Non-obviousness finding for Relistor® OB-listed formulation patent reversed due to structural and functional similarity to prior art compounds

Valeant Pharm. Int., Salix Pharm., Inc. et al. v. Mylan Pharm. Inc., et al., Actavis LLC

Docket No. 2018-2097
April 8, 2020

Brief Summary: DC grant of SJ of non-obviousness of OB formulation patent reversed and remanded based on structural and functional similarity of compound with prior art and failure to consider obvious-to-try evidence.

Summary: Mylan appealed DC grant of summary judgment (SJ) that claim 8 of Orange Book-listed (for Relistor®, one of eight OB-listed patents) Salix’s US 8,552,025 relating to stable methylnaltrexone preparations (“a pH between about 3.0 and about 4.0”, “stable to storage for 24 months at about room temperature”) is not invalid for obviousness. The FC panel reviewed the DC’s decision de novo (required by Third Circuit (NJ) law) to determine whether there is any “genuine dispute as to any material fact”, construing “the evidence in the light most favorable to the nonmovant” (FRCP 56(a); Anderson, US 1986). Mylan argued there was a motivation to “prepare and…arrive[] at the preparation of claim 8 via routine optimization of pH” (e.g., “obvious to try”) in view of US 5,866,154 (“Bahl”) for teaching stable naltrexone compositions with a pH of 3.0-3.5; US patent application (“Oshlack”) describing stable naltrexone compositions with an adjusted pH of “about 3 to about 5, but preferably to about 4”; a journal article (“Fawcett”) showing the stability of naltrexone “dwindled over time, and the pH of the formulations at all temperatures fell from 3.5 to 3.2”; and two treatises regarding the most useful pH for drugs (e.g., “with amide or ester linkages are prone to hydrolysis”). The DC disagreed with Mylan “because none of the references taught methylnaltrexone formulations”, “the evidence did not support that ‘adjusting pH would be the first variable formulators would consider to improve stability’”, and “that long-term stability of methylnaltrexone was a predictable result of arriving at a pH range of 3 to 4” (e.g., “a ‘large gap’ between [expert] testimony and the specified claimed pH range of 3 to 4 with its claimed stability profile of 24 months”). The FC panel explained that the DC focused “the remainder of its analysis” on “how the prior art references and expert testimony of record failed to establish” stabilization “based on pH alone” (e.g., neither Bahal nor Oshlack “taught a formulation ‘without added stabilizers’”; “the art did not contemplate an injectable solution ‘made stable over the long term by pH alone”). The FC panel agreed “with Mylan that the record supports a prima facie case of obviousness here” since “the pH range recited in claim 8 clearly overlaps with the pH range in the record art”, “these molecules bear significant structural and functional similarity”, and “prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness” (“When compounds share significant structural and functional similarity, those compounds are likely to share other properties, including optimal formulation for long-term stability.”; citing e.g., In re Peterson (FC 2003), In re Dillon (FC 1990) (“skilled artisans can expect structurally similar compounds to have similar properties”), In re Deuel (FC 1995) (“[s]tructural relationships may provide requisite motivation or suggestion to modify”); In re Merck, FC 1986 (close structural similarity and similar use); Anacor, FC 2018 (“compounds with common properties are likely to share other related properties as well”)). The FC panel did write that this “holding should not be misconstrued to mean that molecules with similar structure and similar function can always be expected to exhibit similar properties for formulation” (e.g., critical range, unexpected beneficial properties, teaching away (Geisler (FC 1997), Woodruff (CCPA 1990), Peterson). Thus, the FC panel found the grant of SJ to be an error.

The FC panel also agreed with Mylan that there were factual disputes precluding SJ (e.g., “disregarded Mylan’s obvious-to-try evidence because the pH ranges taught in the prior art were not sufficiently narrow”, “bounded range of pH 3 to 4 presents a finite number of narrower pH ranges for a skilled artisan to try” (KSR, US 2007), “no requirement that for a variable to be obvious to try, it must be the first variable a person of skill would alter”, “[a]bsolute predictability…not required”). Thus, the DC grant of SJ was reversed and remanded.

Posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away, Summary Judgment | Leave a comment

Public FDA hearing is a printed publication, Hulu IPR decision does not apply to examination

Ex parte Antonio J. Grillo-Lopez

Appeal 2018-006082 (Appln. No. 13/524,837)
Precedential (designated April 7, 2020)

Brief Summary: Public FDA hearing held to be printed publication and “the framework set forth in the Hulu decision for IPR proceedings does not apply to examination” (burden on petitioner vs. “burden-shifting framework”).

Summary: The Appellant requested rehearing of a prior Board decision affirming the Examiner’s rejections as obvious, which was denied in this decision. The Board concluded that an FDA Transcript of the July 25, 1997 meeting of FDA’s Biological Response Modifiers Advisory Committee was a printed publication. The Appellant argued that the Board “conflat[es] the concept of the hearing itself being public with the question of whether the FDA Transcript is a printed publication”, “does not articulate any reason that an ordinary skilled person would have read the Federal Register”, “notice of a public hearing is not evidence that a later printed publication was made sufficiently available to an ordinarily skilled person exercising reasonable diligence”, and “attendance at the oral hearing by an ‘interested member of the public’ is not evidence that a later printed publication was made sufficiently available”. The Board was not persuaded, finding “a prima facie case exists that an interested artisan would have been aware of the notice of meeting published in the Federal Register” (e.g., “once an ordinarily skilled artisan is aware of the meeting regarding rituximab, he or she also would have known of the existence of the transcript and been able to obtain a copy with the exercise of reasonable diligence”; Bayer, CCPA 1978; SRI Int’l, FC 2008). FN4 explains that “the advisory committee meeting, without more, transforms the transcript of the meeting into a printed publication”. The Board also explained that in an IPR “a petitioner is required to present evidence and arguments sufficient to show that it is reasonably likely that it will prevail in showing the unpatentability of the challenged claims” (Hulu, PTAB Dec. 20, 2019, precedential), but “[i]n contrast, the examination context involves a burden-shifting framework under which the USPTO can shift the burden to the application to come forward with rebuttal evidence or argument to overcome a prima facie case” (Ex Parte Albert, BPAI 1984). Thus, the Board concluded that “the framework set forth in the Hulu decision for IPR proceedings does not apply to examination.”

Posted in Inter Parties Review (IPR), IPR, Public Accessibility | Leave a comment

IPR claim construction of “effective amount” based on prosecution history and obviousness conclusions affirmed; no abuse of discretion in Board’s denial to amend after modifying institution decision

Genentech, Inc. v. Andrei Iancu (USPTO)

Docket No. 2019-1263, -1265, -1267, -1270
IPRs 2017-00731, -01121, -02063, -00737, -01122, -01960
March 26, 2020

Brief Summary: Board’s claim construction (e.g., “effective amount”), obviousness conclusion and denial of amendment after modifying its institution decision under SAS affirmed.

Summary: Genentech (GT) appealed Board IPR final written decisions (FWDs) finding the challenged claims of US 7,846,441 and 7,892,549 relating to methods for treating cancers that overexpress the ErbB2 receptor with an antibody “which binds to epitope 4D5” unpatentable for obviousness, and the Board’s denial of GT’s motion to amend in the -00731 IPR. In reaching its obviousness decisions, “the Board construed the claim terms ‘an amount effective to extend the time to disease progression in the human patient’ and ‘an effective amount’ to be in comparison to no treatment.” The FC panel reviewed the Board’s claim construction de novo as it is “based solely on intrinsic evidence”, and explained that “[t]he prosecution history ‘is often of critical significance in determining the means of the clams’” ((Teva, US 2015; Vitronics, FC 1996; Springs Window, FC 2003 (FC 2003)). During prosecution, in response to an indefiniteness rejection as to the “extend the time” limitation, GT stated that “the combination…is administered in an amount effective to extend the time to disease progression relative to an untreated patient” which “[t]he Board determined…was an express choice, which defined the claim term and led to the issuance of the ‘441 patent.” While GT argued that the Board erred by relying “on its exchange by using it ‘to override the meaning evident from the specification”, the FC panel found that “[t]he specification does not…define the disputed terms” and that GT had “expressly rejected” another comparator (“taxoid alone”) provided by the examiner (“Genentech provided an unequivocal, direct response to the examiner’s inquiry….”; “applies equally to the same claim term that appears in the ‘549 patent, which shares a specification and is in the same family.”) The FC panel therefore concluded that the “extend the time” and “an effective amount” limitations were correctly construed by the Board.

The Board also found GT did not have “a statutory right to amend” under section 316(d)(1) or 316(d)(2) after modifying its decision to include institution on Ground 1 based on the SAS decision (US 2018), and found GT “failed to establish good cause”. The Board also held that, alternatively, “Petitioner’s request for adverse judgment as to Ground 1 under [section] 37 CFR 42.73(b) mooted the issue.” The FC panel found that the Board’s conclusions were not an abuse of discretion “of its own procedural rules”.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Obviousness, Prosecution History Estoppel | Leave a comment

Rejected claim construction proposal during IPR was not prosecution history estoppel, FC affirms infringement under DOE; second infringement decision reversed

Galderma Labs., Nestle Skin Health S.A. et al. v. Amneal Pharm. LLC et al.

Docket No. 2019-1021
March 25, 2020

Brief Summary: DC finding of infringement of certain claims affirmed as statements made in related IPR was not prosecution history estoppel; finding of infringement of others reversed for lack of “particularized testimony”.

Summary: Amneal appealed DC finding that it infringes the asserted claims of Galderma’s “Chang Patents” (US 8,206,740; 8,394,405; and 8,470,364) and the “Ashley II Patents” (US 8,603,506; US 9,241,946) relating to low-dose doxycycline formulations for treating skin disease (e.g., acne, rosacea). IPR proceedings regarding the Chang Patents are referred to in the FC panel opinion (see FN1). The Chang Patents relate to compositions of an Immediate Release (IR) (defined by the ‘740 patent as having “no enhanced, delayed or extended release effect”) and a Delayed Release (DR) (not expressly defined) component. The DC found “that Amneal’s product contained the equivalent of the claimed 10 mg DR portion and entered judgment of infringement of Amneal” (infringement under the doctrine of equivalents (DOE)), which Amneal was incorrect because “clearly and unmistakably surrendered subject matter” during the ‘740 IPR (Aylus Net., FC 2017) such that the claim could not encompass “a drug that begins dissolving or ‘leaking’ in the stomach”. While Galderma agreed with this definition, the FC panel explained that the Board rejected that limited definition and thereby “clearly put the public on notice that the meaning of delayed release…is not limited to formulations requiring that there by no substantial release in the stomach” (i.e., “those arguments do not impact claim scope”). The FC distinguished its American Piledriving decision (FC 2011), in which “the patentee had ‘unambiguously argued’ a particular construction during reexamination and, ‘regardless of whether the Examiner agreed…its statements still inform the proper construction”, because those statements were “not made during [IPR] review”, “were used to inform claim construction not prosecution history estoppel”, and the examiner did not “clearly and expressly reject[] the patentee’s proposed construction” (see also Shire Dev., FC 2015). The FC panel also found that the DC “did not clearly err in finding infringement under the” DOE since “Amneal’s product’s combination ‘performs the same function in the same way to achieve the same result as the 10 mg DR portion claimed in Chang”.

The DC also found infringement of the Ashley II Patents under the DOE. Galderma argued the FC panel lacked jurisdiction to hear that portion of the appeal because of “actions taken by Amneal regarding its ANDA after filing its Notice of Appeal”, but the FC panel held “that Amneal’s actions did not divest this court of subject matter jurisdiction” and “that there remains a justiciable controversy” (Ferring, FC 2014; W.T. Grant, US 1953). The Ashley II Patents relate to methods for treating rosacea by oral administration of low-dose doxycycline “wherein the amount results in no reduction of skin microflora during a six-month treatment, without administering a bisphosphonate compound.” This DC judgment was reversed “[b]ecause the record wholly lacked the particularized testimony to find infringement”.

Posted in Claim Construction, Doctrine of equivalents, Infringement, Inter Parties Review (IPR), IPR, Prosecution History Estoppel, Uncategorized | Leave a comment

FB improperly joined to its existing IPRs under 315(c); various obviousness conclusions affirmed and vacated

Facebook, Inc. v. Windy City Innovations, LLC

Docket No. 2018-1400-3, -1537, -1540-41 (IPR2016-00=1156-59, IPR2017-00659, -00709
March 18, 2020

Brief Summary: Board improperly joined FB as a party to its own existing IPRs under section 315(c); various obviousness conclusions affirmed-in-part, vacated-in-part, and affirmed.

Summary: Windy City (WC) sued Facebook (FB) for infringement of US 8,548,245; 8,694,657; 8,473,552; and 8,407,356 related to methods for handling “‘out-of-band’ multimedia information” and “‘censorship’ of content”. FB filed petitions for IPR of each of the four patents on the last day of the one-year window from the date WC filed its complaint (section 315(b); see FN3 regarding the Board’s decision not to institute IPR against two of the claims and the FC’s decision not to revive those grounds (SAS, US 2018)). Then, “]m]ore than four months after the one-year deadline to file IPRs” (section 315(b)), WC “identified the claims of each patent it was asserting in the [DC] case” and FB “then prepared two additional petitions for IPR challenging the[] additional asserted claims” asking the Board to join these to the existing proceedings under section 315(c), which the Board did (e.g., “not likely to affect the scope of the trial significantly”, APJs raised concerns with permitting a party to, essentially, join itself” (Nidec, FC 2017)). WC argued in this appeal of the Board’s final written decisions (FWDs) that section 315(c) “does not authorize same-party joinder” or “joinder of new issues material to patentability, such as new claims or new grounds”, and the FC panel agreed. The FC panel explained that explained, however, that “an essential premise of the Board’s decision was that [section] 315(c) authorizes two proceedings to be joined, rather than joining a person as a party to an existing proceeding” and that this is not allowed under section 315(c), but is the subject of section 315(d). However, it understood the Board to have “in fact joined Facebook ‘as a party’ to its existing IPRs” which is not authorized under “[t]he clear and unambiguous language of” section 315(c), noting that “the Board’s Precedential Opinion” (Proppant, PTAB March 13, 2019) incorrectly “came to the opposite conclusion” (see the concurrence, no deference due under Chevron (US 1984)). The FC panel explained that “the language in 315(c) does not more than authorize the Director to join 1) a person 2) as a party, 3) to an already instituted IPR”, and not to join “new issues” (which is allowed under section 315(d)). The FC panel therefore vacated the relevant parts of the Board’s FWDs.

The Board’s FWDs also addressed FB’s allegations of obviousness. The Board’s decision was affirmed-in-part and vacated-in-part with respect to the ‘245 patent (e.g., FB’s position “is based on attorney argument rather than evidence in the record”), the ‘657 patent (e.g., “[a] person of ordinary skill is…not an automaton” (KSR, US 2007), “straightforward and predictable choice”); affirmed as to the ‘552 patent (not unpatentable) (e.g., “Roseman does not satisfy this limitation”); and affirmed-in-part as to the ‘356 patent (“obvious to combine”).

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

IPR decision of obviousness of method of treatment claim reversed for erroneous claim construction

Kaken Pharm. Co., Inc., Bausch Health Cos. Inc. v. USPTO

Docket No. 2018-2232 (IPR2017-00190, -01429)
March 13, 2020

Brief Summary: IPR obviousness decision reversed based on erroneous claim construction in method of treatment claim.

Summary: Kaken appealed PTAB (“Board”) IPR decision finding all claims of US 7,214,506 directed to a method for treating…onychomycosis” by “topically administering” and antifungal agent (the azole agent KP-103) to the nail (e.g., toenail) of a subject. Acrux filed the IPR petition alleging obviousness based on multiple prior art references (JP ‘639, U.S. Pat. No. 5,391,367, and the non-patent references “Hay” and the “Kaken Abstracts”). The FC panel opinion explains that the ‘506 patent states as an “object of the patent to provide a topical treatment that is effective more quickly than oral medications”, the traditional treatment that “required long treatment periods and could cause gastrointestinal disorders”. The Board determined that “‘treating onychomycosis’ includes treating ‘superficial mycosis that involves disease of the skin or visible mucosa’”, rejecting Kaken’s argument that the term refers to “the keratinized nail plate and underlying nail bed”. The FC panel found the Board’s “broadest reasonable interpretation” of this term to be “unreasonable” “in light of the specification and prosecution history”, and that it should be defined as Kaken argued. While the definition of “nail” in the specification “includes skin structures surrounding the nail plate”, the FC panel found that “the Board drew an unwarranted inference from that broad definition” and that “[a]s a matter of ordinary meaning…when the specification says that ‘onchomycosis’ is a disease involving invasion of the ‘nail’, it does not compel a conclusion that the disease can invade any part of the defined ‘nail’” (e.g., “this language alone does not support the Board’s conclusion”; similar discussion regarding the meaning of “superficial mycosis”; “Other parts of the specification, which explain that an effective topical treatment would need to penetrate the nail plate, support Kaken’s construction.”; In re Power Int., FC 2018). The prosecution history was also found to support Kaken’s position, including statements in response to double-patenting rejection that “[o]nchomycosis is a condition that specifically affects the nail plate” and “that the ‘present invention shows the unexpected ability of an azolylamine derivate to penetrate the nail and be retained by the nail” which led to withdrawal of the rejection (“This exchange would leave a skilled artisan with no reasonable uncertainty about the scope of the claim language in the respect at issue here.”; citing Phillips (FC 2005), Hynix (FC 2011), Standard Oil (FC 1985), Microsoft (FC 2015); see FN2 explaining that “[t]he intrinsic evidence in this case is decisive, making it unnecessary to review the expert evidence” (SIPCO, FC 2019)). And “[t]he Board relied on its erroneous claims construction throughout its consideration of facts that were part of its obviousness analysis”, and therefore reversed the Board’s decision without “prejudge[ing] the effect the withdrawal of Acrux has on how the Board should proceed on remand.”

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

DC patent ineligibility holding for Illumina’s fetal DNA-related claims reversed

Illumina, Inc., Sequenom, Inc. v. Ariosa Diagnostics, Inc. et al.

Docket No. 2019-1419
March 17, 2020

Brief Summary: DC finding that Illumina’s fetal DNA-related claims are patent ineligible reversed.

Summary: Illumina appealed DC decision finding certain claims of Illumina’s US 9,580,751 and 9,738,931 as ineligible under section 101 for being directed to natural phenomenon. The independent claims of each patent are directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA (e.g., “extracting DNA from a substantially cell-free sample of blood”, “producing a fraction of the DNA extracted”, and “analyzing a genetic locus in the fraction”). In its analysis, the FC panel wrote: “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” It explained that “it is undisputed that the inventors of the ‘751 and ‘931 patents discovered a natural phenomenon” but also that “at step one of the Alice/Mayo test, ‘it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to’” (CellzDirect, FC 2016; see also Athena, FC 2019 (holding diagnostic claims ineligible), Endo Pharm., FC 2019 (holding method of treatment claims patent-eligible)). The question is whether the inventor “claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discover of the natural phenomenon.” The FC panel adopted “Illumina’s articulation of the natural phenomenon, i.e., that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream” and found that the claimed “process achieves more that simply observing…or detecting the presence of that phenomenon” (e.g., the claimed “methods include specific process steps…to increase the relative amount of fetal DNA as compared to maternal DNA in the sample”). The claims at issue in the earlier Ariosa decision (FC 2015) were distinguished as being “directed to a method ‘for detecting a paternally inherited nucleic acid’…or a method ‘for performing a prenatal diagnosis’”, the “only operative steps” being “amplifying”, “detecting”, and “subjecting [it]…to a test” or detecting it (e.g., “[T]he inventors…discovered that cell-free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists.”) This case was also distinguished from Myriad (US 2013) since “the claims here are not directed to the cell-free DNA itself” (the Myriad claims “were ineligible because they covered a gene rather than a process for isolating it”). The FC panel views CellzDirect as “instructive” in that those inventors “patented an ‘improved process of preserving hepatocytes’” and “not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles.” Thus, the ‘751 and ‘931 claims were found not to be directed to patent ineligible subject matter under step on of the Alice/Mayo test and are therefore patent eligible. Judge Reyna dissented, arguing that “the claims are directed to [the] natural phenomena…that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood” and, e.g., does not “alter[] the naturally occurring substances themselves” (Genetic Techs., FC 2016; Ariosa) and should therefore be ineligible.

Posted in Patent Eligibility (101), Patentability, Uncategorized | Leave a comment