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  • In re Boloro Global Ltd. (Fed. Cir. 2020)

    Federal Circuit Extends Arthrex to Patent Prosecution

        By James Lovsin and Alexa Giralamo* —

    Federal Circuit SealThis week, the Federal Circuit extended its holding in Arthrex, Inc. v. Smith & Nephew, Inc., that administrative patent judges ("APJs") were improperly appointed in violation of the Appointments Clause, to ex parte proceedings in In re Boloro Global Limited.

    Under Article II, Section 2, Clause 2 of the Constitution, Congress has the authority to vest power in the President or in the Heads of Departments to appoint inferior officers, but must retain its power for principal officers.  The Supreme Court considers certain hallmark factors of inferior officer status, including removability by a principal officer.  In Arthrex, in the context of IPR proceedings, the Federal Circuit severed a portion of Title 35 to give the PTO Director, a principal officer, the power to fire APJs without cause, explaining that such authority would create the necessary oversight to consider APJs inferior officers.  The Court denied petitions for rehearing en banc in March.

    In Boloro, the patent applicant appealed to the Federal Circuit the Board’s judgment rejecting its patent applications and filed a pre-brief motion to vacate and remand, citing Arthrex and VirnetX Inc. v. Cisco Sys., Inc., 958 F.3d 1333 (Fed. Cir. 2020) (applying the Arthrex holding in the context of inter partes reexamination).  In opposing the motion, the PTO argued that Arthrex and VirnetX do not apply to ex parte appeals to the Board because the PTO Director has complete control over patent examination.  The Court, however, granted the motion, explaining that it saw no principled reason to depart from Arthrex and VirnetX.  After all, APJs deciding ex parte appeals were appointed the same way as APJs deciding IPRs and inter partes reexaminations.

    It will be interesting to see how the Federal Circuit and the PTO handle the application of Arthrex to ex parte appeals in the near term.  IPRs are time-limited in a way that ex parte proceedings are not.  Since Arthrex was decided, the Federal Circuit has vacated and remanded many IPR judgments to the Board.  In response, the Board issued a general order in May holding all impacted matters in abeyance until the Supreme Court resolves a petition for certiorari on Arthrex.  Last month, both the IPR petitioner, Smith & Nephew, and the PTO filed cert. petitions with the Supreme Court.

    The Board's judgment in Boloro issued before the date that the Federal Circuit in Arthrex severed a portion of the AIA to remedy the Appointments Clause violation.  It is unlikely that the Federal Circuit would apply Arthrex to Board judgments in ex parte appeals that issued after Arthrex was decided because the Court in Arthrex ruled that it corrected the appointments issue at that time.  The Court has also held that normal rules of waiver and forfeiture apply to Appointment Clause challenges in IPRs and is likely to do so as well for ex parte appeals.

    Nevertheless, patent applicants should still carefully consider the impact of Arthrex and Boloro to their ex parte appeals in the event that the Supreme Court grants certiorari on whether APJs were properly appointed.  If the Supreme Court concludes that there is a violation of the Appointments Clause and affirms the Federal Circuit in that respect, the Court could conclude that the remedy for that violation is different than what the Federal Circuit did in Arthrex putting into question all actions by the Board.

    In re Boloro Global Ltd. (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, Dyk, and Reyna
    Opinion by Circuit Judge Dyk

    * Ms. Giralamo is a student at The UIC John Marshall Law School, focusing her studies on Intellectual Property Law.  She currently serves as the Articles Editor for the UIC JMLS Review of Intellectual Property Law Journal and is a summer associate at McDonnell Boehnen Hulbert & Berghoff LLP. Before attending law school, Alexa obtained her B.S. in Mechanical Engineering, accompanied by a minor in Aerospace Engineering, from Santa Clara University.

  • In re Zunshine (Fed. Cir. 2020)

    By Donald Zuhn –-

    Federal Circuit SealEarlier today, the Federal Circuit affirmed the rejection by the Patent Trial and Appeal Board of claims 1-3 of U.S. Patent Application No. 15/726,162 as being patent ineligible under 35 U.S.C. § 101.  The '162 application, which is entitled "An Iterative Process of Squeezing Excess Food out of Daily Food Intake to Achieve and Maintain Weight Loss Using Hunger as a Feedback Mechanism," is directed to a method for weight loss.  The '162 application contains three independent claims, of which claim 1 is representative:

    1.  A process wherein, on day one, you–which stands for a user of the process– cut your food intake during all three regular meals, break-fast, lunch, and dinner, by 1/3 and keep it that way for 3 months, and follow the how-to-eat rules: (1) no food unless you are hungry, or it is your regular mealtime, breakfast, lunch, or dinner, (2) if you are hungry and it is not your regular mealtime, you drink a glass of water, first, and wait 10-15 minutes; if you are still hungry, then you eat a snack, and (3) the amount of the snack is determined by your BMI (body mass index) and the time left before the next regular meal or bedtime, whichever comes first.

    During prosecution of the application, the Examiner rejected claims 1-3 of the '162 application as being patent ineligible under § 101.  The Applicant, Mr. Zach Zunshine, appealed the rejection to the Board, which affirmed the Examiner's rejection.  In particular, the Board agreed with the Examiner that the claims recite an abstract idea, concluding that the claims describe methods of managing personal behavior, and that the claims do not recite any limitations that integrate the abstract idea into a practical application.

    In affirming the Board, the Federal Circuit similarly concluded that claims 1–3 are directed to an abstract idea.  The Court explained that "[e]ach of claims 1–3 amount to nothing more than reducing food intake to achieve weight loss and snacking to curb hunger," adding that "[h]umans have long managed their personal diets in such a manner, and thus claims 1–3 are directed to an abstract idea."  Citing Trading Techs. Int’l, Inc. v. IBG LLC, 921 F.3d 1084, 1092 (Fed. Cir. 2019), the Court also noted that "[t]he fact that the claims might add a 'degree of particularity' as to the amount that food intake is reduced 'does not impact our analysis at step one.'"

    In response to the Applicant's argument that claims 1–3 are not directed to abstract ideas because these claims "represent specific improvements in the field of calorie-restrictive diets," analogizing the '162 application to McRO, Inc. v. Bandai Namco Games America, 837 F.3d 1299 (Fed. Cir. 2016), and Rapid Litigation Management, Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016), the Court responded that:

    [U]nlike the specific improvements recited by the claims in those cases, the purported improvement in claims 1–3—i.e., solving the "hunger problem" in calorie-restricted weight-loss diets—is neither a technical improvement tied to a specific apparatus nor an improvement of an existing technological process.  Instead, in this case, the solution to the hunger problem in claims 1–3 is itself an ineligible abstract idea.

    In response to the Applicant's argument that claims 1-3 teach the treatment of a disease (i.e., obesity and diseases afflicting the overweight and obese) and are patent eligible like the claims in Vanda Pharmaceuticals Inc. v. West Ward Pharmaceuticals International, Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the Court disagreed, noting that:

    In Vanda, we did not hold that all methods of treating a disease are categorically patent eligible, but explained that the claims at issue were patent eligible because they were directed to "a specific method of treatment for specific patients using a specific compound at specific dose to achieve a specific outcome."  887 F.3d at 1136 (emphases added).  Claims 1–3 are quite different.  The claims merely direct a user to manage his or her food intake according to a series of rules that humans have long followed in managing their diets.  Such personal management of food intake is an abstract idea that is not patent eligible.

    The Court determined that the claims of the '162 application were different from those found to be patent eligible in Vanda, pointing out that the claims at issue here "merely direct a user to manage his or her food intake according to a series of rules that humans have long followed in managing their diets," and concluding that "[s]uch personal management of food intake is an abstract idea that is not patent eligible."

    Turning to the second step of the Alice/Mayo inquiry, the Court determined that nothing in the claims, either individually or as an ordered combination, transformed the claims into a patent-eligible application of the abstract idea recited therein.  In response to the Applicant's argument that the elements of claims 1–3 are not found in the prior art and together the elements produce "spectacular" weight loss, the Court responded that "[t]he purported inventive concepts . . . are nothing more than the abstract ideas themselves," and that the suggested novelty of the claims fails to transform the abstract idea of limiting food intake into a patent-eligible process.  The Court therefore affirmed the Board's determination that claims 1-3 of the '162 application are patent ineligible under § 101.

    In re Zunshine (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Chief Judge Prost and Circuit Judges Newman and O'Malley
    Per curiam opinion

  • Genentech, Inc. v. Immunex Rhode Island Corp. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealIn a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar product Mvasi in Genentech, Inc. v. Immunex Rhode Island Corp.

    The issue arose over the notice of commercial marketing requirement under 42 U.S.C. § 262(l)(8)(A):

    (8) Notice of commercial marketing and preliminary injunction

    (A) Notice of commercial marketing

    The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).

    Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin.  Amgen's biosimilar, Mvasi, was granted FDA approval on September 14, 2017, and Amgen provided notice of intent to commercially market on October 6, 2017.  However, Amgen did not market at that time, but filed supplements to its abbreviated biologic licensing application (aBLA) in August 2018, wherein Amgen added a new manufacturing facility and amended its label.  Amgen decided to launch on July 8, 2019, and Genentech moved in district court for a temporary restraining order (TRO) to prevent launch, on the grounds that the aBLA supplements triggered a requirement for a new notice of intent to commercially market.  The District Court denied the motion and Genentech appealed.

    The Federal Circuit affirmed, in an opinion by Judge Moore joined by Judges O'Malley and Hughes.  The panel held that the plain meaning of the statute "makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product" (emphasis in opinion).  There was no evidence that the product had changed and thus the court held that "Genentech . . . had notice of Amgen's intent to commercially market Mvasi as required under Section 262(l)(8)(A) as early as October 6, 2017."  Genentech's argument was that the phrase "licensed under subsection (k)" in the statute is defined "by particular manufacturing facilities and labeling" and that the supplements Amgen submitted involved adding a manufacturing facility and amending the Mvasi label, and this constituted a distinct biological product that triggered a requirement for a new notice.  The panel recognized Section 262(k), not Section 262(l)(8)(A) specifies the disclosure required for licensure, and that Section 262(l)(8)(A), in contrast, involves timing of notice and when the biosimilar product is marketed.

    The opinion expressly relied on the Supreme Court's decision in Sandoz v. Amgen that construed the licensing requirement Section 262(l)(8)(A) narrowly to merely mean that the biosimilar product must be licensed on the date of first commercial marketing.  (It could be argued, of course, that in that case the word is surplusage because no drug can be marketed without FDA approval.)  But the Court had been clear that "Section 262(l)(8)(A)'s notice requirement is separate from Section 262(k)'s licensure requirements" and the Federal Circuit's opinion applied the law in the same way here, stating "[a] biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product."

    There has been discussion elsewhere regarding the unconventionality (if not the potential procedural impropriety) of the Federal Circuit hearing the appeal on denial of a motion for a temporary restraining order (this being the first time the Court has done so), especially in view of precedent where the Court denied such relief, see, Nikken USA, Inc. v. Robinson-May, Inc., 217 F.3d 857 (Fed. Cir. 1999).  While that decision was consistent with Supreme Court precedent, see Office of Personnel Management v. American Fed'n of Gov't Employees, AFL-CIO, 473 U.S. 1301 (1985) (and arguably this one is not), the Nikken decision was nonprecedential.  Under such circumstances, it is unlikely that policy concerns did not play a role.  After all, the decision was consistent with facilitating an early appearance of Amgen's Mvasi biosimilar on the market which should reduce pubic drug costs, which has been the policy goal and justification for the biosimilar licensing provisions of the BPCIA since its inception.  An argument could be made that refusing to take the appeal would have led to the same result, but by speaking to the issue the Court made it less likely that any such attempts to delay marketing would occur for other biosimilars in future.  That outcome in itself might be sufficient justification for the Court to resolve this issue here.

    Genentech, Inc. v. Immunex Rhode Island Corp. (Fed. Cir. 2020)
    Panel: Circuit Judges Moore, O'Malley, and Hughes
    Opinion by Circuit Judge Moore

  • Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common ownership in applying the judicially created doctrine of obviousness-type double patenting (ODP), in Immunex Corp. v. Sandoz Inc.  This decision may serve to complicate the legal landscape for patent licensees when addressing a common ownership question.  As in the St Regis Mohawk Tribe v. Mylan decision, ultimately contract law, not patent law, provides the basis for the Court's decision in this case.

    The case arose in litigation under the Biologics Price Competition and Innovation Act (BPCIA, relevant provisions codified under 42 U.S.C. § 262(l)) over Sandoz' biosimilar application for its product Erelzi, a generic form of Enbrel® (etanercept), which is used for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis.  Etanercept is a fusion protein "made by combining a portion of a 75 kilodalton human tumor necrosis factor receptor protein (the extracellular portion) with a portion of immunoglobulin G1 (IgG1), specifically, the portion including the hinge region, CH2 and CH3 domains."  Immunex is the exclusive licensee of Hoffmann-La Roche for U.S. Patent Nos. 8,063,182 (to the etanercept composition of matter) and 8,163,522 (methods for making etanercept).

    Immunex received FDA approval for Enbrel® and entered into a royalty-bearing license agreement for Roche for patents and applications that contained claims relevant to this product (including the '182 and '522 patents).  Amgen later acquired Immunex and entered into an "Accord and Satisfaction" agreement with Roche, the purpose of which was "to eliminate the continuing obligations to pay royalties to Roche."  The terms of this agreement gave Immunex a "paid-up, irrevocable, exclusive license to the U.S. patent family for the patents-in-suit."  Relevant to the Federal Circuit's decision, the Agreement gave Immunex "the sole right to grant sublicenses, to make, have made, use, sell, offer for sale and import products covered by the patent family" and "the exclusive right to prosecute patent applications in the U.S. patent family."  Immunex also received the right to enforce the patents in the first instance, Roche reserving the right to sue (and retain all damages received) upon Immunex' notice that it would not bring suit.  Also, Roche can practice the claimed invention only for internal, research purposes under the terms of the agreement.

    Sandoz stipulated to Infringement and trial was held on patent validity.  The District Court held that Sandoz had not established by clear and convincing evidence that the claims were invalid for obviousness, failure to satisfy the written description requirement nor obviousness-type double patenting.  With regard to the OPD issue, the District Court set forth the following reasons why Sandoz' arguments were not persuasive:

    (1) that Sandoz's proposed test for common-ownership does not apply;
    (2) even if that test applies, the patents-in-suit and the asserted double-patenting reference patents are not commonly owned;
    (3) even if they are commonly owned, the two-way, rather than the one-way test for obviousness-type double patenting applies as to some of the double-patenting references; and
    (4) the patents-in-suit are patentably distinct from each of the asserted double patenting references.

    Sandoz appealed.

    The Federal Circuit affirmed, in an opinion by Judge O'Malley joined by Judge Chen; Judge Reyna filed a dissenting opinion directed to the ODP issue.  The opinion characterized Sandoz' common ownership argument as "novel," in that although the patents in suit are owned by Roche they are "effectively" owned by Immunex under the Accord & Satisfaction agreement.  This amounted to an application of the "all substantial rights" test used to determine standing to sue under 35 U.S.C. § 281.  The majority agreed that this test can be "informative" in determining common ownership but Sandoz has not done so here because "the agreement at issue here did not transfer all substantial rights from the assignee, Roche, to the exclusive licensee, Immunex."  Further:

    Under Sandoz's theory of common ownership, if a party is the effective patentee for purposes of the ability to bring an infringement suit, then it is also an effective patentee for purposes of obviousness-type double patenting," according to Sandoz and if the rule were contrary an assignment can be turned into a license.  In particular, "if a party acquires all substantial rights in a patent application, including the right to control prosecution, then obviousness-type double patenting should apply to prohibit issuance of claims that are not patentably distinct from claims in patents already owned by that party.

    The majority expressly rejected Immunex' position, that common ownership arises only when "the relevant inventions were owned by the same entity at the time of the invention," citing MPEP § 804.03(II) for its analysis of 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C. 103(c)(1).  The majority further rejected Immunex' historical argument that revisions to the patent statute in 1984 created a "gap" that ODP was intended to fill to prevent two patents arising on obvious variants of a patented invention, citing In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985) (the opinion noting that the Court had more recently rejected this interpretation in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377, 1386 (Fed. Cir. 2003), as has the PTO in Ex Parte Maurice, No. 2005-2463, 2005 WL 4779419, at *2 (B.P.A.I. Sept. 19, 2005)).

    The Federal Circuit agreed with Sandoz that the interpretation that the "all substantial rights" test was an appropriate measure for common ownership was more consistent with the purpose of the ODP doctrine, but refused to "import into this judicially-created doctrine the entirety of our body of law analyzing who is a statutory 'patentee' pursuant to 35 U.S.C. § 281," making the distinction:

    We conclude only that where one of the rights transferred is the right to prosecute the patent at issue, identification of the effective "patentee" is informative in evaluating whether the patents are "commonly owned" for purposes of obviousness-type double patenting.

    Here, the Accord and Satisfaction agreement did not satisfy this test, according to the panel majority.  While there are many factors that can be assessed for this determination, the panel focused on two:  "enforcement and alienation," and "the scope of the licensee's right to sublicense, the nature of license provisions regarding reversion of rights, the duration of the license grant, and the nature of any limits on the licensee's right to assign its interests in the patent," citing Alfred E. Mann Found. v. Cochlear Corp., 604 F.3d 1354, 1360-1 (2010).  Under Delaware law, the majority applied the de novo standard of review regarding interpreting the District Court's construction of the terms of the contract and clear error for parole evidence of the parties' intent (although in view of the express terms of the agreement the Federal Circuit found no need to resort to parole evidence).

    With regard to the parties' intent, the District Court found, and the Federal Circuit agreed, that the parties "specifically intended for the Accord & Satisfaction to be a license such that Roche would remain the owner of the patents-in-suit."  This determination was supported in the District Court by the express language of the agreement (wherein it was termed a "license") as well as testimony from an Amgen witness.  This portion of the District Court's opinion came in for criticism by the panel opinion, the majority stating that "we have clarified that 'whether a transfer of a particular right or interest under a patent is an assignment or a license does not depend upon the name by which it calls itself, but upon the legal effect of its provisions,'" citing Lone Star Silicon Innovations LLC v. Nanya Tech. Corp., 925 F.3d 1225, 1230 (Fed. Cir. 2019) (emphasis in original) (quoting Waterman v. Mackenzie, 138 U.S. 252, 256 (1891)).

    But the panel opinion is intentionally parsimonious in instructing that rather than "import[ing] into [the] judicially created doctrine [of obviousness-type double patenting] the entirety of our body of law analyzing who is a statutory 'patentee' pursuant to 35 U.S.C. § 281," rather setting forth the principle that "only that where one of the rights transferred is the right to prosecute the patent at issue, identification of the effective 'patentee' is informative in evaluating whether the patents are 'commonly owned' for purposes of obviousness-type double patenting" (emphasis in opinion).  The panel opinion held that the party having the right to control prosecution satisfies the "all substantial rules" test, and as a result "prevent[s] the unjustifiable issuance of claims that are patentably indistinct from claims already owned by that party."  Perhaps most importantly, "looking to the 'all substantial rights' test achieves the proper balance between deterring gamesmanship in prosecution, on the one hand, and avoiding any chilling effect on routine collaborations and licensing between parties working in the same field of research, on the other."

    Applying these principles to this case, the panel majority held that Roche had not transferred all substantial rights to Immunex and thus the patents were not commonly owned because the license was not substantially an assignment, as Sandoz had argued.  Considering the enforcement and alienation provisions of the agreement the Federal Circuit majority held that it is "clear" that Roche did not transfer all its substantive rights in the patents.  For the panel majority, retention by Roche of the "secondary" right to sue for infringement was dispositive, saying it was "thoroughly inconsistent" with a conclusion that the license was effectively an assignment.

    The opinion expressly distinguished the Court's earlier decision in Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245 (Fed. Cir. 2000), because there the licensee could frustrate the licensor's secondary right to sue by offering putative infringers a license, whereas here Immunex could not do so once Roche's secondary right has been triggered by Immunex's decision not to bring suit.

    The panel also considered Roche retaining the right to veto any assignment by Immunex to a third party to be inconsistent with transfer of all substantial rights in the license.

    The majority also affirmed the District Court's decision that Sandoz had not established by clear and convincing evidence that the claims were invalid for obviousness or failure to satisfy the written description requirement (Judge Reyna did not dissent from this part of the opinion).  Regarding written description, the panel affirmed the District Court's decision that the existence of the full-length p75 amino acid sequence in the prior art adequately supported claims directed to a fusion protein between full-length p75 and the Fc portion of IgG, even though the specification only disclosed such a fusion protein comprising a truncated p75 sequence, on the grounds that "[i]t is well-established that a patent specification need not re-describe known prior art concepts," citing Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) (these sequences were also available to the public from deposited materials).  In addition, the panel credited the District Court's reliance on expert witness testimony, wherein the lower court was due deference under the clear error standard of review.

    Regarding obviousness, the panel found unpersuasive Sandoz' arguments regarding motivation to combine and secondary indicia.  The panel found Sandoz' own arguments at trial and in post-trial motions regarding the relationship between motivation to combine and use of etanercept for treating inflammatory disorders contradicted its position.  For the relevant objective indicia (clinical success, long-felt need, and failure of others) the panel held that the District Court had properly concluded that Immunex had demonstrated the required nexus between the claims and the etanercept product.  As stated in the opinion, "Sandoz's arguments regarding objective indicia are merely disagreements with the district court's weighing of the evidence," which is not clear error.

    Judge Reyna's dissent on the ODP question amounted to his disagreement with the majority's application of the "all substantial rights" standard to the Accord and Satisfaction agreement between the parties; he discerned "gamesmanship" in the course of prosecuting the patents-in-suit.  On substantive law, Judge Reyna also opined that the "one-way" test for obviousness-type double patenting should be applied to this situation.  His reasoning was that because the District Court found that both the Patent Office and Roche were responsible for the delay in prosecution leading to the later-filed application granting first as a patent, the situation did not satisfy the requirement for applying the two-way test that the Patent Office be solely responsible for the delay.

    Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges O'Malley, Reyna, and Chen
    Opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Reyna

  • Chicken Origins Established (But Philosophical Questions Remain)

    By Kevin E. Noonan —

    Gallus gallus domesticusThe domesticated chicken, Gallus gallus domesticus, is the most numerous domestic animal and a preferred source of animal protein.  Chicken domestication has been thought (based on traditional measures) to have arisen in the Holocene (beginning ~11,650 years ago) from related species subspecies of wild jungle fowl, including five subspecies of red jungle fowl (RJF):  G. g. gallus, G. g. spadiceus, G. g. jabouillei, G. g. murghi, and G. g. bankiva, using traditional morphological methods of comparison.  But these methodologies have been stymied (with regard to a definitive determination regarding which of these subspecies was the progenitor) because there are no features of the bone morphology that distinguish one subspecies from another.

    Recently, an international group of researchers published a paper entitled "863 genomes reveal the origin and domestication of chicken" in Cell Research (2020).  This paper provides data consistent with modern domestic chickens being descendants of one of these subspecies, Gallus gallus spadiceus, which today exists in Southwestern China, northern Thailand and Myanmar.  However, these studies also showed that as chickens were "translocated" through South and Southeast Asia in association with human dispersal there arose interbreeding with local red jungle fowl subspecies and other species.  As a consequence, the White Leghorn chicken (the predominant commercially important breed) is a genetic mosaic of ancestries from other RJF subspecies.

    Prior studies of domesticated chicken ancestry were based on mitochondrial DNA that suggested chickens were domesticated multiple times in different cultures.  Because the domestic chicken can interbreed with wild subspecies relatives, including ones never domesticated, misleading results can be (and according to this work, were) obtained when based on mtDNA (which acts like a single genetic marker).  The methodologies used in these studies, whole genome sequencing (WGS), provides a more robust source of genetic information, and accordingly has been performed in previous studies in other species, in plants as well as animals.  Such studies have been performed on chickens, but as the authors explain, these studies have been limited to domestic chickens and did not include genetic information from putative ancestor species, which information is necessary to do the comparisons needed to elucidate the genetic consequences of chicken domestication.  This paper provides that information.

    The authors report that they performed WGS on 627 domestic chickens, 142 RJFs encompassing all five subspecies, 12 green jungle fowls (G. varius), 2 gray jungle fowls (G. sonneratii), and 4 Ceylon jungle fowls (G. lafayettii).  These genomes analyzed along with 76 previously published genomes (69 chickens and 7 RJF).

    Genetic comparison of 149 RJF genomes clustered them into 5 clades, with G. g. bankiva, being basal to all RJF subspecies. Statistical analysis indicated that there was "a long history of gene flow between RJF subspecies."  Nevertheless, these authors' analyses "indicate[d] that all RJF subspecies are genetically differentiated, which generally correspond to their geographic ranges and taxonomic classifications," these authors report.  They conclude from these results that:

    G. g. bankiva is the most divergent subspecies and has a time to the most recent common ancestor (TMRCA) with the other RJF subspecies prior to 500 kya.  . . .  The TMRCA of the four other RJF subspecies was between 50 and 125 kya [thousand years ago].  These analyses indicate that all of the RJF subspecies diverged from one another substantially earlier than the advent of chicken domestication.

    The paper next considered the geographic origin of domestic chickens.  "The phylogeny constructed with all 149 RJFs and 696 domestic chickens supports a monophyletic clade composed of some wild G. g. spadiceus specimens and all but two of the 696 domestic chickens."  All domestic chicken populations are most closely related to wild G. g. spadiceus, with the split of G. g. spadiceus from domestic chickens having taken place ~9500 ± 3300 years ago.

    Geographically, the authors report two clades:

    Clade I includes chickens from Europe and the Americas (including European broiler and egg layer chickens of White Leghorn, White Plymouth, Rhode Island Red and Cornish breeds), Iran, Pakistan, India, Bangladesh and northwestern China (i.e., Tibet and Xinjiang provinces bordering India).  Clade II contains mostly northern, central, and southern Chinese village chickens (i.e., from Shanxi and Jiangxi provinces).  Branches basal to the two clades, but within the total diversity of chickens, include 128 chickens sampled almost exclusively from the Yunnan province of China, Thailand, Vietnam and Indonesia.  These individuals may represent the earliest domestic lineages or have admixed with local RJF subspecies.

    This is illustrated as follows:

    Figure a
    Starting from this origin (which contradicts earlier estimates that domestic chickens arose during the Neolithic in northern China), the authors further report that specimens from alternative locales (such as the Indus Valley in what is now Pakistan) "showed a deeper divergence from chickens than the remaining birds of G. g. murghi collected from northeastern India."  These data were consistent with mtDNA analyses and with the congruence of the estimated divergence time (54,800 +/- 5,100 years ago) between G. g. murghi and G. g. spadiceus subspecies and the estimated divergence time between G. g. spadiceus and domestic chickens (i.e., the two subspecies diverged prior to divergence of either subspecies with domestic chickens).  However, due to introgression after domestication, these authors determined that G. g. murghi contributed 3.8-22.4% of the genome of modern White Leghorn domesticated chickens.  These analyses also supported earlier studies suggesting that three additional species (green jungle fowl with Indonesia chicken, Ceylon jungle fowl with Sri Lankan chicken, and the gray jungle fowl) contributed to the modern domesticated genome, although contributions from the former two species occurred at low frequencies.

    Turning to specific genetic features related to adaptation of domestic chickens that were subjected to positive selection therefore, these authors report that these included "genes bearing signal of selection are associated with development of nervous system, muscle and bone as well as regulation of growth, metabolism and reproduction."  Specifically, these genes included "multiple genes with evidence of selection are found in the neural crest development pathway, including FGFR1 (fibroblast growth factor receptor 1), MYC-l, ERBB4, and BMPs."  Of particular significance was detection of positive selection of the FGFR1 gene, which is known to be involved in the regulation of embryonic development and skeletogenesis and has been found in other domesticated animals including horses and carp.  The involvement of these and other genes (including GNRH-I (gonadotropin-releasing hormone 1) and KIF18A (kinesin family member 18A)), involved in embryogenesis, may be related to the domesticated chicken phenotypes of increased fertility and increased egg production compared with their wild relatives.

    Finally, these researchers report that a missense mutation in thyroid stimulating hormone receptor, previously thought to be a genetic marker for domestication, was fixed in the ancestral G. g. spadiceus (but only in this subspecies).

    The authors close by stating:

    The novel findings from this study provide new insights into the origin and evolutionary history of domestic chickens.  The identification of unique genomic landscapes of all RJF subspecies and three additional jungle fowl species suggests that conservation efforts should be made to safeguard them from extinction.  These rich genomic resources will pave the way to facilitate ongoing explorations into the biocultural history of the relationship between humans and chickens as well as the development of fast-growing, high-quality and cost-effective lineages.

    Image of "A cock and a hen roosting together" by Andrei Niemimäki, from the Wikimedia Commons under the Creative Commons Attribution-Share Alike 2.0 Generic license.

  • Conference & CLE Calendar

    CalendarJuly 7, 2020 – "Antibodies and non-obviousness at the EPO" (Mathys & Squire) – 6:00 to 7:00 pm (GMT Summer Time)

    July 7, 2020 – "Oral Argument Opportunities for Newer Attorneys in the PTAB and Other Venues" (Federal Circuit Bar Association) – 3:00 to 4:00 pm (EDT)

    July 8, 2020 – European Biotech Patent Law Webinar (D Young & Co) – 9:00 am, noon, and 5:00 pm (BST)

    August 5-6, 2020 – Advanced Summit on Life Sciences Patents Conference (American Conference Institute)

  • ACI Advanced Summit on Life Sciences Patents Conference

    ACIAmerican Conference Institute (ACI) will be holding its 18th Advanced Summit on Life Sciences Patents conference on August 5-6, 2020 as a VIRTUAL conference.

    The conference will offer presentations on the following topics:

    • Strengthening International Patent Protection for Small Molecules and Antibodies by Enhancing Written Description and Enablement
    • Exploring the Realities of the New USPTO Guidance on Section 101 to Uncover New Meaning of "Invention or Discoveries"
    • Understanding How the Latest Doctrine of Equivalents Decisions in the U.S., Europe, and Asia is Influencing Patent Protection Strategies
    • Minimizing Infringement Risks in Licensing Agreements In the U.S. and Europe
    • Social Contracting: How Does This Affect the Design of Patent Portfolios
    • Examining Inherency and Obviousness from Brand and Generic Perspectives in the U.S. and Europe

    In addition, two pre-conference workshops will be offered on August 4, 2020.  The first, entitled "Masterclass on Drafting Life Sciences Patent Applications in the U.S., Europe and Asia," will be offered from 9:00 am to 12:30 pm, and the second, entitled "Working Group on Developing Effective Patent Filing Strategies for Combination Products," will be offered from 1:30 to 5:00 pm.

    The registration fee for the conference and both workshops is $1,895.  Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-762-762CX09.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.

    Patent Docs is a media partner of ACI's 18th Advanced Summit on Life Sciences Patents Conference.

  • European Biotech Patent Law Webinar

    D Young & CoD Young & Co will be offering its next European biotech patent law update on July 8, 2020.  The webinar will be offered at three times: 9:00 am, noon, and 5:00 pm (BST).  D Young & Co European Patent Attorneys Simon O'Brien and Catherine Keetch will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • Webinar on Antibodies and Non-obviousness at the EPO

    Mathys & SquireMathys & Squire will be offering a webinar entitled "Antibodies and non-obviousness at the EPO" on July 7, 2020 from 6:00 to 7:00 pm (GMT Summer Time).  Martin MacLean and Hazel Ford of Mathys & Squire LLP will discuss the arguments that are most likely to be effective when addressing inventive step objections at the European Patent Office in the antibody field, including the effects or advantages that might be relied upon, and the types of evidence that might be deployed to support an antibody claim.  They will also discuss the breadth of claims that might be obtained in different circumstances based on current EPO practice, and will consider when questions of lack of enablement are most likely to arise in an antibody case.

    While there is no cost to participate in the program, those interested in attending the webinar can register here.

  • FCBA Program on Oral Argument Opportunities for Newer Attorneys

    Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) PTAB/TTAB Committee will be offering a remote program entitled "Oral Argument Opportunities for Newer Attorneys in the PTAB and Other Venues" on July 7, 2020 from 3:00 to 4:00 pm (EDT).  Megan Raymond of Paul, Weiss, Rifkind, Wharton & Garrison LLP will moderate a panel consisting of Hon. Scott Boalick, Chief Judge, U.S. Patent and Trademark Office, Patent Trial and Appeal Board; Hon. Virginia M. Kendall, District Judge, U.S. District Court for the Northern District of Illinois; Hon. Jacqueline Wright Bonilla, Deputy Chief Judge, U.S. Patent and Trademark Office, Patent Trial and Appeal Board; and Vaishali Udupa of Hewlett Packard Enterprise.  The panel will discuss oral argument opportunities for newer attorneys across venues, with a focus on the USPTO's new Legal Experience and Advancement Program ("LEAP"), which is intended to encourage the professional development of junior patent attorneys and agents appearing before the PTAB through increased training and opportunities for oral advocacy.

    The webinar is complimentary for FCBA members and students, $50 for government/academic/retired attendees, or $175 for private practitioners.  Those interested in registering for the program, can do so here.