluation of secondary consideration evidence with respect to the required nexus.

Summary: Fox appealed IPR final decision in which the USPTO (“Board”) finding the challenged claims of SRAM’s US 9,182,027 covering an improved bike chainring not invalid for obviousness. Two IPRs address two different sets of claims, the “outboard offset claims” (-00472 IPR) and the “inboard offset claims” (-00118 IPR), and the Board made similar findings in each decision. The outboard offset claims of the -00472 IPR are addressed in this FC panel opinion. The FC panel opinion explains that two prior art references (“JP-Shimano” and the US “Parachinni” patent) “disclose every limitation…and that a skilled artisan would have been motivated to combine the references…because the skilled artisan would have recognized that the combination of the two features would improve chain retention better than either feature alone.” However, “based on its analysis of secondary considerations”, the Board also found that FOX had not shown obviousness since “SRAM was entitled to a presumption of nexus between the challenged outboard offset claims and secondary considerations evidence pertaining to SRAM’s X-Sync product” but only with respect to “chainrings, not sales or industry praise of X-Sync cranksets or drivetrains”. “FOX argued that SRAM’s products are not coextensive with the challenged claims because the products include numerous unclaimed features”, citing Therasense (Fed. Cir. 2010), but the Board rejected that argument and “determined that FOX could not rebut the nexus presumption”. The FC panel agreed with FOX “that the Board applied the wrong standard”, explaining that while “a patentee is entitled to a rebuttable presumption of nexus” if “the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed’”, this is not so “if the patented invention is only a component of a commercially successful machine or process” (Demaco, Fed. Cir., 1988; SightSound, Fed. Cir. 2015; Therasense; In re Huang, Fed. Cir. 1996). The FC panel also wrote that it has “never held that the existence of one or more unclaimed features, standing alone, means nexus may not be presumed” as “there is rarely a perfect correspondence between the claimed invention and the product” (“[I]f the unclaimed features amount to nothing more than additional insignificant features, presuming nexus may nevertheless be appropriate.”) Here, the FC panel concluded that “no reasonable fact finder could conclude, under the proper standard, that the X-Sync chainrings are coextensive with the patent claims” or that the differences are “insignificant” and found the Board erred on this point. The FC panel explained that continuation-related evidence is only relevant “if the claims of both patents generally cover the same invention” (WBIP, Fed. Cir. 2016; PPC Broadband, Fed. Cir. 2016). The FC panel affirmed the Board’s conclusions that there was a motivation to combine the references, and found that “FOX did not waive its right to a remand” under SAS (US 2018) because “it filed a motion to remand even before its opening brief was due” (Google LLC, Fed. Cir. 2019).

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations), Uncategorized | Leave a comment