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  • News from Abroad: Israel PTO Proposes to Stop Rejecting Divisional Applications for “Overlap” with Parent Cases

    By Dan Feigelson* —

    IL PTOMany patent practitioners will never have need to file a patent application in Israel, a country of nine million people that's geographically smaller than New Jersey.  But if you're one of those practitioners who does file in Israel from time to time — and I suspect that readers of Patent Docs file in Israel at a higher rate than the general practitioner population — you'll be pleased to know that the Israel PTO (ILPTO) recently proposed a change in patent examination practice that portends relief for beleaguered applicants:  the ILPTO plans to tighten the criteria for rejecting claims of an applicant's application for "overlap" with the claims of another of the applicant's applications (or granted patents).  The upshot will be that the ILPTO will no longer make such rejections in the case of divisional applications on the basis of the claims of an ancestor application.

    By way of background, section 2 of the Israel patent statute says that an applicant may obtain a patent for his invention.  Like 35 U.S.C. § 101, Israel section 2 has been interpreted to mean you can get one patent per invention.  So you can't get two claims of the same scope in two different patents.

    Where the difficulty has arisen is when the claims of an applicant's separate applications are of different, but nevertheless overlapping, scope.  To illustrate, suppose a parent application claims a single chemical compound, and a related child application claims a genus of compounds that encompasses that compound.  In the U.S., such a situation would give rise not to a statutory double-patenting rejection under § 101 (since the claims are not of identical scope), but to an obviousness-type double-patent rejection.  And the response in the U.S. would be to file a terminal disclaimer, which would achieve two things:  it would ensure that the two patents expire at the same time (generally not an issue since June 1995, when the U.S. switched to a 20-years-from-earliest-filing-date-system); and it would ensure that the patents must be co-owned for the later-issuing patent to be enforceable.

    In Israel, until now, that same set of facts would also result in the ILPTO rejecting the child claim(s), and the assertion made by the ILPTO would be that the child claim(s) "overlap" with the parent claim(s).  The problem is that whereas in the U.S., it's recognized that obviousness-type double-patenting is a judicially created-doctrine, in Israel, there is no comparable case law.  Thus, despite the fact that the statute seems to be clear that only identical claims in two of an applicant's applications are forbidden (section 13 says that it's the claims that define the invention, which would seem to mean that as long as the claims aren't of identical scope, section 2 doesn't apply), the ILPTO has for years taken the view that section 2 precludes the allowance of such "overlapping" claims.  In other words, the ILPTO conflates statutory double-patenting with obviousness-type double-patenting.  As one might expect, this practice has not been without criticism, see, e.g., here, here, here, and here.

    Although it has been proposed that the ILPTO adopt a terminal disclaimer practice like that in the U.S., until now the only way for an applicant to overcome an "overlap" rejection has been to either remove the offending matter from the claims of one of the applications (either by deleting one or more positive recitations from the offending claim(s), or introducing one or more provisos), or to show that the offending claims constitute a non-obvious selection over the earlier claims.  (The latter option shows the paucity of the logical underpinnings of the ILPTO's position:  if the statute requires that there be no overlap between the scope of the claims in an applicant's different applications, a showing of non-obviousness doesn't obviate the double-patenting problem.)

    The ILPTO's approach to "overlap" has been vexing for pharma and biotech applicants in Israel.  For example, if an examiner is willing to allow claims of a narrower scope than the applicant believes it is entitled, in the U.S. the applicant will take the allowance of the narrower claims now, and fight for the broader claims in a continuation, knowing that it may be necessary to file terminal disclaimer to get around the claims of the parent case.  But in Israel, taking the narrower claims in the parent case might presage an "overlap" rejection, which at best would necessitate figuring out a way to eliminate that "overlap," a task that sometimes requires a significant investment of time, and in some cases might not be easily or satisfactorily accomplished.

    The ILPTO's obsession with overlap hasn't been a headache just for applicants and their patent counsel.  It's also been a source of wasted examiner time, as examiners have been instructed to conduct search-and-destroy mission against "overlap" as part of their job.

    It was apparently this last aspect of the practice that finally got the attention of the powers-that-be at the Israel PTO.  In a notice published on December 29, 2019, regarding proposed revisions to the Examination Guidelines (the ILPTO's equivalent of the MPEP), the ILPTO proposes to forego raising "overlap" rejections in cases of patent applications, or a patent application and a patent, which are (a) owned by the same entity and (b) have the same filing date, provided that the two documents do not contain claims of "literally or substantively" identical scope.  This means that the ILPTO plans to stop raising "overlap" rejections in cases of parent and divisional applications, as long as the claims are of different scopes.

    The specific proposed amended wording of the Examination Guidelines regarding "overlap" (in Hebrew) can be found here beginning at page 30.  The ILPTO has asked for comments on the proposed revisions to the Guidelines, to be sent to Patentim_Bhina@justice.gov.il by January 29, 2020.  It is expected that this proposal will be formally implemented soon thereafter; rumor has it that the ILPTO is in fact already implementing this change.

    * Daniel Feigelson is a patent practitioner based in Israel, who from time to time writes about U.S. and Israel patent issues at www.iliplaw.com.

  • WHO Reports Reveal Weak Pipeline for Antibiotic Agents

    By Donald Zuhn –-

    World Health OrganizationLast week, the World Health Organization (WHO) issued two reports suggesting that declining private investment and lack of innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections.  The WHO reports address fifty antibiotics (and ten antibacterial biologics) that are currently in clinical and preclinical development (see "Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline" and "Antibacterial agents in preclinical development").  However, the WHO reports indicate that these compounds "bring little benefit over existing treatments and very few target the most critical resistant bacteria (Gram-negative bacteria)."

    The Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, noted that "[n]ever has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent," adding that "[n]umerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines."  WHO also pointed out that research and development for antibiotics is primarily driven by small- or medium-sized enterprises, and that large pharmaceutical companies continue to exit the field of antibiotic research.

    With respect to its review of the clinical development of antibiotic agents, WHO noted that of the fifty antibiotics in the pipeline, 32 target pathogens that appeared on WHO's 2017 list of priority pathogens, but that the majority of antibiotics in clinical development have limited benefits when compared to existing antibiotics.  In addition, only two of the fifty antibiotics are active against multi-drug resistant Gram-negative bacteria, which WHO indicated are spreading rapidly and require urgent solutions.  The WHO report also highlights a "worrying gap in activity" against NDM-1 (New Delhi metallo-beta-lactamase 1), an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics.  According to the WHO report, there are only three antibiotics in the pipeline that can be used to treat resistant bacteria expressing NDM-1 (often referred to as "superbugs").  As for its review of the preclinical development of antibiotic agents, the WHO report suggests that an optimistic scenario is for the first two to five products to become available in about 10 years.

    WHO Assistant Director-General for Antimicrobial Resistance, Hanan Balkhy, stated that "[i]t's important to focus public and private investment on the development of treatments that are effective against the highly resistant bacteria because we are running out of options."  WHO also noted that with respect to antibiotic research and development, WHO and the Drugs for Neglected Diseases Initiative (DNDi) have established the Global Antibiotic Research and Development Partnership (GARDP), a non-profit research and development organization that is working with more than fifty public and private sector partners in twenty countries to accelerate the development of new and improved antibiotics to tackle drug-resistant infections.  GARDP's goal is to deliver five new treatments by 2025.

  • BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc. (Fed. Cir. 2020)

    By Donald Zuhn –-

    Federal Circuit SealLast week, the Federal Circuit issued a per curiam Order in BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc., denying a petition for a panel rehearing or rehearing en banc filed by Appellant BioDelivery Sciences International, Inc.  Judge Newman dissented from the denial of the petition for rehearing en banc.

    The dispute between the parties arose when BioDelivery sought inter partes review of claims 1, 4, 6–9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125–127 of U.S. Patent No. 8,765,167, citing seven prior art grounds of anticipation or obviousness.  The U.S. Patent and Trademark Office Patent Trial and Appeal Board instituted the IPR on most, but not all, of the challenged claims, and on one of the grounds.  The PTAB ultimately issued a Final Written Decision finding claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 of the '167 patent to be patentable.

    BioDelivery appealed to the Federal Circuit, which received briefing and argument before the Supreme Court issued its decision in SAS Institute Inc. v. Iancu.  On BioDelivery's motion, the Federal Circuit directed the PTAB "to implement the Court's decision in SAS."  In response, the PTAB "modif[ied its] Decision to Institute and instead deny the Petition in its entirety, thereby terminating [the] proceeding," and in particular, "ORDERED that Petitioner's request for inter partes review of claims 1, 4, 6–9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 125–127 of the '167 patent is denied and no inter partes review is instituted."

    Judge Newman, dissenting from the denial of the petition for rehearing en banc, stated that:  "I write because of the significance of the balance of agency and judicial authority, and the rules of procedural law in the administrative state."  Noting that the Supreme Court in SAS held that 35 U.S.C. § 318(a) requires that in an inter partes review the PTAB must decide all of the claims and grounds challenged in the petition, Judge Newman indicated that "the PTAB had not met this requirement for these cases [the appeal consolidated three separate PTAB decisions]."  In particular, Judge Newman noted that "[t]he PTAB did not comply with the Remand Order, stating that it would be inefficient and expensive to include the additional claims and grounds," with the PTAB explaining in its Decision on Remand that "[b]ecause the overwhelming majority of unpatentability grounds presented by Petitioner fail to meet the standard for institution of inter partes review, we find that instituting trial as to those grounds at this time is neither in the interest of the efficient administration of the Office, nor in the interest of securing an inexpensive resolution of this proceeding."  In her dissent, Judge Newman writes that:

    [M]y colleagues hold that the PTAB is not required to comply with the court's Remand Order, and further hold that this non-compliance is not reviewable.  This action raises critical issues of agency authority, judicial responsibility, and the constitutional plan.

    Judge Newman declares that "[m]y concern is with the PTAB's position that it need not follow the court's Remand Order, for reasons of efficiency and expense," adding that "[s]uch agency authority cannot be discerned in the America Invents Act, and contravenes decades of constitutional jurisprudence."  Citing Banks v. United States, 741 F.3d 1268, 1276 (Fed. Cir. 2014) (quoting Briggs v. Pa. R. Co., 334 U.S. 304, 306 (1948)), Judge Newman notes that agency action is bound by the mandate rule, which:

    [D]ictates that 'an inferior court has no power or authority to deviate from the mandate issued by an appellate court.'  Once a question has been considered and decided by an appellate court, the issue may not be reconsidered at any subsequent stage of the litigation, save on appeal.

    Judge Newman also observes that "[t]he legislative record contains no contemplation of a PTAB procedure whereby, after full PTAB trial and decision and appeal to the Federal Circuit, the PTAB could annul the appeal and remove the entire action and decisions and procedure from history, insulated from review."  As a result, Judge Newman found the PTAB's action in this case to be "seriously flawed."  According to Judge Newman, "[t]he PTAB's refusal to comply with our Remand Order to implement the Supreme Court's ruling warrants en banc attention," and she therefore dissented from the denial of the petition for rehearing en banc.

    BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc. (Fed. Cir. 2020)
    Per curiam
    Before Chief Judge Prost and Circuit Judges Newman, Lourie, Dyk, Moore, O'Malley, Reyna, Wallach, Taranto, Chen, and Hughes; dissenting opinion by Circuit Judge Newman

  • Conference & CLE Calendar

    CalendarJanuary 22, 2020 – "Top Patent Law Stories of 2019" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 22, 2020 – "Pot Topic: IP Issues for the New Recreational Weed Industry in Illinois" (The Intellectual Property Law Association of Chicago Young Members' Committee) – 5:30 to 9:00 pm (CT), Chicago, IL

    January 23, 2020 – "PTAB Year in Review" (Foley & Lardner) – 1:00 to 2:00 pm (CT)

    January 23, 2020 – "Text and Data Mining Laws: International Developments" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    January 28, 2020 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – Alexandria, VA

    January 28, 2020 – "Obtaining Patent Protection for Polymorphs of Drug Compounds" (J A Kemp) – 3:30 to 4:30 pm (GMT)

    January 30, 2020 – "American Axle: Does Patent Subject Matter Eligibility Depend on Enablement?" (Fitch Even) – 12:00 to 1:00 pm (ET)

  • BCP Customer Partnership Meeting

    USPTO Building FacadeThe U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on January 28, 2020 at the USPTO Headquarters in Alexandria, VA.  The agenda for the meeting is as follows:

    • Welcoming and Opening Remarks (10:30 – 10:40 am ET) — Gary Jones and Andrew Wang, Directors, and Karl Skowronek, Director (Acting), TC1600, USPTO

    • Restriction practice (10:40 – 11:20 am) — Janet Andres, SPE, TC1600, USPTO

    • Orange Book and biologic patent study 11:20 – 12:00 pm) — Michelle Ankenbrand, Lead Administrative Patent Judge, and Jason Repko, Administrative Patent Judge, PTAB, USPTO

    • Lunch/Networking (12:00 – 1:00 pm)

    • Patent term adjustment (1:00 – 1:50 pm) — Kery Fries, Senior Legal Advisor, OPLA, USPTO

    • Satisfying the written description requirement for living inventions (1:50 – 2:50 pm) — Bethany Reid Roahrig, Patent Agent, Setter Roche LLP

    • Break (2:50 – 3:00 pm)

    • Subject matter eligibility (101) update (3:00 – 4:30 pm) – Zachariah Lucas, QAS, TC1600, USPTO

    • Closing Remarks (4:30 – 4:40 pm) – Directors, TC1600, USPTO

    Additional information regarding the BCP customer partnership meeting, including registration information for those wishing to attend the meeting or register for online participation, can be found here.

  • IPO Webinar on Text and Data Mining Laws

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Text and Data Mining Laws: International Developments" on January 23, 2020, from 2:00 to 3:00 pm (ET).  Aaron Chalfoos of Jones Day, Professor Bernt Hugenholtz of the University of Amsterdam, and Gail Zarick of IBM will discuss:

    • The many aspects of law that govern text and data mining (TDM) in the U.S., including copyright, the Computer Fraud and Abuse Act, contract law, and state law claims such as criminal trespass and unjust enrichment
    • Basic relevant differences between EU and U.S. copyright law, including the difference between "fair dealing" and "fair use"
    • The importance of the EU Database Directive and the recently approved EU Directive on Copyright, which includes specific provisions on TDM
    • The relevant legal landscape in Japan and China
    • A roadmap for how in-house counsel should approach due diligence on TDM issues

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Webinar on Patent Protection for Polymorphs of Drug Compounds

    J A KempJ A Kemp will be offering a webinar entitled "Obtaining Patent Protection for Polymorphs of Drug Compounds" on January 28, 2020 from 3:30 to 4:30 pm GMT (Greenwich Mean Time).  Chris Milton and Guy Brain of J A Kemp will discuss some of the issues faced during the drafting and prosecution of patent applications for polymorphs and how those issues can be addressed.  The webinar will also address the following topics:

    • How to draft claims directed to polymorphs
    • Other drafting tips for polymorph applications
    • Establishing novelty and inventive step for polymorphs

    Those wishing to register can do so here.

  • Webinar on American Axle & Mfg. Inc. v. Neapco Holdings LLC

    Fitch EvenFitch Even will be offering a webinar entitled "American Axle: Does Patent Subject Matter Eligibility Depend on Enablement?" on January 30, 2020 from 12:00 to 1:00 pm (ET).  Stanley A. Schlitter and Andrew C. Wood of Fitch Even will discuss the following:

    • The district court and Federal Circuit decisions in this case
    • Arguments presented in the amici briefs
    • How American Axle comports with the USPTO's patent eligibility guidance
    • Strategies for litigators and prosecutors regarding Alice in view of American Axle

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealLast week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc. v. Hospira, Inc.  In doing so, the panel majority (over a dissent by Judge Newman) illustrated anew the importance of the deference the U.S. Patent and Trademark Office (and particularly the Patent Trial and Appeal Board) is due under the Administrative Procedures Act, and how that deference can be outcome determinative under the right circumstances.

    The case arose before the PTAB in an inter partes review (IPR) of U.S. Patent No. 7,807,799, which claimed methods for purifying antibodies comprising a CH2/CH3 region using Protein A affinity chromatography.  The claimed methods are directed to an improvement wherein the amount of Protein A contaminant in the antibody eluate is minimized (substantially to zero).  The opinion characterized the claimed method as a "standard purification technique," relying on high affinity, reversible binding to CH2/CH3 regions, which methods were capable of "reducing leaching of protein A . . . by reducing [the] temperature" of the "composition that is subjected to protein A affinity chromatography."  The inventors found that leaching can be minimized by performing chromatography at temperatures between 10-18°C (the specification also disclosing a broader range of 3-20°C).  Claim 1 of the '799 patent is representative:

    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.

    The primary references asserted by Hospira in its IPR was International Publication No. WO 95/22389 and a scientific reference contributed by van Sommeren and colleagues to a treatise entitled Effects of Temperature, Flow Rate and Composition of Binding Buffer on Adsorption of Mouse Monoclonal IgG1 Antibodies to Protein A Sepharose 4 Fast Flow, 22 PREPARATIVE BIOCHEMISTRY 135 (1992), as well as other secondary references that were applied in combination with the '389 PCT publication for the Board's obviousness determinations.  The '389 PCT publication disclosed Protein A purification of antibodies performed at room temperature, defined as 18-25°C, which overlapped with the '799's temperature range of from about 10°C to about 18°C.  The Board held all claims in IPR (1-3 and 5-11) to be anticipated by the '389 PCT publication or obvious in light of the '389 PCT publication or the van Sommeren reference as primary reference, in combination with other secondary references.  Genentech appealed and also challenged the constitutionality of applying IPRs retroactively in view of the '799 patents priority date; the Federal government intervened to address this issue on appeal.

    The Federal Circuit affirmed, in an opinion by Judge Chen joined by Chief Judge Prost; Judge Newman dissented.  Regarding the Board's anticipation decision, the Federal Circuit relied on the overlap of the temperature ranges, on the basis that the method disclosed in the '389 PCT publication was directed to purifying antibodies comprising the CH2/CH3 region and included a Protein A purification step performed at room temperature, defined in the specification as the range of 18-25°C.  The Federal Circuit's opinion  states 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," citing Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870–71 (Fed. Cir. 2015).  The question that a court must answer, according to the opinion, is "whether the patentee has established that the claimed range is critical to the operability of the claimed invention," citing Ineos and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018).  The Board found that Genentech had not carried this burden and (curiously, perhaps) Genentech did not challenge this finding on appeal.

    The Board also found that the '389 PCT publication taught that Protein A column chromatography was performed throughout at room temperature (18-25°C, i.e., the overlapping temperature range).  Genentech attempted to challenge this interpretation on the ground that "room temperature" as disclosed in the '389 PCT publication was precisely that, the temperature of the room in which the chromatography was performed and not the temperature of the components, buffers, etc. used in the purification.  Genentech based this argument in part on the temperature of the source material to be subjected to chromatography (i.e., antibody preparations from cells cultured at 37°C) in the absence of instructions in the '389 PCT publication to cool this material to "room temperature" and relied on testimony from its expert.  Hospira's expert, on the contrary, argued that those of skill in the art would perform chromatography at "ambient" (room) temperature.  The Federal Circuit majority held that "substantial evidence supports the Board's finding that the HCCF subject to protein A affinity chromatography in WO '389 is within the claimed temperature range of claim 1."  The majority identified portions of Genentech's expert's testimony that it disagreed with (correctly, in the majority's view) and held that "to the extent the experts disagreed with one another, the Board reasonably chose to credit the testimony of [Hospira's expert] over the testimony of [Genentech's expert], another instance where the deference the Court is mandated to give fact questions to the Board under Dickinson v. Zurko was dispositive.  The Federal Circuit majority also rejected Genentech's argument that the Board's decision was contrary to the Court's precedent (thus converting the issue to a question on law) and affirmed the Board's determination that Genentech's claims were invalid for anticipation by the disclosure in the '389 PCT publication.

    Turning to the Board's decision that the claims were also obvious over the combination of the disclosure of the '389 PCT publication in combination with a variety of other prior art references, the panel majority relied on their precedent that "[i]f the relevant comparison between a disputed claim limitation and the prior art pertains to a range of overlap-ping values, 'we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness,'" citing In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).  This has the effect of raising a presumption of obviousness, according to the opinion, thus shifting the burden on the patentee to rebut the presumption (which the Board held Genentech did not do and the panel majority affirmed).  Genentech neither showed that the temperature range was critical to the invention nor that the prior art did not recognize temperature as being "result-effective" (two ways to achieve the required rebuttal).  This latter stratagem was ineffective in the Board's view because the prior art understood Protein A leaching to be the result of proteolysis, and that proteolysis was affected by temperature.  Moreover, according to the Court, "[t]he Board reasonably found that a skilled artisan would have been motivated to optimize the temperature given the teachings of the prior art, and that given the ease with which temperature can be varied, finding an optimal temperature range would have been nothing more than routine experimentation."  The panel majority rejected Genentech's argument that the purported desire to reduce Protein A leaching was relevant only in large-scale, industrial applications of the technique, not at least because Genentech's claim was not limited to these circumstances.

    Finally, the Board held that the objective indicia of nonobviousness did not change their conclusion that Genentech's claims were obvious, and the panel majority affirmed this determination.

    The majority's opinion closes with the Court's rejection of Genentech's challenge that inter partes review are an unconstitutional violation of the Fifth Amendment (for reasons substantially identical to the Court's earlier opinion in Celgene Corp. v. Peter, 931 F.3d 1342, 1356–63 (Fed. Cir. 2019)), nor the Seventh Amendment nor Article III.

    Judge Newman dissented, on the basis inter alia that the invention had actually solved a real world problem and that the majority's affirmance ignored the value the invention brought to the art.  "The court presents a hindsight determination that this apparently simple solution to a difficult problem is anticipated and obvious, although it was not known or obvious to the scientists who were attempting to solve the problem of leaching contamination, and the experts for both sides agreed that the solution presented in the '799 patent was new to them," Judge Newman writes.  She sees the complexities involved in arriving at this solution, and the failure in the art to disclose the solution rebuts, for the Judge the Board's invalidation on anticipation and obviousness grounds.  On the merits, Judge Newman discounts the overlap at 18°C as supporting anticipation, because her understanding of the law would require the temperature range disclosed in the  '389 PCT publication (18-25°C) to be the same as the claimed temperature range (10-18°C).  And Judge Newman rejects the "optimization" basis for the Board's obviousness determination (and the majority's affirmance), stating that:

    [T]he question is not whether it would have been easy to cool the material to the 10°C – 18°C range; the question is whether it would have been obvious to do so.  Contrary to the Board's and the court's view, this is not a matter of optimizing a known procedure to obtain a known result; for it was not known that cooling the material for chromatography would avoid contamination of the purified protein with leached protein A.

    Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)
    Panel: Chief Judge Prost and Circuit Judges Newman and Chen
    Opinion by Circuit Judge Chen; dissenting opinion by Circuit Judge Newman

  • Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealIt seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals LLC v.  Alvogen Malta Operations Ltd.; Acorda Therapeutics, Inc. v. Roxane Labs., Inc.).  This tendency was most recently illustrated in the Federal Circuit's decision in Hospira, Inc. v. Fresenius Kabi USA, LLC.

    The issue arose in ANDA litigation, where the District Court found claim 6 of U.S. Patent No. 8,648,106 to be obvious:

    6.  A ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof disposed within 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, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 4 μg/mL.

    (Wherein the italicized portion of the claim is recited expressly in independent claim 1, from which claim 6 depends.)

    The claim encompasses Hospira's Precedex (dexmedetomidine) product, a sedative, first developed in the 1980's.  However, its earliest developer (Farmos) had difficulty getting FDA approval, and it was later sold by Abbott as a concentrate (at a concentration of 100 micrograms/mL) in 2mL vials, that needed to be diluted for use at a concentration of 4 micrograms/mL (the prevailing belief being that the drug was unstable at its therapeutically effective concentration.  Hospira determined that it could be prepared at the lower concentration, the inventors having discovered that the diluted formulation was stable and active over a prolonged period of time, with there being some evidence that nitrogen sparging was important to confer the stability properties.  The advantages of the invention (i.e., not needed to be dilutes at point of care) included avoidance of errors/overdose, greater convenience, and reduced frequency of contamination, among others.

    The District Court held claim 6 to be obvious over the prior art concentrate and knowledge of one having skill in the art.  The Court further depended on the 4 microgram/mL formulation being expressly taught in the prior art with the sole distinction recited in the claim being the "less than 2% degradation limitation," which the Board held was an inherent property of the 4 microgram/mL embodiment.  The District Court considered fact and expert testimony, specifically defendant expert's testimony (disputed by Hospira) regarding that the concentration of the drug had no effect on stability.  The basis for the District Court's decision was synopsized in the Federal Circuit's opinion:

    A [person of ordinary skill in the art] would have a considerable understanding of organic chemistry.  Based on his or her understanding of the chemical properties of dexmedetomidine, a [person of ordinary skill in the art] would have expected it to be stable in room-temperature storage conditions for at least five months (based presumably on evidence adduced at trial).

    The Court heard (ultimately persuasive) expert testimony that the chemical structure of dexmedetomidine would be "a rock stable molecule" under normal conditions based on its aromatic ring structure and lack of hydrolyzable and oxidizable groups.

    The Federal Circuit affirmed, in an opinion by Judge Lourie, joined by Judges Dyk and Moore.  The Court affirmed the District Court's application of the inherency doctrine as applied to its obviousness determination, noting that inherency is established in the context of obviousness when "the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art" and that Fresenius had satisfied this standard.

    On appeal, Hospira argued that the evidence that the 2% limitation was inherent was adduced from samples made according to the patent disclosure, and thus not prior art; the weakness of this argument is that inherency almost by definition arises where the inherent property existed in the prior art but was not appreciated in the art.  The opinion notes that, as here, "extrinsic evidence can be used to demonstrate what is 'necessarily present' in a prior art embodiment even if the extrinsic evidence is not itself prior art," citing Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1345 (Fed. Cir. 2018), and Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003).  In addition, the opinion states that "the work of the inventor or the patentee can be used as the evidence of inherency," citing Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012), and Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1327–28 (Fed. Cir. 2001).

    An important aspect of the Federal Circuit's opinion is that "[t]he inherent teaching of a prior art reference is a question of fact," Par Pharm. v. TWI Pharm., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014), and under the standard of review for fact issues (clear error), the District Court's fact determinations are entitled to substantial (almost plenary, in practice) deference.  The opinion sets forth the importance of this deference explicitly:

    Hospira's arguments on appeal cannot change the trial record, which included more than 20 samples that all met the about 2% limitation.  The trial record also included testimonial and statistical evidence that dexmedetomidine is a very stable drug at any concentration; thus, simply adding solvent to dilute it by a factor of 25—from 100 μg/mL, which was known to be stable, to 4 μg/mL—does not affect its inherent stability.  On that record, it was not clearly erroneous for the district court to find that the about 2% limitation was necessarily present in the prior art.

    The opinion particularly notes regarding Hospira's failure to rebut the application of inherency principles that "Hospira did not present evidence of even a single sample of the 4 μg/mL preferred embodiment that failed to meet the about 2% limitation."

    Another issue Hospira raised against the District Court's decision related to the interplay between the inherency standard and obviousness determination with regard to the requirement that there be a reasonable expectation of success.  To the extent that the District Court erred the Court said it was harmless error, specifically because the Court "engag[ed] in unnecessary analysis in evaluating whether the chemical properties of the dexmedetomidine molecule, the information in the Precedex Concentrate and Dexdomitor labels, and the industry guidance for stability testing would enable a person of ordinary skill to have had a reasonable expectation of successfully achieving the about 2% limitation."  Presumably the panel's basis for this analysis of because once the inherent property is appreciated or discovered that would supply the reasonable expectation of success.

    Finally, the opinion notes that, as in many cases, disclosure in the patent specification (in hindsight) provides support for the argument that the claims are invalid:

    Here, the '106 patent itself states that the invention was based on "the discovery that dexmedetomidine prepared in a premixed formulation . . . remains stable and active after prolonged storage."  '106 patent, col. 3 ll. 6–10 (emphasis added).

    In addition to the promulgation of the idea that inherency is available to be used to support for obviousness, this decision makes clear that the Court (or some members of the Court) is of a mind to consider claims in a restrictive, rather than permissive way.  It is clear that like "mere" isolation in other contexts the discovery of novel properties, not appreciated in the prior art will be treated as inherently present in the art and thus can be used for determining obviousness.  This tendency has support in earlier Federal Circuit decisions (for example, that "[i]t is well-settled that the inclusion of an inherent, but undisclosed, property of a composition does not render a claim to the composition nonobvious," Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999)) but its extension to obviousness under the recent case law indicates that prudence suggests applicants limit statements of discoveries as the basis for their inventions and to include some evidence that claims to an invention, like this one, contain limitations that distinguish over any inherent properties (e.g., by reciting the need for treating the diluted formulation by nitrogen sparging).  Doing so might (just might) provide a basis for asserting that what provokes or illustrates the inherent property was itself not inherent and thus preclude determining that the invention is obvious.

    Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, Dyk, and Moore
    Opinion by Circuit Judge Lourie