• Myriad

    By Donald Zuhn —

    In an order issued by the Federal Circuit this morning in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad"), the Court has requested that the parties file simultaneous supplemental briefs of not more than 20 pages by June 15, 2012 to address the following issue:

    What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and to method claim 20 of the '282 patent?

    The Federal Circuit also indicated that it would accept amici curiae briefs of not more than 15 pages, to be submitted by June 15, 2012.  The Court expressly invited the United States to file an amicus brief.

    Finally, the Federal Circuit noted that oral argument would be held at 10:00 am on July 20, 2012.

    Federal Circuit SealThe Federal Circuit's order comes in response to the Supreme Court's decision on March 26, 2012 to grant the petition for writ of certiorari in Association for Molecular Pathology v. Myriad, vacate the judgment, and remand the case back to the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories (see "Supreme Court Remands Myriad Case").

  • By Donald Zuhn —

    USPTO SealOn April 20th, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 23662) requesting comments as to whether the U.S. should bar certain patent applications from publication and issuance as "detrimental to the nation's economic security."  The notice also seeks comments regarding changes to existing procedures for reviewing patent applications that might be detrimental to national security.

    The Office's proposal to place economically significant applications under a secrecy order comes pursuant to a request from Congress.  The notice indicates that a report on the 2012 Appropriations Bill by the Subcommittee on Commerce, Justice, Science, and Related Agencies stated that:

    By statute, patent applications are published no earlier than 18 months after the filing date, but it takes an average of about three years for a patent application to be processed.  This period of time between publication and patent award provides worldwide access to the information included in those applications.  In some circumstances, this information allows competitors to design around U.S. technologies and seize markets before the U.S. inventor is able to raise financing and secure a market.

    H.R. Rpt. 112–169, at page 18 (July 20, 2011).

    The notice also indicates that the Subcommittee instructed the Office to consult with the appropriate agencies and "develop updated criteria to evaluate the national security applications of patentable technologies [and] to evaluate and update its procedures with respect to its review of applications for foreign filing licenses that could potentially impact economic security."  According to the notice, the Subcommittee described "economic security" as "ensuring that the United States receives the first benefits of innovations conceived within this country, so as to promote domestic development, future innovation and continued economic expansion."

    Washington - Capitol #3Pursuant to the Subcommittee's request, the Office now seeks comments as to whether an economic security screening procedure, which borrows from the current national security screening procedure, should be considered.  The Office also seeks comments on whether the national security screening procedures are adequate.  With regard to economically significant applications, the Office "seeks to obtain feedback on whether the United States Government should institute a new regulatory scheme, modeled from that applied to national security concerns," which "would institute a secrecy order that forbids applicants from disclosing subject matter deemed to be detrimental to national economic security for such period as the national interest requires."  The Office provides a list of questions for which it seeks comment on economic security-based secrecy orders at pages 23664-65 of the notice.  A number of questions for which the Office seeks on national security-based secrecy orders is provided at page 23665 of the notice.

    Comments regarding new procedures for handling applications detrimental to the nation's economic security or current procedures for handling applications detrimental to national security must be submitted by June 19, 2012.  Comments can be sent by e-mail to SecrecyOrder.Comments@USPTO.gov, or by regular mail to:  Mail Stop Congressional Relations, Attention: Jim Moore, P.O. Box 1450, Alexandra, VA 22313–1450.

  • CalendarMay 1, 2012 – Prometheus in the Post-Bilski Age: Patentable Subject Matter Under Continued Attack (Strafford) – 1:00 – 2:30 pm (EDT)

    May 2, 2012 – Patent Prosecution under the AIA: Strategies for Before, During and After the Transition to First-Inventor-to-File (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    May 2, 2012 – Patent Reform Strategies in the Life Sciences: Assessing 'First-to-File' and Freedom to Operate under the New Rules (Elsevier Business Intelligence, CHI-California Healthcare Institute, and Merrill Datasite®) – 1:00 – 2:00 pm (EDT)

    May 3, 2012 – In-Depth Analysis of Mayo v. Prometheus: What it Means for the Future of Medical Diagnostic Patents (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

    May 3, 2012 – Of "Use" and Labels: Recent Appellate Decisions in Hatch-Waxman Litigation (Intellectual Property Owners Association) – 2:00 – 3:00 pm (ET)

    May 8, 2012 – GW Law Symposium on Intellectual Property (George Washington University Law School, Mayer Brown, and Cornerstone Research) – Washington, DC

    May 10, 2012 – The America Invents Act and Beyond: International Grace Period and Post–Grant Review (Intellectual Property Owners Association) – Brussels, Belgium

    May 16-18, 2012 – Fundamentals of Patent Prosecution 2012: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

    May 22-23, 2012 – Biosimilars*** (American Conference Institute) – New York, NY

    June 8-12, 2012 – 2012 MidYear Meeting (Association of American Law Schools) – Berkeley, CA

    June 13-15, 2012 – Fundamentals of Patent Prosecution 2012: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

    June 18-21, 2012 – BIO International Convention (Biotechnology Industry Organization) – Boston, MA

    June 20-21, 2012 – International Forum on Pharma Patent Lifecycles*** (C5) – London, England

    June 25-26, 2012 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    July 11-13, 2012 – Fundamentals of Patent Prosecution 2012: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Of 'Use' and Labels: Recent Appellate Decisions in Hatch-Waxman Litigation" on May 3, 2012 beginning at 2:00 pm (ET).  A panel consisting of James Hurst of Winston & Strawn, LLP; Andrea Kamage of Johnson & Johnson; and Christina Markus of King & Spalding will review the Supreme Court's decision in Caraco v. Novo Nordisk and the Federal Circuit's decisions in AstraZeneca v. Apotex and Bayer v. Lupin, and discuss how these decisions will influence the future of patent prosecution and litigation.

    The registration fee for the webinar is $120 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • 2012midyearThe Association of American Law Schools (AALS) will be holding its 2012 MidYear Meeting on June 8-12, 2012 Berkeley, CA.  The MidYear Meeting will consist of two workshops, the latter entitled: "Workshop on When Technology Disrupts Law: How Do IP, Internet and Bio Law Adapt?"  The latter workshop will take place from June 10-12.  According to the meeting brochure, the workshop is directed to law teachers interested in intellectual property, internet, and bio law, and will offer presentations on the following topics:

    • Keynote: User Innovation as a Challenge to Intellectual Property Paradigms
    • Open Innovation Panel
    • Commercializing Open Innovations
    • Open Biology
    • Updating the Regulatory Infrastructure: Domestic Regulatory
    • Teaching Biotech
    • Gene Patenting Debate — featuring Patent Docs author Dr. Kevin Noonan of McDonnell, Boehnen, Hulbert & Berghoff LLP and Daniel Ravicher of the Benjamin N. Cardozo School of Law, Yeshiva University.
    • Biotech Patents: A Perspective from a Biotech Executive Who Has Been a Venture Capitalist
    • Big Data / Evolutionary / Genomics

    A schedule for the latter workshop can be found here and a brochure for the workshop, including a program and list of speakers, can be found here.

    The registration fee for the workshop is $545 (faculty of member and fee-paid schools) or $645 (faculty of non fee-paid law schools) (discounts are available for those registering by May 3).  Those interested in registering for the workshop can do so here.

  • By Kevin E. Noonan —

    A large part of the debate on patenting genetic diagnostic method and isolated genes has revolved around the effects of such patents on what is loosely termed "personalized medicine."  Personalized medicine can be summarized as a dream/holy grail/GATTACA future of universal genetic information — every infant having her genomic DNA sequence determined at birth and contained on a medical identity card, to determine what diseases she may get, what drugs she should not and even who she should or should not marry (or at least mate with).  It is the most recent of the promises of the biotechnology or genetic revolution, made possible (in theory) by the fruits of the Human Genome Project; advances in genomic sequencing technology (as described in The $1,000 Genome and elsewhere) have quickened the expectations surrounding the technology.  But many have begun to wonder why this genetic fruit is taking so long to ripen (see, for example, "How Bright Promise of Genetic Testing Fell Apart"), and a recent study published in Science Translational Medicine may provide some clues.

    CoverThe article, entitled "The Predictive Capacity of Personal Genomic Sequencing," was published on April 2, 2012 by Nicholas Roberts, Kenneth Kinzler, Bert Vogelstein, and Victor Velculescu from the Howard Hughes Medical Institute at Johns Hopkins University Kimmel Cancer Center; Joshua Vogelstein from the Department of Neuroscience, Johns Hopkins University; and Giovanni Parmigiani from the Department of Biostatistics and Computational Biology, Dana Farber Cancer Center and the Department of Biostatistics, Harvard School of Public Health.  The paper presents the results of a bioinformatics study on monozygotic twin pairs, using whole genome sequencing (WGS) that was interrogated for 24 different diseases.  For 23 of the 24 diseases tested, the results were negative, i.e., uninformative results for 19 of the 24, with risk of 50-80% for disease as compared with the general population.  However, 90% of the tested individuals were alerted to "a clinically significant predisposition" to at least one disease thus reflecting a silver lining if not a rainbow from the data.

    The paper notes that there is an estimate of three million sequence variants per person (K. A. Frazer et al.,  2009, "Human genetic variation and its contribution to complex traits," Nat. Rev. Genet. 10: 241-51); of these, thousands of genetic variants have been associated with human disease, including Mendelian traits (e.g., sickle cell anemia), SNPs (e.g., Huntington's s disease), or by genome-wide association studies (GWAS) (examples include familial pancreatic cancer and Miller syndrome).

    The paper addresses the question of what the benefit of such information would be, defining "benefit" as "receiving information indicating that the risk of disease is increased or decreased to a degree that would alter an individual's lifestyle or medical management."  The authors recognize that it is impossible to assess these benefits generally, but monozygotic twins present the possibility to make this assessment:  as they have in many other instances, the identity of genetic information make it possible that diseases and other traits with a large genetic component should be experienced in common between twins:  "If one twin of the pair has a disease, then the probability of the other twin developing that disease is dependent on the genome whenever that disease has some genetic component."  However, the paper also notes that "[t]he general public does not appear to be aware that, despite their very similar height and appearance, monozygotic twins in general do not always develop or die from the same
    maladies," citing Wong et al., 2005, "Phenotypic differences in genetically identical organisms: The epigenetic perspective," Hum. Mol. Genet. 14 Spec No 1, R11-R18, and "Identical Twins Not As Identical As Believed," ScienceDaily, reflecting a limitation in the predictive power of genetic disease assessment even between individuals having almost identical genetic complements.  (Interestingly, even monozygotic twins are not necessarily identical genetic copies of one another, there being copy number variants between them; Bruder et al., 2008, "Phenotypically concordant and discordant monozygotic twins display different DNA copy-number variation profiles," Am. J. Hum. Genet. 82: 763-71.)  The twin populations were selected from "the Swedish Twin Registry, Danish Twin Registry, Finnish Twin Cohort, Norwegian National Birth Registry and the National Academy of Science – National Research World War II Veteran Twins Registry."

    The authors also define "heritability" as the difference between the incidence of disease in monozygotic twins compared with dizygotic twins, "reflect[ing] the average genetic contribution to disease" in the population of twins studied.  Averages not as informative as distributions in this regard, since a given average incidence of disease could reflect either "a small fraction of twin-pairs with genometypes [(i.e., a complete genomic DNA sequence from an individual)] conferring high genetic risk or a larger fraction of twin-pairs with genometypes conferring a moderate genetic risk."  This challenge is illustrated by an example:

    Suppose a woman receives a whole-genome test result indicating that she has a 90% lifetime risk (the total risk over her entire life) of developing breast cancer.  She may decide to have a prophylactic double mastectomy to prevent this outcome.  Similarly, if the test indicated an 80% or even a 50% lifetime risk of developing breast cancer, she may consider mastectomy.  On the other hand, if the test indicated only a 14% risk of developing breast cancer, then mastectomies would be considered by very few women, given that most women today do not opt for prophylactic mastectomies even though the lifetime risk of developing breast cancer in the general population is 12%.

    The authors adopt the threshold of a "positive predictive value" of 10%, meaning that 10% of patients with a "positive" test result are expected to develop a disease, according to Clarke-Pearson, 2009, "Clinical practice. Screening for ovarian cancer," N. Engl. J. Med. 361: 170-77.  However, for several diseases, including chronic fatigue syndrome, gastro-esophageal reflux disorder, coronary heart disease-related death and general dystocia, this threshold is inappropriate due in part to the prevalence of these diseases in the population; for these diseases the threshold is a two-fold higher risk of disease compared with the general population.  In addition to these diseases, the study assessed the risk for coronary artery disease, stroke, cancer (bladder, breast, colorectal, lung, leukemia, ovarian, pancreatic, prostate and stomach), thyroid autoimmunity, diabetes (types 1 and 2), Alzheimer's disease, dementia, Parkinson's disease, irritable bowel syndrome, pelvic organ prolapse, and stress urinary incontinence.

    The bulk of paper set forth a mathematical treatment of these biostatistics that is beyond the scope of the discussion here; the results, on the other hand, are informative.  These include:

    •  "The fraction of patients that would receive a positive test varies widely from disease to disease."
    •  "The majority of patients (>50%) who would ultimately develop 13 of the 27 disease categories would not test positive, even in the best-case scenario."
    •  "There were four disease categories — thyroid autoimmunity, type I diabetes, Alzheimer's disease, and coronary heart disease-related deaths in males — for which genetic tests might identify more than 75% of the patients who ultimately develop the disease."
    •  "The fraction of individuals in the population who would receive positive test results for each disease is small."
    •  For 22 of the 27 disease categories studied, "a negative test would not indicate a risk that is less than half that in the general population, even in the best-case scenario" (which is probably not sufficient to warrant changes in behavior, lifestyle, or preventative medical practices).
    •  An exception is Alzheimer's disease, where a negative test "could indicate as little as a ~12% relative risk of disease compared to the entire twin cohort . . . .  Knowledge of such a reduced risk might be comforting and relieve anxiety, particularly to those with a family history of Alzheimer's disease."
    •  ">95% of men and >90% of women could receive at least one positive test result."
    •  Many of these results represent the best-case scenarios and thus the true benefits of genetic disease testing may be overestimated.

    The authors' conclusions are a dose of cold water on the hopes and expectations of many in the field (and even more laypersons outside the field, including policymakers, judges, and even Supreme Court justices):

    [O]ur results suggest that genetic testing, at its best, will not be the dominant determinant of patient care and will not be a substitute for preventative medicine strategies incorporating routine checkups and risk management based on the history, physical status and life style of the patient.

    The authors best state the significance of an accurate assessment of the likelihood of predictive genetic testing:  "Recognition of these merits and limits [for genetic diagnostic testing] can be useful to consumers, researchers, and industry, as they can minimize unrealistic expectations and foster fruitful investigations."  These are words policymakers should no doubt heed when considering changes to established patent and other policies based on perhaps unrealistic prospects for a brighter genetic future.

  • By Sherri Oslick —

    Gavel  In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report. 

    Depomed Inc. et al. v. Watson Laboratories Inc. Florida et al.
    1:12-cv-00492; filed April 18, 2012 in the District Court of Delaware

    • Plaintiffs:  Depomed Inc.; Valeant International (Barbados) SRL
    • Defendants:  Watson Laboratories Inc. Florida; Watson Pharmaceuticals Inc.; Watson Pharma Inc.

    Infringement of U.S. Patent Nos. 6,488,962 ("Tablet Shapes to Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage Forms, issued December 3, 2002) and 7,780,987 ("Controlled Release Dosage Forms," issued August 24, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Depomed's Glumetza® (metformin hydrochloride extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

    Eli Lilly and Company v. Apotex Inc. et al.
    1:12-cv-00499; filed April 17, 2012 in the Southern District of Indiana

    • Plaintiff:  Eli Lilly and Company
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

    OSI Pharmaceuticals LLC et al. v. Roxane Laboratories Inc.
    1:12-cv-00465; filed April 13, 2012 in the District Court of Delaware

    • Plaintiffs:  OSI Pharmaceuticals LLC; Pfizer Inc.; Genentech Inc.
    • Defendant:  Roxane Laboratories Inc.

    Infringement of U.S. Patent Nos. RE41,065 ("Alkynyl and Azido-Substituted 4-Anilinoquinazoline," issued May 5, 1998), 6,900,221 ("Stable Polymorph on N-(3-Ethynylpheny1)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof," issued May 31, 2005), and 7,087,613 ("Treating Abnormal Cell Growth With A Stable Polymorph on N-(3-Ethynylpheny1)-6,7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride," issued August 8, 2006) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of OSI's Tarceva® (erlotinib, used to treat non-small cell lung cancer and advanced pancreatic cancer).  View the complaint here.

    Pfizer Inc. et al. v. Dr. Reddy's Laboratories Ltd. et al.
    1:12-cv-00467; filed April 13, 2012 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Pfizer Pharmaceuticals LLC; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.; CP Pharmaceuticals International CV
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

    Infringement of U.S. Patent No. 6,455,574 ("Therapeutic Combination," issued September 24, 2002) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Pfizer's Caduet® (atorvastatin calcium — the active ingredient in Lipitor® — and amlodipine besylate — the active ingredient in Norvasc® — used to treat high cholesterol in combination with treating hypertension, angina, and/or coronary artery disease).  View the complaint here.

    Purdue Pharma L.P. et al. v. Mylan Pharmaceuticals Inc. et al.
    1:12-cv-02959; filed April 13, 2012 in the Southern District of New York

    • Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

    Allergan, Inc. v. Sandoz, Inc. et al.
    2:12-cv-00207; filed April 13, 2012 in the Eastern District of Texas

    • Plaintiff:  Allergan, Inc.
    • Defendants:  Sandoz, Inc.; Alcon Laboratories, Inc.; Alcon Research, Ltd.; Falcon Pharmaceuticals, Ltd.; Apotex, Inc.; Apotex Corp.; Watson Laboratories, Inc.

    Infringement of U.S. Patent No. 8,133,890 ("Combination of Brimonidine and Timolol for Topical Ophthalmic Use," issued March 13, 2012) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Allergan's Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution, used to treat glaucoma).  View the complaint here.

  • By James DeGiulio —

    FDAIn February, the U.S. Food and Drug Administration published three draft guidance documents on biosimilars and the abbreviated biosimilar approval pathway created by the Biologics Price Competition and Innovation Act of 2009 ("ABLA pathway") (see "FDA Publishes Draft Guidelines for Biosimilar Product Development").  The FDA provided a 60 day period for stakeholders to provide comments on the guidances, opening a docket for the each of the three draft guidance documents, FDA-2011-D-0602 (Quality Considerations), FDA-2011-D-0605 (Scientific Considerations), and FDA-2011-D-0611 (Questions and Answers).  The FDA received a submissions from a wide array of stakeholders, including the Biotechnology Industry Organization (BIO), which published its comments on BIO's website on April 16.  BIO filed a separate comments document for each of the three guidance documents, first introducing the organization and thanking the FDA for the opportunity to comment on the guidances before launching into the group's positions.  Both the Scientific Consideration and Quality Considerations comments contain an index that proposes line-by-line changes to the FDA guidance language, which will not be discussed here.

    Biotechnology Industry Organization (BIO)As an organization representing many innovators with currently available reference products (RP), BIO advocates that the FDA expand the requirements to prove biosimilarity significantly beyond the minimum tests required in the statute, and generally recommends policies that make it more difficult to obtain ABLA approval.  Business motives aside, BIO presents a persuasive and scientifically sound justification for each of its positions on how the ABLA pathway should be administered moving forwad.  Biosimilar applicants would be hard-pressed to argue that the minimum study requirements listed in the statute provide all the data needed to establish a safe and efficacious biosimilar product in most situations.  Overall, BIO commends the FDA for its first effort — but makes it clear that the U.S. biotech industry still needs substantially more guidance before the ABLA pathway can be endorsed as clear and safe.  There can be no disagreement that the FDA is tasked with challenging policy decisions:  ensuring patient safety with sufficient biosimilarity testing, yet somehow keeping the costs of biosimilar approval low enough to encourage applicants to choose to file an ABLA over a BLA, which currently represents an infinitely more predictable approval route.

    Scientific Considerations Guidance

    The first and most lengthy of BIO's comments covers the Scientific Considerations guidance, and was authored by Kelly Lai, the Director of Science and Regulatory Affairs at BIO.  To open the comment, BIO notes its extensive experience with biosimilar products, referencing the group's benchmark document BIO Principles on Follow-On Biologics, which was sent to key legislators in 2007 and emphasizes the required balance between patient safety and incentives to innovate that is required of a biosimilar approval pathway.  Of note, BIO also requests that FDA publish future biologic product-specific guidances that include specific statistics and/or ranges acceptable for a determination of biosimilarity.  This is currently the model followed under the European Medicines Agency (EMA) biosimilar framework, which has published several product guidances, including most recently on monoclonal antibodies.

    BIO recognizes the need for distinguishing biologics and biosimilars from traditional small molecule generic drugs, both in terms of complexity and the quantity of clinical data required for approval.  Of course, noting particularly that they are merely similar, not identical, like generic small molecule drugs.  The FDA has introduced a number of distinguishing factors proposed by BIO in previous agency submissions, but BIO lists additional key issues that must be evaluated during biosimilar approval.

    The group voices several concerns with the FDA guidance as written.  Of particular concern to BIO is the use of the word "should" throughout the document.  Especially in the context of demonstrating biosimilarity using analytical or animal/human clinical studies, the FDA generally uses the word "should" to indicate that something is suggested or recommended, but not required.  BIO takes issue with the use of this word where certain studies are fundamental and/or necessary for a determination of biosimilarity, as it falls short of conveying that these studies are required — BIO prefers "is expected to" or "will need to," such as the key phrase:  "It is expected that the expression construct for a proposed biosimilar product will encode the same primary amino acid sequence as its reference product."

    BIO asserts that the language of the guidance is inconsistent with the statute, in that it implies that clinical trials are only a "residual requirement" that is triggered if there are gaps in the analytical, PK/PD, and safety results.  Instead, BIO advocates for a more extensive clinical trial requirement for biosimilarity, requesting that the FDA necessarily require several additional studies beyond the statutory minimum, including animal toxicity studies and human clinical trials evaluating safety and efficacy.  BIO further advocates that the minimum clinical trials required by the statute, human PK/PD and immunogenicity human trials, be enhanced.  Due to the multitude of factors affecting immunogenicity, the trial must be of sufficient duration to assess the effects of immunogenicity on PK, biodistribution, safety, and efficacy, and a significantly laborious pharmacovigilence for all biosimilars, that must extend into the post-marketing period for at least one year (more for certain products).

    The organization is extremely wary of the FDA's allowance of extrapolation of data to other indications and patient populations by the biosimilar applicant.  BIO suggests a "cautious approach," where the FDA accepts this type of data only if:  (1) the mechanisms and sites of action for both indications are very well understood; (2) there are no significant differences between PK and bio-distribution in patient populations; and (3) the clinical study in the original indication is highly sensitive to differences that may emerge from the new indication, including immunogenicity.  Even if these criteria are met, BIO suggests that a confirmatory clinical study be conducted on PK/PD and immunogenicity for all indications.  Further, the FDA's requirement that only "most sensitive" population be tested is insufficient, for defining such a population will often be impossible, especially if indications affect different organ systems in the human body.  Further, at times, one population may display the most immunogenicity, while another population shows the most efficacy.  Therefore, a single population study fails to address these two important safety issues.

    A related issue is the FDA's explicit allowance of biosimilar approval for subsets of route of administration, presentations, and conditions of use.  BIO's main point here is prominent and efficient labeling of the biosimilar product, with an emphasis on the differences between the biosimilar and the RP.  Of course, an emphasis on the differences in the product will have the effect of discouraging patient switching.  However, the point is well taken with regard to a lack of identity of these various product properties, and the FDA may avoid a finding of interchangeability of product property identity is lacking.  As a good example of the multitude of scenarios the FDA has yet to identify, BIO asks for clarification as to what level of supplementation will be required to add new indications to the ABLA applications.  In particular, the scenario where the BLA holder secures approval for a new indication for the RP, and the biosimilar applicant wishes to add that new indication to its label.

    Quality Considerations Guidance

    The second comments document on Quality Considerations guidance was authored by Andrew J. Emmett, Managing Director of Science and Regulatory Affairs at BIO.  BIO points out that all biosimilars must be evaluated in the context of all that is in the public domain regarding aspects of the manufacturing process.  However, BIO asks for additional clarification regarding the FDA's scientific and technical expectations, including clarity regarding the term "fingerprint-like analysis."  Indeed, this term is repeated throughout the guidance, referencing mysterious "additional product attributes" and their correlation to clinical safety and efficacy, consistency in manufacture, or some other meaningful feature for establishing biosimilarity.  The "fingerprint-like analysis" approach is discussed by the FDA in (slightly) greater detail in Kozlowski et al. in the New England Journal of Medicine, but the term remains vague at best (see "FDA Looks to Multiple Sources, Including EMA Guidelines, in Developing Biosimilar Approval Standards").  The origin of this approach appears to be the EMA monoclonal antibody guidelines, although how it translates to overall biosimilarity evaluation remains to be seen.

    An interesting (albeit not unexpected) position from BIO is that any intentional differences in host cell type, primary structure, formulation, or immediate package and those of the RP should disqualify the applicant for ABLA filing.  BIO advocates that any applicants introducing avoidable differences between the two products must seek approval using a BLA, otherwise the biosimilar applicant is unethically introducing the risk of undetected and clinically significant adverse events.  If differences between the biosimilar and the RP can be avoided, this is the best approach to control the proposed biosimilar's safety, effectiveness, and immunogenicity profiles.  With these unavoidable differences, BIO recommends placing the burden on the ABLA filer to affirmatively show that any design differences do not to result in a clinically meaningful difference between the biosimilar and reference product, which should require at least one clinical study.  This seems reasonable; biosimilar applicants certainly will expect that more differences between their product and the RP will lead to additional testing and cost.  Indeed, changes in formulation excipients, equipment, raw materials used in the manufacturing process for the active ingredient, the container closure system and the cold chain distribution system could potentially have an impact on safety and/or efficacy of the biologic.  BIO cited patient safety for this rigorous standard, which is valid, but an unmentioned benefit is the closer to identical the biosimilar product is to the RP, the likelihood improves that the biosimilar product is covered by one or more BLA holder patents.

    Questions and Answers Regarding Implementation

    The third comments document on the Q&A Guidance was authored by Sandra J.P. Dennis, BIO Deputy General Counsel, and is the shareholder's chance to respond to the policy changes implemented by the FDA following the first round of public hearings.  The comments on the Q&A Guidance is organized by individual questions.  While many of the issues have been discussed under the Scientific and/or Quality Considerations, there are several key points raised in the third comments set.

    BIO disputes the FDA's definition of "protein," which was added to the PHSA in order to consolidate approval of all "proteins" via BLAs; inclusion of this term also forecloses the filing of New Drug Applications (NDAs) for polypeptide products that are longer than 40 amino acids.  BIO criticizes this 40 amino acid cutoff as arbitrary, and instead advocates a more flexible standard, including more consideration of the presence of higher order structure.  BIO advances the same critique of the 100 amino acid cutoff for defining a "chemically synthesized polypeptide," which is excepted from BPCIA coverage.

    A major topic of interest at the 2011 BIO International Convention seminar on biosimilars was the access of confidential information by the ABLA applicant and the BLA holders (see "Docs at BIO: Session on Patent Litigation Tactics and Strategies for Biosimilars").  In its comments, BIO requested explicit recognition from the FDA that certain information contained within the BLA, including manufacturing facilities, must be treated as confidential.  BIO generally disfavors the comparison of a prospective biosimilar to a non-U.S. licensed product, but in particular, it raises significant concerns over the confidentiality of RP manufacturing sites, in that this (non-public) information will be critical in determining whether it is appropriate to rely on studies involving a foreign comparator product.  BIO points out that several key points must be remedied with regard to confidentiality/trade secret protection during all ABLA reviews.  A non-exhaustive list includes:  (1) FDA's regulations on disclosure of BLA information must be updated for consistency with the BPCIA, for several provisions of a BLA become public immediately; (2) confidential commercial and trade secret information in a BLA must be protected from intentional or inadvertent use or disclosure; (3) an ABLA application must stand on its own, in that FDA approval of ABLA must be based upon ABLA data and "publicly-available information" (redacted BLA "action packages" published by FDA) regarding the RP; and (4) procedures must be adopted to assure proper review of ABLA and avoid potential disclosure or reliance upon the reference BLA.  BIO adamantly notes that the BPCIA does not authorize or permit reliance on non-public information regarding the reference BLA, and the FDA must ensure the ABLA is absent any reliance on non-public BLA information (such as from IND or biosimilar development meetings).

    Finally, BIO suggests that the FDA should require biosimilar applicants to certify compliance with section 351(l)(2) of the PHSA, which requires the biosimilar applicant to timely provide the reference product sponsor with the ABLA and such other information that describes the process or processes used to manufacture the biosimilar product.  Should a biosimilar applicant seek to opt out of the certification notice provisions by failing to provide the required information, the FDA should adopt a policy that it will refuse to file the biosimilar application.

    As discussed, BIO's comments have the effect of rendering ABLA approval more difficult, both for the safety of U.S. patients, and for the competitive advantage of its BLA holder innovator members.  Regardless of these business interests, and enhanced level of proof of safety and/or efficacy for ABLAs adds credibility to the FDA's determination of biosimilarity for these complex and potentially under-characterized therapeutics.  To support these comments, BIO intends to provide testimony at the FDA public hearing on the draft guidances scheduled for May 11, 2012.

    For both sides of the story, Patent Docs will present an analysis of the comments and positions suggested by biosimilar developers in a future post.

  • By Sherri Oslick —

    Gavel  In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report. 

    Purdue Pharma, L.P. et al. v. Varam, Inc. et al.
    2:12-cv-01898; filed April 12, 2012 in the Eastern District of Pennsylvania

    • Plaintiffs:  Purdue Pharma, L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendants:  Varam, Inc.; KVK-Tech, Inc.

    Purdue Pharma L.P. et al. v. Varam, Inc. et al.
    1:12-cv-02814; filed April 10, 2012 in the Southern District of New York

    • Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendants:  Varam, Inc.; KVK-Tech, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,508,042 ("Controlled Release Oxycodone Compositions," issued April 16, 1996), 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Varam's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the SDNY complaint here.

    UCB Inc. et al. v. Mallinckrodt Inc.
    1:12-cv-00463; filed April 12, 2012 in the District Court of Delaware

    • Plaintiffs:  UCB Inc.; UCB Manufacturing Inc.
    • Defendant:  Mallinckrodt Inc.

    Infringement of U.S. Patent No. 6,344,215 ("Methylphenidate Modified Release Formulations," issued February 5, 2005) following a paragraph IV certification as part of Mallinckrodt's filing of an ANDA to manufacture a generic version of UCB's Metadate CD® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

    Astrazeneca Pharmaceuticals LP et al. v. Intellipharmaceuticals Corp. et al.
    1:12-cv-02855; filed April 11, 2012 in the Southern District of New York

    • Plaintiffs:  Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
    • Defendants:  Intellipharmaceuticals Corp.; Intellipharmaceuticals International Inc.

    Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Intellipharmaceuticals' filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

    Abbott Laboratories v. Roxane Laboratories Inc.
    1:12-cv-00457; filed April 10, 2012 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006), 7,364,752 ("Solid Dispersion Pharamaceutical Formulations," issued April 29, 2008), and 5,648,497 ("Retroviral Protease Inhibiting Compounds," issued July 15, 1997) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Abbott's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection).  View the complaint here.

    Depomed, Inc. v. Impax Laboratories, Inc. et al.
    3:12-cv-02154; filed April 10, 2012 in the District Court of New Jersey

    • Plaintiff:  Depomed, Inc.
    • Defendants:  Impax Laboratories, Inc.; Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

    Infringement of U.S. Patent Nos. 6,340,475 ("Extending the Duration of Drug Release Within the Stomach During the Fed Mode," issued January 22, 2002), 6,488,962 ("Tablet Shapes To Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage Forms," issued December 3, 2002), 6,635,280 ("Extending the Duration of Drug Release Within the Stomach During the Fed Mode," issued October 21, 2003), 6,723,340 ("Optimal Polymer Mixtures for Gastric Retentive Tablets," issued April 20, 2004), 7,438,927 ("Methods of Treatment Using a Gastric Retained Gabapentin Dosage," issued October 21, 2008) and 7,731,989 ("Gastric Retained Gabapentin Dosage Form," issued June 8, 2010) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Depomed's Gralise® (gabapentin, used for the management of postherpetic neuralgia).  View the complaint here.

    Roxane Laboratories, Inc. v. Abbott Laboratories
    2:12-cv-00312; filed April 10, 2012 in the Southern District of Ohio

    Declaratory judgment of invalidity and noninfringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006) and 7,364,752 ("Solid Dispersion Pharamaceutical Formulations," issued April 29, 2008) in conjunction with Roxane's filing of an ANDA to manufacture a generic version of Abbott's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection).  View the complaint here.

  •     By David Boundy —

    USPTO SealThe Patent Office recently requested comment on the paperwork that applicants submit during post-filing, pre-allowance patent prosecution (Patent Processing (Updating), 77 Fed. Reg. 16813, Mar. 22, 2012).  This is a highly significant opportunity to seek reform of problematic PTO regulations, one that only comes once every three years.  This comment period gives the public access to an oversight officer outside the PTO whose job is to help reduce costs and unnecessary paperwork burden associated with PTO regulations or MPEP guidance.  The PTO has invited the public to challenge long-standing rules, and to seek reform.

    The Paperwork Reduction Act is one of the key administrative law statutes that governs PTO rule making, along with the Administrative Procedure Act and several others.  A quick tutorial on the Act is at the bottom of this article — but before we get there, let's look at the subject matter of this comment period.

    This comment period asks for comments on regulations or MPEP provisions relating to post-filing prosecutions that increase paperwork burden unnecessarily:

    • regulations or MPEP guidance that compel you to expend more time than required by statute, or for no observable reason
    • regulations or MPEP guidance that increase burden because of ambiguity
    • regulations or MPEP guidance that increase burden because they appear to be inconsistent with the patent statute or Administrative Procedure Act

    Congress gave you this opportunity to challenge such regulations and guidance, if your concern slots into one of the kinds of avoidable paperwork that the Act covers.

    The Notice itself asks the public to comment on several questions.  To elaborate the questions, here are the kinds of issues that have resulted in significant changes to PTO regulations in the past:

    1.  Do the PTO's regulations and guidance minimize paperwork burden?  How can they be modified to do so?  Under the Paperwork Reduction Act, agencies are "required to minimize the burden on the public to the extent practicable."1  Are the current rules structured to minimize the burden of the paperwork it requires from you?  How could the regulations be improved to reduce burden, or to improve clarity or utility?  For example:

    • Are there MPEP requirements that go above fair interpretation of the statute or 37 C.F.R.?  For example, both 35 U.S.C. § 121 and 37 C.F.R. § 1.141 authorize the PTO to restrict "independent and distinct" inventions, but MPEP Chapter 800 encourages examiners to restrict inventions that are "independent or distinct."  The PTO can't override the statute via the MPEP.  When the PTO does so to impose more paperwork burden than authorized by statute, the PTO violates the Paperwork Reduction Act.  (See below for the "public protection" provision, and unenforceability of regulatory content of the MPEP.)
    • Are there "unwritten rules" that were never validly promulgated, but that the PTO enforces anyway?  Examples include memoranda of April 2007 and January 2010 on restriction and election of species that were never promulgated through valid rule making procedure, and that have been obsoleted by subsequent revisions of the MPEP, but that the PTO continues to enforce.
    • Is there a 37 C.F.R. regulation that either has no statutory authorization, or requires more from you than the statute does?  For example, 35 U.S.C. § 113 only authorizes the PTO to require drawings "where necessary for the understanding of the subject matter."  However, 37 C.F.R. § 1.83(a) states "The drawing in a nonprovisional application must show every feature of the invention specified in the claims."  The PTO can't ask more from you than the statute does.
    • Are there regulations that are gratuitously burdensome?  37 C.F.R. § 1.111(b), until 2004, permitted you to file a supplementary amendment up until the time it would "unduly interfere with an Office action being prepared."2  In 2004, the Office amended § 111 to cap your right to amend at the six month statutory deadline,3 no matter whether it affected PTO efficiency or not.  The PTO's stated reasons violate the Paperwork Reduction Act — agencies cannot regulate in their self-interest.

    2.  Burden estimates:  Are the PTO's burden estimates for various tasks reasonably correct?  The estimate must account for all time spent on a task, including reviewing instructions, gathering information, thinking and planning, and filling out a paper, and filing it.  If you are skeptical of either the PTO's numbers or estimation methodology, you are invited to comment.  Among the PTO's current estimates are the following:

    • For a statutory disclaimer or terminal disclaimer, all legal research, investigating facts, evaluating options, consulting with the client, making the decision, filling out the form, and filing it takes (on average) 12 minutes.
    • Evaluating a final Office Action to decide whether to appeal or RCE, starting down one path and changing your mind, preparing the form, and filing it, takes (on average) 12 minutes.
    • Preparing an IDS, on average, takes 10 hours
    • The PTO is not permitted to rely on speculation, guesswork, or hope for its estimates.  The PTO is required to have "objective support" for its estimates, including a duty to "consult with the public" before publishing these estimates.4  "The USPTO estimates . . ." is not a legally-sufficient basis for estimation of burden.

    Scope of the request for comment

    This comment period covers essentially everything that you file in a patent prosecution after the initial filing of an application and recording of an assignment, and before appeal or allowance:

    • replies to restriction requirements and election of species requirements
    • replies to Office Actions on the merits
    • most petitions (a few exceptions are noted below)
    • notices of appeal and pre-appeals
    • Information Disclosure Statements and prior art search

    This comment period does not cover the following phases of prosecution, which are broken out in separate Paperwork categories:

    • initial filings of applications, declarations, and the like5
    • sequence listings6 and biological deposits7
    • Power of Attorney8
    • PCT international stage9
    • reexamination filings10

    The Paperwork Reduction Act, in overview

    The Paperwork Reduction Act (44 U.S.C. § 3501 to 3519, especially §§ 3506, 3507, and 3512), and regulations issued by the Executive Office of the President for "controlling paperwork burdens on the public" (5 C.F.R. Part 1320), bar the PTO from requiring applicants to submit information that:

    • is unnecessary for the proper performance of the functions of the agency;11
    • is "unnecessarily duplicative" of "information otherwise reasonably accessible to the agency";12
    • has poor or no "practical utility" — that is, an agency may only collect information that has "actual, not merely the theoretical or potential, usefulness . . . to or for an agency, taking into account its accuracy, validity, adequacy, and reliability, and the agency's ability to process the information it collects . . . in a useful and timely fashion";13
    • is of poor quality14 or clarity;
    • is more burdensome than necessary on those who are to respond — the PTO must "[take] every reasonable step to ensure that the proposed collection of information . . . is the least burdensome necessary."15
    • regulations must be "written using plain, coherent, and unambiguous terminology."16

    The Paperwork Reduction Act is administered by the Office of Management and Budget within the Executive Office of the President.  Each agency must seek OMB clearance of any regulation that imposes paperwork burden; if OMB denies clearance, the agency cannot enforce the regulation.17,18

    Note that the Paperwork Reduction Act does not control statutes — if Congress says you have to submit information to the PTO, or the Federal Circuit's inequitable conduct law requires submission of information of limited relevance, then the Paperwork Reduction Act provides no relief from those requirements.  However, if the PTO imposes regulations for form of the information to be submitted, and those regulations violate any of the bullet points above, then the Paperwork Reduction Act gives you a right to request amendment to the regulation.

    The PTO has to obtain re-approval for these items every three years.  Thus, this review gives the public an opportunity to propose ways to reduce the burden and to bring to the PTO's attention any violations of the Paperwork Reduction Act, and to request amendment to the regulations that would bring the PTO into compliance with the Act.  Indeed, the PTO's Federal Register Notice specifically asks you to comment on "ways to minimize the burden of the collection of information," either by revising the regulation or by revising procedures for submission (e.g., electronic filing), and you should take the PTO up on its invitation.

    How and where you should send your comments

    There is no set form for a comment to the PTO; an email or letter works just fine.  You can find examples on OMB's web page for the 2008 Appeal Rules.19  Comments should be submitted to the PTO by May 21, 2012 (though a couple days delay is usually tolerated, especially if you send an email by May 21 to indicate that your comments will follow in a few days), to:

    • By email to InformationCollection@uspto.gov with "0651–0031 comment" in the subject line of the message
    • By fax to 571–273–0112, marked to the attention of Susan K. Fawcett
    • By mail to Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450

    If you have any questions, please phone me at 212-294-7848 or email me at DBoundy [at] Cantor [dotcom].

    Boundy, DavidDavid Boundy (at left) is Vice President and Assistant General Counsel for Intellectual Property at a New York brokerage and investment banking firm.  In 2008, David led the teams that made presentations to the Office of Management and Budget showing Paperwork Reduction Act violations for the Continuations, 5/25 Claims, IDS, Markush, and Appeal rules.  OMB either directed PTO to withdraw its request for clearance, or withheld approval, for each of these regulations.

    _________________________________________

    1  Dole v. United Steelworkers of America, 494 U.S. 26, 32 (U.S. Sup. Ct. 1990).
    2  See http://web.archive.org/web/20041101225636/http://www.uspto.gov/web/offices/pac/mpep/documents/appxr_1_111.htm.
    3  U.S. Patent & Trademark Office, Changes To Support Implementation of the United States Patent and Trademark Office 21st Century Strategic Plan; Final Rule, 69 Fed. Reg. 56481, 56516-17, http://www.gpo.gov/fdsys/pkg/FR-2004-09-21/pdf/04-20936.pdf (Sept. 21, 2004).
    4  44 U.S.C. § 3506(c)(2)(A) and § 3506(c)(1)(A)(iv); 5 C.F.R. § 1320.8(a)(4) and (d)(1).
    5  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0031
    6  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0024
    7  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0022
    8  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0035
    9  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0021
    10  http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0651-0064
    11  44 U.S.C. § 3506(c)(3)(A) and 5 C.F.R. § 1320.5(d)(1)(i) ("To obtain OMB approval of a collection of information, an agency shall demonstrate that it has taken every reasonable step to ensure that the proposed collection of information: (i) Is the least burdensome necessary for the proper performance of the agency's functions. . .").
    12  44 U.S.C. § 3506(c)(3)(B) and 5 C.F.R. § 1320.5(d)(1)(ii).
    13  44 U.S.C. § 3502(11) and 5 C.F.R. § 1320.3(l)
    14  Information "quality" is defined in OMB's information quality guidelines, 67 Fed.Reg. 8451-60, http://www.whitehouse.gov/omb/fedreg_final_information_quality_guidelines (Feb. 22, 2002), and PTO's information quality guidelines, 67 Fed.Reg. 22052, http://www.uspto.gov/products/cis/infoqualityguide.jsp (May 2, 2002).
    15  44 U.S.C. § 3506(c)(2)(A)(iv) and 5 C.F.R. § 1320.5(d)(1)(i).
    16  44 U.S.C. § 3506(c)(3)(D) and 5 C.F.R. § 1320.9(d).
    17  44 U.S.C. § 3512 and 5 C.F.R. § 1320.6.
    18  http://www.reginfo.gov/public/do/DownloadDocument?documentID=44055&version=2 (In January 2008, "At the direction of OMB" the PTO removed the Continuations, Claims, and IDS rules from its requests for clearance at OMB.  At the time, the Tafas case was in briefing for summary judgment.  The PTO allowed Tafas to grind on for another 18 months before this information was made public.
    19  The 2008 appeal rules were stayed on the day they were to go into effect in December 2008, because those letters convinced OMB to withhold approval under the Paperwork Reduction Act.