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  • Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007)

        By Kevin E. Noonan —

    Logo
    The Federal Circuit today affirmed a District Court finding that ANDA filer Ivax Pharmaceuticals and co-Defendant Cipla had not shown by clear and convincing evidence that Forest Laboratories’ patent-in-suit for Lexapro® was invalid.  In doing so, the CAFC answered (for now) the question of whether a patent on a particular, biologically-active enantiomer of a patented drug is obvious.

    Fl
    The case was brought by Forest under 37 U.S.C. § 271(e)(2)(A) upon Ivax’s filing of an ANDA for Lexapro®, a selective serotonin reuptake inhibitor used to treat depression.  The patent-in-suit, U.S. Reissue Patent No. 34,712, claimed the substantially pure (+)-enantiomer of citalopram (termed "escitalopram"):

    A compound selected from substantially pure (+)-1-(3-Dimethylaminopropyl)-1-(4′-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof.

    (‘712 patent, Claim 1); Lexapro® is an oxalate salt formulation.  The parties stipulated that the subject of Ivax’s ANDA would infringe the ‘712 patent, and that if valid, filing the ANDA constituted infringement under the statute.  Accordingly, the issue at trial was whether the ‘712 was invalid as alleged in Ivax’s Paragraph IV certification.

    There were three grounds of invalidity asserted by Ivax and Cipla before the District Court.  First, the Defendants alleged that the compound claims of the patent-in-suit were invalid as being anticipated by a prior art reference (the Smith reference) that discussed selective serotonin reuptake inhibitors (including citalopram).  However, "substantially pure" (+)-enantiomer of citalopram was not explicitly disclosed in the reference, and the District Court found that the reference did not enable the skilled worker to produce it.  Specifically, the technique taught in the reference for separating enantiomers was new and unpredictable, and there was evidence that Smith himself, as well as others including the inventor of the ‘712 patent, failed in attempting to produce escitalopram using the method.  The District Court found that the Smith reference was not enabled for producing escitalopram, and thus that the claims of the ‘712 patent were not anticipated.

    On the question of obviousness, the District Court found that the Smith reference would not provide the skilled worker with a reasonable expectation of success at separating the citalopram enantiomers, and that success was sufficiently uncertain that the worker would be motivated to discover new compounds rather than try to separate the enantiomers.  Regarding the method claim (claim 11), the District Court found that the art did not describe the reactions recited in the claim.

    Finally, the District Court found that claim 11 was not invalid for being impermissibly broadened more than two years after the patent issued.  In reissue, claim 11 was amended to recite that a (-)diol intermediate was converted to (+)citalopram; the claim as issued recited that (+)citalopram was produced from a (+)diol intermediate.  The District Court found that the error was merely a typographical error, and would have been appreciated by a worker of ordinary skill.

    The Federal Circuit affirmed the District Court on all three asserted grounds of invalidity in an opinion written by Judge Lourie; the opinion was unanimous on all issues except extension of the statutory injunction to co-Defendant Cipla (Judge Schall dissenting that the statute did not permit Cipla to be enjoined).  For both anticipation and obviousness, the Federal Circuit found that Ivax did not establish that the District Court had committed clear error; instead, the CAFC stated that Ivax had merely "emphasize[d] the evidence that is favorable to their desired outcome without addressing the evidence favorable to Forest."  In doing so, Ivax did not establish "why the district court was not entitled to rely on the evidence favorable to Forest or demonstrate that the evidence favorable to them heavily outweighed the evidence favorable to Forest" and thus did not satisfy their burden on appeal of showing that the District Court’s factual determinations were clearly erroneous.

    On the question of obviousness, the Federal Circuit relied on the District Court’s factual determinations that were, according to the panel, applied using the analysis set forth in Graham v. John Deere Co.; KSR Int’l Co. v. Teleflex, Inc. was not cited by the CAFC, or apparently by the parties.  The Federal Circuit also affirmed that correction of the typographical error was not an impermissible broadening under the reissue statute.

    The significance of this decision is found more in what the Federal Circuit did not say than in its relatively pedestrian affirmance.  An open question remaining after KSR is whether enantiomer patents would fall within the ambit of the Supreme Court’s seemingly-expansive dicta regarding what is obvious to try:

    When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.

    For20200
    Enantiomer patents can be fitted within at least a portion of this framework.  There are typically "market pressures" for producing a more effective drug; in cases where only one of the enantiomers is biologically-active, effectiveness should double.  Enantiomers also provide the ultimate in "finite number" of "identified" solutions:  namely, two.  The question is whether the "solution" – the substantially purified enantiomer – is sufficiently predictable and leads to anticipated success.  In the Lexapro® case, the art did not identify which of the two enantiomers was the active one, and the evidence established that separation of the enantiomers was sufficiently unpredictable that the District Court opined that the skilled worker was motivated to investigate new drugs rather than tackle separation of the enantiomers.  On these facts, the enantiomer claim satisfied the requirements for non-obviousness.

    Cipla_logo
    The dissent raises an interesting issue of statutory interpretation.  The majority affirmed the scope of the injunction to include Cipla, who was to have produced the drug for distribution by Ivax.  Cipla had not supplied Ivax with any infringing drug, however, and its contributions to Ivax’s ANDA were limited to information on bioequivalence.  Judge Schall in dissent considered Cipla immunized from the District Court’s injunction on two grounds:  first, that 35 U.S.C. § 271(e)(4)(B) provides for an injunction only against the ANDA filer; and second, that Cipla’s activities fell within the scope of 35 U.S.C. § 271(e)(1) under the interpretation of that statute by the Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd.  Although the majority’s policy imperative is understandable (without the injunction Cipla could partner with another ANDA filer and challenge the validity of the ‘712 patent anew), Judge Schall’s analysis seems more firmly rooted in the plain language of the statute.

    Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007)
    Panel: Senior Circuit Judge Friedman and Circuit Judges Lourie and Schall
    Opinion by Circuit Judge Lourie, concurring-in-part and dissenting-in-part opinion by Circuit Judge Schall

    Additional information regarding this case can be found at the Orange Book Blog and Patently-O.

  • An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice

        By Donald Zuhn —

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office’s nearly two hour webcast on August 23, 2007 (and the webcast’s accompanying 109-page presentation), and the Office’s 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.


    37 C.F.R. § 1.114:

    Under revised 37 C.F.R. § 1.114, an applicant will be allowed to file only a single request for continued examination (RCE) without a petition and showing in a single application family.  The Patent Office defines an application family as including an initial application and its continuation or continuation-in-part applications.  The requirements of revised Rule 114, when coupled with the requirements of Rule 78(d)(1) (which were discussed in an earlier article in this series), create a "2 + 1" rule that allows an applicant to file only two continuation or continuation-in-part applications and only one RCE per application family without any justification.  As with Rule 78(d)(1)(vi), an applicant may exceed the one RCE limit of Rule 114 by filing a petition, fee, and showing that an amendment, argument, or evidence sought to be entered with the RCE could not have been submitted earlier in prosecution.

    Federal_register_cover_2
    Compared with the prior version of the rule, under revised Rule 114(a), an applicant’s right to file an RCE is severely restricted.  In particular, if an applicant fails to satisfy the conditions of § 1.114(f)(1)-(3), an RCE must be accompanied by a petition under § 1.114(g).

    New Rule 114(f) – the prior version of § 1.114 contained only five subparts – provides the conditions under which an applicant may file an RCE without a petition under § 1.114(g).  Rule 114(f)(1) allows an applicant to file an RCE without a petition under § 1.114(g) provided that an RCE has not been previously filed in (1) that application, (2) a prior-filed application whose benefit is claimed in that application, or (3) an application that claims the benefit of that application (excluding applications that satisfy the provisions of Rule 78(d)(1)(ii)-(iv)).  In other words, Rule 114(f)(1) allows an applicant to file a single RCE in either an initial application or its continuation applications without a petition under § 1.114(g).

    Rules 114(f)(2) and (f)(3) allow an applicant to file an RCE without a petition under § 1.114(g) in a divisional application (or one of its continuations) provided that an RCE has not been previously filed in (1) that divisional application, (2) a continuation of that divisional application, or (3) an application that claims the benefit of that divisional application (excluding applications that satisfy the provisions of Rule 78(d)(1)(ii)-(iv)).  In other words, Rules 114(f)(2) and (f)(3) allow an applicant to file a single RCE in a divisional or its continuations without a petition under § 1.114(g).

    When an applicant is unable to satisfy the conditions of § 1.114(f)(1)-(3), new Rule 114(g) allows the applicant to file an additional RCE provided that the applicant also files a petition, fee, and showing that an amendment, argument, or evidence sought to be entered with the RCE could not have been submitted earlier in prosecution.  According to the Patent Office’s final rule notice, a petition under § 1.114(g) including only an information disclosure statement as the submission required under § 1.114(c) would not be granted because the IDS would not constitute "[an] amendment, argument, or evidence."

    As described in the Patent Office’s new rules FAQ (see Question E6), the PTO will determine on a case-by-case basis whether an applicant’s showing is satisfactory.  Factors that the Patent Office will consider when deciding whether to grant a petition include: (1) whether an applicant should instead file an appeal or petition to withdraw the finality of an Office action, (2) the number of other filed applications having substantially identical disclosures, and (3) whether the showing was submitted with reasonable diligence.  The PTO warns, however, that "[a]pplicants should not rely upon the availability of additional continuing applications or RCEs in prosecuting an application."

    New Rule 114(h) provides that the filing of an improper RCE – including an RCE with a petition under § 1.114(g) that is not grantable – will not stay any period for reply.

    The changes to § 1.114 apply to any application in which an RCE is filed on or after November 1, 2007.  According to the final rule notice, therefore:

    a petition under 37 CFR 1.114(g) must accompany any request for continued examination filed on or after November 1, 2007, in an application in which a request for continued examination has previously been filed, or in a continuation application or continuation-in-part application of an application in which a request for continued examination has previously been filed, or in an application whose benefit is claimed in a continuation application or continuation-in-part application in which a request for continued examination has previously been filed.

    Thus, in those situations where an RCE has not yet been filed in an application family, an applicant would be wise not to try to squeeze in a "freebie" before November 1, 2007, since such an RCE filing would eliminate the possibility of filing an RCE after November 1, 2007 (i.e., under the new rules there are no freebies).

    For additional articles in this series, please see:

    For additional information on this and other related topics, please see:


    Changes to Rule 114:

    (a) If prosecution in an application is closed, an applicant may, subject to the conditions of this section, file a request for continued examination of the application accompanied by a submission, the fee set forth in § 1.17(e), and if required, a petition under paragraph (g) of this section accompanied by the fee set forth in § 1.17(f), prior to the earliest of:

    (1) Payment of the issue fee, unless a petition under § 1.313 is granted;
    (2) Abandonment of the application; or
    (3) The filing of a notice of appeal to the U.S. Court of Appeals for the Federal Circuit under 35 U.S.C. 141, or the commencement of a civil action under 35 U.S.C. 145 or 146, unless the appeal or civil action is terminated.

    * * *

    (d) If an applicant files a request for continued examination under this section after appeal, but prior to a decision on the appeal, the request for continued examination will also be treated as a request to withdraw the appeal and to reopen prosecution of the application before the examiner. An appeal brief (§ 41.37 of this title), a reply brief (§ 41.41 of this title), or related papers will not be considered a submission under this section.

    * * *

    (f) An applicant may file a request for continued examination under this section in an application without a petition under paragraph (g) of this section if the conditions set forth in at least one of paragraphs (f)(1), (f)(2), or (f)(3) of this section are satisfied:

    (1) A request for continued examination under this section has not previously been filed in any of:

    (i) The application;
    (ii) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such application; and
    (iii) Any application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such application, not including any nonprovisional application that satisfies the conditions set forth in § 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

    (2) The application is a divisional application that satisfies the conditions set forth in § 1.78(d)(1)(ii), and a request for continued examination under this section has not previously been filed in any of:

    (i) The divisional application; and
    (ii) Any application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application, not including any nonprovisional application that satisfies the conditions set forth in § 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

    (3) The application is a continuation application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional application and satisfies the conditions set forth in § 1.78(d)(1)(iii), and a request for continued examination under this section has not been filed in any of:

    (i) The continuation application;
    (ii) The divisional application; and
    (iii) Any other application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application, not including any nonprovisional application that satisfies the conditions set forth in § 1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).

    (g) A request for continued examination must include a petition accompanied by the fee set forth in § 1.17(f) and a showing that the amendment, argument, or evidence sought to be entered could not have been submitted prior to the close of prosecution in the application, except as otherwise provided in paragraph (f) of this section.
    (h) The filing of an improper request for continued examination, including a request for continued examination with a petition under paragraph (g) of this section that is not grantable, will not stay any period for reply that may be running against the application, nor act as a stay of other proceedings.

  • An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims

        By Donald Zuhn —

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice
    regarding the new rules, the Patent Office’s nearly two hour webcast on
    August 23, 2007 (and the webcast’s accompanying 109-page presentation), and the Office’s 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.


    37 C.F.R. § 1.75(b):

    The prior version of 37 C.F.R. § 1.75(b) simply reads as follows:

    (b)  More than one claim may be presented provided they differ substantially from each other and are not unduly multiplied.

    Federal_register_cover
    The new version of 37 C.F.R. § 1.75(b), which provides a revised practice for the examination of claims in an application, expands on the simple requirements of the prior version of this subsection by some 522 words and five new subparts.  The provision that has received the most attention is § 1.75(b)(1), which limits the number of claims in any one application – in the absence of an examination support document (ESD) – to no more than five independent claims and no more than twenty-five total claims.

    The introductory text of Rule 75(b) sets forth some standard rules regarding dependent claims.  In particular, this portion of the rule allows an applicant to present one or more claims in dependent form, wherein the dependent claim is required to incorporate by reference all the limitations of the claim to which it refers and to specify a further limitation of the subject matter of the previous claim.

    Rule 75(b)(1) states that an applicant must file an examination support document (ESD) complying with § 1.265 before the issuance of a first Office action on the merits when an application contains (or is amended to contain) more than five independent claims or more than twenty-five total claims (5/25 rule).

    Rule 75(b)(2) states that the following claims will be treated as independent claims when determining whether an application complies with the 5/25 rule (as well as for fee calculation purposes): (a) a claim that refers to another claim but does not incorporate by reference all the limitations of that claim, and (b) a claim that refers to a claim of a different statutory class of invention.

    Rule 75(b)(3) states that an applicant will be notified when an application contravenes the 5/25 rule of § 1.75(b)(1) and an ESD has not been filed.  When the non-compliance with the 5/25 rule appears to be inadvertent, a two-month, nonextendable deadline will be set for filing an ESD or reducing the number of claims (for applications filed on or after November 1, 2007; applications filed before November 1, 2007 will get a two-month deadline extendable to six months).  However, when an applicant fails to submit an ESD before the issuance of a first Office action on the merits, the applicant will only be permitted to reduce the number of claims to comply with the 5/25 rule.

    Rule 75(b)(4) states that when two commonly owned applications contain a patentably indistinct claim, all of the claims in each application – and not just the patentably indistinct claim – will be treated as being present in the other application for purposes of determining whether the applications comply with the 5/25 rule.  Rule 75(b)(4) applies to any copending nonprovisional applications containing patentably indistinct claims – including applications having a continuity relationship – but not in issued patents containing patentably indistinct claims.

    In its final rule notice, the Patent Office notes that Rule 75(b)(4) is intended "to preclude an applicant from submitting multiple applications to the same subject matter (with claims that are patentably indistinct), each with five or fewer independent claims or twenty-five or fewer total claims, for the purpose of avoiding the requirement to submit an examination support document."  More importantly, the final rule notice also states that:

    An applicant may present up to five independent claims and twenty-five total claims in an initial application and each continuing application, provided that continuing applications that contain patentably indistinct claims are not prosecuted in parallel with the initial application or each other.  Thus, an applicant may present up to fifteen independent claims and seventy-five total claims to a single invention via an initial application and two continuing applications that are filed and prosecuted serially.

    Needless to say, the requirements of Rule 75(b)(4) beg the question of how an applicant might practically prosecute two continuations in parallel as depicted, for example, on the left half of slide 20 of the Patent Office’s PowerPoint presentation on the Claims and Continuations Final Rule.

    Because 35 U.S.C. § 120 requires that a prior application be pending when a continuing application is filed, and Rule 75(b)(4) also applies to copending nonprovisional applications having a continuity relationship, the Patent Office has determined that an application will be treated as no longer pending for the purposes of § 1.75(b)(4) if (1) a notice of allowance is issued (unless the application is withdrawn from issue), (2) the Office recognizes the application is abandoned, (3) a notice of appeal to Federal Circuit is filed (unless the appeal is terminated), or (4) a civil action under 35 U.S.C. §§ 145 or 146 is commenced (unless the civil action is terminated).

    Because divisional applications by definition do not contain patentably indistinct claims, such applications fall outside of Rule 75(b)(4).  Continuations of such divisionals, however, are not safe from the requirements of this rule.

    Rule 75(b)(5) states that claims withdrawn from consideration as being drawn to a non-elected invention (unless subsequently reinstated or rejoined) will not be taken into account in determining whether an application complies with the 5/25 rule.  Such claims will also not be considered with respect to the requirements of Rule 75(b)(4).  However, if such claims are later reinstated or rejoined, the claims will be considered with respect to the requirements of both § 1.75(b)(1) and (4).  The claims must be withdrawn as the result of an Office-initiated requirement under § 1.142, 1.146, or 1.499 (regardless of whether the election is with or without traverse), or as the result of the acceptance of a suggested restriction requirement under § 1.142(c).

    The requirements of Rule 75(b) apply to all applications filed or entering national stage on or after November 1, 2007 and all applications for which an Office action on the merits has not been issued before November 1, 2007.  If the requirements of Rule 75(b) were not enough, noncompliance with this rule will also have Patent Term Adjustment ramifications.

    For additional articles in this series, please see:

    For additional information on this and other related topics, please see:


    Text of new Rule 75(b):

    (b) More than one claim may be presented provided they differ substantially from each other and are not unduly multiplied. One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. A dependent claim must contain a reference to a claim previously set forth in the same application, incorporate by reference all the limitations of the previous claim to which such dependent claim refers, and specify a further limitation of the subject matter of the previous claim.

    (1) An applicant must file an examination support document in compliance with § 1.265 that covers each claim (whether in independent or dependent form) before the issuance of a first Office action on the merits of the application if the application contains or is amended to contain more than five independent claims or more than twenty-five total claims. An application may not contain or be amended to contain more than five independent claims or more than twenty-five total claims if an examination support document in compliance with § 1.265 has not been filed before the issuance of a first Office action on the merits of the application.
    (2) A claim that refers to another claim but does not incorporate by reference all of the limitations of the claim to which such claim refers will be treated as an independent claim for fee calculation purposes under § 1.16 (or § 1.492) and for purposes of paragraph (b) of this section. A claim that refers to a claim of a different statutory class of invention will also be treated as an independent claim for fee calculation purposes under § 1.16 (or § 1.492) and for purposes of paragraph (b) of this section.
    (3) The applicant will be notified if the application contains or is amended to contain more than five independent claims or more than twenty-five total claims but the applicant has not complied with the requirements set forth in paragraph (b)(1) or (b)(4) of this section. If the non-compliance appears to have been inadvertent, the notice will set a two-month time period that is not extendable under § 1.136(a) within which, to avoid abandonment of the application, the applicant must comply with the requirements set forth in paragraph (b) of this section.
    (4) If a nonprovisional application contains at least one claim that is patentably indistinct from at least one claim in one or more other pending nonprovisional applications, and if such one or more other nonprovisional applications and the first nonprovisional application are owned by the same person, or are subject to an obligation of assignment to the same person, the Office will treat the claims (whether in independent or dependent form) in the first nonprovisional application and in each of such other pending nonprovisional applications as present in each of the nonprovisional applications for purposes of paragraph (b) of this section.
    (5) Claims withdrawn from consideration under §§ 1.141 through 1.146 or § 1.499 as drawn to a nonelected invention or inventions will not, unless they are reinstated or rejoined, be taken into account in determining whether an application exceeds the five independent claim and twenty-five total claim threshold set forth in paragraphs (b)(1), (b)(3), and (b)(4) of this section.

  • A Complete Diploid Human Genome Reveals Some Surprises

        By Kevin E. Noonan —

    J_craig_venter_institute_2
    As reported earlier by a variety of news sources, the J. Craig Venter Institute published today the sequence of a complete diploid human genomic complement, fitting that of the eponymous Dr. Venter (below), on the Public Library of Science (PLoS) website.  This sequence differs in several ways from previously-published "complete" human genomic DNA sequences.  First, it was produced from a single individual, whereas the earlier sequences were from several (Dr. Venter’s own earlier work included sequences from five individuals, including himself).  Second, although this isn’t the first individual genomic DNA complement sequenced (that honor, fittingly, went to James Watson), it is the first diploid sequence reported (that is, where there was an effort to sequence both chromosomes of an individual).  This approach made it possible for the Venter group (and their collaborators) to compare DNA sequences from each of the chromosomes Dr. Venter inherited from his mother and father, and some of the results were unexpected.

    Venter_craig
    When compared with the human reference sequence contained in the National Center for Biotechnology Information, Dr. Venter’s DNA revealed more than 4 million DNA variants, over a million of which (30%) were novel (indicating a great deal of sequence variation in an individual).  These variants included single nucleotide polymorphisms (SNPs, more than 3.2 million), substitutions of 2-206 basepairs (bp) (>50,000), heterozygous insertions or deletions of 1-571 bp (almost 300,000), homozygous insertions or deletions of 1-82,711 bp (more than 559,000) and 90 inverted sequences.  Although the genetic variation that was not related to SNPs accounted for only 22% of the "events," the non-SNP variation comprised 74% of the variant bases.  Confirming earlier genetic work by Richard Lewontin and others, 44% of the gene (protein-coding) sequences detected were heterozygous for one or more variants.

    The authors took advantage of improvements in the technology, especially in the open source Celera comparison and alignment algorithms used to assemble the sequence (which was produced using Venter’s random shotgun cloning/sequencing techniques that helped his team compete with the much larger effort of the Human Genome Project to produce the first human genomic sequence several years ago).  These results provided about 120 megabases (Mbp) of sequence used to align earlier versions of the human genome or to fill in gaps in those sequences; 14 Mbp of these sequences were previously unreported.

    When the frequency and position of the SNPs and insertion/deletion (indel) events were mapped, 42% of SNPs and 91% of indels were found to have been eliminated in coding regions, presumably by natural selection.  This is particularly apt for the indels, most of which result in a frameshift in the coding sequence that would produce a non-functional protein.  When the genetic diversity of the alleles from the two parental chromosomes were compared, 11,718 heterozygous and 9,434 homozygous coding SNPs were found, as were 236 heterozygous and 627 homozygous coding indels.  The authors calculated that at least 17% (4,107/23,224) of Dr. Venter’s genes contained nonsynonymous SNPs that would produce different proteins, and 44% of genes (10,208/23,224), or almost half, have at least one heterozygous variant in the either the untranslated (UTR) or coding regions that would affect the amino acid sequence of the encoded protein or gene expression due to differences in elements contained in the UTRs.  This is likely to be an underestimate, since it does not include variation in non-coding regions involved in gene regulation (for example, promoter, enhancers, and other regulatory elements).

    The authors estimate that there is a minimum of 0.5% variation between different diploid genomes (that is, between different individual humans).  The significance of this result will be appreciated when it is realized that there is only an estimated 2% difference between human and chimpanzee genomic DNA sequences.  This amount of human genetic variability is remarkable, and the authors admit that the amount of variability in heterochromatic regions "largely escaped analysis in this study."

    These results are exciting for the prospect of better understanding human genetic variability, and in particular identifying variability important for phylogeny versus that important for intraspecies variability.  However, this work also points out the long way there is to go for the long-awaited, "practical" benefits of the explosion of human genetic information obtained in the past decade (such as personalized medicine).  It has been a hallmark of biotechnology that the ability to view the possible applications of the technology has exceeded the capacity to exploit those insights to expeditiously develop the applications.  It will likely be many years before the insights gleaned from Dr. Venter’s genomic DNA sequence will be truly useful; for now we can but marvel at the accomplishment and the underlying genetic complexity of one individual human.

  • Court Report

        By Sherri Oslick —

    Gavel_17
    About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.

    Ocular Research of Boston, Inc. v. Allergan
    2:07-cv-00385; filed August 31, 2007 in the Eastern District of Texas

    Infringement of U.S. Patent No. 5,578,586 ("Dry eye treatment process and solution," issued November 26, 1996) based on defendants’ manufacture and sale of products, and by undertaking processes, embodying the patented inventions.  View the complaint here.


    Human Genome Sciences Inc. v. Amgen Inc. et al
    1:07-cv-00526; filed August 30, 2007 in the District Court of Delaware

    Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Immunex (now Amgen) in the interference between U.S. Patent Application 10/005,842 ("Death Domain Containing Receptor 5"), assigned to Human Genome Sciences, and U.S. Patent No. 6,642,358 ("Receptor That Binds TRAIL," issued November 4, 2003), assigned to Immunex.  View the complaint here.


    Sandoz, Inc. v. Eli Lilly and Company
    2:07-cv-04100; filed August 27, 2007 in the District Court of New Jersey

    Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/Hyperactivity Disorder," issued August 19, 1997) in conjunction with Sandoz’s filing of an ANDA to manufacture a generic version of Lilly’s Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  View the complaint here.


    Celgene Corporation v. Barr Laboratories, Inc. et al.
    2:07-cv-04050; filed August 23, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 7,230,012 ("Pharmaceutical Compositions and Dosage Forms of Thalidomide," issued June 12, 2007) following an amendment of Barr’s ANDA to manufacture a generic version of Celgene’s Thalomid® (thalidomide, used to treat erythema nodosum leprosum and multiple myeloma) to include a paragraph IV certification of the ‘012 patent.  View the complaint here.

  • An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications

        By Donald Zuhn —

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice
    regarding the new rules, the Patent Office’s nearly two hour webcast on
    August 23, 2007 (and the webcast’s accompanying 109-page presentation), and the Office’s 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.


    37 C.F.R. § 1.78(d)(1):

    The prior version of 37 C.F.R. § 1.78 contained subparts (a) to (c).  Among the new subparts added to Rule 78 is subpart (d), which is further divided into five parts.  Rule 78(d) provides conditions under which an application may claim the benefit of a prior-filed nonprovisional or International application.  In particular, a nonprovisional application will be entitled to claim the benefit of one or more prior-filed copending nonprovisional applications or international applications designating the U.S. only if it satisfies the requirements set forth in at least one of the paragraphs of § 1.78(d)(1)(i) through (d)(1)(vi).  In the event that an applicant makes a benefit claim that does not satisfy at least one of the paragraphs of Rule 78(d)(1)(i) through (d)(1)(vi), the Patent Office will refuse to enter the benefit claim, or will delete the claim if present.

    Federal_register_cover
    Rule 78(d)(1)(i) specifies that a continuation or continuation-in-part application of a prior-filed nonprovisional application is permitted when (1) the continuation or continuation-in-part application claims the benefit of no more than two prior-filed applications, and (2) any application whose benefit is claimed has its benefit claimed in no more than one other nonprovisional application (excluding applications that satisfy the provisions of Rule 78(d)(1)(ii)-(iv)).  Rule 78(d)(1)(i), therefore, allows an applicant to continue prosecution of an application via two continuation applications, a continuation application and a continuation-in-part application, or two continuation-in-part applications.

    Rule 78(d)(1)(ii) specifies that a divisional application is permitted when the divisional application (1) contains claims to a non-elected invention that was subject to a restriction or unity of invention requirement in a prior-filed application, and (2) the non-elected invention was not examined in the prior-filed application.  Rule 78(d)(1)(ii), therefore, allows an applicant to obtain examination of claims that have been withdrawn from consideration in a prior-filed application due to a restriction or unity of invention requirement.

    Rule 78(d)(1)(iii) specifies that a continuation of a divisional application is permitted when (1) the divisional application satisfies the benefits of § 1.78(d)(1)(ii), (2) the continuation discloses and claims only an invention that was not disclosed and claimed in the divisional application, (3) the application claims the benefit of only the divisional application, any application to which the divisional application claims the benefit pursuant to § 1.78(d)(1)(ii), and no more than one intervening prior-filed nonprovisional application (i.e., only one continuation application of the divisional application filed between the divisional application and the second continuation application of the divisional application), and (4) no more than one other nonprovisional application claims the benefit of the divisional application.  Rule 78(d)(1)(i), therefore, allows an applicant to continue prosecution of a divisional application via two continuation applications (but not a continuation-in-part application, since the PTO states in its final rule notice that Rule 78(d)(1)(iii) was not designed "to permit an applicant to seek patent protection for a new invention that merely bears some relationship to an invention or inventions that were disclosed and claimed in a divisional application").

    Rule 78(d)(1)(iv) applies to "bypass" continuation or continuation-in-part applications.  A bypass application is an application that claims the benefit of an international application that did not enter the national stage.  Under Rule 78(d)(1)(iv), an applicant filing a bypass application will be permitted to file "one more" continuation or continuation-in-part application without having to file a petition and showing under § 1.78(d)(1)(vi), provided that (1) a Demand for international preliminary examination has not been filed and the basic national fee has not been paid for the international application, and the international application does not claim the benefit of any other nonprovisional application or international application designating the U.S., and (2) the bypass application claims the benefit of no more than three prior-filed applications, and any application whose benefit is claimed has its benefit claimed in no more than two other nonprovisional applications (excluding applications that satisfy the provisions of Rule 78(d)(1)(ii)-(iv)).

    Rule 78(d)(1)(v) applies to situations in which a prior-filed nonprovisional application becomes abandoned due to an applicant’s failure to timely reply to a Notice of Missing Parts.  Under Rule 78(d)(1)(v), an applicant filing such an application will be permitted to file "one more" continuation or continuation-in-part application without having to file a petition and showing under § 1.78(d)(1)(vi), provided that the application claims the benefit of no more than three prior-filed applications, and any application whose benefit is claimed has its benefit claimed in no more than two other nonprovisional applications (excluding applications that satisfy the provisions of Rule 78(d)(1)(ii)-(iv)).

    Rule 78(d)(1)(vi) permits an applicant to file a continuing application claiming the benefit of a prior-filed application without satisfying Rule 78(d)(1)(i)-(v), provided that the applicant also files a petition, fee, and showing that an amendment, argument, or evidence sought to be entered with the continuing application could not have been submitted during the prosecution of the prior-filed application.  Rule 78(d)(1)(vi), therefore, allows an applicant to continue prosecution of an application via a continuing application to obtain consideration of an amendment, argument, or evidence that could not have been submitted during the prosecution of the prior-filed application.  The petition must be provided within four months of the filing date or entry into national stage of the continuing application.

    As described in the Patent Office’s new rules FAQ, the PTO will determine on a case-by-case basis whether an applicant’s showing is satisfactory.  Factors that the Patent Office will consider when deciding whether to grant a petition include: (1) whether an applicant should instead file an appeal or petition to withdraw the finality of an Office action, (2) the number of other filed applications having substantially identical disclosures, and (3) whether the showing was submitted with reasonable diligence.  The PTO warns, however, that "[a]pplicants should not rely upon the availability of additional continuing applications or RCEs in prosecuting an application."

    The requirements of Rule 78(d)(1) apply to any application filed on or after November 1, 2007, or any application entering national stage on or after November 1, 2007.

    For additional articles in this series, please see

    For additional information on this and other related topics, please see:

    Text of new Rule 78(d)(1):

    (d) Claims under 35 U.S.C. 120, 121, or 365(c) for the benefit of a prior-filed nonprovisional or international application. A nonprovisional application (including an international application that has entered the national stage after compliance with 35 U.S.C. 371) may claim the benefit of one or more prior-filed copending nonprovisional applications or international applications designating the United States of America under the conditions set forth in 35 U.S.C. 120 and paragraph (d) of this section.

    (1) A nonprovisional application that claims the benefit of one or more prior-filed copending nonprovisional applications or international applications designating the United States of America must satisfy the conditions set forth in at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section. The Office will refuse to enter, or will delete if present, any specific reference to a prior-filed application that is not permitted by at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section. The Office’s entry of, or failure to delete, a specific reference to a prior-filed application that is not permitted by at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of this section does not constitute a waiver of the provisions of paragraph (d)(1) of this section.

    (i)(A) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than two prior-filed applications; and
    (B) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than one other nonprovisional application, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.

    (ii)(A) The nonprovisional application is a divisional application as defined in paragraph (a)(2) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application that was subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121; and
    (B) The divisional application contains only claims directed to an invention or inventions that were identified in such requirement to comply with the requirement of unity of invention or requirement for restriction but were not elected for examination and were not examined in the prior-filed application or in any other nonprovisional application, except for a nonprovisional application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional application and satisfies the conditions set forth in paragraph (d)(1)(iii) or (d)(1)(vi) of this section.

    (iii)(A) The nonprovisional application is a continuation application as defined in paragraph (a)(3) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional application that satisfies the conditions set forth in paragraph (d)(1)(ii) of this section;
    (B) The nonprovisional application discloses and claims only an invention or inventions that were disclosed and claimed in such divisional application;
    (C) The nonprovisional application claims the benefit under 35 U.S.C. 120, 121, or 365(c) of only the divisional application, any application to which such divisional application claims benefit under 35 U.S.C. 120, 121, or 365(c) in compliance with the conditions set forth in paragraph (d)(1)(ii) of this section, and no more than one intervening prior-filed nonprovisional application; and
    (D) The divisional application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than one other nonprovisional application, not including any other divisional application that satisfies the conditions set forth in paragraph (d)(1)(ii) or any nonprovisional application that claims the benefit under 35 U.S.C. 120 or 365(c) of such other divisional application and satisfies the conditions set forth in paragraph (d)(1)(iii) or (d)(1)(vi) of this section.

    (iv)(A) The nonprovisional application claims benefit under 35 U.S.C. 120 or 365(c) of a prior-filed international application designating the United States of America, and a Demand has not been filed and the basic national fee (§ 1.492(a)) has not been paid in the prior-filed international application and the prior-filed international application does not claim the benefit of any other nonprovisional application or international application designating the United States of America;
    (B) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed applications; and
    (C) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than two other nonprovisional applications, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.

    (v)(A) The nonprovisional application claims benefit under 35 U.S.C. 120 or 365(c) of a prior-filed nonprovisional application filed under 35 U.S.C. 111(a), and such nonprovisional application became abandoned due to the failure to timely reply to an Office notice issued under § 1.53(f) and does not claim the benefit of any other nonprovisional application or international application designating the United States of America;
    (B) The nonprovisional application is either a continuation application as defined in paragraph (a)(3) of this section or a continuation-in-part application as defined in paragraph (a)(4) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed applications; and
    (C) Any application whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such nonprovisional application has its benefit claimed in no more than two other nonprovisional applications, not including any nonprovisional application that satisfies the conditions set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this section.

    (vi) The nonprovisional application is a continuing application as defined in paragraph (a)(1) of this section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application, is filed to obtain consideration of an amendment, argument, or evidence that could not have been submitted during the prosecution of the prior-filed application, and does not satisfy the conditions set forth in any of paragraphs (d)(1)(i) through (d)(1)(v) of this section. A petition must be filed in such nonprovisional application that is accompanied by the fee set forth in § 1.17(f) and a showing that the amendment, argument, or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application. If the continuing application is an application filed under 35 U.S.C. 111(a), this petition must be submitted within four months from the actual filing date of the continuing application. If the continuing application is a nonprovisional application which entered the national stage from an international application after compliance with 35 U.S.C. 371, this petition must be submitted within four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f) in the international application.

  • Conference & CLE Calendar

    Calendar_16
    September 6, 2007 – Assessing the New USPTO Multi-Patent Rules (West LEGALworks)

    September 6-7, 2007 – Emerging Issues in Biotechnology Law (American Law Institute & American Bar Association) – Washington, D.C.

    September 12, 2007 – Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office)

    September 18, 2007 – Trying a Patent Validity Case in a Post-KSR World (Practising Law Institute)

    September 18-19, 2007 – Pharma/Biotech Patent Boot Camp (American Conference Institute) – San Francisco, IL***

    September 19, 2007 – Final USPTO Rules on Claims and Continuations (Practising Law Institute)

    September 20, 2007 – KSR International Co. v. Teleflex, Inc.: Where Do We Stand Five Months Out? (West LEGALworks)

    September 24-25, 2007 – Biosimilars 2007 (Scherago International, Inc.) – George Washington University, Washington, D.C.

    September 26-27, 2007 – Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA***

    September 27-28, 2007 – Biotechnology: Business and Legal Developments (Law Seminars International) – Seattle, WA

    October 10-12, 2007 – Stem Cells European Business Summit – Edinburgh, Scotland

    October 12, 2007 – Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) – Chicago, IL

    October 25-26, 2007 – Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) – Washington, D.C.***

    October 25-27, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) – Palm Springs, CA

    November 13-15, 2007 – Pharma and Biotech Collaborative Agreements (American Conference Institute) – New York, NY***

    ***Patent Docs is a media sponsor of this conference or CLE.

  • PLI CLE Concerning the Impact of KSR on Patent Litigation

    Practising Law Institute (PLI) #1 Practising Law Institute (PLI) will be offering a webcast entitled: "Trying a Patent Validity Case in a Post-KSR World" on September 18, 2007 from 1:00-2:00 PM (EST).  Speakers Keith L. Slenkovich of Thelen Reid Brown Raysman & Steiner LLP, Douglas R. Nemec of Skadden Arps Slate Meagher & Flom, and Mark D. Flanagan of Wilmer Cutler Pickering Hale and Dorr LLP will discuss the practical effect of the Supreme Court's decision in KSR Int'l Co. v. Teleflex, Inc. on trial dynamics and strategies, how to take advantage of the new KSR standard when attempting to obtain a finding of invalidity, and the tools that remain available to patentees seeking to establish the validity of their patents over the KSR

    standard.  In addition, the speakers will cover the following topics and issues:

    • The relationship between the KSR standard and secondary considerations of non-obviousness under Graham v. John Deere;
    • Jury instructions implementing the KSR standard;
    • Post-KSR Federal Circuit decisions that implement the new obviousness standard.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so online at the WestLegalEdcenter.

  • West LEGALworks® CLE on KSR Int’l Co. v. Teleflex, Inc.

    West LEGALworks West LEGALworks® will be offering a webcast entitled:  "KSR International Co. v. Teleflex, Inc.: Where Do We Stand Five Months Out?" on September 20, 2007 from 1:00-3:00 PM (EST).  Speakers Thomas C. Goldstein and Jeffrey K. Sherwood of Akin Gump Strauss Hauer & Feld LLP and Robert Greene Sterne and Kenneth C. Bass, III of Sterne, Kessler, Goldstein & Fox PLLC will discuss where the patent community stands five months after the Supreme Court's decision in KSR International Co. v. Teleflex, Inc.  In particular, the speakers will provide an overview and analysis of the "obviousness doctrine" in the wake of KSR, discuss recent actions by the U.S. Patent and Trademark Office's Board of Patent Appeals and Interferences (BPAI) and the Central Reexamination Unit, examine the recent "post-KSR" rulings issued by the Federal Circuit and U.S. District Courts, explore the current landscape for practitioners focusing on preparing and prosecuting patents, and discuss how "obviousness" is coming into play in the litigation arena.

    The registration fee for this webcast is $150.  Those interested in registering for the webcast, can do so online at the WestLegalEdcenter.

  • PLI CLE on New Continuation and Claims Rules

    Practising Law Institute (PLI) #1 Practising Law Institute (PLI) will be offering a webcast on the final USPTO rules on claims and continuations on September 19, 2007 from 1:00-2:00 PM (EST).  Speakers Robert J. Spar, former Director of the Office of Patent Legal Administration of the U.S. Patent and Trademark Office, and John M. White, Director of Patent Professional Development of the Practising Law Institute, will provide information to facilitate a clearer understanding of the new rules, and steps that practitioners should consider taking in their patent prosecution practice.  In particular, the speakers will cover the following topics and issues:

    With respect to claims:

    • Limits on the number of independent and dependent claims that may be presented for examination.
    • What happens if you're over the claims limit?
    • Refunds for excess claims.
    • The Examination Support Document (ESD).
    • Options if you file multiple applications.
    • Any loopholes to exceed the limits in parallel applications.
    • Any notification requirements and presumptions that will be imposed.
    • What is required to rebut a presumption of double patenting?

    With resect to continuations:

    • Limits on Continuations, RCE's, CIPs, and Divisionals.
    • What happens if you (inadvertently) exceed the limits, or fail to meet the requirements?
    • What kind of justification would be acceptable?
    • Will a voluntary divisional be permitted, and if not, what becomes of unclaimed subject matter?
    • When may an involuntary divisional be filed?
    • When does it make sense to file a CIP?
    • Should you present claims to multiple inventions in your first application, and voluntarily propose a restriction requirement?

    With regard to the effective date of the new rules and transition issues:

    • When and how will each of the new limits be effective for: (a) applications to be filed on or after the effective date; (b) the existing backfile of unexamined applications; and (c) applications in which an action on the merits has been given?
    • What should you be doing now to prepare for the many different prosecution imposed criteria that will soon be effective relative to applications in each of these three statuses?

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so online at the WestLegalEdcenter.