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  • Webinar on Determining and Correcting Patent Inventorship

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" on February 27, 2014 from 1:00 to 2:30 pm (EST).  Jill K. MacAlpine, Ph.D., of Finnegan Henderson Farabow Garrett & Dunner and Lauren L. Stevens of Global Patent Group will provide guidance for patent counsel on identifying and determining inventorship and will offer best practices for correcting errors regarding inventorship, as well as offer practical experiences and perspectives gained from working with the AIA over the past year — and outline lessons from recent court decisions.  The webinar will review the following questions:

    • What questions should be asked to determine inventorship?
    • What steps does counsel need to take when inventorship must be corrected?
    • What impact, if any, does the AIA have on inventorship determination?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by January 31, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • More Q&A from Webinar on Top Patent Law Stories of 2013

        By Kevin E. Noonan & Donald Zuhn —

    MBHB Logo 2On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013."  The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories.  Posts on our top fourteen stories can be found here (stories #11 to #14), here (stories #7 to #10), here (stories #4 to #6), and here (stories #1 to #3).  The ten stories that we addressed during the webinar were:

    ➤ Supreme Court Decides AMP v. Myriad
    ➤ Myriad Unbowed, Asserts Patents Broadly Against Competitors
    ➤ Supreme Court Decides Monsanto v. Bowman
    ➤ Supreme Court Decides FTC v. Actavis
    ➤ First-Inventor-to-File Provisions of Leahy-Smith America Invents Act Take Effect
    ➤ Rules of Practice Revised to Implement Patent Law Treaty
    ➤ EPO Removes Time Limit for Filing Divisional Applications
    ➤ Media and Congress Combat Patent Trolls
    ➤ District Court Finds Prenatal Diagnostic Method Not Patent Eligible
    ➤ 23andMe Patent and Diagnostic Test Create Controversy

    While we tried to answer several questions before the presentation was concluded, we ran out of time to answer every question posed by attendees, and wanted to provide answers to some of the questions we could not get to.

     

    Q:  Why don't plaintiffs ever attack Myriad's patents on 103 obviousness grounds?

    Kevin:  This question has at least two answers:

    First, the AMP plaintiffs didn't want to use Section 103 as a basis, because they were trying to obtain a categorical exclusion of DNA patenting (which could only be done under Section 101).  Using Section 103, the ACLU would have had to try to invalidate gene patents one at a time.

    Second, the defendants in several of the pending Myriad patent infringement suits have asserted invalidity under Section 103; the problem is that applying old methods to new compounds is not generally obvious per se (although in some instances it might be).

     

    Q:  Does the Myriad decision mean that naturally occurring cDNA, such as those derived from retroviruses, are not patent-eligible?

    Kevin:  Probably.  The rationale is that what is patented has to be different and different by human agency; I don't think obtaining retroviral cDNA is enough.

     

    Q:  Could 35 U.S.C. § 101 be amended to re-define or clarify "Law of Nature"?

    Kevin:  I think it unlikely (mostly because it is impossible for Congress today to craft language that would cover natural laws discovered in future).  In addition, the Supreme Court has a habit of taking Congressional actions to overturn its decisions and coopting them; for example, Graham v. Deere has a statement that Congress "merely included in the statute the limitations on patentability drawn by the Court in its jurisprudence," when the reality was that Giles Rich and P.J. Federico included Section 103 to strip from the Court its ability to judge patentability by the Justices' subjective opinion of whether a claimed invention was sufficiently "inventive."  Similar to the standard Justice Breyer resurrected in Mayo v. Prometheus.

     

    Q:  Is there any discussion regarding modifying the "directed to or encompassing a human organism" bar enacted as part of the Leahy-Smith AIA?

    Kevin:  Not that I know of.  That provision seems to incorporate the 13th Amendment prohibition on having an ownership interest in a human being and little else.

     

    Q:  The patent on Monsanto's Roundup-Ready soybean expired in 2010 but the company seems to have gotten a patent term extension — how did they do that?

    Kevin:  The patent (U.S. Patent No. 5,352,605) was granted under the old regime where a patent received a 17-year term from its grant date.  This patent was granted October 4, 1994, which suggests that it should have expired on October 4, 2011.  The PTO website does not show this patent as having expired.

    The only provisions I can think of for this application having a longer term is that some patentees complained to Congress that they would be harmed by the change in patent term provisions under the law and Congress enacted a bill that set the term as either 17 or 20 years, depending on which was longer.  20 years from 10/4/1994 would be 10/4/2014.  If that's when it expires we will know I am right.

     

    Q:  Is prior case law regarding secret commercial use for more than one year working a forfeiture on the trade secret user's right to patent still good law?

    Kevin:  Regarding whether the trade secret user will be precluded from patenting by their own commercial use, the answer is in flux.  On a policy level the answer should be yes, but it could be that the Federal Circuit could decide that the risk of losing to another under first to file has eliminated the policy basis for the rule (I don't think so, but I am not the CAFC).

    And defensively, I think that the prior user rights provisions reduce the need to patent, because the prior user has a defense against a later patentee.

     

    Q:  How can one reconcile holding methods as trade secret with FDA disclosure requirements?

    Kevin:  I have two scenarios; the first is less secure, and the second is more speculative.

    In the first possibility, you take all reference to the genes and redact them in any public version of your documents, or perhaps encode them (DNA1, DNA2, etc.) and provide the FDA with a key that is not publicly disclosed.  This alternative has the risk that, under FOIA, lawsuit, or Congressional mandate, the Agency will disgorge the information at some point.

    The second possibility is that you refuse to disclose the identity of the genes to the FDA, and if they do not grant regulatory approval you take the method abroad and find somewhere that will permit you to market it without disclosure.  Once you have a track record (3-5 years) you write to the heads of the relevant disease Patients' Rights Group (PRG) and tell them that people in (country where you are marketing) can predict whether they will get (relevant disease) but the FDA doesn't permit Americans to have access to it.  Under some circumstances you could run your business offshore, but in others you could encourage the PRG to write their Congressional representative and tell the FDA to let Americans have the benefits of your method.  The distinction between this scenario and scenarios regarding drugs is that for drugs people might believe there is a safety risk, but here disclosure is merely a matter of public policy that the individual is unlikely to care more about than their own health.  I have no idea whether this will work; the point is that court decisions and patent "reform" laws have unintended consequences and where we place the incentives often direct the outcome we get.

     

    Q:  Under the Patent Law Treaty, does the 2-month grace period relate to the failure to claim priority or the failure to file an application within one year?

    Don:  The Patent Law Treaty (PLT) and Patent Law Treaty Implementation Act of 2012 (PLTIA) provide for "the restoration of the right of priority to a foreign application or the benefit of a provisional application in a subsequent application filed within two months of the expiration of the twelve-month period (six-month period for design applications) for filing such a subsequent application" (78 Fed. Reg. 62368, emphasis added).  The final rule issued by the Patent Office also states that:

    [W]ith respect to the right of priority to a prior-filed foreign application that if the subsequent application is filed after the expiration of the twelve-month period (six-month period in the case of a design application) set forth in 35 U.S.C. 119(a), but within two months from the expiration of the twelve-month period (six-month period in the case of a design application), the right of priority in the subsequent application may be restored upon petition and payment of the applicable fee if the delay in filing the subsequent application within the twelve- or six-month period was unintentional.  The Office is providing with respect to benefit of a prior-filed provisional application that if the subsequent application is filed after the expiration of the twelve-month period set forth in 35 U.S.C. 119(e), but within two months from the expiration of the twelve-month period, the benefit of the provisional application may be restored upon petition and payment of the applicable fee if the delay in filing the subsequent application within the twelve-month period was unintentional.

    (id.; emphasis added).  The rules specifying the time for filing a priority claim (37 C.F.R. § 1.55(d)) and making a delayed priority claim (37 C.F.R. § 1.55(e)) remain unchanged under the PLT and PLTIA.  In particular, a "claim for priority must be filed within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application in an original application filed under 35 U.S.C. 111(a)," and if the claim for priority is not filed within this time frame, "the claim may be accepted if the priority claim was unintentionally delayed," and the applicant submits the required petition, Application Data Sheet, and petition fee (along with a certified copy of the foreign application, if necessary).

     

    Q:  When does the revised rule that removes the time limit for filing EP divisional applications come into force?

    Don:  Amended Rule 36 EPC, in which the 24-month time limits within which divisional applications must be filed, takes effect on April 1, 2014.

     

    Q:  Regarding the new claim interpretation standard under the Innovation Act, how is the "ordinary and customary meaning" standard different from the "broadest reasonable interpretation" standard?

    Don:  The Innovation Act would require that the Patent Trial and Appeal Board construe claims in Post-Grant and Inter Partes Reviews using the same standard as the district courts.  In particular, the Act specifies that "each claim of a patent shall be construed as such claim would be in a civil action to invalidate a patent under section 282(b), including construing each claim of the patent in accordance with ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent."  In Phillips v. AWH Corp., the Federal Circuit noted that "the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application."  The Court also noted that:

    In many cases that give rise to litigation,  . . . determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art.  Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to "those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean."  Those sources include "the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art."

    (citations omitted).  Section 2111 of the MPEP notes that "[t]he Federal Circuit's en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the 'broadest reasonable interpretation' standard," and cites In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997), for the proposition that:

    [T]he PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit.  Rather, the "PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant's specification."

    Section 2111 also notes that during patent examination "the focus of the inquiry regarding the meaning of a claim should be what would be reasonable from the perspective of one of ordinary skill in the art."

  • Medtronic, Inc. v. Mirowski Family Ventures, LCC (2014)

    By Andrew Williams —

    Supreme Court Building #1Earlier today, in Medtronic, Inc. v. Mirowski Family Ventures, LLC, the Supreme Court held that "when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee."  Justice Breyer wrote the opinion for a unanimous Court, reversing the Federal Circuit's earlier opinion from 2012.  Based on the tenor of the questioning during oral argument, this outcome was not surprising.  However, this case now disrupts the balance of power between a patent holder and a licensee.  It is often the case that an agreement reached between two parties is mutually beneficial to both.  Now, thanks to this opinion, licensees may be emboldened to subsequently force the patent holder to prove that the licensed products or processes infringe the patents at issue.  The licensee would have little risk in doing so because the patent holder cannot assert counterclaims.  Therefore, the best that can be hoped for from the patentee's point of view is to maintain the status quo.  This could end up creating a disincentive for patent holders from entering into licensee agreements.  At the very least, patent holders will need to be mindful of this decision and its impact while negotiating the terms of any license.

    MedtronicAs we have reported previously, this case was the inevitable consequence of the Supreme Court's MedImmune decision, which allowed a patent licensee to challenge the validity and/or non-infringement of a patent in a DJ action without repudiating the license.  In that case, the Court reasoned that "[t]he rule that a plaintiff must destroy a large building, bet the farm, or (as here) risk treble damages and the loss of 80 percent of its business, before seeking a declaration of its actively contested legal rights finds no support in Article III."  Medlmmune, Inc. v. Genentech, Inc., 549 U.S. 118, 134 (2007).  However, in such cases, the licensee is not actually under the threat of an infringement action, so the Court essentially created a patent-license exception to the Article III case-or-controversy requirement.  In fact, even though the licensee now has standing to bring such a DJ action, the patent holder does not have reciprocal standing to even bring infringement counterclaims.  This contributes to the dichotomy by which the patent holder has everything to lose and nothing to win.

    In the present case, the Court relied on three legal propositions to conclude that the burden of proving infringement should remain with the patentee in MedImmune-type cases:  (1) "the burden of proving infringement generally rests upon the patentee," (2) "'the operation of the Declaratory Judgment Act'" is only procedural, and (3) "'the burden of proof' is a 'substantive aspect of a claim.'"  The Court did, however, point to three "practical considerations" that also lend support to this conclusion.  The first stems from the potential scenario that Justice Scalia raised during oral argument:

    Let's assume that we put the burden of proof where you [the patent holder] want it.  Okay?  So this declaratory judgment action is defeated.  All right?  Nonetheless, they [the licensee] say:  Still and all, we are going to go ahead and not pay any royalties.  And then you bring – – you bring an infringement action, right?

    Justice Scalia noted that in such a scenario, the entire case would need to be relitigated, because the best that the patent holder can establish in the original DJ case "is that [the licensee] didn't prove non-infringement."  Justice Breyer posed essentially the same scenario, but considered what would happen if the evidence was inconclusive, such that neither side could establish infringement/non-infringement by a preponderance of the evidence.  The result would be that both sides would lose the infringement question in the respective actions, thereby leaving that issue undecided and ultimately resulting in uncertainty among the parties.  To head off any criticism that this scenario might be "fanciful," Justice Breyer pointed out that the Restatement (Second) of Judgments provides that relitigation of an issue is not precluded if the burden of proof is different in the second case.  Thus, this is potentially a real concern.

    The logic of the other two "practical considerations" is more suspect.  First, Justice Breyer repeated the concern of Medtronic (the licensee in this case), pointing out that "an alleged infringer" would have to "negate every conceivable infringement theory."  Notwithstanding the fact that referring to the licensee as an "alleged infringer" is somewhat misleading, because the license would make any allegation of infringement impermissible, the underlying assumption is questionable.  To defeat an allegation of infringement of one or more patent claims, an alleged infringer need only establish that one element of the broadest claim or claims is missing.  If the licensee cannot meet this evidentiary hurdle, perhaps they should not be able to bring a DJ action in the first place.  Of course, the possibility of an infringement theory under the Doctrine of Equivalents complicates the matter, but in general, establishing non-infringement can be a more clear-cut than establishing infringement, because for the latter, all elements of an asserted claim must be proven.  Furthermore, it isn't clear why "[a] patent holder is in a better position than an alleged infringer to know, and to be able to point out, just where, how, and why a product (or process) infringes a claim," as Justice Breyer suggested.  This is especially true considering that the alleged product (or process) is likely within the possession of the licensee.

    The last suggested "practical consideration" centered on the original purpose articulated in the MedImmune case:  to avoid the "dilemma" that would be caused by requiring a licensee to choose "between abandoning his rights or risking suit."  Of course, Justice Breyer had to acknowledge that a shift in burden would not deprive Medtronic of the right to seek a DJ action.  Nevertheless, he wrote that requiring the licensee to bear the burden of proof of non-infringement would "create a significant obstacle," thereby putting such a party at a disadvantage.  However, if a non-infringement position is so weak that a shift in burden would create an obstacle to filing suit, maybe the licensee should not be filing a DJ action.

    The Court had little concern over the impact that this case would have on the patent community.  In response to the Intellectual Property Owners Association's concern that the Court's holding would permit a licensee to "force the patentee into a full-blown patent infringement litigation," Justice Breyer shifted the "blame" to the patent holder.  The license in dispute in this case had a provision for identifying any new Medtronic products that would be subject to the license.  The patent holder was permitted to identify any new products that it believed were covered by the patent, and if Medtronic disagreed, they were contractually permitted to initiate a DJ action.  Nevertheless, Justice Breyer described the situation as the patent holder setting "the present dispute in motion by accusing Medtronic of infringement."  Of course, characterizing it this way makes it easier to "see no convincing reason why burden of proof law should favor the patentee."  Finally, Justice Breyer pointed out that the public interest in maintaining a "well-functioning patent system" is offset by its interest in preventing patent holders from exacting royalties for the use of ideas beyond the scope of the patents at issue.  As this author has had it explained to him, when any Judge or Justice uses the phrase "patent monopoly," you can be certain things are not going to go well for the patent holder.  As an indication, Justice Breyer used that phrase twice in the penultimate paragraph discussing the public interest.

    As a final note, the Court did address the issue of jurisdiction raised by Tessera Technologies, Inc.'s Amicus brief.  The issue was whether the federal courts had subject-matter jurisdiction to hear this case, considering that the nature of the action that the declaratory judgment defendant would have brought could be characterized as seeking damages for a breach of contract.  Of course, this problem also stems from this Court's MedImmune decision, which allowed standing in a case where there was really no genuine dispute "of sufficient immediacy and reality."  Nevertheless, the Court was not convinced.  Instead, the case that the declaratory judgment defendant would have brought, according to Justice Breyer, would have been one for patent infringement, because Medtronic would have had to stop paying royalties.  "The relevant question concerns the nature of the threatened action in the absence of the declaratory judgment suit," and as such, the Court found that this case was "properly characterized as an action 'arising under an Act of Congress relating to patents.'"

    Medtronic, Inc. v. Mirowski Family Ventures, LCC (2014)
    Opinion of the Court by Justice Breyer

  • Institut Pasteur v. Focarino (Fed. Cir. 2013)

    By Donald Zuhn —

    Institut PasteurLast month, the Federal Circuit dismissed an appeal by Institut Pasteur of a determination by the Board of Patent Appeals and Interferences affirming the rejection of claim 14 of U.S. Patent No. 7,309,605 in an inter partes reexamination requested by Precision BioSciences.  The Federal Circuit also reversed the Board's affirmance of the rejection of claims 10 and 12 of U.S. Patent No. 6,610,545, and vacated and remanded the Board's affirmance of the rejection of U.S. Patent No. 6,833,252.  Both the '545 and '252 patents were also the subject of inter partes reexaminations requested by Precision BioSciences.

    The '605, '545, and '252 patents, which are owned by Institut Pasteur, claim methods and tools for the site-directed insertion of genes into eukaryotic chromosomes.  The claimed methods and tools take advantage of the discovery by the Institut Pasteur in the early 1990's of a class of enzymes called group I intron-encoded (GIIE) endonucleases.  Institut Pasteur demonstrated that GIIE endonucleases, which have recognition sites of over eighteen nucleotides (and therefore provide superior specificity over other endonucleases), could cleave chromosomal DNA in eukaryotic cells, and that eukaryotic cells were able to successfully repair such cleavages via homologous recombination.  All three of the patents at issue expired on May 6, 2012.

    Claim 1 of the '605 patent, which was not at issue on appeal (and which includes amendments, indicated by underlining, that were proposed by Institut Pasteur during reexamination) recites:

    1.  A method for inducing at least one site directed double-stranded break in the chromosomal DNA of an organism comprising:
        (a)  providing an isolated, viable cell of said organism containing at least one Group I intron encoded endonuclease recognition site at a location in the chromosomal DNA of the cell,
        (b)  providing said Group I intron encoded endonuclease to said cell by genetically modifying the cell with a nucleic acid comprising said Group I intron encoded endonuclease or by introducing said Group I intron encoded endonuclease protein into the cell such that the Group I intron encoded endonuclease cleaves said Group I intron encoded endonuclease site at the location in the DNA of the cell.

    Claim 14 of the '605 patent, which was at issue, recites:

    14.  The method of claim 1, wherein said method further comprises providing to said cell
        a plasmid comprising a DNA sequence homologous to the sequence of the chromosome, which allows homologous recombination, and
        a modified sequence,
        wherein said Group I intron encoded endonuclease cleaves the Group I intron encoded endonuclease recognition site,
        whereby said cleavage promotes the insertion of said modified sequence into said chromosomal DNA of said cell at a specific site by homologous recombination.

    Claim 7 of the '545 patent, which was not at issue on appeal (and which includes amendments proposed by Institut Pasteur during reexamination) recites:

    7.  A method for in vivo site directed genetic recombination in an organism comprising:
        (a)  providing a transgenic eukaryotic cell having at least one Group I intron encoded endonuclease recognition site inserted at a unique location in a chromosome;
        (b)  providing an expression vector that expresses said endonuclease in said transgenic cell;
        (c)  providing a plasmid comprising a gene of interest and a DNA sequence homologous to the sequence of the chromosome, allowing homologous recombination;
        (d)  transfecting said transgenic cell with said plasmid of step (c);
        (e)  expressing said endonuclease from said expression vector in said cell; and
        (f)  cleaving said at least one Group I intron encoded endonuclease recognition site with said endonuclease, whereby said cleavage promotes the insertion of said gene of interest into said chromosome of said organism at a specific site by homologous recombination.

    Claims 10 and 12, which were at issue, depend from claim 7 and limit the method to yeast and mammalian cells, respectively.

    Finally, claim 1 of the '252 patent (the patent's only independent claim) recites:

    1.  A recombinant mammalian chromosome comprising an exogenous Group I intron encoded endonuclease site,
        wherein the endonuclease site is within an integrated nucleic acid sequence from a vector,
        wherein the site is selected from the group consisting of an I-SceIV site, an I-CsmI site, I-PanI site, I-SceII site, an I-CeuI site, an I-PpoI site, an I-SceIII site, an I-CreI site, an I-TevI site, an ITevII site, an I-TevIII site, and an I-SceI site.

    In 2009, Precision BioSciences filed inter partes reexamination requests for the '605, '545, and '252 patents (as well as a fourth patent not involved in the appeal).  The Office granted all four requests, and the Examiner rejected most claims as anticipated or obvious.

    On appeal, the Board affirmed the Examiner's rejections as to obviousness, basing its decision on two references (Quirk and Bell-Pedersen) that disclosed using a GIIE endonuclease to transfer DNA from a plasmid to non-chromosomal DNA in bacterial cells.  In particular, the Board determined that there was reason to substitute the nonchromosomal prokaryotic DNA of Quirk and Bell-Pedersen with chromosomal DNA of a eukaryotic cell, and that one of skill in the art would have a reasonable expectation of success based on two other references (Frey and Dujon), which the Board characterized as disclosing cleavage of chromosomal DNA in yeast cells.  The Board considered evidence that the claimed inventions were praised, copied, and licensed by the industry, but determined that the evidence did not outweigh the strong case of obviousness.  Institut Pasteur appealed the Board's affirmance of the Examiner's rejections to the Federal Circuit.

    In dismissing the appeal as to claim 14 of the '605 patent, the Federal Circuit noted that the patent had expired since the Board's decision, and that Institut Pasteur did not dispute that the Office could not issue amended claims for an expired patent if the amendments change the claim’s scope.  The Court concluded that the amendments Institut Pasteur proposed during reexamination did narrow the scope of claim 1 and dependent claim 14.  In countering Institut Pasteur's argument that the amendments to claim 1 did not change the scope of claim 14 because the unamended claim was implicitly limited to chromosomal DNA, the Court explained:

    That homologous recombination occurs between the targeted DNA and an introduced plasmid that is homologous to a chromosome does not require that the targeted DNA actually be chromosomal DNA.  It requires only that the targeted DNA be homologous to chromosomal DNA.  Non-chromosomal DNA, such as mitochondrial DNA or DNA in an additional plasmid, can be homologous to chromosomal DNA.  Thus, the original claim covered situations where nonchromosomal DNA is the targeted DNA.  The amendment substantively narrowed the claim in requiring chromosomal DNA as the target.

    The Court therefore determined that the amendments narrowed the scope of claim 14 (claim 1 not being at issue on appeal), and concluded that the Office could not issue the amended claim now that the '605 patent had expired.

    In reversing the Board's decision with respect to claims 10 and 12 of the '545 patent, the Federal Circuit noted that the "key issue" in determining whether claims 10 and 12 of the '545 patent are invalid for obviousness was:

    [W]hether the relevant skilled artisan — after reading Quirk's and Bell-Pedersen's disclosure that a GIIE endonuclease can promote targeted gene transfer into non-chromosomal DNA in prokaryotic cells — would have expected that a GIIE endonuclease would successfully promote targeted gene transfer into the chromosomal DNA of eukaryotic cells, and thus had good reason to pursue that possibility.

    (emphasis in opinion).

    The Court also noted that the Board, in ascertaining the scope and content of the prior art, made factual determinations that were not supported by substantial evidence, and that the Board also failed to give proper consideration to teachings in the prior art that targeting a cell's chromosomal DNA could be toxic to the cell, and to the evidence of industry praise and the licensing of Pasteur's invention.  The Court first concluded that the Board had erred in finding that the Frey and Dujon references showed that a GIIE endonuclease cleaved yeast chromosomal DNA when expressed in yeast cells.  The Court explained that Frey discloses cleaving yeast chromosomes that had been extracted from yeast cells and purified, not chromosomes still "in yeast cells," and that Dujon was silent about what type of DNA is cleaved.  For Dujon, the Court noted that "the PTO bears the burden of demonstrating a prima facie case of obviousness," and that "Dujon's language is insufficient to establish that the GIIE endonuclease targeted chromosomal DNA."

    The Court added that "[t]he Board compounded its erroneous findings by ignoring teachings that targeting a GIIE endonuclease to chromosomal DNA in a living cell could be highly toxic to the cell."  The Court also pointed out that "the Board identified no reason at all that a skilled artisan would have pursued a method toxic to cells."

    Finally, the Court indicated that Institut Pasteur had "presented compelling evidence that the industry has licensed, praised, and copied its inventions," and that the Board did not properly weigh this evidence.  That evidence consisted of a declaration from the CEO of the exclusive licensee of the '545 patent that the exclusive licensee had entered into more than a dozen sublicenses.  The Board had discounted this evidence because the declaration failed to establish that the sublicensees licensed the '545 patent to gain access to the claimed subject matter as opposed to other technology described, but not claimed, in the patent.  As for the evidence of industry praise, the Board acknowledged the connection between industry praise and the claimed step of homologous recombination, but found that step to be possessed by the prior art.

    In vacating the Board's decision with respect to the '252 patent, the Court indicated that it was remanding for consideration of "whether one of ordinary skill would have been motivated simply to create a recombinant chromosome with a GIIE endonuclease recognition site — without having the reasonable expectation . . . that the GIIE endonuclease could successfully cleave the recognition site and that homologous recombination could successfully repair the break."  The Court explained that because the Board "mistakenly thought that there was sufficient motivation for the '545 patent," the Board did not consider whether motivations other than those for the '545 patent would have made the subject matter of the '252 patent, which essentially claims the first step of the methods of claim 10 and 12 of the '545 patent, obvious.

    Institut Pasteur v. Focarino  (Fed. Cir. 2013)
    Panel: Circuit Judges Newman, Clevenger, and Taranto
    Opinion by Circuit Judge Taranto

  • Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

    By Josh Bosman —

    National Tsing Hua UniversityLast week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis."  The '920 patent, which is assigned to National Tsing Hua University in Taiwan, contains claims to a method of determining the risk of liver cancer and metastasis.

    The inventors demonstrated that alpha-mannosidase RNA expression levels, specifically MAN1A1, MAN1A2 and MAN1B1, in liver tissue obtained from hepatitis B virus positive liver cancer patients were approximately double the levels of control liver tissue, with increased RNA expression levels correlating with a more advanced cancer stage.  Interestingly, MAN1C1 RNA expression levels in stage I or II liver cancer patients were approximately half the level than that in normal liver tissue.

    A review of the file history of the '920 patent indicates that the Examiner issued a rejection of the claims under 35 U.S.C. § 101 in a non-final Office Action mailed December 4, 2012 for being drawn to a non-statutory method for having a "natural princip[le]" as a limiting step without reciting additional steps that integrate the natural principle into the claimed invention.  The Examiner asserted that the natural principle constituted the levels of MAN1A1, MAN1A2, MAN1B1, MAN1C1, and MMP9 in samples from a subject as compared to controls are indicative of risk of liver metastasis.  The Examiner stated that, according to Mayo v. Prometheus, a claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventors have practically applied, and added something significant, to the natural principal itself.

    As originally filed, claim 6 of the '920 patent recited:

    6.  A method for diagnosis of liver metastasis, comprising the steps of:
        (A)  providing a sample obtained from a subject;
        (B)  assessing the expression level of four subtypes of α-mannosidase genes consisting of MAN1A1, MAN1A2, MAN1B1 and MAN1C1 in the sample;
        (C)  comparing MAN1A1, MAN1A2, MAN1B1 and MAN1C1 expression level in the sample with those in a normal control; and
        (D)  determining whether the subject having a risk of liver metastasis in accordance with the result of step (C);
        wherein while the MAN1A1, MAN1A2 and MAN1B1 expression levels in the sample are higher than those in the normal control, and the MAN1C1 expression level in the sample is lower than that of the normal control, such that the subject is determined to have a risk of liver metastasis.

    In response to the § 101 rejection, the Applicant amended claim 6 to add limitations of "specific markers" to detect and assess and compare the expression level by the "specific markers."  Furthermore, the Applicant asserted that claim 6 must be performed using the substantial "specific markers" and thus, the claim amounts to significantly more than a natural principle itself.

    In Applicant's response filed on April 8, 2013, claim 6 was amended as follows:

    6.  (Currently amended)  A method for diagnosis determining risk of liver metastasis metastatic liver cancer, comprising the steps of:
        (A)  providing a sample obtained from a subject;
        (B)  assessing the RNA expression level of four subtypes of α-mannosidase genes consisting of MAN1A1, MAN1A2, MAN1B1 and MAN1C1 in the sample by detecting with one or a plurality of specific markers;
        (C)  comparing the specific markers of MAN1A1, MAN1A2, MAN1B1 and MAN1C1 expression level in the sample with those in a normal control; and
        (D)  determining whether the subject having has a risk of liver metastasis of liver cancer in accordance with the result of step (C);
        wherein a subject with while the MAN1A1, MAN1A2 and MAN1B1 expression levels in the sample that are higher than those in the normal control, and [[the]] MAN1C1 expression level in the sample that is lower than that of the normal control, such that the subject is determined to have indicates the subject has a high risk of liver metastasis of liver cancer,
        wherein the sample and the normal control are liver biopsy or blood sample.

    In the next and final Office Action mailed May 29, 2013, the Examiner withdrew the § 101 rejection without comment, but issued a rejection under 35 U.S.C. § 112, second paragraph, for the unclear recitation of "markers" in claim 6.  In order to expedite prosecution, the Examiner proposed amendments to claim 6 that removed the "specific markers" amendment made by the Applicant.  In a response to the final Office Action filed in August of 2013, the Applicant amended claim 6 (which issued as claim 1 in the '920 patent) to include the Examiner's recommended amendment to remove the recitation of "specific markers."  The application was allowed in September.

    Claim 1 of the '920 patent recites:

    Claim 1.  A method for determining risk of metastatic liver cancer, comprising the steps of:
        (A)  providing a sample obtained from a subject;
        (B)  assessing the RNA expression level of four subtypes of alpha-mannosidase genes consisting of MAN1A1, MAN1A2, MAN1B1 and MAN1C1 in the sample by detecting MAN1A1, MAN1A2, MAN1B1 and MAN1C1 RNA expression levels in the sample;
        (C)  comparing the MAN1A1, MAN1A2, MAN1B1 and MAN1C1 expression levels in the sample with MAN1A1, MAN1A2, MAN1B1 and MAN1C1 expression levels in a normal control; and
        (D)  determining whether the subject has a risk of metastasis of liver cancer in accordance with the result of step (C);
        wherein a subject with MAN1A1, MAN1A2 and MAN1B1 expression levels in the sample that are higher than those in the normal control, and MAN1C1 expression level in the sample that is lower than that of the normal control has a high risk of metastasis of liver cancer, wherein the sample and the normal control are liver biopsies.

  • Court Report

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Biosuccess Biotech Co. Ltd. v. Rich Pharmaceuticals Inc. et al.
    2:14-cv-00310; filed January 14, 2014 in the Central District of California

    • Plaintiff:  Biosuccess Biotech Co. Ltd.
    • Defendants:  Rich Pharmaceuticals Inc.; Imagic LLC; Richard L Chang Holdings LLC; Ben Chang; Does 1 through 10 inclusive

    Infringement of U.S. Patent. No. 6,063,814 ("Phorbol Esters as Anti-Neoplastic and White Blood Cell Elevating Agents," issued May 21, 2000) based on defendants use of PD-616 and/or TPA for the treatment of victims of leukemia and stroke.  Also, various claims sounding in state law, including misappropriation of trade secrets, etc.  View the complaint here.

    Pegasus Laboratories, Inc. v. Lowlite Investments, Inc.
    6:14-cv-00051; filed January 10, 2014 in the Middle District of Florida

    • Plaintiff:  Pegasus Laboratories, Inc.
    • Defendant:  Lowlite Investments, Inc. d/b/a Olympia Compounding Pharmacy

    Infringement of U.S. Patent Nos. 5,747,476 ("Treatment of Equine Protozoal Myeloencephalitis," issued May 5, 1998), 6,255,308 (same title, issued July 3, 2001), and 6,448,252 (same title, issued September 10, 2002) based on Olympia's manufacture and sale of a compounded medication containing sulfadiazine and pyrimethamine ingredients for the treatment of equine protozoal myeloencephalitis.  View the complaint here.

  • Conference & CLE Calendar

    CalendarJanuary 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 22, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (EST)

    January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

    January 23, 2014 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EST)

    January 23-24, 2014 – IP Counsel Exchange for Biosimilar Applicants & Sponsors*** (Momentum) – New York, NY.

    January 30, 2014 -"Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

    February 13, 2014 – "Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges — Insulating Your Patent Portfolio From New Threats" (Strafford) – 1:00 to 2:30 pm (EST)

    February 18, 2014 – "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    February 20, 2014 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; and Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EST)

    February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    ***Patent Docs is a media partner of this conference or CLE

  • ACI FDA Boot Camp

    New York #2American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 12-13, 2014 in New York, NY.  ACI faculty will help attendees:

    • Master the basics of the application and approval processes for drugs, biologics, and devices;
    • Comprehend the structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDHR;
    • Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
    • Learn how devices are classified, monitored, and regulated;
    • Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
    • Recognize the pivotal role of labeling in the drug and biologics approval process;
    • See the importance of cGMPs to the post-approval regulatory process; and
    • Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.

    FDA Boot CampIn particular, ACI's faculty will offer presentations on the following topics:

    • The Basics: Understanding and Working with the FDA — Jurisdiction, Organization, and Operations
    • The Nature of the Approval Process
    • Understanding the Clinical Trial Process for Drugs and Biologics
    • Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
    • Part 1 — Patents, Trademarks and Other IP Protections and Mechanisms
    • Part 2 — Hatch-Waxman and BPCIA Overview
    • Drugs and Biologics: Labeling
    • cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
    • Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
    • Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
    • Adverse Events Monitoring, Pharmacovigilance and Risk Management

    A pre-conference workshop on the "Fundamentals of FDA Regulatory Law" and "Resolving Ethical Challenges Encountered During the Drug Approval Process" will be offered on March 11, 2014 from 1:00 to 5:00 pm.  The first part of the workshop will provide a basic overview of FDA regulations and will prepare attendees for the in-depth discussions that will take place throughout the conference, and explore ethical issues that may arise in the context of communications with FDA on behalf of clients.  The second part of the workshop will explore ethical issues that may arise in the context of communications with FDA on behalf of clients.

    Two post-conference master classes will be offered on March 13, 2014.  The first master class, entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics," will provide an in-depth overview of biosimilars as well as analyses of bioequivalence and exclusivities and their role in patent and product life cycle management.  The second master class, entitled "Post-Approval Marketing Guidance and Preemption Protocols," will address issues that arise post-approval, including advertising, promotion, and off-label promotion and enforcement, as well as preemption fundamentals.

    An agenda for the conference can be found here, and additional information regarding the workshop and master classes can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference InstituteThe registration fee is $2,295 (conference alone), $2,895 (conference and workshop or conference and one master class), or $3,295 (conference, workshop, and one master class).  Those registering by February 13, 2014 will receive a $200 discount.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's FDA Boot Camp conference.

  • ACI Conference on Medical Device Patents

    Chicago #1American Conference Institute (ACI) will be holding its 4th Advanced Summit on Medical Device Patents on March 24-26, 2014 in Chicago, IL.  The conference will allow attendees to:

    • Utilize the new AIA inter partes review and post-grant review procedures to your advantage in the crowded and litigious medical device patent field;
    • Prepare for increased NPE and PAE litigation in the medical device space and position your device IP portfolio to drive down the cost of settlements;
    • Determine the value of device IP in light of evolving damages case law and prevent the next billion dollar medical device patent infringement verdict;
    • Protect medical device patents post-Mayo v. Prometheus and Myriad and construct claims to withstand § 101 patentability challenges;
    • Execute a cohesive international medical device opposition practice strategy for established and emerging markets and demystify global standards for patentability and claim construction; and
    • Understand when to raise the inequitable conduct defense under the continually evolving Therasense standard.

    Medical Device PatentsIn particular, ACI's faculty will offer presentations on the following topics:

    • Keynote: USPTO Update on Patent Reform: Statistical Breakdown and Best Practices Learned from the First Year of Implementation
    • Examining the Impact of AIA Post-Grant Review and Inter Partes Review Procedures on Traditional Medical Device Patent Litigation
    • Setting the Stage Pre-Trial: Mock Markman Hearing and Claim Construction Strategy Session
    • The Incredible Shrinking Patent World: Protecting Medical Device Patents in Light of Increasingly Strict § 101 Patentability Standards
    • The In-House Perspective on Medical Device Patent Litigation: Limiting Liability and Managing and Reducing Costs
    • Bracing for the Impact of NPEs and PAEs in the Medical Device Space: How to Defend Against These Entities and What We Can Learn from Them
    • Joint Indirect Infringement Post-Akamai: Bracing for the Fallout on Prosecution and Litigation Strategies
    • Case Spotlight on Medtronic v. Boston Scientific: Determining Who Bears the Burden of Proof in a Declaratory Judgment Action
    • View From the Bench: The Judicial Perspective on Medical Device Patent Litigation
    • Rethinking Medical Device Damages: Updated Strategies for Calculating Damages and Determining Valuation in Light of Evolving Federal Circuit Case Law
    • Focus on Bard v. Gore: Exploring the Evolution of the Law of Willful Infringement and Enhanced Damages
    • Developing a Global Patent Strategy to Protect Medical Device IP in Emerging and Established Markets
    • Ethics and Medical Device IP: An Update on the Continued Evolution of Inequitable Conduct and Overview of the New PTO Ethical Rules

    In addition, a pre-conference interactive working group session entitled "Mastering the Intricacies of USPTO Practice Post-Patent Reform: Supervisory Patent Examiners Weigh In on Medical Device Patents" will be offered from 8:30 am to 12:00 pm on March 24, 2014, and a post-conference master class entitled "Obviousness with Cardiac Devices, Diagnostics and Orthopedics: A Practical Guide to Combating Rejections at the PTO and Mounting a Challenge in the Courts" will be offered from 9:00 am to 12:00 pm on March 26, 2014.

    The agenda for the Medical Device Patents conference can be found here, and the agenda for the pre-conference interactive working group session and post-conference master class can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference InstituteThe registration fee for the conference is $2,295 (conference alone), $2,895 (conference and pre-conference session or post-conference master class), or $3,295 (conference, pre-conference session, and post-conference master class).  Those registering by January 31, 2014 will receive a $300 discount, and those registering by February 28, 2014 will receive a $200 discount.  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Medical Device Patents conference.

  • Webinar on Patent Procurement and Prosecution Strategies

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges — Insulating Your Patent Portfolio From New Threats" on February 13, 2014 from 1:00 to 2:30 pm (EST).  Christopher A. Bullard of Oblon Spivak McClelland Maier & Neustadt and Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt will provide an overview of the current USPTO's Patent Trial & Appeal Board (PTAB) and patent litigation landscape with an eye toward emerging trends and challenges for patents owners, and offer best practices to minimize the threat of post-grant patent challenges as well as prosecution strategies to strengthen and/or insulate patent portfolios from PTAB attack.

    The webinar will review the following questions:

    • What are the emerging challenges for patent owners under the current PTAB landscape?
    • What is the PTAB's impact on patent portfolios and what steps can counsel take to strengthen portfolios?
    • What proactive steps in patent procurement and prosecution can counsel take to minimize the threat of post-grant challenges?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.