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  • MBHB Webinar on Alice Corp. v. CLS Bank International

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Alice Corp. v. CLS Bank International: General Purpose Computers Cannot Save Inventions Directed to Abstract Ideas" on August 19, 2014 from 10:00 am to 11:15 am (CT).  MBHB attorney Rory P. Shea and Patent Docs contributor and MBHB attorney Michael S. Borella, Ph.D. will cover the potential implications of the Alice decision on patents directed to computer-implemented inventions.  Topics to be discussed during the webinar will include:

    • A review of the Alice decision
    • A review of the additional guidance that the Alice decision may provide on the two-part test for determining patent-eligibility
    • A discussion of how the Alice decision may impact the prosecution and litigation of claims directed to computer-implemented inventions going forward

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO Webinar on Alice v. CLS Bank

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Alice v. CLS Bank: How Far Has the Needle Moved?" on July 15, 2014 beginning at 2:00 pm (ET).  A panel consisting of Scott Bornstein of Greenberg Traurig LLP, Michael Chernoff of MDB Capital Group LLC, and Robert Sachs of Fenwick & West LLP will address the following questions:

    • How much will Alice impact patent applications at the USPTO, Covered Business Method post-grant proceedings at the PTAB, and invalidity arguments in district court?
    • What kinds of applications and patents are most vulnerable?
    • What will the USPTO, district courts, and the Federal Circuit do with the vague tests articulated by Alice regarding "abstract ideas" and "inventive concept"?
    • What can patent owners and applicants who are at risk do to shore up their IP protection?

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • AbbVie Deutschland GmbH v. Janssen Biotech, Inc. (Fed. Cir. 2014)

    Absent Description of Representative Species to Support Entire Genus, Functionally Defined Genus Claim Lacked Adequate Written Description

    By Donald Zuhn —

    AbbvieLast week, in AbbVie Deutschland GmbH v. Janssen Biotech, Inc., the Federal Circuit affirmed judgments by the District Court for the District of Massachusetts in infringement and interference actions involving AbbVie Deutschland GmbH & Co., KG; AbbVie Bioresearch Center, Inc.; and AbbVie Biotechnology Ltd. ("AbbVie") and Janssen Biotech, Inc. and Centocor Biologics, LLC ("Centocor").

    In the infringement action, AbbVie had filed suit against Centocor in the District of Massachusetts for infringement of claims 29, 30, 32, and 64 of U.S. Patent 6,914,128 and claim 11 of U.S. Patent 7,504,485.  Following a trial on validity, a jury determined that the asserted claims were invalid for lack of written description, lack of enablement, and for obviousness.  The District Court denied AbbVie's post-trial motions for judgment as a matter of law and a new trial.

    CentocorIn the inference action, Centocor had sought review under 35 U.S.C. § 146 of a determination by the Board of Patent Appeals and Interferences in an interference between Centocor's U.S. Patent Application 10/912,994 and AbbVie's '128 patent.  The Board awarded priority to AbbVie and determined that the contested claims of the '128 patent were not invalid for obviousness.

    In an opinion by Judge Lourie, joined by Judge Chen with Judge O'Malley concurring in the judgment, the Federal Circuit determined that the Board's decision in the interference proceeding lacked finality for purposes of collateral estoppel, the evidence supported the jury verdict that the claims lacked adequate written description, and there was no reversible error in the District Court's evidentiary rulings or jury instructions relating to written description that warranted a new trial.  The Federal Circuit therefore affirmed the District Court's judgments of invalidity in both the infringement and interference actions.

    The '128 and '485 patents are directed to fully human antibodies that bind to and neutralize the activity of human interleukin 12 (IL-12).  The patents, which share the same written description, disclose the amino acid sequences of nearly 300 antibodies having a range of IL-12 binding affinities.  The antibodies described in the patents were developed using phage display, with AbbVie initially identifying an antibody, Joe-9, that had low affinity for IL-12.  To improve the IL-12 affinity of Joe-9, AbbVie introduced mutations into the CDR sequences of that antibody, identifying an improved antibody, Y61.  Site directed mutagenesis was then employed to generate additional antibodies from Y61, with one antibody, J695, showing a significant increase in IL-12 binding and neutralizing activity.  Because all of the antibodies described in the patents were derived from Joe-9, all of the antibodies have VH3 heavy chains and Lambda light chains like Joe-9.  The antibodies described in the '128 and '485 patents also share at least 90% amino acid sequence similarity in their variable regions; with more than 200 of the described antibodies differing from Y61 at a single amino acid residue and sharing 99.5% similarity in the variable regions.

    The claims of the '128 and '485 patents that were at issue in the appeals define the claimed antibodies by their function — i.e., IL-12 binding and neutralizing characteristics — rather than by structure.  Representative claim 29 of the '128 patent recites:

    29.  A neutralizing isolated human antibody, or antigen-binding portion thereof that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1×10-2 s-1 or less, as determined by surface plasmon resonance.

    Centocor markets a human IL-12 neutralizing antibody under the brand name Stelara®.  Centocor's IL-12 antibody, which was developed using transgenic mice technology, has VH5 type heavy chains and Kappa type light chains, and shares about 50% sequence similarity in the variable regions as compared to Joe-9.

    After filing the '994 application, which is directed to IL-12 antibodies, Centocor provoked an interference with AbbVie's '128 patent.  During the interference, Centocor filed motions on the issues of obviousness and priority.  Following the Board's decision to award priority to AbbVie and finding the '128 patent not invalid for obviousness, AbbVie filed suit against Centocor for infringement of the '128 and '458 patents, and Centocor filed two actions in the District Court for the District of Colombia seeking judicial review of the Board's interference decisions under § 146, as well as a declaratory judgment of noninfringement and invalidity of the '128 and '485 patents.  Those actions were transferred to Massachusetts and consolidated with AbbVie's infringement action.

    At trial, the District Court denied AbbVie's motion of summary judgment that Centocor was collaterally estopped from challenging the validity of the '128 patent because it had failed to invalidate the patent during the interference proceeding.  After construing the claims, the District Court entered summary judgment that Centocor had infringed the asserted claims of the '128 and '458 patents, and the issue of validity was tried before a jury.  Centocor challenged the validity of the '128 and '458 patents on the basis of written description, enablement, obviousness, and anticipation, arguing that the antibodies described in the patents were not representative of other members of the functionally claimed genus, which included Centocor's antibody.  The differences between AbbVie's Joe-9 and J685 antibodies and Centocor's Sterlara-brand antibody were presented in Federal Circuit opinion as follows:

    Table
    The jury determined that the asserted claims of the '128 and '458 patents were invalid for lack of adequate written description, lack of enablement, and obviousness.  AbbVie then moved for JMOL on the grounds on which it lost, or for a new trial alleging that the District Court erred with respect to its evidentiary rulings and jury instructions.  The District Court denied both motions and entered final judgment, and AbbVie appealed.  On appeal, AbbVie challenged the District Court's denial of (1) AbbVie's motion for summary judgment that Centocor was collaterally estopped from raising invalidity defenses in the infringement action after the interference proceeding, (2) AbbVie's motion for JMOL on the issues of written description and enablement, and (3) AbbVie's motion for a new trial based on alleged errors in the District Court's evidentiary rulings and jury instructions.

    With respect to the collateral estoppel issue, the Federal Circuit determined that Centocor was not estopped from raising invalidity defenses in the infringement action because the Board's priority and nonobviousness decisions lacked finality for purposes of collateral estoppel.  The Court explained that because "a party seeking review of a decision of the Board under § 146 may 'shor[e] up evidentiary gaps' in the agency record by presenting live testimony, which could not be presented to the PTO," Board decisions reviewed under § 146 are not binding final judgments precluding a losing party from litigating the same or related issues in a parallel proceeding.  In particular:

    [Centocor was] entitled to present new evidence at least with respect to the issues of priority and obviousness in the underlying interference action.  The factual record in the interference action was therefore open as to those issues, subject to a de novo determination by the district court.  Consequently, the Board's priority and nonobviousness decisions lacked the requisite finality for purposes of collateral estoppel.

    With respect to AbbVie's motion for a new trial, the Federal Circuit determined that the District Court did not abuse its discretion in excluding additional testimony from AbbVie's expert regarding the USPTO's reasoning for concluding that the '128 and '458 patents satisfied the written description requirement.  The Court noted that "[i]n view of the record as a whole, including the substantial evidence of structural differences between Stelara and the Joe-9 antibodies and the fact that the jury considered the number of structurally similar antibodies disclosed in AbbVie's patents," the District Court did not abuse its discretion in excluding the additional testimony of AbbVie's expert.  As for the District Court's jury instructions, the opinion refers to AbbVie's argument that the instructions were prejudicial "as a last ditch argument," concluding that "[t]aken as a whole, the jury instruction reasonably apprised the jury on weighing evidence relevant to the written description issue."

    Finally, with respect to AbbVie's motion for JMOL on the issues of written description and enablement, the Federal Circuit determined that substantial evidence supported the jury's verdict of invalidity for lack of adequate written description of the claimed genus and affirmed the District Court's denial of JMOL on that issue.  The opinion began its analysis of the issue by noting that "the requirement for an adequate written description serves a different purpose from that of the claims," citing Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1347 (Fed. Cir. 2010), for the proposition that "[c]laims define and circumscribe, the written description discloses and teaches."  The Court explains that:

    When a patent claims a genus using functional language to define a desired result, "the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus."  We have held that "a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus" [citations omitted].

    According to the opinion, in the instant appeals "[t]he question . . . is whether the ['128 and '458] patents sufficiently otherwise describe representative species to support the entire genus."  In answering this question, the opinion analogizes the claimed genus to a plot of land, stating that:

    [I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus.  He only described a portion of it.  That is the case here.

    While cautioning against "tak[ing] the analogy of a plot of land too far in thinking of written description issues because, even if one builds a house only in one corner of the plot, one may still own the whole plot," the opinion continues by explaining that:

    One describes a plot of land by its furthest coordinates, in effect drawing a perimeter fence around it.  That may be akin to the function of patent claims to particularly point out and distinctly circumscribe the outer boundaries of a claimed invention.  With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus.

    Returning to the appeals at hand (and IL-12 antibodies), the opinion states that "[h]ere, the jury heard ample evidence that AbbVie's patents only describe one type of structurally similar antibodies and that those antibodies are not representative of the full variety or scope of the genus," noting that all of the antibodies described in the patents were derived from Joe-9, have VH3 heavy chains and Lambda light chains like Joe-9, and share at least 90% amino acid sequence similarity in their variable regions, and that more than 200 of the antibodies differ from Y61 at a single amino acid residue.  In contrast, Centocor's antibody, which is encompassed by the scope of the claimed genus, has VH5 type heavy chains and Kappa type light chains, and shares about 50% sequence similarity in the variable regions as compared to Joe-9.

    While acknowledging that "[i]t is true that AbbVie's patents need not describe the allegedly infringing Stelara in exact terms," the opinion states that "the patents must at least describe some species representative of antibodies that are structurally similar to Stelara."  Suggesting that "[f]unctionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus," the opinion also indicates that "[i]t is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date." However:

    [T]he record here does not indicate such an established correlation.  Instead, AbbVie used a trial and error approach to modify individual amino acids in order to improve the IL-12 binding affinity.  Moreover, the '128 and '485 patents do not describe any common structural features of the claimed antibodies.  The asserted claims attempt to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as Stelara, whereas the patents do not describe representative examples to support the full scope of the claims.

    Judge Lourie therefore concluded that substantial evidence supported the jury verdict of invalidity for lack of an adequate written description of the claimed genus, and affirmed the District Court's denial of JMOL on that issue.

    In an opinion concurring in judgment, Judge O'Malley noted that she would have affirmed the District Court's judgment invalidating the asserted claims in the '128 and '485 patents for obviousness, pointing out that this was "a finding from which AbbVie does not appeal."  Judge O'Malley explained that:

    [B]ecause AbbVie did not appeal the district court's finding of obviousness, our decision on the jury instruction issue controls the outcome of this case.  If we find no prejudicial error in the challenged jury instruction, the finding of obviousness stands and the patent is invalid.  Alternatively, if we hold that the jury instruction is erroneous, AbbVie is entitled to a new trial on all validity issues.

    With respect to the jury instruction, Judge O'Malley writes (quoting Judge Lourie) that "'[t]aken as a whole, the jury instruction reasonably apprised the jury on weighing evidence relevant to' both the written description and obviousness findings."  As for Judge Lourie's discussion of the written description issue, Judge O'Malley "express[es] no opinion regarding the thoughtful written description analysis in the majority opinion," adding that "I simply do not think it necessary or dispositive to the outcome of this case."

    In summary, the Federal Circuit found that Centocor was not collaterally estopped from raising invalidity defenses in the infringement action, that substantial evidence supported the jury verdict that the asserted claims were invalid for lack of an adequate written description, and that the District Court did not abuse its discretion in denying AbbVie's motion for a new trial with respect to the jury's written description verdict.  The Federal Circuit therefore affirmed the District Court's judgments in both the infringement and interference actions.

    AbbVie Deutschland GmbH v. Janssen Biotech, Inc. (Fed. Cir. 2014)
    Panel: Circuit Judges Lourie, O'Malley, and Chen
    Opinion by Circuit Judge Lourie; concurring opinion by Circuit Judge O'Malley

  • Continued Chaos in Obama Administration Patent Policy

    By Kevin E. Noonan —

    Washington - White House #2President Obama has reportedly decided against nominating Johnson & Johnson executive Philip Johnson in the face of political pressure from the hi-tech industry and Members of Congress, including Senator Charles Schumer (D-NY), as reported by The Wall Street Journal and GigaOm ("White House pulls plug on controversial Patent Office nominee after tech sector backlash").

    The proposed nomination, floated as a trial balloon last month, and its fate illustrate the rift between the biotech and pharma industry, who rely on patent exclusivity to provide the return on investment necessary to bring new drugs to market, and the IT industry, who are more concerned with the threat of so-called "patent trolls."  Mr. Johnson was known to oppose troll legislation that passed the House last fall and stalled in the Senate this spring (purportedly as the result of pressure from trial lawyers who feared the fee-shifting provisions in the bill would provide precedent for such provisions to spread from patent litigation to other lawsuits).

    There has been speculation about the fate of Michelle Lee, the current interim Deputy Director, but if the President was going to nominate her it would seem he would have done so by now.

    As the result of the President's decision not to nominate Mr. Johnson, the Office remains without a Director (for about 18 months and counting).  Because the time remaining on the President's term continues to diminish, the likelihood that a quality nominee would be willing to take on PTO leadership without sufficient time to make a difference is becoming less and less.  As the current subject matter eligibility Guidance shows, the Office needs a Director but the chances it will actually get one are becoming smaller and smaller.

  • Docs @ BIO: The Rest of the Story

    Bloomberg BNA Hosts Panel on Subject Matter Eligibility

    By Kevin E. Noonan —

    BIO International ConventionLast month at the BIO convention, Randy Kubetin, Managing Editor of Bloomberg BNA's Life Sciences Law & Industry Report moderated a panel entitled "Patent Eligibility from the Trenches: Practical Implications of the Supreme Court's Mayo and Myriad Decisions."  The panel provided a counterpoint to the USPTO's presentation earlier in the day (see "USPTO Provides Update on Myriad-Mayo Guidance"), which set forth the Office's position on subject matter eligibility.  This panel consisted of Theresa "Terry" Stanek Rea, former Deputy Director of the PTO under David Kappos and Acting Director upon his departure; Dr. Dianna DeVore, Senior Vice President, IP and Legal Affairs, Ariosa Diagnostics Inc. (familiar to readers for taking the position that nothing related to natural products or diagnostic methods is or should be patent eligible; Katherine Neville, a patent prosecutor from Marshall Gerstein and Borun in Chicago; and Matthew MacFarlaine, an author of Bloomberg BNA's Report, Stopped at the Threshold: The Practical Implications of the Supreme Court's Mayo and Myriad Decisions on Biotechnology Patent Practices (see "Bloomberg BNA Issues Report on PTO's Patent Eligibility Guidance").

    Mr. Kubetin introduced the panel and the topic by recapitulating some of his rhetoric he used in an earlier press conference introducing the Report:  speaking of the Mayo and Myriad cases and the USPTO Guidance, he asserted that the cases and the Guidance had "rewritten the playbook" and were (to use PTO Official June Cohan's phrase) "game changers."

    He then introduced the panel and Ex-Deputy Director Rea was the first to speak.  Asking that the session should be "highly entertaining" and "interactive, she presented what she called a "where we are" talk with regard to the Guidances and recent case law.  She argued that the Court's "judicial exceptions" were a "coarse filter" better assessed using substantive patent law.  She also asserted that in a close case, where patent eligibility is a tossup, the Office should choose to let an application pass through the Section 101 test.  She said that the Office was looking for "bright line" tests and for the public's help in properly applying the Court's rubrics, citing the Office's May 9th forum on the scope of the Guidances.  She also cautioned restraint by the Office, and asked the audience to advise clients to encourage them to pursue claims outside the scope of the Guidelines to help the Office "get it right."  She also mentioned that the deadline for written comments was extended by the Office until July 31, 2014 and said "[e]ach and every person in [the audience] has a moral duty" to provide comments on the Guidelines to help the Office "get it right."

    But she acknowledged that the "easy days" of having patent eligibility satisfied merely by reciting that a natural product was "isolated and purified" are gone, and what the Office needs are distinctions from the case law, particularly from the "scholars."  Ms. Rea also believes (from anecdotal evidence) that the Office and even certain examiners are looking for help in making the right determination; in this regard Ms. Rea cited the seven additional examples issued by the Office, including the one involving production of an antibiotic in yeast, which she believes should be patent eligible (unfortunately contrary to the Court's Cochrane v. Badische Anilin Soda Fabrik, 111 U.S. 293 (1884) precedent).

    Ms. Rea also argued (by example) for transparency by the Office, recalling her experience with the Written Description Guidelines from January 2001 and Director Kappos's supplemental guidelines in 2010, both of which were fully vetted through the formal agency rulemaking process.  She then directed her argument to why "getting it right" was important to her (as it should be to all of us, grey-haired or not): "I want as many drugs as possible and as many diagnostic tests as possible so I can look as good as possible for as long as possible."  She ended her portion of the panel by reminding the audience of the comments earlier in the morning by former Solicitor General Nancy Linck, agreeing that the Office should err on the side of patentability and said that she has optimism that the Office will do the right thing but needs our help in getting there.

    Next to speak was Dianna DeVore, Chief Patent Counsel of Ariosa Diagnostics; for those with short memories, Ariosa has taken the position (in its case against Sequenom) that genetic diagnostic tests utilizing "naturally occurring" fetal DNA were invalid under Section 101.  Dr. DeVore began her talk by stating that the "optimism is now over" and that the issue isn't how to get patents to grant from the Office but on how they can be enforceable.  Dr. DeVore acknowledged that the issues have not been completely resolved and that the current state of the law has had a "chilling effect" on diagnostics.  A result of this chilling effect is a "change IP regime," from "content based" (presumably genetic information) to "technology based," for example technology applicable to many diagnostics areas (she cited prenatal diagnostics and oncology as examples).  While admitting that not everyone believes these changes are good for diagnostics (a brave understatement particularly in front of this audience), she then predicted that as a result of the changes in the law, genetic diagnostic technology would rely more on trade secrets than patent protection, saying that the worst case scenario for a genetic diagnostics company would be to disclose its "secret sauce" in a patent application without being able to protect its methods.  (Without impugning Dr. DeVore's motivation it is clear that such a regime favors companies like Ariosa because it not only does not require disclosure but actively discourages it, so that the "term" of a proprietary diagnostic method can last far longer than the statutory patent term.)  Former Deputy Director Rea then piped up, saying that this scenario "really scares her" because the point of the patent system was disclosure; if Dr. DeVore's predictions became true the future would create specialized "institutes" where patients would need to visit to get a diagnosis.  Under these circumstances these institutes would "control" such testing because it would be difficult if not impossible to reverse engineer the test.  Dr. DeVore deflected this criticism by reminding the audience of the competition between the Scolnick lab and Mary Claire King's lab over the BRCA genes, implying that this sort of competition could avoid the consequences Ms. Rea had envisioned.  Unfortunately, while in the BRCA case there could have been such competition, the type of diagnostics Ms. Rea was talking about is unlikely to have the same sort of competition if only because such diagnostic tests are unlikely to involve inheritance of a single gene having the cancer-predisposing effects of BRCA (if only for the reason that it is one of the very few having such effects).

    Dr. DeVore also conflates the Mayo and Myriad holdings (as Ariosa has in its arguments to the District Court and the Federal Circuit), illustrated as saying the holdings were "not internally consistent" because producing cDNA from mRNA was "routine" (and implying that cDNA thus should not be patent eligible subject matter).

    Dr. DeVore ended her talk by mentioning the Court's decision in Alice Corp. v CLS Bank, saying that she has been "surprised" that the Court had been so interested in this area of the law.  She also stated that she believes the Federal Circuit will ultimately determine where the lines on patent eligibility will be drawn.

    Ms. Katherine Neville was the next speaker, and her talk was directed to the expanded scope of patent ineligibility in the Guidance that she said included antibodies, antibiotics, and other natural products.  She said that in her experience as a patent prosecutor for Biomarin and other pharmaceutical clients she had seen "viable 101 rejections and ridiculous ones, and cited the NIH study on the source of approved drugs over the past thirty years that has been discussed at the BIO IPCC meeting in April (see "Sherry Knowles 'Speaks Truth to Power' on the PTO's § 101 Guidelines").

    Ms. Rea again spoke up, reminding the audience that such drugs would not be brought to market unless a company can have an exclusivity position, citing bacitracin and taxol as examples.  Finally, Ms. Neville spoke about alternative claiming methods (such as methods of treatment) and the limitations of using these claim forms rather than claiming such natural products as compositions.

    The final speaker was Matt MacFarlaine, one of the authors of the Bloomberg BNA Report, and his presentation was largely a recap of the information disclosed in Bloomberg BNA's earlier press conference.  His message:  that the Office was broadly applying the Guidance on a case-by-case basis, to invalidate many claims encompassing widely varying subject matter (including in a particular example methods for identifying products of selective breeding of cod using genetic testing; these claims were deemed patent ineligible).  The pattern the authors detected was to "reject first" and then review an applicant's response to determine whether it overcame the assertion of patent ineligibility.

    Mr. Kubetin then started the truly interactive part of the program, presenting three claims and having the audience vote on whether the claims were patent eligible under the Guidances.  These claims were related to the following technologies:

    • A method for optimizing treatment of breast cancer with Tamoxifen, patterned very closely to the claim invalidated in Mayo;

    • A method for amplifying DNA patterned very closely on claims to the polymerase chain reaction (PCR); and

    • A vector comprising a nucleic acid operatively linked to a heterologous promoter.

    Perhaps not surprisingly, the vast majority of audience participants believed the first claim not to be patent eligible, based on its similarity to the Mayo claim.  This sentiment seemingly ignored the question of whether it was known (at the time the method was invented) that Tamoxifen was a treatment for breast cancer; the similarity to the Mayo claim was enough for most of the audience to arrive at its conclusion of patent ineligibility.  At least one questioner pointed out that this sentiment was based on the assumption that Tamoxifen was not a new compound and posed the question of whether the result would be different if it was novel (Dr. DeVore remained steadfast in her position that this claim would just be a natural correlation whether Tamoxifen was a new compound or not.)

    The other two claims were deemed by the majority of the audience to be patent eligible.  However, one audience member reacted to the PCR claim by stating that "this was exactly what the Supreme Court was trying to get rid of in Myriad, . . . control of genetic information."  Unless this was an ACLU plant, this outburst provided a measure of how far the ACLU's position has taken hold even among BIO attendees.  However, it is important to realize that this position conflates claims to a method for obtaining (genetic) information with the information itself, and also forgetting that genetic information per se is not patent eligible and has never been patented.  The recombinant DNA claim was less controversial if only because it was polled at the very end of the session (which had of course gone overtime); from earlier discussions it was clear that even this claim had some audience members believing that patent eligibility would depend on whether making recombinant DNA was "routine and conventional," something the Supreme Court has not held but criteria clearly implicated in the Office's Guidance.

    Taken together, this session, Bloomberg BNA's press conference regarding its Report, and the PTO's session earlier in the day firmly established that the law of subject matter eligibility is in flux throughout the patenting space, a situation created by the Supreme Court, abetted by the USPTO and the excessive Guidances, and one that decidedly does not "Promote the Progress of . . . the Useful Arts."

  • IPO Releases List of Top 300 Patent Holders for 2013

    Life Sciences Top 49

    By Donald Zuhn —

    IPO #2Last month, the Intellectual Property Owners Association (IPO) announced the release of its 31st annual list of the top 300 organizations receiving U.S. patents.  Patent Docs Readers may recall that the U.S. Patent and Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."

    The IPO compiled its list by counting the number of utility patents granted during 2013 that listed an organization or a subsidiary as the owner on the printed patent.  The IPO notes that if an assignment to an organization or its subsidiary was recorded after the patent was printed, the patent was not counted, and further, that patents that were granted to two or more organizations jointly were attributed to the organization listed first on the patent.  The IPO also noted that 277,835 patents were issued in 2013, which was an increase from the 253,155 patents that issued in 2012.  The top fifteen companies on the IPO Top 300 are listed below (click on table to expand):

    2013 Top 15
    Falling out of the Top 15 in 2013 were Seiko Epson Corp. and Toyota Jidosha K.K., which dropped to 19th and 22nd, respectively.  Replacing those companies in the Top 15 were Google, Inc. and Apple, Inc.

    As in past years, Patent Docs used the IPO's list of top patent holders to compile a list of the top "life sciences" companies and organizations receiving U.S. patents in 2013.  In the past seven years, the number of life sciences companies and organizations making the list has gone from 51 in 2006 to 47 in 2007, 43 in 2008, 47 in 2009, 56 in 2010, 53 in 2011, 50 in 2012, and 49 last year.  Each organization's IPO top 300 ranking for 2013 is indicated in the "2013 IPO Rank" column; the IPO top 300 ranking for 2012 (if available) is indicated in the "2012 IPO Rank" column; and the change in number of patents from 2012 is indicated in "+/- from 2012."  The Life Sciences Top 49 is listed below (click on table to expand):

    2013 Top 49Life sciences companies and organizations that failed to make the IPO top 300 in 2013 after making it in 2012 included Dongbu Hitek Co., Ltd. (#224 on the IPO top 300 for 2012), DSM IP Assets B.V. (273), AstraZeneca AB (288), and Toray Industries Inc. (296).  Life sciences companies new to this year's list are indicated in green text.

    Please note that some of the companies and organizations listed above may be involved in work outside the life sciences sector, and therefore, a portion of the patents granted to these companies and organizations may be directed to other than life sciences-related inventions.  In addition, our list is a little inclusive in that we included medical device companies.

    For additional information regarding this topic, please see:

    • "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
    • "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
    • "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
    • "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
    • "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
    • "IPO Releases List of Top 300 Patent Holders," May 22, 2008
    • "IPO Posts List of Top 300 Patent Holders," April 20, 2007

  • Court Report

            By Sherri Oslick —

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

    Eli Lilly and Company et al. v. Panacea Biotec, Ltd.
    1:14-cv-01064; filed June 26, 2014 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
    • Defendant:  Panacea Biotec, Ltd.

    Infringement of certain of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of Panacea's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00111; filed June 26, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals, Inc.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00820; filed June 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis Corp.; Novartis AG; Novartis Pharma AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,465,504 ("Substituted 3,5-Diphenyl-1,2,4-Triazoles and Their Use as Pharmaceutical Metal Chelators," issued October 15, 2002) and 6,596,750 (same title, issued July 22, 2003) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exjade® (deferasirox, used for the treatment of chronic iron overload due to blood transfusions).  View the Delaware complaint here.

    Shire LLC et al. v. Ranbaxy Inc. et al.
    1:14-cv-00827; filed June 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Shire LLC; Shire Development LLC; Supernus Pharmaceuticals Inc.
    • Defendants:  Ranbaxy Inc.; Ohm Laboratories Inc.; Ranbaxy Laboratories Ltd.

    Infringement of U.S. Patent Nos. 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title, issued November 2, 2004) based on Ranbaxy's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.

    Pfizer Inc. et al. v. CFT Pharmaceuticals LLC
    2:14-cv-00714; filed June 20, 2014 in the Eastern District of Wisconsin

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; Pfizer Manufacturing Holdings LLC; PF Prism CV
    • Defendant:  CFT Pharmaceuticals LLC

    Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of CFT's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
    1:14-cv-00106; filed June 20, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

  • Conference & CLE Calendar

    CalendarJuly 9, 2014 – "Nautilus and Limelight: The Supreme Court Keeps Chipping Away at Patentees" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    July 9-11, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    July 20-22, 2014 – 2014 Annual Meeting & Conference (National Association of Patent Practitioners) – Alexandria, Virginia

    July 22, 2014 – "America Invents Act: Patent Strategies and Reforms Counsel Needs to Know" (Commercial Law WebAdvisor) – 1:00 to 2:30 pm (Eastern)

    July 24, 2014 – "Protecting IP Rights After Limelight Networks v. Akamai: Implications for Divided Patent Infringement and Inducement — Prosecuting and Litigating Patent Claims Following the New Supreme Court Decision" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 30, 2014 – "Ask the Office: New Guidance on Functional Claiming" (American Bar Association Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    July 30, 2014 – "Alice Corp. v. CLS Bank: Patent Eligibility of Software-Related Inventions" (Strafford) – 1:00 to 2:30 pm (EDT)

    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

  • Webinar on Protecting IP Rights After Limelight Networks v. Akamai

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Protecting IP Rights After Limelight Networks v. Akamai: Implications for Divided Patent Infringement and Inducement — Prosecuting and Litigating Patent Claims Following the New Supreme Court Decision" on July 24, 2014 from 1:00 to 2:30 pm (EDT).  Sona De and Gene W. Lee of Ropes & Gray will provide guidance to patent counsel on the impact of the new Limelight Networks Inc. v. Akamai Techs. Inc. decision on patent litigation and prosecution, and discuss the divided infringement loophole and outline steps to protect IP rights.  The webinar will review the following questions:

    • What are the implications of the Limelight Networks Inc. v. Akamai Techs. Inc. decision for infringement claims?
    • What best practices in patent claim drafting can counsel employ to minimize the risk of infringement?
    • What is the impact of the decision for method claims?

    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.

  • Webinar on AIA Patent Strategies

    Commercial Law WebAdvisor
    Commercial Law WebAdvisorwill be offering a webinar entitled "America Invents Act: Patent Strategies and Reforms Counsel Needs to Know" on July 22, 2014 from 1:00 to 2:30 pm (Eastern).  Aaron D. Charfoos of Dykema Gossett PLLC will examine the changes to the patent system introduced by the AIA, as well as strategies in-house counsel and other attorneys advising businesses can employ to put themselves at an advantage when applying for and challenging patents.  The webinar will address the following topics:

    • How the America Invents Act altered the landscape of obtaining and challenging patents,
    • How the change from a “first-to-invent” to a “first-to-file” system affects how patents are awarded,
    • Steps counsel and businesses need to take to secure the earliest possible filing date,
    • New ways to challenge patents after they issue, specifically Inter Partes Review (IPR) and Covered Business Method Review (CBMR),
    • Procedural benefits to IPR and CBMR compared to civil proceedings, and
    • Other litigation assessment strategies.

    The registration fee for the webinar is $299.  Those interested in registering for the webinar, can do so here.