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  • Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz.  Amgen had petitioned for rehearing on the panel's decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure to the reference product sponsor of a biosimilar applicant's application and relevant manufacturing information was optional rather than mandatory.  Sandoz petitioned for rehearing on the panel's decision that the District Court had erred in deciding that the 180-day noticed of commercial marketing for the biosimilar product could not be given to the reference product sponsor prior to FDA approval of their biosimilar application.  As is common, the Court's order denying each party's petition contained no information regarding how the individual judges of the Court had voted, and there were no dissents to the decision accompanying the order.

    Each party must now decide whether to file a petition for certiorari to the Supreme Court; grant of the petition may be more likely (at least with regard to Amgen's petition) in view of the seeming conflict between the courts' construction of the statutory language and that language's plain meaning, as well as the fractured nature of the panel's decision.

  • What May Be the IP Provisions of the Trans Pacific Partnership Agreement

    By Kevin E. Noonan —

    The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible:  they have kept the details of the draft agreement secret from the press and public in the United States, Canada, Mexico, Australia, Singapore, Malaysia, Japan, Chile, Peru, Vietnam, New Zealand, and Brunei Darussalam (as well as the rest of the world over six years of deliberations.  Secrecy has not been absolute, of course, with the Wikileaks website periodically publishing purported drafts of the agreement.  With the announcement on October 5th that the parties have come to substantial agreement, Wikileaks once again released portions of the agreement.  Relevant here are the purported provisions regarding intellectual property (see "TPP Treaty: Intellectual Property Rights Chapter").

    The IP portion of the agreement is contained in provisionally numbers Section QQ.  The Objectives of the agreement with regard to IP are stated as follows:

    The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

    The substantive IP portions of the Agreement govern copyrights, trademarks and patents, and Section QQ.E.20 is specifically drawn to biologic drugs.  Consistent with the efforts of the Obama administration to reduce the term of market exclusivity of biologic drugs from 12 years as provided by the Biologic Price and Competition and Innovation Act (BPCIA) to 7 years (even at the risk of scuttling agreement over passage of the omnibus healthcare reform legislation termed "Obamacare"), the TPP provides that the signatory nations will provide "effective market protection [] for a period of at least 8 years from the date of first marketing approval of that product" or, in the alternative "a period of at least 5 years from the date of first marketing approval."  These provisions don't mandate protection of less than 12 years under current U.S. law but provide a pathway for reducing the term.

    In like vein, the Agreement defines patentable subject matter as being "any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application" (Section QQ.E.1).  But before the U.S. patent community anticipates that ratification of the TPP will return the U.S. to status quo ante of the Mayo/Myriad/Alice trilogy of recent Supreme Court cases, the Agreement also provides that "Each Party may also exclude from patentability: diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; animals other than microorganisms; and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes." (Section QQ.E.1.3).

    More worrisome (for those who believe that developing a harmonized worldwide IP regime providing predictable rights, the drafters of the TPP have learned the lessons of the GATT/TRIPS agreement and its later modification by the WTO, inter alia by the Doha Declaration.  Thus, Section QQ.A.Y provides:

    1. Parties may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Chapter.

    2. Appropriate measures, provided that they are consistent with the provisions of this Chapter, may be needed to prevent the abuse of intellectual property rights by rights holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

    Congress granted the President so-called "fast-track authority" for the TPP, which means that Congress can ratify the agreement, or not, but cannot amend the agreement or filibuster Senate consideration.  Opposition to the TPP has been voiced by putative Democratic Party Presidential nominee Hillary Clinton and her nearest challenger, Sen. Bernie Sanders (I-VT), as well as groups like the Electronic Frontier Foundation, Public Citizen and several unions.  Ratification of the TPP might be the crowning achievement of the Obama Presidency, which includes normalizing relations with Cuba, reducing U.S. military presence on Iraq and Afghanistan, and Obamacare.  But there is sufficient opposition to the agreement that its ratification is not assured and provides a juicy target for political shenanigans as the 2016 election cycle approaches.

    Patent Docs will provide a more in-depth review when the official version of the TPP is released.

  • Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

    By Kevin E. Noonan —

    Spectrum PharmaceuticalsLast week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz.  In so doing, the Court deferred to the factual determinations made by the lower court for no clear error and agreed on de novo review with the District Court's legal conclusions.

    The case involved leucovorin, a drug used to "ameliorate the toxic effects of methotrexate during cancer chemotherapy . . . to treat folate deficiency [] and to enhance the efficacy of 5-fluorouracil cancer treatment" and sold by exclusive licensee Spectrum Pharmaceuticals as Fusilev®.  The molecule exists as a pair of diastereomers, designated 6S and 6R, in a 50/50 mixture.  The 6S diastereomer, also called levoleucovorin, has the biological activity of the drug.

    Spectrum, the exclusive licensee of Orange Book-listed U.S. Patent No. 6,500,829, asserted claims 1, 2 and 5-9

    Claim 1.  A pharmaceutical composition for therapeutic use which consists essentially of a therapeutically effective amount sufficient for the treatment of human beings for methotrexate rescue or folate deficiency, of a pharmaceutically acceptable compound which is a (6S) diastereoisomer selected from the group consisting of (6S) leucovorin (5- formyl-(6S)-tetrahydrofolic acid) and pharmaceutically acceptable salts and esters of (6S) leucovorin; wherein the compound consists of a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) diastereoisomer, the balance of said compound consisting of the (6R) diastereoisomer; in combination with a pharmaceutically acceptable carrier.

    Claim 2 recites the limitation that the 6S diastereomer was 95% of the composition by weight.  The specification discloses that "a typical daily dose" is up to 150 mg of the 6S isomer for use with methotrexate, 25-150 mg for use with 5-FU and 2-25 mg for treating folate deficiency.

    Claim 5.  A pharmaceutical composition for therapeutic use for the treatment of human beings comprising:
        a pharmaceutically acceptable composition which is a (6S) diastereoisomer selected from the group consisting of (6S) leucovorin (5-formyl-(6S)-tetrahydrofolic acid) and pharmaceutically acceptable salts and esters of (6S) leucovorin, wherein the composition consists of a mixture of (6S) and (6R) diastereoisomers and consists of at least about 92% by weight of the (6S) diastereoisomer, the balance of said composition consisting of the (6R) diastereoisomer; and a pharmaceutically acceptable carrier; and
        said composition being of a quantity at least sufficient to provide multiple doses of said mixture of (6S) and (6R) diastereoisomers in an amount of 2000 mg per dose.

    (Claims 6-9 recited additional limitations that the opinion states were not relevant to the issues on appeal.)

    The claims were rejected during prosecution as being anticipated or obvious over a prior art reference disclosing synthesis of levoleucovorin, which the applicants addressed by adding claims 5-9 and "emphasizing the specific claim limitations relating to quantities of the specified mixture, which were allegedly not disclosed by the prior art."  When this was unsuccessful the inventors appealed, and the claims were eventually granted inter alia on the grounds that the quantity limitations could not be met by the cited art.

    Sandoz #1Sandoz's generic version of the drug was specified as "single-use vials with 175 mg or 250 mg of levoleucovorin, indicated for [use with] methotrexate [] at doses of 7.5–75 mg per dose."  On this basis the District Court granted summary judgment of non-infringement of claims 5-9, on the ground that Sandoz's product would not provide a minimum of 2000 mg per dose and rejected Spectrum's argument that Sandoz would import in aggregate "at least two doses of 2000 mg per dose."

    The District Court also held that Spectrum was barred by prosecution history estoppel from relying on the doctrine of equivalents based on statements made during prosecution.  Specifically, Sandoz argued that applicants had distinguished the prior art based on the "more stringent quantity limitations" of their claims.  The District Court held that these arguments amounted to "a clear and unmistakable surrender of subject matter covering pharmaceutical composition quantities less than what is required to provide two or more doses of, at minimum, 2000 mg per dose of the mixture."

    With regard to Sandoz's validity challenge of claims 1 and 2, the District Court found that the prior art disclosed "(i) leucovorin as a mixture of (6R) and (6S) diastereoisomers; (ii) that the therapeutic usefulness of leucovorin derives wholly from the (6S) isomer; and (iii) a rationale for investigating a purified (6S) isomer product for use in 5-FU combination therapy."  That prior art included references not considered by the Office, that disclosed methods for making purified levoleucovorin (the 6S diastereomer), and that these methods would "invariably" produce a mixture of the 6S and 6R diastereomers but also "a highly pure 6S isomer."  Finally, the District Court held that the prima facie obviousness determination was not rebutted by secondary considerations because Spectrum did not provide a nexus between any of the factors (including long-felt need and commercial success as evidenced by successful licensing) and the invention.

    The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Wallach and Hughes.  The validity question, according to the opinion, rested on the balance between the motivations set forth in KSR v. Teleflex (wherein "'design need or market pressure or other motivation' may provide a suggestion or motivation to combine prior art elements in the manner claimed") and impermissible hindsight reconstruction of the invention.  Here, Spectrum argued (somewhat bizarrely) that the question the Court should consider was whether there was any motivation in the art to contaminate purified (100%) preparations of the 6S diastereomer with small amounts of the 6R diastereomer.  Sandoz countered that the District Court correctly considered whether the skilled worker would have been motivated to increase the percentage of the 6S diastereomer from 50/50 mixtures of leucovorin, and that "it had no burden to show a motivation to contaminate the prior art pure (6S) isomer compound" (emphasis in opinion).  The Court noted that typically arguments related to purified diastereomers (or enantiomers) related to pharmaceuticals were centered on whether it would have been obvious to purify one of the isomers from a mixture, citing several ANDA cases.  This case, in contrast, revolved around "whether a substantially pure compound would have been obvious when both the 50/50 mixture and the pure compound were known in the art," and agreed with the District Court that it would.

    The Federal Circuit found no clear error in the District Court's factual determination that the skilled worker would have been motivated by the knowledge that the biological activity of leucovorin resides in one diastereomer to differentially purify that isomer from a mixture, stating that "there is always in such cases a motivation to aim for obtaining a pure, resolved material."  And similarly, the Court found that there would be no motivation (or reason) to contaminate a purified isomer to obtain an "impure" mixture.  But this argument, advanced by Spectrum, was not persuasive on the issue of non-obviousness because the "slightly impure (92%-95%) mixture was not shown to have any "unexpected advantages over the prior art pure material, the less-than-pure material, and any others of similar concentration."  In addition, the Federal Circuit agreed with the District Court that the motivation to purify the biologically active 6S isomer would apply to "substantially pure" preparations as well as "pure" levoleucovorin.  The opinion asserted that the evidence showed than "numerous" researchers had recognized the 6S isomer as possessing the biological activity had undertaken the effort to purify that isomer from the mixture and many succeeded (whether prior to the '829 patent's priority date or after was unclear in the opinion).

    This motivation, and the evidence of a reasonable expectation of success as shown by the success of these "numerous" other researchers, was enough to satisfy the panel that the District Court did not err in finding claims 1 and 2 to be obvious.  The opinion also stated that Spectrum did not show "any" evidence of unexpected results based on the substantial clinical equivalence of purified 6S leucovorin and preparations that are 92-95% pure.

    The opinion also held that whether or not the prior art at issue before the District Court was enabling did not change its conclusion, based on "the whole spectrum of prior art available before the invention was made" which would have enabled the skilled worker to prepare substantially pure levoleucovorin (despite the rubric that enablement is not a requirement for a prior art reference to render a claim obvious).

    Finally, the panel agreed with the District Court that Spectrum did not establish any of the objective indicia of non-obviousness sufficient to rebut the prima facie case, based on the equivalence of the prior art mixtures and the substantially pure levoleucovorin as claimed in claims 1 and 2 of the '829 patent.

    With regard to non-infringement, the Federal Circuit also affirmed, based on its agreement with the District Court that Sandoz would be entitled by FDA approval of its ANDA to sell "single-use vials with 175 mg or 250 mg of substantially pure levoleucovorin" for the methotrexate indication for which the approved administered dose would be limited to 7.5-75 mg.  This was "far less" than the "at least two doses of 2000 mg each" recited in claims 5-9 of the '829 patent, and thus Spectrum had not established literal infringement.  As for infringement under the doctrine of equivalents, the panel opinion found that the "claim amendments and distinguishing statements on the prior art during prosecution" estopped Spectrum from asserting infringement under the doctrine.  The opinion notes that the prosecution history contained several instances where the dosage was relied upon to distinguish the prior art by amendment and argument, including arguments made to the Board on appeal.

    Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)
    Panel: Circuit Judges Lourie, Wallach, and Hughes
    Opinion by Circuit Judge Lourie

  • Guest Post — The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Psychobiotics

    This is the third article in a series on advancements in microbiome research and development.  This installment reviews the area of microbiome research known as the "gut-brain-axis" and therapies related thereto, which have been dubbed "pyschobiotics." Upcoming articles will continue to review important topics in this technology area, and patents of interest.

    By Jessica Miles* and Anthony D. Sabatelli** —

    Research into the microbiome focuses heavily on bacteria living in the gut, which houses more bacteria than any other organ.  These bacteria are being studied not only because they play a role in gastrointestinal disorzers like Inflammatory Bowel Disease (IBD), Crohn's Disease, and colorectal cancer, but also because they can influence diverse and distal organs.  The gut-brain-axis — the term for the neurochemical pathway between the intestine and the brain — is a prominent example of such a relationship.  As the research is starting to progress in this area, we are also beginning to see patents relating to this area.

    The gut-brain-axis and "psychobiotics"

    The gut-brain-axis begins with the enteric nervous system (ENS), a network of neurons that runs through the gastrointestinal tract.  From there, the gut communicates with the brain via the vagus nerve, which connects the ENS to the central nervous system, transmitting signals up the spinal cord and to the brain.  However, the link between bowel and brain is bidirectional, as the brain controls the immune system and other autonomic functions that shape the bacterial populations living in the gut.

    The gut microbiota shapes brain function by promoting the synthesis of neurochemicals that directly interact with the ENS.  The trillions of microbes living in the human intestine produce a multitude of chemicals, called metabolites.  Some metabolites are the byproducts of bacterial fermentation of dietary fiber; one of these, butyrate, influences brain function by regulating neuronal gene expression.  Others modulate critically important neuroendocrine molecules.  For example, work published earlier this year demonstrates that specific gut microbiome members interact with intestinal cells to stimulate serotonin production, indicating that these bacteria play a principle role in regulating the body's reservoir of this important neurotransmitter and mood-regulator.  Additional recent and emerging research implicates gut bacteria in the production of such well-known neurotransmitters as dopamine, gamma-Aminobutyric acid (GABA), histamine, noradrenaline, and adrenaline.

    Underlining the connection between the brain and the gut, patients with neurological and psychiatric disorders such as depression, anxiety, autism, and childhood hyperactivity often present with gastrointestinal illness.  Because of this connection, and the fact that the intestine is the main site of synthesis for many of these psychoactive compounds, beneficial bacteria with potential psychiatric and neurological effects are being called "psychobiotics."

    Current State of R&D

    A watershed moment for psychobiotics came in 2013, when researchers at UCLA provided some of the earliest evidence that gut bacteria can alter human brain function and mood.  This work came after several papers reported that probiotic strains could reduce depression- and anxiety-like behaviors in mice.  Since then, there has been interest in understanding the interplay between bacteria and mood disorders and how pyschobiotics might be used to improve brain development and lessen behavioral symptoms associated with conditions such as autism.  Notably, one of the first patents relating to this area of research was issued earlier this year.  U.S. Patent No. 8,927,242 (reviewed in detail in the previous installment) generally relates to a bacterial therapy for treatment of a subset of psychiatric disorders in children, called PANDAS.  This patent was granted to NuBiome, a California-based company specializing in treatments for autoimmune disorders.

    There are also several patents pending for psychobiotic-based treatments.  Symbiotix cofounder Sarkis Mazmanian has filed for two patent applications in this area of research: one relates to the use of bacterial probiotics for the treatment of anxiety, autism, and autism spectrum disorder, while the other relates to other therapies, including fecal transplantation, to treat these disorders.  Autism researcher Sydney Finegold has also filed two patent applications, both relating to the use of antimicrobials andprobiotics to treat behavorial disorders.  Another application, US 20140301995, generally relates to manipulating bifidobacteria and clostridia in the gut to improve serotonin levels.  US 20150152484 covers the characterization of Prevotella, Coprococcus, Prevotellaceae, or Veillonellaceae bacteria in ASD patients.  US 20150259728, which was filed in March, describes a treatment of anxiety-like behavior and stress-induced inflammation in children.  The treatment is a prebiotic:  a non-digestible carbohydrate that stimulates growth of the gut microbiota.

    Closing

    The gut-brain-axis represents an exciting frontier for microbiome studies.  Despite their infancy, psychobiotics hold great promise for difficult-to-treat mood and psychiatric disorders.  Although current patent and commercialization activity in this research area is low, this activity will increase as research this field continues to grow.

    * Jessica Miles is a Technology Specialist at Dilworth IP
    ** Dr. Sabatelli is a Partner with Dilworth IP

    For additional information regarding this topic, please see:

    • "Guest Post — The Emergent Microbiome: A Revolution for the Life Sciences – Part II, 2015 Patent Trends," August 11, 2015
    • "Guest Post — The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders," August 10, 2015

  • USPTO News Briefs

    By Donald Zuhn –

    USPTO Extends After Final Consideration Pilot 2.0 Program

    USPTO SealLast week, the U.S. Patent and Trademark Office indicated on its website and through a Patents Alert e-mail that the After Final Consideration Pilot 2.0 (AFCP 2.0) program has been extended through September 30, 2016.  The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program"), modified in May 2013 (see "USPTO News Briefs"), and extended last year (see "USPTO News Briefs") provides examiners with a limited amount of non-production time — three hours for utility and reissue applications — to consider responses filed following a final rejection.

    In implementing the original AFCP, the Office described six limited situations in which further amendments or arguments may be considered under the AFCP:

    1.  The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action.
    2.  The amendment places the application in condition for allowance by rewriting objected-to claims in independent form.
    3.  The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search.
    4.  The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims.
    5.  The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search.
    6.  The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]

    When the Office implemented the AFCP 2.0 program, it described three main differences between the original AFCP and the AFCP 2.0:  (1) an applicant must file a request to participate in the AFCP 2.0; (2) a response after final rejection under the AFCP 2.0 must include an amendment to at least one independent claim; and (3) when a response does not result in a determination that all pending claims are in condition for allowance, the examiner will request an interview with the applicant to discuss the response.  The requirements for participating in the AFCP 2.0 are as follows:

    (1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
    (2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
    (3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the notice, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
    (4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
    (5) the required papers must be filed via the EFS-Web.

    The Office has noted that applicants submitting AFCP 2.0 requests will receive a specialized form (PTO-2323) in response to requests.  The form will communicate the status of the submission, and if applicable, also accompany an interview summary.  Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.


    USPTO Extends Quick Path Information Disclosure Statement Pilot Program

    The U.S. Patent and Trademark Office also announced last week on its website and through a Patents Alert e-mail that the Quick Path Information Disclosure Statement (QPIDS) pilot program has also been extended to September 30, 2016.  The QPIDS pilot program, which was implemented by the Office in May of 2012 (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program") and extended last year (see "USPTO News Briefs"), allows applicants to have an Information Disclosure Statement (IDS) considered after the issue fee has been paid and without having to file a Request for Continued Examination (RCE).

    Under the QPIDS pilot program, an examiner will consider IDS submissions made after the issue fee has been paid (and provided that the conditions below are met) to determine whether prosecution should be reopened.  Where the examiner determines that no item of information in the IDS necessitates reopening prosecution, the Office will issue a corrected notice of allowability and the application will pass to issue, thereby eliminating the delays and costs associated with RCE practice.  To be eligible to participate in the pilot program, an application must be an allowed utility or reissue application for which the issue fee has been paid and the patent has not yet issued, and a QPIDS submission must be made electronically via the EFS-Web.  The QPIDS submission must include the following:

    • A transmittal form that designates the submission as a QPIDS submission (e.g., form PTO/SB/09);
    • An IDS accompanied by a timeliness statement set forth in 37 CFR 1.97(e), with the IDS fee set forth in 37 CFR 1.17(p) — note: the QPIDS pilot program does not eliminate the requirements that an IDS be accompanied by the statement of 37 C.F.R. § 1.97(e)(1) or (2) and the fee set forth in 37 C.F.R. § 1.17(p)).
    • A Web-based ePetition to withdraw from issue under 37 CFR 1.313(c)(2), with the petition fee set forth in 37 CFR 1.17(h); and
    • An RCE, which will be treated as a "conditional" RCE, with the RCE fee under 37 C.F.R. 1.17(e) — note: the IDS fee under 37 C.F.R. § 1.17(p) will be automatically returned if the examiner decides to reopen prosecution, necessitating that the RCE be processed, and the RCE fee will be automatically returned if the examiner determines that prosecution need not be reopened.

    Additional information regarding the QPIDS pilot program can be found on the Office's QPIDS webpage.


    USPTO Implements Automated Interview Request System

    Last month, the U.S. Patent and Trademark Office announced via a Patents Alert e-mail that it was implementing a new online interview scheduling tool, USPTO Automated Interview Request (AIR).  USPTO AIR allows Applicants to request an in-person, telephonic, or video conference interview with an Examiner for their pending patent application by submitting an online form.  Additional information regarding USPTO AIR can be found here.

  • 101 Patient Organizations Ask Congress to Curb IPR Abuse

    By Donald Zuhn —

    Washington - Capitol #5Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent protections for the biopharmaceutical innovation our communities rely on to achieve a better quality of life."  While commending the House Judiciary Committee for its work to combat "the problem of patent trolls," the group noted that it "remain[ed] concerned that the bill does not address some forms of abuse in our patent system that, left unaddressed, could undermine the investments that sustain medical research into lifesaving treatments and cures."

    And the form of abuse in the patent system that is drawing the attention of the organizations?  That would be inter partes review (IPR) proceedings.  The letter contends that "IPR opened the door to abuses that threaten the unique and specialized mechanisms under the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA)."  According to the group "Congress established these carefully-crafted patent dispute resolution frameworks to balance the interests of innovators, generic and biosimilar manufacturers, and, most importantly, the individuals waiting for a treatment or cure."

    The letter explains that "[d]eveloping new medical treatments can cost billions of dollars and take more than a decade of research and development," and that "[b]oth small and large research and development companies rely heavily on the certainty of their patents to justify the significant long-term, risky investments needed to obtain approval from the U.S. Food and Drug Administration, often many years after a patent is granted."  According to the organizations, "[c]urrent abuses in the IPR proceedings could ultimately undermine the ability to raise capital and recoup development costs needed to fund future research."  Suggesting that Congress never intended IPR proceedings to undermine the patent dispute resolution frameworks in Hatch-Waxman and BPCIA, the group concludes its letter by "urg[ing] Congress to include language in H.R. 9 that would preserve the highly-detailed and sophisticated systems designed by Hatch-Waxman and BPCIA to avoid weakening the patents that sustain medical research."  The letter does not provide any details about the specific language the organizations seek.

    The organizations that were signatories to the letter were as follows:  Addario Lung Cancer Foundation; AIDS Delaware, Inc.; Alabama Lifespan Respite Resource Network; Allergy & Asthma Network; Alliance for Patient Access; Alzheimer's Association; American Autoimmune Related Diseases Association; Asthma & Allergy Foundation of America, New England Chapter; Asthma and Allergy Foundation of America; Benign Essential Blepharospasm Research Foundation; Bladder Cancer Advocacy Network; Brain Injury Association of Nebraska; Bridge the Gap – SYNGAP Education and Research Foundation; California Hepatitis C Task Force; California Senior Advocates League; Caregiver Action Network; Chris4Life Colon Cancer Foundation; Community Health Charities of Nebraska; Cure SMA; Delaware HIV Consortium; Dystonia Medical Research Foundation; Elder Care Advocacy of Florida; Epilepsy California; Epilepsy Foundation; Epilepsy Foundation New England; Epilepsy Foundation of Connecticut; Epilepsy Foundation of Florida; Epilepsy Foundation of Greater Chicago; Epilepsy Foundation of Kentuckiana; Epilepsy Foundation of Michigan; Epilepsy Foundation of Mississippi; Epilepsy Foundation of Nevada; Epilepsy Foundation Heart of Wisconsin; EveryLife Foundation for Rare Diseases; Florida State Hispanic Chamber of Commerce; Global Colon Cancer Association; Global Genes; Hannah's Hope Fund; HEALS (Hepatitis Education Awareness & Liver Support) of the South; HealthHIV; Healthy Women; Hepatitis Foundation International; ICAN, International Cancer Advocacy Network; Immune Deficiency Foundation; International Essential Tremor Foundation; International Foundation for Autoimmune Arthritis; Kentucky and S. Indiana Stroke Association; Kidney Cancer Association; Lupus and Allied Diseases Association, Inc.; Lupus Foundation of America; Lupus Foundation of Florida; Lupus Foundation of Northern California; Lupus Foundation of Southern California; Massachusetts Association For Mental Health, Inc.; Men’s Health Network; Mental Health America of Indiana; Michigan Lupus Foundation; Minnesota State Grange; MLD Foundation; NAMI Alabama; NAMI Greater Des Moines; NAMI Indiana; Nashville CARES; National Alliance on Mental Illness; National Association of Hepatitis Task Forces; National Association of Social Workers, NC Chapter; National Council for Behavioral Health; National Grange; National Hispanic Council on Aging; National Minority Quality Forum; National MS Society; National Prostate Cancer Awareness Foundation; National Psoriasis Foundation; Neurofibromatosis, Inc. Mid-Atlantic; New England Community for Cancer Survivorship; New Jersey Association of Mental Health and Addiction Agencies, Inc.; Ovarian Cancer National Alliance; Parent Project Muscular Dystrophy; Parkinson's Action Network; Prevent Cancer Foundation; Rare and Undiagnosed Network (RUN); RetireSafe; Rio Grande Valley Diabetes Association; Rocky Mountain Stroke Center; Rush to Live; Rx Partnership; Salud USA; Solidarity Project Access Network; St. Baldrick's Foundation; ST/Dystonia, Inc.; Texas Nurse Practitioners; The AIDS Institute; The ALS Association; The Playing For Life Foundation; Tuberous Sclerosis Alliance; United Spinal Association; US Pain Foundation, Inc.; Veterans Health Council; Vietnam Veterans of America; Wellness and Education Community Action Health Network; and ZERO – The End of Prostate Cancer.

  • Conference & CLE Calendar

    CalendarOctober 12, 2015 – "Hedge Fund IPR Challenges to Pharma Patents: Latest Developments and Strategies to Strengthen Patents — Lessons From PTAB Denial of Acorda Therapeutics IPR, Celgene's Sanctions Motion, and More" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 13, 2015 – Post-Grant Practice Roundtable Discussion (George Washington Law School) – George Washington University Law School

    October 13, 2015 – Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (EDT)

    October 15, 2015 – "Foreign Patent Filings and PCT National & Regional Phase Entries" (Intellectual Property Law Association of Chicago Paralegal Committee and International Patents Committee) – Chicago, IL

    October 20, 2015 – "Trust Everybody, but Cut the Cards" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    October 20, 2015 – "Will My Patent Make Cents? How Courts and the USPTO Affect Patent Portfolio Value" (American Bar Association (ABA) Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    October 22, 2015 – "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinion" (Strafford) – 1:00 to 2:30 pm (EDT)

    November 16-17, 2015 – Patent Litigation 2015 (Practising Law Institute) – New York, NY

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

  • Webinar on Patent Portfolio Value

    ABAThe American Bar Association (ABA) Center for Professional Development and Section of Intellectual Property Law will be offering a live webinar entitled "Will My Patent Make Cents? How Courts and the USPTO Affect Patent Portfolio Value" on October 20, 2015 from 1:00 to 2:30 pm (ET).  Joseph T Miotke (moderator), Alton Lee Hare, Brian O'Shaughnessy, Krista F. Holt, and Scott Weingust will give a brief overview of how patent valuation is conducted and when it should be considered, discuss the factors that affect the value of a patent, including the American Invents Act and recent case law (CLS Bank v. Alice Corp.), and share best practices and practical tips, to help attendees assist clients with how to get the most out of their patent portfolios.

    The registration fee for the webcast is $150 for members, $95 for sponsor members, and $195 for the general public.  Those interested in registering for the webinar, can do so here.

  • Webinar on Patent Eligibility Post-Alice Corp.

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Demonstrating Patent Eligibility Post-Alice Corp. Decision — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinion" on October 22, 2015 from 1:00 to 2:30 pm (EDT).  Michael L. Kiklis and Stephen G. Kunin of Oblon McClelland Maier & Neustadt will examine recent decisions applying the Supreme Court's decision in Alice Corp. v. CLS Bank on patent eligibility, and discuss the guidance from these opinions and offer best practices for addressing patent eligibility issues.  The webinar will review the following questions:

    • How are the courts applying the framework for patent eligibility created in Alice Corp.?
    • How can patent litigation defendants take advantage of the guidance for Section 101 challenges?
    • What are best practices for patent counsel to demonstrate patent eligibility?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • USPTO Patent Quality Chat Webinar Series

    USPTO SealThe U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series on October 13, 2015 from 12:00 to 1:00 pm (EDT).  The latest webinar, which will be hosted by Assistant Deputy Commissioner for Patent Operations Robert Oberleitner and Director of the Ombudsman Program Dale Shaw, will address the topic of Special Programs for Patent Prosecution.  Mr. Oberleitner will be discussing the opportunities applicants currently have to participate in patent prosecution initiatives and will be hearing feedback and listening to additional stakeholder ideas on those initiatives.  Mr. Shaw will be sharing details about the Ombudsman Program and will be encouraging feedback on how to improve this program.

    The webinar can be viewed using this link, and stakeholder participation will be solicited via the e-mail address: PatentQualityEventParticipationBox@uspto.gov.

    Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.