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  • Rep. Goodlatte Releases Report on H.R. 9

    By Kevin E. Noonan —

    House of Representatives SealLast week, Rep. Bob Goodlatte, Chairman of the House Judiciary Committee, released a 200-page Report on H.R. 9, "The innovation Act," introduced by Chairman Goodlatte with several co-sponsors earlier this year.  The bill sets forth several "reforms" of U.S. patent law, primarily directed to addressing the "problem" of so-called "patent trolls."

    The Report sets forth the language of the bill and a provision-by-provision explication of the bill in its entirety.  Much of the majority's Report sets out the purported "new consensus" constituting "broad agreement" among "industry leaders from different sectors . . . on a common set of reforms that will address the most serious abuses currently afflicting the patent-enforcement system."  The majority Report expresses the sentiment that "[e]very member of this Committee wishes to see the patent system fulfill its constitutional mandate to ''promote the progress of science and the useful arts.'''  The Report also states that:

    It is the goal of this Committee to ensure that American manufacturing, small businesses, and start-up companies are protected against patent-enforcement abuse, while also ensuring that the patent system continues to protect and encourage American ingenuity.  The Innovation Act, which has earned the support of a broad coalition of America's most innovative companies, recalibrates the Nation's patent-enforcement mechanisms in a manner that strikes a balance between these overlapping and sometimes conflicting goals, and that ensures that the Nation's patent system continues to drive technological innovation and economic growth.

    Most of the remainder of the majority section of the Report sets forth testimony, from this and the last Congress that illustrate this "new consensus."  (Included in these sections of the majority Report are the views of USPTO Director Lee, who agrees with the expressed need for litigation reform but is much less supportive of the changes in PTO, especially PTAB, procedures.)  For most provisions in the law (particularly the litigation-related provisions), the Report contains quotations from such hearing testimony supporting the changes encompassed by the bill.  These include the provisions related to attorney's fees, heightened pleading standards, mandatory joinder, venue, patent ownership transparency, the customer-suit exception, and "recommendations to the Judicial Conference," including changes in discovery rules.

    This pattern changes when the Report moves onto the provisions changing how intellectual property rights are discharged in bankruptcy and "corrections and improvements to the America Invents Act."  Here, the Report discusses the historical and policy reasons for the changes that would be effected by enactment of the bill.  An example of the former change is elimination of the "could-have-raised" estoppel provisions of the post-grant review provisions of the AIA.  The Report cites statements from the AIA's legislative history that inclusion of this estoppel was a simple mistake that needed correction inter alia because of its negative effects on the effectiveness of the post-grant review provisions of the law.  The Report set forth reasons for and against changing the claim construction standard before the PTAB in post-grant review and inter partes review proceedings, with the weight of these considerations favoring changing the broadest-reasonable-interpretation standard to the standard used by courts as set forth in Phillips v. AWH Corp.  These changes do not extend to covered business method reviews, however, the Report noting that recent Supreme Court cases (including Bilski v. Kappos and Alice Corp. v. CLS Bank Corp.) make the validity of these claims sufficiently questionable that "the Committee finds it unnecessary to burden the Board with applying the district courts' claim-construction approach to define the precise metes and bounds of the unpatentable subject matter claimed in such patents."

    The Report also castigates the Federal Circuit from departing from settled law (traced to Thomson-Houston Elec. Co. v. Ohio Brass Co.) in support of its codification of obviousness-type double patenting.  The bill proposes changes in 35 U.S.C. § 121 (to eliminate the provisions related to OTDP) in favor of election provisions as part of revised § 102(e)(2).  These new § 102 provisions would prevent the abuses (litigation by different patentees over claims that are not patentably distinct) that are the only justification for the continued vitality of the OTDP doctrine in view of the changes in patent term effected by the GATT/TRIPS agreement.

    The Report also addresses the policy concerns behind the provisions of the bill that abrogate the Supreme Court's Gunn v. Minton decision and once again bring patent malpractice cases under the Federal Circuit's "arising under" jurisdiction.

    The Report sets forth the history of the hearings and witnesses before the committee, and the roll call votes on the bill itself (which passed by a vote of 24-8) and three proposed but defeated amendments.  Director Lee's statement on the bill is also included.

    The minority portion of the Report was signed by nine Democratic members of the committee, including Ranking Member Rep. John Conyers, Jr. and Reps. JACKSON LEE, JOHNSON, JR., DEUTCH, BASS, CICILLINE, and PETERS.  The minority Report sets forth several reasons against the bill.  Under the heading "The Innovation Act Limits The Rights Of All Patent Holders, Not Just So–Called ''Patent Trolls,'' And Presents Other Policy Concerns," the minority Report sets out the following negative consequences of certain provisions of the bill:

    • Impose burdensome pleading requirements for plaintiffs that exceed what is required in other civil cases and which demand details plaintiffs may not know before conducting discovery (Section 3(a));
    • Discourage, through a presumptive fee shifting standard, small businesses and individual inventors from bringing meritorious lawsuits because the risk of having to pay the other sides court costs may outweigh the benefits of winning (Section 3(b));
    • Deter investments by venture capitalists in entrepreneurs, start-ups, and individual inventors through harsh joinder rules that may make the investors liable for paying attorneys' fees (Section 3(c));
    • Limit discovery for plaintiffs that will lead to costly litigation and case delays (Section 3(d)); and
    • Improperly shield some of the most culpable infringers through an over-broad stay of litigation for end users of infringing products (Section 5).

    The minority Report then discusses in depth the grounds these Representatives have for concluding that the heightened pleadings requirements will prevent meritorious lawsuits by "legitimate inventors"; that the fee-shifting provisions favor parties with "deep pockets" and can similarly prevent meritorious claims from inventors to be brought; that the joinder provisions can be expected to chill investment in individual inventors and entrepreneurs; that the discovery provisions are better left to the courts to develop and as written invite abuse; and that the customer stay provisions could "deprive legitimate patent owners of meaningful relief."  This section also characterizes the change in the post-grant review estoppel provisions as being "controversial" and not just a "scrivenor's error" that needs more robust consideration and debate before being enacted.

    The minority Report also contends that the bill will be ineffective in  achieving its purported goals, in a section having the heading "The Innovation Act Does Not Effectively Address The Deceptive Use Of Demand Letters, Stop Abuse Of Post-Grant Proceedings At The USPTO, or Improve Patent Examination Quality At The USPTO."  This section addresses the particular problem of "extortionate use of demand letters," the "abuse" of post-grant proceedings (including use of inter partes review by certain hedge funds) and the problems in patent quality caused by fee diversion of USPTO user fees.

    The final section of the minority Report, entitled "Recent Developments Make Many Of The Provisions In The Innovation Act Unnecessary," sets out the changing landscape of patent law since the bill was first proposed  These include that:

    • Courts are Already Awarding Fees at a Much Higher Rate
    • Patent Case Filings Have Decreased Significantly Over the Last Year
    • Pleading Standards are Already Set to Increase Due to the Elimination of Form 18
    • District Courts Have Developed Local Case Management Rules
    • The USPTO Has Begun an Enhanced Patent Quality Initiative

    (This section also contends, perhaps somewhat gratuitously, that "H.R. 9 Is More Objectionable than the Senate's PATENT Act.")

    The minority Report concludes (urging their colleagues to "reject this flawed measure"):

    Congress must respond to the problems of abusive patent litigation in the courts and the gaming of the patent process at the USPTO, and we are willing to work with any and all stakeholders and interested parties to develop a fair process to find common sense solutions.  That is why we supported amendments at the Committee markup to make reasonable improvements that would protect patent rights, while still curtailing abusive patent litigation and exploitation of the patent process.  We must take a targeted approach that includes deterring further abuses of IPR proceedings and ending fee diversion from the USPTO to ensure adequate hiring, proper training of examiners, and sustained patent quality.  And, serious patent reform legislation must stop the extortionate use of deceptive demand letters.  Unfortunately, we cannot support H.R. 9 because it includes changes that go well beyond the problems of so-called ''patent trolls;'' it creates an imbalance in the patent system tilted against individual inventors and small businesses; and it will have a chilling effect on innovation.

    While many have considered eventual passage of H.R. 9 to be a near certainty, the bill did not come to the House floor for a vote before the August recess.  As mentioned in the minority Report there is a competing (and different) bill in the Senate and that bill has not been passed out of committee.  Thus, the fate of H.R. 9, and patent "reform" generally, is much less certain in this Congress that it appeared in January when Rep. Goodlatte introduced the bill.

  • Trustees of Columbia University v. Illumina, Inc. (Fed Cir. 2015)

    By Andrew Williams —

    IlluminaOne of the first IPR petitions ever filed, IPR2012-0006, was related to biotechnology — specifically DNA sequencing.  Illumina, Inc. filed that petition, and two others, IPR2012-00007 and IPR2013-00011, against patents owned by The Trustees of Columbia University in the City of New York ("Columbia").  The PTAB issued its Final Written Decisions in early 2014, canceling all of the challenged claims, which we reported at the time (see "IPR Update — The First Biotech IPR Decisions").  The Federal Circuit just recently concluded its review of these cases, affirming the decision of the Board.  The clear take away message from this decision is that anyone wanting to challenge a PTAB decision is likely going to face an uphill battle.  Even though the Court did write an opinion in this case, albeit non-precedential, the expectation is that the majority of IPR reviews appealed to the Federal Circuit will end in Rule 36 affirmances.  It is possible that the extreme deference that the Court appears to be showing the Patent Office could be a direct result of the deluge of cases that are anticipated for the next couple of years (if not longer).  Perhaps by signaling the uphill nature of these appeals, the Court may be attempting to discourage a perfunctory appeal in every case. Or, they may be setting the stage to make the Rule 36 judgements easier to issue.  Of course, there is another possible explanation.  It is conceivable that the first few petitions filed were really strong and/or were filed against low-hanging fruit.  As stronger patents get challenged, the PTAB may find themselves faced with closer cases, which may result in an increase in reversals or remands issued by the Federal Circuit.  Only time will tell.

    In our previous review of the PTAB decisions, we provided a detailed explanation of the technology in this case.  Briefly, nucleotide analogues for use in sequencing by synthesis were at issue, which is a technique of sequencing by which every added nucleotide is determined using a label, such as a fluorescently detectable label.  Basically, this technology involves incorporating a labeled nucleotide analogue into a primer strand using DNA polymerase, in a manner comparable to that used when a DNA strand is synthesized.  Normally, when a DNA strand is synthesized, the 5' position of the sugar in a new incoming nucleotide is linked to the 3'-OH group of the sugar of a preexisting nucleotide in the strand under synthesis.  The difference in this sequencing technique, though, is that the newly incorporated nucleotide analogues have cleavable chemical groups capping the 3'-OH to prevent the incorporation of any successive nucleotides before the identity of the nucleotide analogue is determined. This nucleotide is identified with a detectable label attached to the nucleotide, with a unique label used for each base (A, C, G, or T).  In order to sequence an entire region of DNA, the 3'-OH cap is cleaved and the process repeated step-wise until the entire sequence is deduced.

    Columbia scientists purported to invent particular nucleotide analogues utilized by this technique.  Specifically, the analogues have the detectable label attached to the base instead of the 3'-OH group, they have a cleavable chemical group capping the 3'-OH group, and at least some of the claims require the use of a deaza-substituted base, such as 7-deazapurine (a deazabase is one in which a natural nitrogen atom in the base ring is substituted with a carbon atom).  The opinion included an example of such a nucleotide analogue from Colombia's briefing:

    Image
    Representative claims of the patents-at-issue, with the emphasis as added by the Federal Circuit noted, include:  Patent No. 7,713,698, claims 1 and 11:

    1.  A method of determining the identity of a nucleotide analogue incorporated into a nucleic acid primer extension strand, comprising:
        a) contacting a nucleic acid template attached to a solid surface with a nucleic acid primer which hybridizes to the template;
        b) simultaneously contacting the product of step a) with a polymerase and four nucleotide analogues which are either (i) aA, aC, aG, and aT, or (ii) aA, aC, aG, and aU, so as to incorporate one of the nucleotide analogues onto the nucleic acid primer and form a nucleic acid primer extension strand, wherein each nucleotide analogue within (i) or (ii) comprises a base labeled with a unique label and contains a removable chemical moiety capping the 3'-OH group of the sugar of the nucleotide analogue, and wherein at least one of the four nucleotide analogues within (i) or (ii) is deaza-substituted; and
        c) detecting the unique label of the incorporated nucleotide analogue, so as to thereby determine the identity of the nucleotide analogue incorporated into the nucleic acid primer extension strand.

    11.  A plurality of nucleic acid templates immobilized on a solid surface, wherein a nucleic acid primer is hybridized to such nucleic acid templates each such nucleic acid primer comprising a labeled incorporated nucleotide analogue, at least one of which is deaza-substituted, wherein each labeled nucleotide analogue comprises a base labeled with a unique label and contains a removable chemical moiety capping the 3'-OH group of the sugar of the nucleotide analogue.

    Patent No. 7,790,869, claims 12 and 15:

    12.  A nucleotide having a base that is attached to a detectable label through a cleavable linker, wherein the nucleotide has a deoxyribose comprising a cleavable chemical group capping the 3' OH group, wherein the cleavable linker is cleaved by a means selected from the group consisting of one or more of a physical means, a chemical means, a physical chemical means, heat, and light, and wherein the cleavable chemical group capping the 3' OH group is cleaved by a means selected from the group consisting of one or more of a physical means, a chemical means, a physical chemical means, heat, and light.

    15.  The nucleotide of claim 12, wherein the base is a deazapurine.

    And Patent No. 8,088,575, claims 1 and 6:

    1.  A method of determining the identity of a nucleotide analogue incorporated into a nucleic acid primer extension strand, comprising: a) contacting a nucleic acid template attached to a solid surface with a nucleic acid primer which hybridizes to the template; b) simultaneously contacting the product of step a) with a polymerase and four nucleotide analogues which are either (i) aA, aC, aG, and aT, or (ii) aA, aC, aG, and aU, so as to incorporate one of the nucleotide analogues onto the nucleic acid primer and form a nucleic acid primer extension strand, wherein each nucleotide analogue within (i) or (ii) comprises a base labeled with a unique label and contains a small removable chemical moiety capping the 3'-OH group of the sugar of the nucleotide analogue, wherein said small cleavable chemical group does not interfere with the recognition of the nucleotide analogue by polymerase as a substrate; and c) detecting the unique label of the incorporated nucleotide analogue, so as to thereby determine the identity of the nucleotide analogue incorporated into the nucleic acid primer extension strand.

    6.  The method of claim 1, wherein said base of at least one of said nucleotide analogues is a deazapurine.

    The PTAB's Failure to Resolve PHOSITA's Qualifications

    The first allegation by Columbia addressed by the Federal Circuit was whether the PTAB erred because it did not resolve what the qualifications would be of a person having ordinary skill in the art.  Columbia's expert asserted that a PHOSITA would have been skilled in "both biology and synthetic nucleotide chemistry," while Illumina's expert's definition did not include any mention of chemistry.  The challenge was that Illumina's expert did not possess the qualifications of a PHOSITA, and therefore was unqualified to opine.

    The Court explained that failure to make explicit finding regarding the level of skill in the art is not necessarily reversible error.  Moreover, it is normally easier to establish obviousness with a higher level of skill.  Thus, because the PTAB found the claim obvious regardless of whether a PHOSITA was skilled in chemistry, it follows that someone with that additional skill would have found the claims at least as obvious (if not more so).  And, because the PTAB found Illumina's expert's qualifications sufficient, its credibility determination was not reversible error.

    Prior Art Disclosures

    The Court next considered whether the prior art contained all of the limitations of challenged claims: (1) a labeled base, (2) a removable 3'-OH cap, and (3) a deaza-substituted base.  The cited art was detailed in our previous post, as mentioned above.  The primary reference, WO 91/06678 ("Tsien"), purportedly described the DNS sequencing by synthesis method, and therefore was a starting point for many of the rejections of the relevant claims.  Tsien disclosed unique labels attached to a base, and a removable 3'-OH chemical moiety (capping group).  Columbia argued that even though a cleavable label attached to a base might have been disclosed, it did not teach such a label with a cleavable tether.  The Board, however, found that because Tsien disclosed these two concepts in adjacent paragraphs, one skilled in the art would have recognized the utility of such a tether.  The Board also cited two additional references, Dower and Stemple, as disclosing base-labeled nucleotides that contain 3'-OH moieties.  The Federal Circuit found there was substantial evidence for the finding that the prior art disclosed "nucleotides with a label on the nucleotide base with a removable 3'-OH group," and "a cleavable tether to release the label" from the base.

    Motivation to Combine

    Columbia also argued that the PTAB erred in concluding that a person of skill in the art would have combined the above-referenced teachings with a 7-deazapurine nucleotide.  Tsien did reference another article, Prober.  And, Prober did disclose the labeling of purines.  However, Columbia asserted that Tsien only cited Prober for the proposition that purines could be labeled.  As such, the argument went, there was no motivation to combine.

    The PTAB had found an express teaching of incorporating a 3'-blocked dNTP having a fluorescent label in the Prober reference.  Moreover, the Federal Circuit pointed out, the motivation to combine can be found even in the absence of an explicit mention of the one reference in the other.  This case was even stronger because Tsien pointed directly to Prober, even if not the specific section of Prober.  The Court found that the PTAB's finding was supported by substantial evidence.

    Reasonable Expectation of Success

    Columbia also argued that the chemistry for creating the claimed nucleotide analogues was complex, and that therefore there would not be a reasonable expectation of success.  However, even Columbia's expert admitted that the synthetic process would have been easily understood by one skilled in the art.  Therefore, the Federal Circuit found substantial evidence supporting the PTAB's finding regarding the expectation.

    Secondary Considerations

    The Court next considered the Board's analysis of the secondary considerations of non-obviousness.

    • Simultaneous Invention weighs modestly in favor of obviousness

    Not quite a consideration of non-obviousness, the near simultaneous invention by two other companies, Solexa (a predecessor of Illumina) and Amersham counseled that the invention was obvious.  Columbia argued that these "inventions" were not prior art, but the Court pointed out that they do not need to be for this consideration.  In fact, if they were, they would have been considered under §§ 102 and 103.

    • Copying does not favor nonobviousness

    Columbia asserted that Manteia, a company whose intellectual property was acquired by Solexa, copied the invention.  However, the Board did not make a specific factual finding regarding whether the invention was copied.  Nevertheless, the Court did find that simultaneous invention can weigh in favor of obviousness, but only does so modestly in this case.

    • Attempted Licensing weights modestly in favor of nonobviousness.

    Columbia also points to Illumina's attempts to license the technology.  However, the Court found that none of the correspondence specifically mentioned the patents at issue.  Therefore, at best, this was only modest evidence of nonobviousness.

    • Commercial Success does not favor nonobviousness

    Columbia alleged that Illumina had significant sales of technology covered by the patents at issue.  However, Illumina pointed out, and the Court agreed, that all of the features proclaimed by Columbia to be responsible for the success of the products could be found in the prior art Tsien reference.  Moreover, the fact that Columbia was relying on Illumina's sales complicated the matter, because the Court could not separate out potential simultaneous invention or copying.

    • Unexpected Results do not favor nonobviousness

    Finally, Columbia asserted that the claimed nucleotides were "unexpectedly" better than pyrosequencing.  The PTAB dismissed this argument because pyrosequencing was not the closet prior art, and therefore was not probative to the determination of nonobviousness.  The Federal Circuit agreed.

    Anticipation

    The Board has also found that certain claims were anticipated by Tsien, and other references independently.  Columbia argued that these references were non-enabling, and did not disclose all of the elements.  Tsien was described as teaching a genus, but not the specific claimed species.  However, the Court pointed out that when a genus is small enough, such that all members can be envisaged, a genus anticipates every species within the genus.  Also, the Court noted that the patents at issue also do not disclose the chemistry required to practice the invention, which suggests that the chemistry required was not novel or nonobvious.  Finally, the Court held that the PTAB did not abuse its discretion in denying Columbia's motion to amend.

    Trustees of Columbia University v. Illumina, Inc. (Fed Cir. 2015)
    Panel: Chief Judge Prost and Circuit Judges Schall and Wallach
    Opinion by Circuit Judge Wallach

  • ABA Journal Accepting Nominations for 9th Annual Blawg 100

    ABA JournalThe ABA Journal has begun work on its 9th annual list of the 100 best legal blogs (or blawgs) and has announced that it is seeking the advice of its readers, via the ABAJournal.com website, on which blogs to include on this year's Blawg 100.  For the past three years, Patent Docs has been honored to be included among the five blogs selected in the IP Law category of the Blawg 100 (see "ABA Journal Announces 2012 Blawg 100"; "ABA Journal Announces 2013 Blawg 100"; and "ABA Journal Announces 2014 Blawg 100").

    Readers interested in nominating a particular blog for the 9th annual Blawg 100 should use the ABA Journal's blawg 100 amici form.  Additional information about the Blawg 100 can also be found on the blawg 100 amici form.  The form requires that anyone making a nomination provide a name, employer or law school, city, and e-mail address.  The ABA Journal requires this information in order to discourage:

    • Bloggers who nominate their own blogs or nominate blogs to which they have previously contributed posts.
    • Employees of law firms who nominate blogs written by their co-workers.
    • Public relations professionals in the employ of lawyers or law firms who nominate their clients' blogs.
    • Pairs of bloggers who have clearly entered into a quid pro quo agreement to nominate each other.

    The ABA Journal, however, welcomes comments (up to 500 words in length) from readers who do not fall into the above categories.

    2013_Blawg100_HorizBadgeFavIn addition, the ABA Journal is encouraging readers to keep the following criteria in mind when nominating blogs:

    • The ABA Journal is primarily interested in blogs in which the author is recognizable as someone working in a legal field or studying law in the vast majority of his or her posts.
    • The blog should be written with an audience of legal professionals or law students in mind.
    • The majority of the blog's content should be unique to the blog and not cross-posted or cut and pasted from other publications.
    • The ABA Journal is not interested in blogs that more or less exist to promote the author's products and services.

    Nominations must be submitted no later than 11:59 pm (CT) on Sunday, August 16, 2014.

  • Court Report

            By Sherri Oslick —

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

    Millennium Pharmaceuticals Inc. v. Dr. Reddys Laboratories, Ltd. et al.
    1:15-cv-00539; filed June 25, 2015 in the District Court of Delaware

    • Plaintiff:  Millennium Pharmaceuticals Inc.
    • Defendants:  Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.

    Millennium Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Ltd. et al.
    1:15-cv-0053940; filed June 25, 2015 in the District Court of Delaware

    • Plaintiff:  Millennium Pharmaceuticals Inc.
    • Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE; Sun Pharmaceutical Industries Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the Dr. Reddy's complaint here.


    Novartis Pharmaceuticals Corp. v. Aurobindo Pharma Ltd. et al.
    2:15-cv-04427; filed June 25, 2015 in the District Court of New Jersey

    • Plaintiff:  Novartis Pharmaceuticals Corp.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.

    Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.


    Cephalon, Inc. v. Fresenius Kabi USA, LLC
    1:15-cv-00536; filed June 24, 2015 in the District Court of Delaware

    Infringement of U.S. Patent No. 8,344,006 ("Liquid Formulations of Bendamustine," issued on January 1, 2013) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.


    Ferring B.V. et al. v. Actavis, Inc. et al.
    Filed June 23, 2015 in the District Court of New Jersey

    • Plaintiffs:  Ferring B.V.; Ferring International Center S.A.; Ferring Pharmaceuticals Inc.
    • Defendants:  Actavis, Inc.; Watson Laboratories, Inc.; Andrx Corp.; Watson Laboratories, Inc. – Florida; Watson Pharama, Inc.

    Infringement of U.S. Patent No. 9,060,939 ("Tranexamic Acid Formulations," issued June 23, 2015) following in conjunction with Watson's filing of an ANDA to manufacture a generic version of Ferring's Lysteda® (tranexamic acid, used to treat heavy menstrual bleeding).  View the complaint here.

  • Conference & CLE Calendar

    CalendarAugust 6, 2015 – "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 (EDT)

    August 10-11, 2015 – "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – San Francisco, CA

    August 11, 2015 – Patent Quality Chat webinar series – Measuring Patent Quality – noon to 1:00 pm (EDT)

    August 13, 2015 – "Defending Patents in IPR Proceedings — Leveraging Motions to Amend and Preliminary Responses, Weighing Secondary Considerations" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 12-14, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    August 20, 2015 – "Inducement to Infringe in Patent Litigation: Protecting IP Rights — Lessons from Commil USA v. Cisco Sys. Inc. and Leveraging Opinions of Counsel" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 24, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Santa Clara, CA

    August 26, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Dallas, TX

    August 27, 2015 – "Meet the New Boss. Same as the Old Boss? Not Even Close under New Mayo/Alice Regime for § 101" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    August 27, 2015 – "Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    August 28, 2015 – Roadshow on Patent Quality and AIA Trials (American Intellectual Property Law Association and U.S. Patent and Trademark Office) – Alexandria, VA

    September 10-11, 2015 - "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL

    September 18, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – San Francisco, CA

    September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    October 2, 2015 – Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) – New York, NY

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

  • AIPLA and USPTO to Hold Roadshows on Patent Quality and AIA Trials

    USPTO SealThe American Intellectual Property Law Association (AIPLA) and U.S. Patent and Trademark Office will be co-hosting a series of cross-country roadshows in August in Santa Clara, CA (August 24); Dallas, TX (August 26); and Alexandria, VA (August 28).  The Santa Clara roadshow is being co-sponsored by the High Tech Law Institute of Santa Clara Law and the Dallas roadshow is being co-sponsored by the IP Section of the Dallas Bar Association.  The full-day program will focus on enhancing patent quality (morning session) and conducting AIA trials (afternoon session) with AIPLA #1numerous speakers from the USPTO and private practice.  The program for the roadshows includes presentations on the following topics:

    Part I.  Patent Quality Initiative, Version 2.0:  What it Means to You

    • The USPTO's Enhanced Patent Quality Initiative
    • Achieving Clarity of Record; Best Practices for Drafting Quality Patent Applications
    • Improving Patent Quality Through Remote Examiner Interviews
    • The PTO's New Quality Metrics

    • Lunch and Keynote Speaker: Russ Slifer, Deputy Under Secretary of Commerce and Deputy Director, USPTO

    Part II.  Trials at the Patent Trial and Appeal Board:  New Rules, Hot Issues and a Live Hearing

    • State of the Board
    • Proposed Rule Changes at the Patent Trial and Appeal Board
    • The Bar's Response to Proposed Rule Changes; Audience Questions and Feedback
    • Hot Issues in PTAB Trials: Coordination of District Court and PTAB; Appeals to the Federal Circuit; Any Changes Imposed by Patent Reform; Other Issues
    • Introduction to Live Hearing
    • Live PTAB Hearing

    The registration fee for the program is $225 (AIPLA member rate), $375 (non-member rate), $35 (student rate), or $95 (government rate).  Those interested in registering for the program, can do so here.

  • PLI Seminar on Developments in Pharmaceutical and Biotech Patent Law 2015

    PLI #1Practising Law Institute (PLI) will be holding a seminar on Developments in Pharmaceutical and Biotech Patent Law 2015 on September 18, 2015 in San Francisco, CA and on October 2, 2015 in New York, NY.  The San Francisco session will also be offered as a webcast.  Topics to be covered at the seminar include:

    • How IPRs relate to ANDA and biosimilar litigation;
    • Preparing to face IPRs;
    • Top pharmaceutical and biotech court decisions from 2014 and 2015;
    • Biosimilars: The approval process, data exclusivity and patent litigation;
    • Recent Supreme Court decisions and the Court's continued focus on patent law;
    • Evolution of the lower courts' approach to indefiniteness and claim construction in view of recent Supreme Court decisions and what it means in pharmaceutical and biotech cases;
    • Patentable subject matter under Section 101 in the aftermath of Myriad and Mayo;
    • Update on USPTO Patentability Guidelines on patentable subject matter;
    • Claim drafting, litigation and legislation in view of recent Section 101 case law;
    • Ethical considerations impacting patent practice, including false declarations and data in patent applications, best mode violations after the AIA, advanced conflict waivers specific to IP matters; and
    • Pre-pleading investigations, document retention, and the use of experts.

    A program schedule and list of speakers for each of the locations can be found here.

    The registration fee for the conference is $1,695.  Those interested in registering for the conference can do so at the PLI website.

  • AIPLA Webinar on Biosimilars

    AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Biosimilars: Regulation, Litigation and New Developments Patent Practitioners and Regulatory Attorneys Should Know" on August 27, 2015 from 12:30 – 2:00 pm (Eastern).  Debora Plehn-Dujowich of Prismatic Law Group, PLLC, James C. Shehan of Hyman Phelps & McNamara, and Sanya Sukduang of Finnegan Henderson Farabow Garrett & Dunner, LLP will review the FDA regulatory pathway for biosimilars in the U.S. and how biosimilar applicants may use data obtained abroad in certain cases.  Issues surrounding litigation for biosimilars will also be covered, such as whether the "patent dance" is optional, and whether other routes such as PTAB trials should be pursued.  Recent developments in biosimilar applications in the U.S. and abroad will also be reviewed, as well as the new Guidance documents published by the FDA.

    The registration fee for the program is $95 (AIPLA member rate) or $150 (non-member rate).  Those interested in registering for the program, can do so here.

  • Drew Hirshfeld Appointed as New Commissioner of Patents

    By Donald Zuhn —

    Hirshfeld, DrewThe U.S. Patent and Trademark Office announced earlier today that U.S. Secretary of Commerce Penny Pritzker has appointed Deputy Commissioner for Patent Examination Policy Drew Hirshfeld to be the new Commissioner for Patents effective immediately.  Mr. Hirshfeld should be familiar to readers of this space for his role, as Deputy Commissioner for Patent Examination Policy, in helping to develop and explain the Office's guidance regarding the examination of claims for subject matter eligibility under 35 U.S.C. § 101.  Mr. Hirshfeld may also be recognizable as the signatory for the Office's "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance"), which was issued in March of 2014; the "Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International," which was issued in June of 2014; and the "2014 Interim Guidance on Patent Subject Matter Eligibility," which was issued last December and which supplemented the Alice guidance and superseded the Myriad/Mayo guidance.

    Mr. Hirshfeld also oversaw the Office of Patent Legal Administration (PCT), Office of Petitions, Office of the Manual of Patent Examining Procedure, Office of PCT Legal, and Office of Patent Quality Assurance.  According to the Office's announcement, Mr. Hirshfeld also played a key role in the creation of the position of Deputy Commissioner for Patent Quality to help the USPTO focus on improving patent quality, and helped implement multiple provisions of the Leahy-Smith America Invents Act of 2011, including the provisions for First-Inventor-to-File, Preissuance Submissions, Inventor's Oath/Declaration, and Supplemental Examination.  Prior to being named Deputy Commissioner, Mr. Hirshfeld served two years as the USPTO Chief of Staff, managing operations and intergovernmental communications for then-Director of the USPTO David Kappos.  He also served as a Supervisory Patent Examiner as well as a Group Director of Technology Center 2100, overseeing Computer Networking and Database workgroups.  Mr. Hirshfeld began his career at the USPTO in 1994 as a patent examiner.  He earned a Bachelor of Science in Mechanical Engineering from the University of Vermont and a Juris Doctor from the Western New England College School of Law.

    Mr. Hirshfeld replaces retired Commissioner Margaret "Peggy" Focarino, the first woman to serve as Commissioner for Patents since the position's creation in 1790, who retired earlier this month after 38 years with the Patent Office.

  • Biotech-specific Subject Matter Eligibility Materials Delayed

    By Kevin E. Noonan —

    USPTO SealPursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject matter eligibility requirement of 35 U.S.C. § 101 (as interpreted by the Supreme Court).  What was not made available were materials related to interpreting the metes and bounds of the statute with regard to natural products or diagnostic methods.  Instead the Office provided the three Appendices referenced in the Notice directed to the effects of the Supreme Court's Alice v. CLS Bank decision.

    Appendix 1 sets forth seven additional examples (in excess of the twenty previously set forth by the Office) related to Alice-type claims.  These include examples taken from Parker v. Flook and Diamond v. Diehr as well as hypothetical examples and cases decided in the inferior courts.

    Appendix 2 is a comprehensive index of all 27 of the Examples from the Office, set forth in tabular form for ease of appreciation of how the Office is making its decisions.

    Appendix 3 has some relevance to the biotech and diagnostic methods audience, which lists nine Supreme Court decisions and thirty-six Federal Circuit and CCPA decisions related to subject matter eligibility.

    PTO sources indicate that the expected biotech and diagnostic methods materials are still in process and are expected to be put up on the PTO website in future.  The extent to which there may be internal dissension regarding such materials, or the effect of Drew Hirschfield's ascension to be Commissioner of Patents on this delay are unknown.

    Patent Docs plans to provide additional information regarding the examples of Appendices 1 and 2 in subsequent posts.