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  • PTAB Update — The Constitutionality Edition

    MCM Portfolio LLC v. Hewlett-Packard Co. (Fed. Cir. 2015)

    By Andrew Williams —

    Federal Circuit SealIn a decision that likely came as no surprise to anyone, the Federal Circuit upheld the constitutionality of IPR proceedings as provided for by the America Invents Act.  With an analysis of two pre-1900 Supreme Court cases (as well as citations to several from the 20th and 21st centuries), the Court in MCM Portfolio LLC v. Hewlett-Packard Company ultimately felt bound by two recent Federal Circuit opinions that had previously considered the constitutionality of ex parte reexaminations.  Because patents are public rights, and "the grant of a patent is primarily a public concern," Congress is able to create administrative procedures for assessing their validity.  Moreover, just because validity can be called into question in an Article III Courts does not mean that federal courts have exclusive jurisdiction over such determinations.  Because the outcome of this case turned on the Court's precedent (which itself had interpreted Supreme Court jurisprudence), any different outcome will necessarily require either the entire Court to rehear the case en banc, or for the Supreme Court to weigh in on the issue.

    This case ultimately stemmed from U.S Patent No. 7,162,549 ("the '549 patent"), entitled "Multimode Controller for Intelligent and 'Dumb' Flash Cards."  The '549 patent related to the coupling of computer systems with flash memory storage systems.  Controllers are responsible for transferring data between a computer and a peripheral device, in this case a flash memory card (such as is used in digital cameras).  The controllers at issue here work to achieve error correction.  Of course, such memory cards come in different flavors.  Therefore, the patent claimed improvements to flash memory card readers by including a controller chip that can determine whether the card has an onboard controller for error correction, and if not, providing for error correction using firmware.

    Patent Owner MCM filed suit against Pandigital more than one year before HP filed its IPR petition against the '549 patent.  These two parties were potentially related because HP resold allegedly infringing digital picture frames from Pandigital.  Nevertheless, the Board rejected the argument that HP was barred from filing the petition because it was only a successive owner of the accused products, and the Board found this insufficient to confer privity.  The Board instituted trial with respect to four claims, finding there was a reasonable likelihood that HP would prevail to as least one claim based on obviousness in view of two prior art references.  In its final written decision, the Board concluded that HP had shown by a preponderance of the evidence that the four claims would have been obvious.  It also rejected the argument that the IPR proceeding violated Article III and the Seventh Amendment of the constitution.

    Real Party In Interest

    MCM challenged the Board's find that HP was not in privity with Pandigital, and as such, the trial never should have been instituted.  As of the date of the oral argument, the only two significant cases on the issue were In re Cuozzo and Versata Development Group v. SAP America.  The Cuzzo Court ruled that 35 U.S.C. § 314(d) prohibit the review of Board decisions related to institution (see "In re Cuozzo Speed Technologies, LLC (Fed. Cir. 2015)").  However, in Versata, the Court reviewed the Board's determination whether a patent was available for CBM review, because (as the Court put it), it goes to the Board's ultimate authority to invalidate (see "Should the Federal Circuit Be Reviewing Any Part of the Decision to Institute? — The Versata Dissent-in-part").  Nevertheless, in the interim, the Federal Circuit issued the Achates Reference Publishing v. Apple case, which was nearly identical to the present case (see "Achates Reference Publishing, Inc. v. Apple Inc. (Fed. Cir. 2015)").  As such, the Court ruled that review of the Board's decision was forbidden by the statute.

    Constitutionality

    As a threshold matter, the Federal Circuit noted that it could review the constitutionality challenge because MCM was questioning the final decision, not the decision to institute.  MCM had argued that the 1898 Supreme Court case of McCormick Harveting Machine v. Aultman dictated the outcome that AIA post-grant challenges were unconstitutional.  That case apparently involved a patent related to automatic twine binders for harvesting machines.  During a district court case, the accused infringer noted that the Patent Owner had sought a reissue patent, but after claims had been rejected, it withdrew the application in favor of the original patent.  The district court held that there could be no infringement because the claims had been found invalid by the Patent Office.  The Supreme Court ultimately disagreed because the patent owner requested return of the original patent, which it had the right to do.  The Federal Circuit interpreted this case to read that the Patent Office, without statutory authority, could not cancel an issued patent, because to do so would deprive the owner of its property without due process of the law.

    The situation is different when Congress provides such authority to the Office.  It was an 1855 Supreme Court case, Murray's Lessee v. Hoboken Land & Improvement Co., that recognized that Congress may or may not provide Article III courts with the authority to adjudicate matters involving public rights.  Such public rights had been found for administrative agencies determining fair rents for holdover tenants; proceedings for unfair importation practices; binding arbitration under the Federal Insecticide, Fungicide, and Rodenticide Act; and for customer reparation proceedings related to broker violations of the Commodity Exchange Act.  On the other hand, the Supreme Court in 2011 held that a bankruptcy court could not enter judgement on a state law tort counterclaim, because that issue did not flow from a federal statutory scheme.  That case, Stern v. Marshall, was more commonly known as the case of Anna Nicole Smith (a fact which, while interesting, has no bearing on IPR proceedings).

    The Federal Circuit concluded that Patent Office proceedings, such as reexams and IPRs, were indistinguishable from the agency adjudications approved of in these above-referenced cases, and were "wholly distinguishable" from the state tort claim issue in the Anna Nicole Smith case.  Of course, the Court had already determined that patents were primarily a public concern in the Patlex Corp. v. Mossinghoff case related to ex parte reexaminations, and therefore did not violate Article III of the constitution.  In fact, the Federal Circuit later considered a second challenge in the Joy Technologies v. Manbeck case, with the same outcome.  The Court therefore felt it was bound by those cases, and that there was no intervening Supreme Court case that dictated otherwise.

    MCM had also alleged that it had a right to a trial by jury under the Seventh Amendment to decide invalidity.  However, Supreme Court precedent indicated that Congress was able to establish administrative procedures to address statutory rights without violating the Seventh Amendment.  In fact, this issue was also addressed and the practice affirmed in the reexamination context in the Patlex and Joy Techs. cases.  Moreover, the mere fact that Markman stated that patent infringement actions were subject to the Seventh Amendment does not mean that patent validity cases cannot be determined by administrative adjudication.

    Obviousness

    Finally, the Court briefly addressed the merits of the case.  The Board had determined that U.S. Patent No. 6,199,122 ("Kobayashi") and WO 98/03915 ("Kikuchi") could be combined to render the four claims of the '549 patent obvious.  The Board found that Kobayashi taught a memory device with a converter, for example, a flash memory card reader.  A sensor would determine if the flash memory card included a controller.  If it did not, a selector connected the flash memory card with an ATA controller.  Kobayashi did not teach a controller that performs error correction.  Kikuchi, on the other hand, taught a flash memory card with a one-chip ATA controller that included an error controller.  The Board found that one skilled in the art would have had the knowledge and inclination to place both functionalities on the same chip.

    The Federal Circuit found that the Board's findings were supported by substantial evidence.  MCM has argued that Kobayashi required that the controller by able to be placed on either the reader or the card. The Court recognized, however, that the proper test for obviousness was whether the combined teachings would have suggested the combination to a skilled artisan.  Therefore, even though the physical incorporation of the two controllers would have conflicted with the Kobayashi instructions, the Board did not err in determining that a single controller chip with error correction functionality would have been obvious.

    MCM Portfolio LLC v. Hewlett-Packard Company (Fed. Cir. 2015)
    Panel: Chief Judge Prost and Circuit Judges Dyk and Hughes
    Opinion by Circuit Judge Dyk

  • Federal Circuit Denies Rehearing En Banc in Ariosa v. Sequenom

    By Kevin E. Noonan —

    Ariosa DiagnosticsThe Federal Circuit declined to rehear en banc the panel decision in Ariosa v. Sequenom.  This decision was not surprising but what may be surprising was that only three judges wrote opinions, one in dissent (Judge Newman) and two concurring with the denial.  The first of these was by Judge Lourie, joined by Judge Moore and the second was by Judge Dyk.  There may be something to be gleaned from these opinions.

    Judge Newman's dissent provides a suggestion of what her colleagues on the Court think about this case:  that is that it was wrongly decided but that the decision was mandated by Supreme Court precedent (in an echo of Judge Linn's concurring opinion in the panel decision).  She disagrees about that mandate, relying on her determination that the facts in this case "diverge significantly" from the factual predicates in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), and in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).  These distinctions include that "the medicinal product and its metabolites were previously known" in Mayo, "leaving sparse room for innovative advance in using this information as a diagnostic dosage tool."  Here, Judge Newman appreciates that in this case, "the claimed method was not previously known, nor the diagnostic knowledge and benefit implemented by the method."

    SequenomSimilarly, in Myriad, the Court noted with approval that the question before it did not involve "patents on new applications of knowledge about the BRCA1 and BRCA2 genes."  In this case, Judge Newman notes that the inventors were not claiming the discovery of paternal DNA in maternal blood, but rather a new diagnostic method that uses that information.  "Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting," Judge Newman writes, finding support in the Supreme Court's caution against such broad generalizations.  Here, this new diagnostic method was "novel and unforeseen, and [] of profound public benefit," quoting the majority opinion by the panel.  She also recognizes that the claims do not preempt further use of the knowledge that paternal DNA can be found in maternal blood or the "development of additional applications" of that knowledge.  She concludes with her view that the issue should be compliance with the other sections of the statute to confirm patentability.

    Judge Lourie's concurring opinion likewise harkens back to Judge Linn's panel opinion concurrence in recognizing that this case is wrongly decided using traditional application of patent law.  Unlike Judge Newman, however, Judges Lourie and Moore believe that the Court's hands are tied by recent Supreme Court precedent.  Instead of belaboring that point, Judge Lourie uses his concurrence "to express some thoughts concerning laws of nature and abstract ideas, which seem to be at the heart of patent-eligibility issues in the medical sciences.  Those thoughts include that "[l]aws of nature are exact statements of physical relationships" in the natural world that are "often represented by equations," following the Supreme Court's lead in citing Einstein's equation regarding the relationship between energy and matter as well as other physical laws (Ohm's Law, Maxwell's equations and Newton's laws of motion).  The issue arises when what is claimed is an application of those laws, which of course is the basis for all claimed inventions, which perforce rely on natural laws or involve natural phenomena, according to Judge Lourie.  This leads him to the current conundrum, that an over-expansion of the Supreme Court's doctrines on patent ineligibility tend to make everything ineligible because of this reliance.

    He diverges from the type of subject matter before the Court in this case to consider abstract ideas, which he says are essentially "mental steps" that are intangible and as such different from subject matter "that involve machines, which are tangible, steps that involve transformation of tangible subject matter, or tangible implementations of ideas or abstractions," distinctions regarding which, he reminds the Supreme Court, it agreed with the Federal Circuit as recently as its decision in Bilski v. Kappos.

    Returning to this case, Judge Lourie acknowledges the concerns of many writing for Appellants and amici that "a broad range of claims of this sort appear to be in serious jeopardy.  It is said that the whole category of diagnostic claims is at risk.  It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern."  His answer:  the deficiency in Sequenom's claims may be that they are indefinite or overbroad but not that they are ineligible on subject matter grounds.  Citing Diamond v. Diehr he contends that "[a]pplications of natural phenomena or laws to a known process may well be deserving of patent protection."  None of the claims at issue merely recite a natural law or are directed to a natural phenomenon, in his view.  The recited steps in the claimed methods "are all physical, and not insignificant, steps requiring human intervention."  The scope of the claims are another issue, but Judge Lourie believes that the "finer filter" of § 112 "might be better suited to treating these as questions of patentability, rather than reviewing them under the less-defined eligibility rules."  And herein lies at least part of the problem between the Federal Circuit and the Supreme Court:  the Supreme Court does not recognize that its patent eligibility rules are "less-defined" nor does the Court believe the substantive portions of the patent statute such as § 112 are preferable in deciding these questions.

    Somewhat courageously Judge Lourie does strike back at the canard that careful and apropos claim drafting is some sort of underhanded way of obtaining claims to the properly unpatentable by stating that "a process, composition of matter, article of manufacture, and machine are different implementations of ideas, and differentiating among them in claim drafting is a laudable professional skill, not necessarily a devious device for avoiding prohibitions," and it is clear that he recognizes that obtaining a proper scope of protection is dependent on drafting claims to accepted classes of patentable (and patent eligible) inventions.

    And then he concedes:

    But focusing on the claims we have rather than those we might have had, the claims here are directed to an actual use of the natural material of cffDNA.  They recite innovative and practical uses for it, particularly for diagnostic testing: blood typing, sex typing, and screening for genetic abnormalities.  And it is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional.  But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.

    He does so even though he understands that the claims are not abstract because they are directed to performing "actual physical steps on a physical material."  And the panel recognized that the claims do not unduly preempt the natural phenomenon, because "there were other uses for cffDNA and other methods of prenatal diagnostic testing using cffDNA that do not involve the steps recited in the various claims."

    And finally:

    In sum, it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts.  But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.

    In the other concurrence, Judge Dyk accepts the "framework" set forth by Mayo and Alice v. CLS Bank as being "an essential ingredient to a healthy patent system, allowing the invalidation of improperly issued and highly anticompetitive patents without the need for protracted and expensive litigation."  But this acceptance is not wholehearted and unqualified, because Judge Dyk also has reservations about "a too restrictive test" as set forth in Mayo that "may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena."  Accordingly he writes to set forth his views but, like his colleagues, believes he is "bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court."

    That language is clear, in his view, that there must be an "inventive concept" that ensures the claim is directed to something "significantly more" than the natural law per se.  "Mayo has unambiguously announced a generally applicable test for determining subject-matter eligibility under § 101 with respect to laws of nature, and we are bound to follow it.  We cannot confine Mayo to its facts or otherwise cabin a clear statement from the Supreme Court.  '[O]nce the Court has spoken, it is the duty of other courts to respect that understanding of the governing rule of law,'" he asserts, citing Rivers v. Roadway Express, Inc., 511 U.S. 298, 312 (1994).  Accordingly he concurs with the Federal Circuit's decision to deny rehearing en banc because the courts are bound by these decisions, and endorses the panel opinion because it properly applied this precedent.

    However, Judge Dyk also acknowledges that the Court's framework under Mayo and Alice works best "when the abstract idea or law of nature in question is well known and longstanding."  He also believes the test to work well with respect to claims reciting abstract ideas, which have formed a greater portion of the Federal Circuit's recent jurisprudence on patent eligibility.  But the "problem" created by Mayo arises from the conclusion that "[an] inventive concept cannot come from discovering something new in nature — e.g., identification of a previously unknown natural relationship or property."  He believes that the Court has not given sufficient weight to the "creativity and novelty" involved in the discovery of the law of nature itself, something "especially true in the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems."  This is particularly true with regard to the tension between Mayo and the later-decided Myriad opinions, which seem to treat differently the patent eligibility of applications of laws of nature and natural phenomena (including natural products) (although that tension is no excuse for not following the Court's precedent as Judge Dyk states in a footnote).

    Turning to the question of (undue) preemption, Judge Dyk, like Judge Lourie appears to believe that this issue may be best addressed by applying other portions of the patent statute rather than § 101 to determine whether a claim applying a natural law or using a product of nature.  "[T]he novelty of a discovery should be enough to supply the necessary inventive concept," he writes, but preemption issues can be avoided by requiring the claims to be "narrow in scope and actually reduced to practice, not merely 'constructively' reduced to practice by filing a patent application replete with prophetic examples" (which was not the case for Sequenom's claims).  Limiting claims to what was actually shown to have utility would be incapable of "too broadly preempt[ing] the use" of the natural law, a concept Judge Dyk finds to be supported by the Supreme Court's opinion in O'Reilly v. Morse.  "This proposed approach, limiting the scope of patents based on new discoveries to narrow claims covering applications actually reduced to practice, would allow the inventor to enjoy an exclusive right to what he himself has invented and put into practice, but not to prevent new applications of the natural law by others," in Judge Dyk's view.  He is aware that making these determinations "could present difficulties of definition and line drawing," but permitting such narrowly tailored patents to pass the patent eligibility test is consistent in his view with the purpose of  § 101.  The benefit to the patent system is the assurance that "only diagnostic and therapeutic method patents limited in their claim scope would survive.  These patents would provide the world with disclosure and useful applications of previously unknown natural laws, and the opportunity to obtain such patents would help to restore the incentive to make those discoveries that the patent system has historically provided."

    After pausing to mention that he does not believe Mayo to have been improperly decided on its facts, Judge Dyk concludes that, alas, even his proposed modification to how courts determine patent eligibility would not save Sequenom's claims.  This is not because the claims are not novel but rather because they are overbroad for reciting methods for detecting "any diagnosis of any disease, disorder, or condition" (provided that such disease, disorder or condition is genetically based and will arise when it is present only in paternal DNA).

    In his final paragraph Judge Dyk states that

    A future case is likely to present a patent claim where the inventive concept resides in a newly discovered law of nature or natural phenomenon, but the claim is narrowly drawn and actually reduced to practice.  That case will, I hope, provide the Supreme Court with an opportunity to revisit the Mayo/Alice framework in this one limited aspect.

    This suggests, perhaps, that Judge Dyk believes this is not that case.

    We know the views of these three judges, as well as Judges Reyna (who wrote the panel opinion), Wallach, and Linn from the panel decision.  The only other thing we know is that there were insufficient votes to review the decision, indicating once again an unwillingness by the Court to confront (or take the lead on) important issues for patent law in the face of Supreme Court disapproval.  Even if the Court believed the Supreme Court's recent turn in patent jurisprudence to be correct, we should expect the country's patent court to state their opinion fully and not in the opinions of a small minority of its members.  At the very least such a discourse would provide the Supreme Court with a better basis for deciding whether it should reconsider the disruption it has visited on protecting U.S. innovation by speaking with so much less than pellucid clarity in its recent subject matter eligibility decisions.

    The deadline for petitioning for certiorari is early next year; should the Court grant the petition it is likely that the case would be argued in it the October 2016 term.

    Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)
    Per curiam

  • IPO Sends Letter to Senate Leaders in Support of Defend Trade Secrets Act

    By Donald Zuhn –-

    IPO #2Yesterday, the Intellectual Property Owners Association (IPO) sent a letter to the Chairman and Ranking Member of the Senate Committee on the Judiciary expressing "strong support" for the Defend Trade Secrets Act of 2015 (S. 1890), which was introduced in the Senate in July.  A corresponding bill (H.R. 3326) was introduced in the House.

    The Senate bill, which is sponsored by Sen. Orrin Hatch (R-UT) and which has received bipartisan support from more than a dozen co-sponsors, would amend Title 18 of the United States Code to provide Federal jurisdiction for trade secret theft.  In particular, the legislation would allow the owner of a trade secret to bring a civil action in U.S. district court for misappropriation of a trade secret that is related to a product or service used in, or intended for use in, interstate or foreign commerce.  The Defend Trade Secrets Act would allow trade secret owners to secure a court order providing for the seizure of property necessary to prevent the propagation or dissemination of a trade secret (if the court determines, inter alia, that a temporary restraining order under Rule 65 of the Federal Rules of Civil Procedure would be an inadequate remedy).  The bill would also require the court issuing the order to hold a seizure hearing within seven days of the issuance of the order in which the party obtaining the order would have the burden of proving that the facts supporting the order are still in effect.

    Washington - Capitol #3Other remedies provided by the legislation for the misappropriation of a trade secret include an injunction to prevent any actual or threatened trade secret misappropriation, payment of a reasonable royalty for future use of the trade secret in exceptional circumstances that render an injunction inequitable, damages for actual loss caused by the misappropriation of the trade secret, damages for any unjust enrichment caused by the misappropriation of the trade secret, exemplary (treble) damages when a trade secret is willfully and maliciously misappropriated, and attorney's fees for willful and malicious misappropriation of a trade secret or a bad faith claim of misappropriation.  Actions under the Defend Trade Secrets Act would have to be commenced not later than five years after the date on which the misappropriation is discovered (or by exercise of reasonable diligence should have been discovered).

    The legislation would also require the Attorney General, in consultation with the Intellectual Property Enforcement Coordinator, Director of the U.S. Patent and Trademark Office, and heads of other appropriate agencies, to submit to the Senate and House Judiciary Committees a report on:

    (1) The scope and breadth of the theft of the trade secrets of United States companies occurring outside of the United States.
    (2) The extent to which theft of trade secrets occurring outside of the United States is sponsored by foreign governments, foreign instrumentalities, or foreign agents.
    (3) The threat posed by theft of trade secrets occurring outside of the United States.
    (4) The ability and limitations of trade secret owners to prevent the misappropriation of trade secrets outside of the United States, to enforce any judgment against foreign entities for theft of trade secrets, and to prevent imports based on theft of trade secrets overseas.
    (5) A breakdown of the trade secret protections afforded United States companies by each country that is a trading partner of the United States and enforcement efforts available and undertaken in each such country, including a list identifying specific countries where trade secret theft, laws, or enforcement is a significant problem for United States companies.
    (6) Instances of the Federal Government working with foreign countries to investigate, arrest, and prosecute entities and individuals involved in the theft of trade secrets outside of the United States.
    (7) Specific progress made under trade agreements and treaties, including any new remedies enacted by foreign countries, to protect against theft of trade secrets of United States companies outside of the United States.
    (8) Recommendations of legislative and executive branch actions that may be undertaken to—
        (A) reduce the threat of and economic impact caused by the theft of the trade secrets of United States companies occurring outside of the United States;
        (B) educate United States companies regarding the threats to their trade secrets when taken outside of the United States;
        (C) provide assistance to United States companies to reduce the risk of loss of their trade secrets when taken outside of the United States; and
        (D) provide a mechanism for United States companies to confidentially or anonymously report the theft of trade secrets occurring outside of the United States.

    Following introduction of the bills, S. 1890 was referred to the Senate Judiciary Committee and H.R. 3326 was referred to the House Judiciary Committee and the Subcommittee on Courts, Intellectual Property, and the Internet.

    The IPO letter in support of the legislation contends that "current legal tools available to remedy trade secret theft are inefficient," and that "current federal law in this area has limitations."  While commending the FBI and Department of Justice for doing a good job enforcing the Economic Espionage Act, the IPO notes that both "have limited resources and numerous priorities and are not able to pursue all trade secret thefts."  The IPO points out that the Defend Trade Secrets Act would allow its members to protect their trade secrets.  In addition, the IPO argues that enactment of the legislation "will place the United States in a position to promote strong trade secrets protection globally, both by creating the “gold standard” by which countries can model their trade secrets laws and by placing the United States in a better position to negotiate trade agreements and other international treaties that provide strong trade secrets protection."

  • USPTO News Briefs

    By Donald Zuhn —

    USPTO and INPI Establish PPH Pilot Program

    INPI_1On November 23, the U.S. Patent and Trademark Office and Brazil's National Institute for Industrial Property (INPI) entered into a Memorandum of Understanding to establish a Patent Prosecution Highway (PPH) pilot program between the two offices.  The two-year pilot program will begin on January 11, 2016 and may be extended upon mutual agreement of the offices.

    PPH programs permit applicants who receive a positive ruling on patent claims from one participating office to request accelerated prosecution of corresponding claims in another participating office.  The USPTO noted that the new PPH pilot program is the centerpiece of the June 2015 U.S.-Brazil Commercial Dialogue Joint Statement on Patent Work Sharing signed by Secretary of Commerce Penny Pritzker and Brazilian Minister of Development, Industry and Foreign Trade, Armando Monteiro.

    Requirements for participation in the USPTO-INPI PPH can be found here.


    USPTO Revises ADS Form

    USPTO SealThe U.S. Patent and Trademark Office announced via a Patent Alert e-mail earlier this month that a revised version of the Application Data Sheet (ADS) form PTO/AIA/14 is now available on the USPTO patents forms page and that applicants can begin using the form as of today.  As we reported previously, the new ADS form was necessitated by changes to the rules of practice that permit applicants to authorize the USPTO to give certain foreign IP offices access to all or part of the file contents of an unpublished U.S. patent application in order to satisfy a requirement for information imposed on a counterpart application filed with the foreign IP office (see "USPTO Revises Rules to Facilitate Access to Applications and File Contents by Foreign IP Offices").

    As the Office notes, applicants are no longer required to check a box on the ADS form to provide the USPTO with authorization to permit a foreign intellectual property office participating in the priority document exchange (PDX) program access to a U.S. priority application or permit access to the search results from a U.S. priority application by the European Patent Office (EPO), and instead, the revised ADS form contains by default the authorization to permit access to the U.S. priority application or search results.  The new form contains opt-out check boxes in place of the old opt-in check box.  Applicants wishing to revoke either of the above authorizations must use forms PTO/SB/39 and PTO/SB/69 rather than the new ADS form.


    USPTO Releases Revised MPEP

    MPEP CoverThe U.S. Patent and Trademark Office announced via a Patents Alert e-mail last month that the Ninth Edition, Revision 07.2015 of the Manual of Patent Examining Procedure (MPEP) has been released.  The new version of the MPEP incorporates changes to the laws, rules, and practice necessitated by the Patent Law Treaties Implementation Act of 2012 (PLTIA) (see "USPTO Issues Final Rule to Implement Patent Law Treaty — Changes Take Effect December 18"), as well as other revisions.  The new version of the MPEP can be access here.


    USPTO Systems Offline on December 5

    EFS-WebThe U.S. Patent and Trademark Office announced via a Patents Alert e-mail earlier today that access to Public PAIR, Private PAIR, EFS-Web, and EFS-Web Contingency will be unavailable from 12:01 am until 11:59 pm ET on Saturday, December 5 to allow for systems maintenance.  The Office noted that availability of the systems will be posted here.

    The Office reminded applicants that during the time that the systems will be down, new patent applications, new international design applications and documents and fees for national stage entry under 35 U.S.C. § 371 may be filed via Priority Mail Express® in accordance with 37 C.F.R. § 1.10, and that other documents and fee payments may be made by facsimile transmission to the USPTO Central Facsimile number at 571-273-8300, by first class mail with a certificate of mailing in accordance with 37 C.F.R. § 1.8, or Priority Mail Express® in accordance with 37 C.F.R. § 1.10.  The Office also reminded applicants that filing of new applications under 35 U.S.C. § 111(a) (other than reissue, design or plant applications) via Priority Mail Express® will still require payment of the non-electronic filing fee ($400 for large entities) under 37 C.F.R. § 1.16(t).  Finally, the Office strongly advised applicants to complete any filings via the EFS-Web prior to the outage period in order to ensure that the submissions are correctly completed.  Questions regarding alternative filing methods to the EFS-Web should be directed to the USPTO Inventor's Assistance Center at 1-800-786-9199 during business hours (Mon-Fri, 8:30 am to 5:00 pm ET).

  • Court Report

            By Sherri Oslick —

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

    Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al.
    1:15-cv-00756; filed August 27, 2015 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
    • Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Par Pharmaceutical, Inc.

    Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,058,291 ("Methods and Compositions For the Treatment of CNS-Related Conditions," issued November 15, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,293,794 (same title, issued October 23, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,338,485 ("Compositions for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,338,486 ("Methods for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), 8,580,858 ("Compositions For the Treatment of CNS-Related Conditions," issued November 12, 2013), and 8,598,233 ("Method for Administering an NMDA Receptor Antagonist To A Subject," issued December 3, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Forest's Namzaric ® (memantine hydrochloride extended-release and donepezil hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.


    The Medicines Company v. Sagent Pharmaceuticals, Inc.
    1:15-cv-07507; filed August 26, 2015 in the Northern District of Illinois

    Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.


    Cephalon Inc. v. Panacea Biotec, Ltd.
    1:15-cv-00735; filed August 25, 2015 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,791,270 (same title, issued July 29, 2014), 8,669,279 ("Solid Forms of Bendamustine Hydrochloride," issued March 11, 2014), 8,883,836 (same title, issued November 11, 2014), and 8,895,756 ("Bendamustine Pharmaceutical Compositions," issued November 25, 2014) following a Paragraph IV certification as part of Panacea's 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.


    Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
    1:15-cv-00145; filed August 25, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; Boehringer Ingelheim Pharma GmbH & Co. KG
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.

    Infringement of U.S. Patent Nos. 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014), 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014), and 8,853,156 ("Treatment For Diabetes In Patients Inappropriate For Metformin Therapy," issued October 7, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products.  View the complaint here.


    Sumitomo Dainippon Pharma Co., Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.
    2:15-cv-06401; filed August 24, 2015 in the District Court of Delaware

    • Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
    • Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent No. 5,532,372 ("Imide Derivatives, and Their Production and Use," issued July 2, 1996) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Sumitomo's Latuda® (lurasidone hydrochloride, used to treat depressive episodes associated with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate and used for the treatment of schizophrenia).  View the complaint here.


    Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al.
    2:15-cv-01455; filed August 24, 2015 in the Eastern District of Texas

    • Plaintiff:  Allergan, Inc.
    • Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Apotex, Inc.; Apotex Corp.; Akorn, Inc.; Mylan Pharmaceuticals, Inc.; Mylan, Inc.

    Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), and 8,685,930 (same title, issued April 1, 2014) following a Paragraph IV certification as part of defenants' filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye).  View the complaint here.

  • Conference & CLE Calendar

    CalendarDecember 1, 2015 - Efficient patent prosecution (U.S. Patent and Trademark Office's Dallas Office) – 2:30 to 5:30 pm (CT) – Dallas, TX

    December 2, 2015 – "USPTO's Subject Matter Eligibility: An Update" (Knowledge Group) – 3:00 to 5:00 pm (ET)

    December 2, 2015 – "Searching, Inventorship, & the Inventor Interview: Practical Legal & Business Considerations" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    December 3, 2015 – "Duty of Candor, Fixing Mistakes, Ex Parte Communications, Sanctions & Professionalism Before the PTAB in Contested Proceedings" (Strafford) – 1:00 to 2:30 pm (EST)

    December 4, 2015 – "Trade Secrets — A Primer For Practitioners" (Corporate Counsel Committee of the Federal Circuit Bar Association) – 12:00 to 1:00 pm (EST)

    December 10, 2015 – "Optimal Use of Provisional Patent Applications: Best Practices and Pitfalls to Avoid" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

    December 17, 2015 – "Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" (Strafford) – 1:00 to 2:30 pm (EST)

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

  • FCBA Webcast on Trade Secrets

    Federal Circuit Bar AssociationThe Corporate Counsel Committee of the Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "Trade Secrets — A Primer For Practitioners" on December 4, 2015 from 12:00 to 1:00 pm (EST).  Charles Matson, Senior Counsel – Innovation, Procter & Gamble will moderate a panel consisting of R. Mark Halligan of FisherBroyles, LLP; David Simon, Senior Vice President of Intellectual Property, Salesforce; and Thomas A. Stevens, Corporate Counsel – Intellectual Property, DuPont.  The panel will cover the basics of trade secret law, enforcement of trade secrets both in civil and criminal courts, pending federal legislation on the civil enforcement of trade secrets, and practical thoughts and considerations in deciding to patent or keep an idea as a trade secret as well as prevent trade secret theft.

    The registration fee for the webinar is $125 (non-member private practitioner), $50 (non-member government/academic/retired), or free (FCBA member).  Those interested in registering for the webinar, can do so here.

  • Webinar on Section 102 and Prior Art

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" on December 17, 2015 from 1:00 to 2:30 pm (EST).  Anthony D. Del Monaco, Doris Johnson Hines, and Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel regarding post-AIA Section 102 and prior art and offer best practices for utilizing prior art in patent applications.  The webinar will review the following questions:

    • How did AIA expand the definition of prior art?
    • What are the Section 102 exceptions and what is the impact on Section 103 art?
    • How can counsel claim — or defend against — post-AIA patent applications asserting priority over pre-AIA applications?
    • What practices should patent counsel employ in order to utilize prior art?

    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 Use of Provisional Patent Applications

    Technology Transfer Tactics will be offering a webinar entitled "Optimal Use of Provisional Patent Applications: Best Practices and Pitfalls to Avoid" on December 10, 2015 from 1:00 to 2:00 pm (Eastern).  Timothy Lohse and Dale S. Lazar of DLA Piper will discuss the benefits and limitations of provisional applications, and the best practices for using provisional applications.  The webinar will cover the following topics:

    • Under what circumstances will a patent claimant get the most out of a provisional patent application?
    • Benefits and limitations of provisionals
    • Identifying and preventing common and damaging mistakes with provisionals
    • Drawings in provisionals: yes, no, or maybe
    • Potential issues with "coversheet" provisionals
    • Meeting written description and disclosure requirements under 35 U.S.C. § 112
    • Should you tie non-provisional patent applications to provisional applications?

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Happy Thanksgiving from Patent Docs

    ThanksgivingThe authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 27th.