•     By Kevin E. Noonan

    Kyl_jon
    During this Congress, the biotech and pharma sectors appeared to be caught flat-footed in the face of a concerted effort by information technology companies and their affiliated pressure groups (like the Coalition for Patent Fairness) to "reform" patent law out of effective existence.  Not this time:  Senator Jon Kyl (R-AZ and Minority Whip; at right) today introduced a patent reform bill that differs dramatically in some ways (but is strikingly similar in others) from S. 1145 introduced last session by Senators Leahy (D-VT) and Hatch (R-UT).  The bill is the result of "months" of meetings with stakeholders excluded from meaningful participation in crafting S. 1145, according to Andrew Noyes, writing today for the New Jersey Congress Daily (see also "Senate Patent Reform Legislation — One Old Bill and One New Bill").

    The bill has thirteen substantive sections (the remainder being technical amendments and other sections relating to the form of the legislation).  These sections include the following:

    Sec. 2:  First inventor to file

    Sec. 3:  Inventor’s oath

    Sec. 4:  Damages

    Sec. 5:  Post-grant review

    Sec. 6:  Patent Trial and Appeal Board

    Sec. 7:  Third party submissions

    Sec. 8:  Venue

    Sec. 9:  PTO regulatory authority

    Sec. 10:  Applicant Quality Submissions

    Sec. 11:  Inequitable conduct

    Sec. 12:  PTO authority to accept late filings

    Sec. 13:  Limitation on damages available in the DataTreasury case

    Sec. 14:  PTO funding

    These provisions will be the subject of more in-depth commentary in future posts.  For now, some of the similarities and differences will be discussed with a view towards identifying where the bill represents improvements over S. 1145, and a few areas where it does not.

    Senate_seal
    Section 13, for example, is a provision very similar to the provision introduced into S. 1145 with some degree of haste and secrecy and a large absence of public review and commentary.  The brain-child of Senator Jeff Sessions (R-AL), it purports to shield from patent infringement liability banks using an electronic check clearing technology owned by a small Texas company, DataTreasury.  One of the major objections to the corresponding provision in S. 1145 is that, if passed, it would represent a "taking" of DataTreasury’s property, for which the U.S. government could be liable in the Court of Claims.  While paling in comparison to the magnitude of the proposed Wall Street bailout currently under consideration by Congress, the amount of the government’s liability to DataTreasury could be as high as $4 billion (accruing to the benefit of the banking industry).  Clearly cognizant of the political difficulties the provision created in S. 1145, Senator Kyl’s bill has a savings provision:  should passage of Section 13 of the bill be found to be a taking, these provisions will become "null and void."

    The "first to file" provisions (Sections 2 and 3) retain the 1-year grace period for an inventor’s own disclosure, but except for derivation proceedings would adopt absolute novelty for any disclosure prior to filing.  The bill provides protection against derivation by a third party from the true inventor, including proceedings before the Office to adjudicate claims of derivation.  Current law regarding interferences and statutory invention registrations are repealed, as are the provisions of 35 U.S.C. § 104 differentiating actions in the U.S. from those occurring abroad.  The bill is devoid of any requirement for a certification that any other major Patent Office has adopted a 1-year grace period, unlike H.R. 1983 passed by the House of Representatives last fall.  Applications can be filed in the name of the true inventor by an "applicant" that includes an assignee or a party to whom the inventor owes an obligation to assign.

    The post-grant review provisions (Section 5) eliminate inter partes reexaminations and provide for two "windows":  the first window expires within nine months of patent grant, and in this window a patent can be opposed on any condition for patentability.  The second window cannot occur before nine months after patent grant date or before termination of "first window" proceedings.  The bases for patent challenge in the second window are limited to novelty and obviousness based on printed publications, patents and patent applications.  Anonymous oppositions are barred, and the real party in interest opposing a patent during the first window would be precluded from petitioning for a second window review.  Moreover, the opposition petitioner must be a party with "a substantial adverse economic interest."  Ex parte reexamination provisions of current law are amended to be limited to actions by a patentee.  The petition for opposition and opposition proceedings are to be published by the Office, except on motion that any paper is filed under seal.  Finally, oppositions will retain some of the estoppel provisions of current inter partes reexamination.

    The Board of Patent Appeals and Interferences is replaced under the bill with a Patent Trial and Appeal Board, which will be responsible for the appeals from adverse patentability determinations as the Board is now.  In addition, the PTAB is intended to make initial determinations as to derivation and preside over all post-grant review proceedings (Section 6).

    There are two provisions regarding prior art.  The first (Section 7) expands the opportunity for third parties to submit relevant art.  Such submissions must be filed with an explanation of their materiality to the patentability of one or more pending claims, and must be filed by the earlier of:  (i) a notice of allowability, (ii) six months after publication of the application, or (iii) the date of the first Office Action containing a rejection.  The second provision, relating to the Applicant Quality Submissions (Section 10) so ardently pursued by the Office, does not make such submissions mandatory.  Instead, the bill provides incentives, including "prosecution flexibility, modifications to requirements for adjustment of a patent term pursuant to section 154(b) of this title, or modifications to fees imposed pursuant to section 9 of the Patent Reform Act of 2008."  In addition, upon certification by the Director that an applicant has complied with AQS requirements, any such portion of the prosecution history cannot be used to construe a patent claim, except with regard to prosecution history estoppel in determining infringement under the doctrine of equivalents.

    The bill does provide the USPTO with expanded authority in three areas.  First, the Office is granted fee-setting authority, albeit subject to Congressional oversight (Section 9).  The Office is also provided the right by statute to keep all of its fees, as well as the right to a patent "enterprise fund" that will permit the Office to retain authority over funds not expended in any fiscal year (Section 14).  Patent Office expenditures are subject to an audit and report to Congress.  More substantively, the Office is given the right to accept certain late filings, including those relating to Patent Term Extension under 35 U.S.C. § 156 (Section 12).  In an effort to prevent the type of inadvertent failure to meet a deadline that occurred in The Medicine Company’s late patent term extension filing, or in the Aristocrat Technologies Australia case, the bill also converts deadlines set out in number of days (30 days, 60 days, 90 days and 180 days) to months (1, 2, 3 and 6 months, respectively).  The Director can deny a request to accept a late filing by mere inaction, and the decision is not subject to judicial review.

    Changes to patent litigation include limitations on venue to districts where the defendant has its principal place of business, a physical presence or has committed acts of infringement, as well as other provisions such as consent of the parties (Section 8).  Changes in how patent damages are to be calculated include specifying by statute how a reasonable royalty is to be determined, including bars on "standardized" damages measurements or using "comparable" patents (Section 4).

    The most controversial provision in the bill regards changes in how inequitable conduct is determined and the consequences of an inequitable conduct finding (Section 11).  First, the bill removes final determinations of inequitable conduct from the courts.  Instead, the court’s role is to determine, on a party’s motion, whether that party has shown by a preponderance of the evidence whether at least one claim in a patent has been procured by inequitable conduct.  The court then will order the patentee to submit the patent for "reissue" by the Patent Office.  If the patentee does not comply within 2 months, the court can hold the patent unenforceable.  The "reissue" proceeding is limited to questions of patentability in light of art not previously submitted to the Office during ex parte examination, and there is no requirement that a patentee make the affirmative assertion that the patent is defective.  In the reissue, one or more claims can be cancelled, and the patentee has the right to submit "a single substitute claim" of "equivalent or narrower scope."  The applicant is permitted no further amendment to the claims, although the claims can be further amended by the Office during prosecution.  Claim scope cannot be broadened, and no continuation applications are permitted.  Neither can a patentee withdraw the patent from reissue; the bill contemplates either that the Office will reissue the patent (whether amended or not depending on the outcome of the reissue proceedings), or that the patentee will be required to surrender the patent.

    The bill also includes sanctions provisions for inequitable conduct, for both the patentee and counsel.  There are civil penalties in the bill, amounting to $150,000 for each act of misconduct and up to $10,000,000 for "exceptional" misconduct, including affirmative fraudulent acts.  This monetary liability is subject to joint and several liability, meaning that counsel with an indigent or bankrupt client could be responsible for satisfying the penalty.  Counsel is also subject to Patent Office discipline for violating ethical rules relating to practice before the Office.

    Inequitable conduct is to be determined by the Office.  The Director must first determine whether there is probable cause to investigate allegations of inequitable conduct, and this determination cannot be appealed.  After a determination that probable cause exists, evidence is adduced by subpoena and oral deposition (by anyone designated by the Director).  This evidence is then used by the Office to decide whether any claim of a patent was obtained by inequitable conduct, a decision that can be appealed only to the Court of Appeals for the Federal Circuit.

    The Kyl bill is very unlikely to be considered in the time remaining for this Congress, especially in view of the impending election and the end of the current administration.  It does, however, give timely notice to Senators Leahy and Hatch, who have declared their intention to re-introduce an equivalent to S. 1145 and move it through the Judiciary Committee, that there will be at least one competing bill and that the pharma and biotech industry, as well as small inventors, universities, not-for-profit institutions, and other stakeholders who do not share the IT industry’s positions on patents are paying attention.

    Patent Docs will provide more in depth discussion of the bill in future posts.  Thanks to Hal Wegner for alerting us to the bill.

  •     By Christopher P. Singer

    Uspto_seal_no_background_2
    In a memorandum dated September 22, 2008, the U.S. Patent and Trademark Office announced that it and the European Patent Office (EPO) have agreed to enter a pilot Patent Prosecution Highway (PPH) program, effective September 29, 2008, for a term of one year.  The addition of the EPO program makes a total of six active PPH programs (either permanent or pilot) in which the USPTO participates (including programs with Japanese, Canadian, Australian, Korean, and U.K. patent offices).  The exception in the European PPH program is that International (PCT) applications are excluded from participation.  Additional requirements for participation in the PPH program can be found at the EPO website (www.epo.org) or the USPTO website (www.uspto.gov), or in the USPTO Notice.

    Epoepc
    Briefly, the Notice lists several requirements for applications to be eligible to participate in the PPH pilot program, including:

    (1)  The U.S. application is a Paris Convention application validly claiming priority under 35 U.S.C. § 119(a) and 37 C.F.R. § 1.55 to one or more applications filed in the EPO.

    (2)  The EPO application(s) have at least one claim that was determined by the EPO to be allowable and Applicant must submit a copy of the allowable claims from the EPO application(s).

    (3)  All the claims must sufficiently correspond or be amended to sufficiently correspond to the allowable claims in the EPO application(s).

    (4)  Examination of the U.S. application for which participation in the PPH pilot program is requested has not begun.

    (5)  Applicant must file a request for participation in the PPH pilot program and a petition to make the U.S. application special under the PPH pilot program (sample form PTO/SB/20EP to be made available from the USPTO website on September 29, 2008).

    (6)  Applicant must submit a copy of all the Office actions relevant to patentability from each of the EPO application(s) containing the allowable claims that are the basis for the request.

    (7)  Applicant must submit an Information Disclosure Statement (IDS) listing the documents cited by the EPO examiner in the EPO Office action, unless an IDS citing those references has already been filed in the U.S. application.

    Questions concerning the Notice or the PPH program can be directed to Magdalen Greenlief, Office of the Deputy Commissioner for Patent Examination Policy, at 571-272-8800 or at magdalen.greenlief@uspto.gov.

  •     By Christopher P. Singer

    Uspto_seal_no_background_2
    The U.S. Patent and Trademark Office (USPTO) issued a press release on September 24, 2008 announcing that the Office had signed a memorandum of understanding with the Korean Intellectual Property Office (KIPO) regarding a comprehensive plan on cooperative patent examination.  The motivation behind this program is to increase patent quality and convenience for applicants in both countries.

    Kipo_2
    The memorandum seeks to promote work-sharing between the USPTO and KIPO through harmonization of patent examination processes.  Particular plans include establishing a common search database, developing a standardized patent classification system, establishing common examiner training, and increasing the use of prior examination results from the other office.  The two patent offices plan to have several meetings later this year to start planning the implementation of these the cooperative projects.

  •     By Donald Zuhn

    Emea
    Last week, Teva Pharmaceutical Industries Ltd. announced that the European Commission’s Directorate General for Enterprise and Industry has granted the company a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product.  Teva had earlier received a favorable opinion for its G-CSF product from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA).

    Teva_3
    According to Teva’s release, the company’s G-CSF product, which will be marketed in Europe under the brand name TevaGrastim® beginning in 2009, is the first G-CSF biosimilar to receive a marketing authorization in the EU.  The EMEA website indicates that the Filgrastim biosimilars Filgrastim ratiopharm, Ratiograstim, and Biograstim all received favorable opinions from the CHMP.

    Filgrastim is an immunostimulating medicinal product that regulates the production and release of functional neutrophils from the bone marrow.  Teva’s version of the drug has been indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.

    Teva noted that the brand product, Amgen’s Neupogen® Filgrastim, had sales of approximately $300 million in the EU from July 1, 2007 to June 30, 2008.

  •     By Sherri Oslick

    Amgen
    Late last week, Magistrate Judge Mary Pat Thynge granted Amgen’s motion of summary judgment of non-infringement as to all asserted claims in Amgen Inc. v. ARIAD Pharmaceuticals Inc., Civil Action No. 06-cv-00259 (D. Del).  At issue was Amgen’s Enbrel® (etanercept, a TNF blocker) product.  (Another Amgen product, Kineret® — anakinra, an IL-1 receptor antagonist — was previously accused of infringement as well, but ARIAD later withdrew its assertion of infringement against this product).

    The case was originally filed by Amgen in April 2006 as a declaratory judgment action of non-infringement and invalidity of U.S. Patent No. 6,410,516 ("Nuclear Factors Associated with Transcriptional Regulation," issued June 25, 2002), directed to certain aspects of the NF-kB transcription factor pathway.  An amended complaint was filed in April 2007 adding a charge of inequitable conduct; the amended complaint was answered with ARIAD’s counterclaims of infringement of the ‘516 patent.

    Ariad
    Judge Thynge’s ruling was based primarily on the testimony of ARIAD’s expert in view of the claim construction of the term "reducing NF-kB activity in [the] cells."  The Court construed this claim limitation, in accordance with Amgen’s proposal, as meaning "taking action inside cells to directly inhibit (interfere or block) an NF-kB activity."  Relying on testimony by ARIAD’s expert that Enbrel® acts only extracellularly, and that she could not think of an infringement argument in the event the Court adopted Amgen’s claim construction, Judge Thynge concluded that there was no issue of material fact concerning ARIAD’s infringement claims against Amgen.

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

    • ARIAD’s press release

    • "Amgen Granted Leave to Introduce New Claims of Inequitable Conduct Against ARIAD," February 7, 2008
    • "Good News, Bad News for ARIAD in NF-kB Case," July 10, 2007
    • "Court Report," April 23, 2007
    • "ARIAD Files Infringement Claim Against Amgen and Wyeth," April 17, 2007
    • "Setback for Ariad in Dispute with Amgen," January 9, 2007

  •     By Donald Zuhn

    Presidential Candidates Support Follow-on Biologics Regulatory Pathway

    Mccain_john
    Last week, Forbes.com reported that representatives of Senator Barack Obama's and Senator John McCain's campaigns have indicated that each candidate, if elected, would place the passage of a follow-on biologics regulatory pathway at the top of his health care agenda.

    The primary sticking point in securing passage of a follow-on biologics bill remains the length of time that innovators would enjoy market exclusivity.  As Patent Docs reported last March, the Biotechnology Industry Organization (BIO), echoing the sentiments of innovators, supports a 14-year period of exclusivity (see "New Follow-on Biologics Bill Introduced in the House").  Generic drug manufacturers, on the other hand, have been pushing for a 5-year period of exclusivity (as evidenced by a Teva-funded report on market exclusivity that was released last week; see "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation").  According to the Forbes.com report, McCain campaign adviser Douglas Holtz-Eakin stated that "Senator McCain's instincts are to make the [exclusivity] period as short as possible so that you Obama_barack_2
    can get products to market more quickly."  Forbes.com also noted that Obama similarly supported making the exclusivity period as short as possible for biotech drugs.  In addition, Obama's health care advisor Dora Hughes noted that the Illinois Senator intends to put an end to the "reverse payment" practice, in which innovators pay generic drug manufacturers to delay introduction of generic drugs.

    Interestingly, Forbes.com also reported that an analyst with Lehman Brothers has predicted that Congress will pass follow-on biologics legislation by 2010, and that such legislation will include a compromise on market exclusivity of 10 years.

    [Update: The Pharmaceutical Business Review has also filed a report on the presidential candidates' positions regarding a follow-on biologics regulatory pathway.]

    Congressman Waxman Says Biotechs Enjoy "Superpatents"

    Waxman_henry
    BioWorld
    reported today on comments Representative Henry Waxman (D-CA) made at a forum at George Washington University on Monday.  Congressman Waxman, whose name is associated with landmark legislation that created a regulatory pathway for chemical therapeutics (i.e., the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984), declared that biotechnology companies "enjoy a monopoly" giving them "something like a superpatent" as a result of the absence of a follow-on biologics regulatory pathway.  According to the BioWorld report, Congressman Waxman stated that "[u]ntil and unless we in Congress act to give the FDA authority to approve generic biologics, the biotech industry will continue to enjoy these permanent monopolies, and employers, insurers and the federal government will continue to pay the staggering monopoly prices we have today."  Not surprisingly (since he has introduced a follow-on biologics bill of his own, H.R. 1038, that parallels the Hatch-Waxman Act), Congressman Waxman found the exclusivity periods specified in three other follow-on biologics bills to be too long (see "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation").  In particular, BioWorld noted that the Congressman argued that "[t]he periods of some of those generic biologic legislative proposals are so long that they are not just unbalanced, they totally transform the legislation into huge giveaways that replace adequate incentives with windfall profits."

    IPO Passes Resolution on Biosimilars

    Ipo_2
    The Intellectual Property Owners Association (IPO), which just concluded its 2008 Annual Meeting in San Diego, announced today that among the resolutions the IPO Board adopted on Sunday was one addressing biosimilar legislation.  The resolution reads:

    RESOLVED, IPO supports, in principle, legislation that would allow approval of a biological product as biosimilar to a reference biological product which:

    (1)  ensures patient safety by granting the FDA authority to approve biosimilars using a scientifically-based, case-by-case approach;

    (2)  promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population; and

    (3)  encourages efficient clarification of intellectual property issues by allowing confidential access to information reasonably relating to the infringement of any patents, including manufacturing and product information, and mechanisms for enforcing the confidential access requirement.

  •     By Kevin E. Noonan

    Supreme_court_seal
    After several years of having its decisions reversed by the Supreme Court — including KSR Int’l Co. v. Teleflex Inc., eBay Inc. v. MercExchange, LLC, Quanta Computer, Inc. v. LG Electronics, Inc., Merck KGAA v. Integra Lifesciences I, Ltd., Microsoft Corp. v. AT&T Corp., Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Dickinson v. Zurko, and Medimmune, Inc. v. Genentech, Inc. — questions have naturally arisen as to the extent of the effects these decisions are having on the Federal Circuit’s institutional fortitude in executing its Congressional mandate of harmonizing U.S. patent law.  These questions are raised anew in two decisions handed down today:  Aristocrat Technologies Australia Pty Ltd. v. International Game Technology and Egyptian Goddess, Inc. v. Swisa, Inc.

    The Aristrocrat case created something of a stir last year when the District Court for the Northern District of California granted summary judgment of invalidity on the two patents in suit.  (An indication of the extent of the stir is that both the U.S. Patent and Trademark Office and the Nanotechnology Industry Organization submitted amicus briefs in a case involving a "slot machine game and system with improved jackpot feature.")  This decision was based on a determination that the U.S. Patent and Trademark Office had "improperly revived" the U.S.national phase of an International application, where the required filing fee was submitted one day later than the 30-month deadline.  The District Court decided that the Patent Office did not have the statutory authority to revive the application, which ultimately granted as U.S. Patent No. 7,056,215, under the "unintentional abandonment" provisions of 37 C.F.R. § 1.137(b), but rather should have required the applicant to satisfy the more stringent "unavoidable abandonment" provisions of 37 C.F.R. § 1.137(a).  Accordingly, the Court held the ‘215 patent to be invalid, and the other patent-in-suit, a continuation application that granted as U.S. Patent No. 7,108,603, was also invalid because the published PCT application was prior art under 35 U.S.C. § 102(b) without the benefit of the lapsed priority claim.  As part of its determination, the District Court also decided that IGT’s assertion of an "improperly revived" application was an affirmative defense under 35 U.S.C. § 282, or in the alternative, that the Court had jurisdiction to consider the defense under the Administrative Procedures Act (5 U.S.C. § 701 et seq.).

    Federal_circuit_seal
    The Federal Circuit reversed, in an opinion written by Judge Linn and joined by Judges Newman and Bryson.  The Court based its decision on statutory construction, specifically whether 35 U.S.C. § 282 was sufficient to include within its auspices IGT’s novel "improper revival" defense.  In concluding it did not, the Court construed the provisions of 35 U.S.C. § 282(2) relating to "any ground specified in part II of this title as a condition for patentabity."  The "conditions for patentability," according to the opinion, were those recited in §§ 101, 102, and 103, and they specifically do not include § 133 that contains the six-month deadline for prosecuting an application.  In doing so the court drew a distinction between these "conditions for patentability" and sections such as § 112, which it characterized as "merely requirements for obtaining a valid patent."  The opinion supports its interpretation with reference to § 282(3), which expressly recites failure to comply with §§ 112 or 251; according to the opinion, IGT’s interpretation (and the District Court’s) would render this portion of the statute redundant, an outcome contrary to the principles of statutory construction.  The CAFC similarly dismissed IGT’s contention, and the District Court’s reliance thereupon, that the "catch-all" provisions of § 282(4) was a sound basis for its decision.  The Federal Circuit stated that this argument "pretermits the fundamental requirement of the subsection — namely, that the act or fact is ‘made’ a defense by the title."  If followed, the District Court’s interpretation of § 282(4) would eliminate the need for § 282(1) through (3); if Congress had "intended to permit any provision of title 35 to constitute a defense in an action involving the validity or infringement of a patent, it could have simply said, in one paragraph rather than four, that a defense lies in ‘any section of this title.’"

    The opinion cited its decision in Magnivision, Inc. v. Bonneau Co. in support of reversal of summary judgment in this case.  The Court in Magnivision stated "[p]rocedural lapses during examination, should they occur, do not provide grounds of invalidity.  Absent proof of inequitable conduct, the examiner’s or the applicant’s absolute compliance with the internal rules of patent examination becomes irrelevant after the patent has issued" (although the decision in a footnote expressly excludes prosecution laches from these "procedural lapses").

    Finally, the Federal Circuit dismissed IGT’s arguments relating to support for the District Court’s decision under the provisions of the APA in a mere two sentences, stating that they were unpersuasive.

    The decision and its basis are unremarkable; the Federal Circuit construed the scope of 35 U.S.C. § 282 and came to a different and more narrow conclusion than the District Court.  What is remarkable is that the CAFC expressly declined to review the underlying basis for the District cCourt’s decision:  the extent of Patent Office authority under the statute on the standard for reviving the "abandoned" national phase application.  While first alluding to its decision to eschew the opportunity for review in a footnote, later in the opinion the Court unabashedly states its intentions:  "[e]ven if we assume that the Patent Act permits revival of an application only upon a showing of unavoidable delay, [that is] a question that we expressly decline to reach in this appeal," said the Court.  Thus, rather than addressing head-on the grounds for the District Court decision, the Federal Circuit based its opinion on a narrow construction of § 282 of the Patent Act.  In doing so, the Court left unanswered an important question of Patent Office authority, the standards for correcting mistakes and irregularities during patent prosecution.

    The other case decided today, Egyptian Goddess, was an en banc reconsideration of the standard to be applied in deciding whether a design patent was infringed.  (The expected significance of this case is illustrated by the fifteen amicus briefs filed by interested industries, legal and other professional societies, and individual companies that might be affected by the Court’s decision.)  Specifically, the Court in an opinion by Judge Bryson addressed the interplay of the "ordinary observer" test for infringement with the "point of novelty" test used in assessing validity, and the interaction between these tests.  The provenance of the "ordinary observer" test is Gorham Co. v. White, a Supreme Court case from 1871, which mandated that:

    [I]f, in the eye of an ordinary observer, giving such attention as a purchaser usually gives, two designs are substantially the same, if the resemblance is such as to deceive such an observer, inducing him to purchase one supposing it to be the other, the first one patented is infringed by the other.

    81 U.S. at 528.  The "point of novelty" test stems from a Federal Circuit case, Litton Systems, Inc. v. Whirlpool Corp., 728 F.2d 1423 (Fed. Cir. 1984); the Federal Circuit expressly rejected appellants’ contention that the Supreme Court had adopted the "point of novelty" test, citing Smith v. Whitman Saddle Co., 148 U.S. 674 (1893).  Rather, the decision stated that the prior art was to be used to help an examiner recognize when a claimed design is unpatentable.  The decision characterizes the prior art as providing a context for assessing patentability of an design patent claim, something that requires the context provided by the prior art.

    Again, a not-so-remarkable result.  However, here the Court’s decision produces a dichotomy between compliance with perhaps contrary Supreme Court precedent and the Federal Circuit’s mandate to bring uniformity to patent law.  Whatever prior art evidence may have been used to interrogate and perhaps satisfy the "point of novelty" requirement under Litton Systems is now limited to providing context for construing design patent claims under Egyptian Goddess.  As the Court recognized, the Litton Systems precedent spawned its own line of cases directed to a patented design’s "point(s) of novelty."  That precedent was effectively overthrown by today’s decision.  It seems fair to ask whether the Federal Circuit is merely correcting an overdevelopment in the law or clarifying how it apportions the burdens of establishing design patent infringement and validity.  It also seems fair to ask whether the Federal Circuit is making its determinations with an increasing awareness that these decisions will be brought under Supreme Court scrutiny.  And it seems eminently fair to ask what effect this seeming preoccupation with Supreme Court oversight will have on whether the Federal Circuit continues to be as aggressively involved in patent law developments as it was in the 15 years that preceded the Supreme Court’s current interest.

  •     By Christopher P. Singer

    Hurricane1
    In a Notice dated September 18, 2008, the U.S. Patent and Trademark Office announced that the postal interruptions cause by Hurricane Gustav in regions of Louisiana and Texas (beginning on August 30, 2008) and by Hurricane Ike in regions of Florida, Louisiana, and Texas (beginning on September 7, 2008) have been deemed to be a "service interruption and emergency" falling within the provisions of 35 U.S.C. § 21(a) and 37 C.F.R. §§ 1.10(i) and 2.195(e).  The Notice suggests that one should contact post offices directly in order to determine whether that post office has been closed or has reopened in a particular area, or visit the U.S. Post Office’s (USPS) website.  Once the USPS through its website announces to the public that the interruption has ended, the designation of "service interruption and emergency" under the provisions will terminate without additional notice from the USPTO.

    Uspto_seal
    It is important to note that the emergency interruption provisions are applicable only to postal interruptions (e.g., post office closed or suspended Express Mail service) and does not provide for the granting of a filing date to correspondence that is not timely filed because of other circumstances (e.g., closing of buildings other than a Post Office).  Petitions to accord a filing date in light of the weather related emergencies can be made under 37 C.F.R. § 1.10(i).  Additional questions regarding this interruption can be directed to Eugenia Jones, Senior Legal Advisor in the OPLA, by phone 571-272-7701 or by e-mail at PatentPractice@uspto.gov.

  •     By Sherri Oslick

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


    National Genetics Institute et al. v. Talecris Biotherapeutics, Inc.

    5:08-cv-00464; filed September 15, 2008 in the Eastern District of North Carolina

    Infringement of U.S. Patent Nos. 5,780,222 ("Method of PCR Testing of Pooled Blood Samples," issued July 14, 1998), 6,063,563 (same title, issued May 16, 2000), and 6,566,052 ("Efficient Algorithm for PCR Testing of Blood Samples" issued May 20, 2003) based on Talecris’ manufacture, use, and sale of products and processes for testing of plasma donations to identify donations having a positive viral indication.  View the complaint here.

    Glaxo Group Ltd. et al. v. Novartis Corp.
    1:08-cv-01570; filed September 12, 2008 in the District Court of the District of Columbia

    Review of various decisions of the Board of Patent Appeals and Interferences declaring various interferences between U.S. Patent Nos. 6,511,652 ("Metered Dose Enhaler for Beclomethasone Dipropionate," issued January 28, 2003), 6,511,653 (same title, issued January 28, 2003), 6,532,955 ("Metered Dose Enhaler for Albuterol," issued March 18, 2003), and 6,546,928 ("Metered Dose Enhaler for Fluticasone Propionate," issued April 15, 2003), assigned to SmithKline Beecham, and U.S. Patent Application No. 10/424,633 ("An Aerosol Container and a Method for Storage and Administration of a Predetermined Amount of a Pharmaceutically Active Aerosol," filed April 28, 2003), assigned to Novartis.  View the complaint here.


    Salix Pharmaceuticals, Inc. v. Novel Laboratories, Inc. et al.

    3:08-cv-04628; filed September 8, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,616,346 ("Non-Aqueous Colonic Purgative Formulations," issued April 1, 1997) following a Paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of Salix’s Osmoprep® (monobasic sodium phosphate and dibasic sodium phosphate, used for cleansing of the colon as a preparation for colonoscopy).  View the complaint here.

  • CalendarSeptember 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

    September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA

    September 22-23, 2008 – 2008 World Stem Cell Summit (Genetics Policy Institute) – Madison, WI

    September 23-24, 2008 – Biotech Patenting (C5) – London, England

    October 6-7, 2008 – Patent Litigation 2008 (Practising Law Institute) – McLean, VA

    October 7-8, 2008 – Global Patent Litigation*** (American Conference Institute) – New York, NY

    October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

    October 15-16, 2008 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Philadelphia, PA

    October 15-16, 2008 – Advanced Courses (Patent Resources Group) – Santa Ana Pueblo, NM

    October 15-17, 2008 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

    October 23-24, 2008 – Patent Litigation 2008 (Practising Law Institute) – Chicago, IL

    October 28-29, 2008 – Pharma/Biotech IP Due Diligence*** (C5) – Amsterdam, Netherlands

    November 10-11, 2008 – Patent Litigation 2008 (Practising Law Institute) – Atlanta, GA

    November 11-13, 2008 – 4th Biosimilars conference (Visiongain) – Philadelphia, PA

    November 12-14, 2008 – Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) – New York, NY

    November 17-18, 2008 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – Boston, MA

    November 17-18, 2008 – Patent Litigation 2008 (Practising Law Institute) – New York, NY

    November 19-20, 2008 – Paragraph IV on Trial*** (American Conference Institute) – New York, NY

    December 8-9, 2008 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – Atlanta, GA

    January 12-13, 2009 – Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) – San Diego, CA

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