Obviousness of Ranges
Genentech v. Hospira, (Fed. Cir. 1/10/20):
Appeal of PTAB decision finding Genentech patent obvious.
The patent claimed a method for reducing impurities resulting from protein A affinity chromatography, which is used to purify antibodies, by reducing the temperature to a range between 10˚C- 18˚C. The USPTO found the claims anticipated or obvious over prior art that disclosed an overlapping range.
- A method of purifying a protein which comprises CH2/CH3 region, comprising subjecting a composition comprising said protein to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C.
Genentech’s specification discloses that “[p]referably, . . . the temperature of the composition is reduced below room temperature, for instance in the range from about 3°C to about 20°C, e.g. from about 10°C to about 18°C.” Id. at col. 18 ll. 4–9. According to the patent, “[t]he temperature of the composition may be reduced prior to and/or during protein A affinity chromatography” and, in a preferred embodiment, involves “lowering the temperature of the harvested cell culture fluid (HCCF) which is subjected to chromatography.”
The PTAB construed “about 18°C,” and based on that claim construction, it concluded that all the challenged claims were unpatentable as anticipated by or rendered obvious over WO 95/22389.
WO ’389 Example 1 discloses a washing step after HCCF is applied to the chromatography column, whereupon the HCCF composition is washed with at least three column volumes of buffer before the antibody is eluted. J.A. 523 at 14:20–23. WO ’389 teaches that “[a]ll steps are carried out at room temperature (18–25°C).”
Claim: about 10 to about 18
Reference: 18 – 25
The temperature range disclosed in WO ’389, “18–25°C,” overlaps with the claimed range of “about 10°C to about 18°C,” regardless of the construction of “about 18°C.”
(Does it? Are endpoints of a range disclosures of a value?? Endpoints themselves are not anticipatory – but entire range can be, if it is disclosed with “specificity” – another bright line test)
Cases in area: Atofina v. Great Lakes Chem. Corp., 441 F.3d 991 (Fed. Cir. 2006) (en banc) (holding that the prior art’s teaching of a broad genus of a temperature range does not necessarily disclose every species within the genus and ruling against a finding of sufficient specificity and anticipation due to disclosure of criticality of narrower temperature range) and ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340 (Fed. Cir. 2012) (finding sufficient specificity and thus, anticipation due to lack of disclosure of the criticality of disclosed range).)
Here, “overlap” at 18 according to Federal Circuit. But that wasn’t what they based the anticipation on – Genentech’s own proposed construction for “about 18°C” embraced temperatures up to 19°C.
The Board found that Genentech failed to establish that the claimed temperature range of “about 10°C to about 18°C” is critical to performing protein A chromatography.
Adjusting temperature of HCCF determined to be result effective, and again, Genentech did not demonstrate criticality of 10 – 18 versus 18 – 25. (Actually, they argued that adjusting temperature was only relevant to scaled-up processes, because it affected purity which was less important than in clinical scale processes. Hospira presented evidence that purity WAS relevant at low-production levels – but the Court brushed that aside noting that the claims were not limited to clinical scale processes.
The Federal Circuit said the overlapping ranges established a prima facie case of anticipation and of obviousness that Genentech failed to overcome with evidence that its claimed range was critical and that its method would not have been obvious to a skilled artisan conducting routine experimentation. Substantial evidence supported the USPTO’s finding that the prior art disclosed the temperature of the composition being purified, rather than the temperature of the lab as Genentech argued.
Markush Language Open or Closed?
Amgen, Inc. v. Amneal Pharmaceuticals, LLC., (Federal Circuit 1/7/20):
Amgen filed suit against Amneal (and others including Piramal Healthcare UK Ltd., a client!) for infringement of US Patent 9,375,405 after each defendant filed an ANDA for a generic version of Sensipar® (cinacalcet, a hyperthyroid drug). Amgen alleged that the proposed ANDA products would infringe the ’405 patent.
The ’405 patent is directed to a rapid dissolution formulation of cinacalcet. Representative claim 1 recites in relevant part:
- A pharmaceutical composition comprising:
(a) from about 10% to about 40% by weight of cinacalcet HCl in an amount of from about 20 mg to about 100 mg;
(c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and
(d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovidine, sodium starch glycolate, croscarmellose sodium, and mixtures thereof…
A critical issue was construction of the binder and disintegrant Markush groups in elements (c) and (d). Amgen argued that the Markush groups recited in elements (c) and (d) should be construed as open-ended, the district court disagreed. Relying on Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350 (Fed. Cir. 2016), the court held that “Amgen ha[d] not overcome the very strong presumption that the Markush groups for the binder and disintegrant elements are closed to unrecited binders and disintegrants.”
The district court determined that Amneal does not infringe the asserted claims because, although Amneal uses a binder and disintegrant product falling within the respective Markush groups, it also uses a binder product and disintegrant product outside the Markush groups. Thus, Amneal’s product does not literally meet the binder and disintegrant claim limitations. Amgen appealed.
On appeal, Amgen first pointed to the claim’s use of the term “comprising,” which it argued “renders the claim open-ended, even when other language restricts the scope of particular claim elements.” Amgen next pointed to the phrase “at least one” found in the binder and disintegrant limitations, arguing that the “consisting of” term “only applies to the group from which ‘at least one’ binder or disintegrant must be selected.”
Amgen also compared the use of “at least one” in the binder and disintegrant limitations to its absence in the Markush group of element (a) of the claim. As Amgen contended, this “at least one” language “would be meaningless if the groups are closed to additional binders and disintegrants and meaningless in view of the claim’s recitations of ‘mixtures thereof’ within the Markush group.
Question – isn’t the normal interpretation that there can be 1 or more than 1 from the limited group??
The Federal Circuit also addressed its previous opinion in Shire Development, LLC v. Watson Pharmaceuticals, Inc., 848 F.3d 981, 984 (Fed. Cir. 2017), which reiterated the “strong presumption” that a claim term introduced with “consisting of” is closed to unrecited elements, and held that the facts in this case were distinguishable.
Looking at Multilayer, the Federal Circuit explained that the limitation at issue claimed “five identifiable inner layers, with each layer being selected from the group consisting of” and then recited a Markush group listing particular resins.
The Multilayer claim:
- A multi-layer, thermoplastic stretch wrap film containing seven separately identifiable polymeric layers, comprising:(a) two identifiable outer layers, at least one of which having a cling performance of at least 100 grams/inch, said outer layer being selected from the group consisting of linear low density polyethylene, very low density polyethylene, and ultra low density polyethylene resins, said resins being homopolymers, copolymers, or terpolymers, of ethylene and alpha-olefins; and(b) five identifiable inner layers, with each layer being selected from the group consisting of linear low density polyethylene, very low density polyethylene, ultra low density polyethylene, and metallocene-catalyzed linear low density polyethylene resins; said resins are homopolymers, copolymers, or terpolymers, of ethylene and C3 to C20 alpha-olefins;wherein each of said two outer layers and each of said five inner layers have different compositional properties when compared to a neighboring layer.
According to the Court, the only issue was the meaning of the “consisting of” language applicable to each layer, and the court “had no occasion to, and did not, consider the effect of the “comprising” transitional phrase.” The Court concluded that the term “consisting of” creates a “very strong presumption that the claim element is ‘closed,’” and that the Multilayer panel held this strong presumption was not overcome, and a product could not fall within the claim if it had resins outside the Markush group in the five identified layers.
The Federal Circuit likewise found that Shire presented a similar construction issue. The claim included two Markush groups with “consisting of” language, and the court was not asked to, and did not, consider the impact of the transition phrase “comprising” in the claim. As in Multilayer, the Shire panel determined that there was insufficient evidence to overcome the strong presumption that “consisting of” closed the Markush groups to additional elements.
Distinguishing its previous decisions in Multilayer and Shire, the Federal Circuit in Amgen noted that the “decisive issue in this case is critically different.” In particular, the court determined that there is “no language in Amgen’s claims indicating that every binder or disintegrant in the claimed formulation must be within the Markush groups, because the claim recites ‘at least one’ binder or disintegrant ‘selected from the group consisting of’ various excipients.” Thus, “[t]he plain language of this claim requires ‘at least one’ of the Markush members and certainly does not indicate that the only binders and disintegrants in the claimed formulation are those listed in the groups.”
According to the Federal Circuit, the patentee’s use of the transition phrase “comprising” further reinforces that additional binders and disintegrants not recited in the Markush group may be present in the claimed formulation.
Because the district court’s noninfringement holding for the Amneal product relied on its incorrect construction, the Federal Circuit vacated and remanded the infringement inquiry back to the district court.
If an applicant’s intent is for the claim to be opened – avoid “selected from… consisting of.” If the intent is to have the claim closed, omit “selected from” and go right to “consisting of.”
What Constitutes a Printed Publication (at IPR Institution Stage)
Hulu, LLC v. Sound View Innovations, LLC, Case IPR2018-01039, Paper 29 (P.T.A.B. Dec. 20, 2019) (POP Review of IPR — precedential):
Before POP review, the PTAB denied institution of Hulu’s petition because there was insufficient evidence to establish that a prior-art reference (Dougherty) qualified as a printed publication. Dougherty’s copyright page indicates four printing dates under the heading “printing history,” an ISBN date, and a copyright date, all of which were before the patent-at-issue’s critical date. Despite this, Sound View disputed Dougherty’s public availability. Hulu sought POP review, which was granted.
The POP held that a petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that a prior-art reference qualifies as a printed publication. This standard “lower than the ‘preponderance’ standard to prevail in a final written decision.” The POP also clarified that this burden is slightly shifted for post-grant reviews, where the standard is “more likely than not” that the party will prevail, as opposed to the “reasonable likelihood” standard of IPRs.
The POP also summarized the law surrounding printed publications. The POP noted that the question of “whether a reference qualifies as a ‘printed publication’ is a legal conclusion based on underlying factual findings” and that “[t]he underlying factual findings include whether the reference was publicly available.” The POP then made several observations regarding public accessibility:
- In certain situations, particularly for manuscripts or dissertations stored in libraries, the inquiry may consider whether a reference was sufficiently indexed, catalogued, and shelved;
- “In other situations, such as for information displayed at meetings and trade shows, indexing is not required if it was sufficiently disseminated;
- What constitutes a printed publication must be determined in light of the technology employed;
- Public accessibility is more than “technical accessibility,” meaning that a work is “not publicly accessible if the only people who know how to find it are the ones who created it;
- A petitioner need not establish that specific persons actually accessed or received a work to show that the work was publicly accessible – a limited distribution can make a work publicly accessible under certain circumstances.
Those circumstances can define that a given reference is “publicly accessible” upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.
Here, the petitioner argued that “conventional markers” of publication (e.g., copyright date, edition identifiers, assignment of ISBN number) should satisfactorily evidence that a reference was publicly available. The POP did not adopt this standard and explained that no particular indicia were per se sufficient at the institution stage. Instead, the petition should provide “strong indicia” of public accessibility.
What constitutes “strong indicia” of accessibility?
The POP recognized several instances where strong indicia had been shown in other cases:
- a package insert for a drug along with a screenshot from an FDA webpage from the Wayback Machine, submitted with declaration testimony;
- a thesis, supported by a declaration from the author’s advisor discussing a university’s publication and indexing practice;
- copyright and release date information supplied with metadata evidence and factual testimony along with an expert declaration.
The POP also identified some examples of weak indicia, such as a dissertation supported by a Joint Statement of Uncontested Facts from a related district court litigation and a conference paper having a 2012 copyright date and “September 2012” on its cover.
The POP overturned the PTAB’s decision and determined that Dougherty was sufficiently shown to be a printed publication for the institution stage. Dougherty bears a copyright date, printing date, and ISBN date, all before the critical date. Further, Dougherty was a textbook published by “an established publisher” in a “well-known book series.” This was deemed sufficient to establish a reasonable likelihood the reference was a publication prior to the patent’s critical date.
Yet – no evidence of publisher’s process, or declaration that was available…??
Other PTAB cases on what constitutes printed publication this year:
Ex parte Grillo-Lopez (1/31/20): Reference found not to be printed publication in IPR was available as printed publication in examination, as burden higher in IPR. (Hulu does NOT apply in examination!)
Cited reference at issue was an FDA transcript, which in an earlier IPR proceeding had been found by the PTAB to not satisfy Section 102(b)’s “printed publication” requirement. However, in ex parte patent prosecution, the Patent Examiner cited this same FDA transcript as a prior art “printed publication.
PTAB: ”In contested cases, “at the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication… in the ex parte patent prosecution context, the examiner met his burden of proof by setting forth the nominal publication date. . . . The Patent and Trademark Office is in no position to establish any thing beyond that. The burden is clearly upon appellants to disprove the prima facie publication date established by the examiner.”