• By Donald Zuhn

    While the patent community has been focusing on Congress' efforts to enact patent reform legislation over the past few months, a number of other bills have been introduced that could, if enacted, significantly impact the biotech and pharma sectors.


    Stem Cell Research Advancement Act of 2011

    DeGette, Diana Last month, Rep. Diana DeGette (D-CO) introduced the Stem Cell Research Advancement Act of 2011 (H.R. 2376).  The bill is similar to legislation that Rep. DeGette introduced in 2006 and 2007.  While her previous efforts in Congress were successful, President Bush vetoed both of the earlier bills.

    Rep. DeGette's latest effort would amend the Public Health Service Act (Title 42) to provide that "the Secretary shall conduct and support research that utilizes human stem cells, including human embryonic stem cells."  In particular, the bill would require that the Secretary, in consultation with the Director of the NIH, "maintain guidelines applicable to the conduct or support of human stem cell research by the Department of Health and Human Services," review the guidelines every three years, and update the guidelines "as scientifically warranted."  The legislation also prohibits funding for human cloning, which is defined as "the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus."  The bill has been referred to the House Committee on Energy and Commerce.

    In a press release posted on her website, Rep. DeGette said that the legislation "would place into statute a framework to ensure such critical research can be conducted unimpeded by political interference."


    Confirming Genetic Diagnostic Test Activity Legislation

    Wasserman Schultz, Debbie Prior to House passage of the Leahy-Smith America Invents Act (H.R. 1249), Rep. Debbie Wasserman Schultz (D-FL) was able to squeeze a provision into House Judiciary Chairman Lamar Smith's (R-TX) Manager's Amendment that would allow a "genetic diagnostic test provider" to perform "confirming genetic diagnostic test activity" without fear of facing a patent infringement action (see "Manager's Amendment (and Others) to H.R. 1249 — Second Opinions in Genetic Diagnostic Testing").  That provision of the House bill was eventually replaced with a provision calling for a study to be conducted by the USPTO Director "on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist."  The Senate bill contains no provisions regarding confirming genetic diagnostic test activity.

    On June 22, one day before the House passed H.R. 1249, Rep. Wasserman Schultz introduced a standalone bill (H.R. 2276) that would "require the Director of the United States Patent and Trademark Office to conduct a study on effective ways to provide confirming genetic diagnostic test activity where gene patents and exclusive licensing exist."  As with H.R. 1249, H.R. 2276 would require that the Director's study include an examination of:

    (1) The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses.

    (2) The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test.

    (3) The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to the interpretation of testing results and performance of testing procedures.

    (4) The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

    The bill has been referred to the House Committee on the Judiciary and Committee on Energy and Commerce.


    Medical Innovation Prize Fund Act

    Sanders, Bernie In May, Sen. Bernard Sanders (I-VT) introduced the Medical Innovation Prize Fund Act (S. 1137), which is intended "[t]o provide incentives for investment in research and development for new medicines, [and] to enhance access to new medicines."  The bill would accomplish these objectives by establishing a Medical Innovation Prize Fund (equal to 0.55% of the gross domestic product — or $80,000,000,000 in 2011) and "by eliminating legal monopolies on the manufacture, distribution, and sale of . . . medicines."  Section 5 of the bill, entitled "Elimination of Exclusive Rights to Market Drug and Biological Products," states that "no person shall have the right to exclusively manufacture, distribute, sell, or use a drug, a biological product, or a manufacturing process for a drug or biological product in interstate commerce."

    The legislation provides that "in lieu of any remuneration the person would have otherwise received for the exclusive marketing, distribution, sale, or use of a drug, biological product, or manufacturing process for a drug or biological product," and "in addition to any other remuneration that such person receives by reason of the nonexclusive marketing, distribution, sale, or use of the drug, biological product, or manufacturing process for a drug or biological product," the person would be "eligible for prize payments from the Fund."  The bill would create a 13-member Board of Trustees for the Fund that would, in part, "award prize payments for medical innovation in accordance with this Act."  The bill also sets forth prize eligibility criteria to be considered by the Board.  Following its introduction, the bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

    Sen. Sanders introduced a similar bill (the Prize Fund for HIV/AIDS Act, S. 1138) for "de-link[ing] research and development incentives from drug prices for new medicines to treat HIV/AIDS."  S. 1138 would create a Prize Fund for HIV/AIDS in an amount equal to 0.02% of the gross domestic product.


    Seed Availability and Competition Act of 2011

    Kaptur, Marcy Earlier this year, Rep. Marcy Kaptur (D-OH) introduced the Seed Availability and Competition Act of 2011 (H.R. 307).  The legislation specifies that "[a]ny person who plants patented seed or seed derived from patented seed may retain seed from the harvest of the planted seed for replanting," provided that the person retaining such seed "submits to the Secretary of Agriculture notice, in such form as the Secretary may require, of the type and quantity of seed to be retained," and "pays the fee established by the Secretary."  The fees collected by the Secretary will be deposited in a Patented Seed Fund, and the Secretary "shall pay the collected fees to the appropriate patent holders, at a frequency that the Secretary determines is appropriate, from the Patented Seed Fund."  The bill would also allow the Secretary of the Treasury to impose a duty on products of certain exported genetically modified seeds when those products are imported into the United States.  The bill was referred to the House Committee on Agriculture and Committee on Ways and Means following its introduction in January, and was referred to the Subcommittee on Nutrition and Horticulture and Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture (both of which are part of the Committee on Agriculture) in March.


    Patent Continuing Disclosure Act

    Issa, Darrell Both the House and Senate versions of the Leahy-Smith America Invents Act (H.R. 1249 and S. 23) would amend the false marking statute (§ 292) of Title 35.  In the House version of the bill, § 292 would be amended to state that "[o]nly the United States may sue for the penalty authorized by [subsection (a)]" and replace current subsection (b) with the following:  "A person who has suffered a competitive injury as a result of a violation of this section may file a civil action in a district court of the United States for recovery of damages adequate to compensate for the injury" (the Senate version would make nearly identical changes to § 292).  The House bill would also amend § 292 such that "[t]he marking of a product . . . with matter relating to a patent that covered that product but has expired is not a violation of this section."

    In March, Rep. Darrell Issa (R-CA) introduced the Patent Continuing Disclosure Act (H.R. 1056), which also addresses the marking of products with an expired patent.  In particular, the bill would amend § 292 such that an item that is marked "shall not be fined under this section after the patent expires if– (A) no change in the manufacturing or production process of the item occurs after the expiration of the patent; or (B) in a case in which a change in the manufacturing or production process of the item occurs after the expiration of the patent, the word 'expired' is placed before the word 'patent' or the patent number."  The bill was referred to the Subcommittee on Intellectual Property, Competition and the Internet of the House Committee on the Judiciary.

  • By Kevin E. Noonan

    BIO International Convention A panel of former Solicitors General and Assistant Solicitors addressed recent Supreme Court precedent in patent law during the BIO International Convention last month.  Moderated by former Federal Circuit Chief Judge Paul Michel, the panel consisted of Seth Waxman, former Solicitor General now at Wilmer Hale; Paul Clement, another former Solicitor General now at Bancroft PLLC; and Thomas Hungar, former Assistant Solicitor General now at Gibson Dunn LLP.

    Supreme Court Building #2 Judge Michel began the discussion with the Microsoft v. i4i case.  Mr. Waxman, who represented prevailing respondent i4i, went first.  He professed to be unsurprised that the Supreme Court decided the case in favor of the patentee and affirmed the Federal Circuit.  Mr. Waxman mentioned the Court's renewed interest in patent cases, and that an affirmance is surprising only because patent cases do not have the possibility of a circuit split, so that when the Court grants certiorari it is usually to reverse.  He said he considered the "real stunner" the decision in Stanford v. Roche because the Court sided with the inventor, but he tempered the significance of this decision by remarking that Stanford, the patent-holder, lost.  He admitted that the "superficial" view was that the Court was going to reverse in i4i, because the case represented another instance of the Federal Circuit deciding in favor of the patentee based on its particular interpretation of the statutory language.  However, he also identified three levels of issues in the case:  the proper interpretation of the relevant provisions of the 1952 Patent Act; the Court's own precedent; and the public policy issues of industrial policy and the innovation economy.  The latter was the "most Titanic battle" and one the Court purported not to address, in the context of each side arguing that it would be a catastrophe if the other side prevailed.

    Mr. Hungar, who represented Microsoft in the case, said that the outcome was best understood as being supported by a line of Supreme Court precedent, particularly from Justice Cardozo that supported i4i's position; he mentioned that he was "bludgeoned" by this precedent by the Court during oral argument.  He mentioned that a possible factor in the Court's apparent change of heart regarding patent cases may be the recent change in personnel, noting that Justice Stevens (due to his antitrust experience) was "one of the most skeptical" members of the Court regarding patent rights, and that Justice Souter had also expressed skepticism of "as much legal protection" of patent rights advocated by its proponents.  He sees Justices Sotomayor and Kagan as having a different view, admitting that it will take "years" for the effects of their views on patent law to be properly appreciated.

    Mr. Clement next provided his comments, and took a slightly broader view.  He reminded the audience that in the seven patent cases decided in the past five years (including eBay Inc. v. MercExchange, L.L.C., KSR Int'l Co. v. Teleflex Inc., MedImmune, Inc. v. Genentech, Inc., Microsoft Corp. v. AT&T Corp., and Quanta Computer, Inc. v. LG Electronics, Inc., excluding Bilski v. Kappos) the Court ruled 59-2 (with 2 recusals) against the Federal Circuit.  Thus, this term is the anomaly he said, particularly when it is remembered that the Court reverses generally about 70% of the time.

    Mr. Clement also mentioned the lack of circuit split in Federal Circuit cases, which skews the results even more in favor of reversal:  the Court takes some cases based on the existence of a circuit split even if they believe the appellate court came to the right decision just to resolve the split, and that possibility does not exist for Federal Circuit cases.  He said that while it may be expected that the Court would show "some greater sense of deference" to the Federal Circuit's expertise, the present situation may be the result of how the Court reacted to the creation of the Federal Circuit 30 years ago.  It appeared, he said, that the Court "breathed a sigh of relief" that it did not need to consider patent cases as it had previously, and that the Federal Circuit "took its cue" from the Court and began to act as a "court of last resort" regarding patents.  As a consequence, Mr. Clement posited that the Federal Circuit came up with rules that would make it easier to handle its docket and to give relatively clear rules to district courts that otherwise rarely encountered a patent case.

    In addition, Mr. Clement suggested that the Court "gently walked away" from statements by Justices like Cardozo and Douglas that "really didn't make a lot of sense."  When the Supreme Court began to review Federal Circuit decisions, it relied on its own precedent — including those Justice Cardozo and Justice Douglas opinions — and did not take into account 20 years of (relatively unfettered) Federal Circuit precedent and the "settled expectations" it raised.  Because he doesn't see this "basic dynamic" to have changed, he thinks the recent affirmances will not become a trend but rather that the Court will continue to reverse the Federal Circuit.  While he agrees that the new Justices have apparently differing views on patenting than the Justices they replaced, he also noted again that the lopsided nature of the Court's opinions reversing the Federal Circuit are not likely to be affected by their votes.

    Mr. Clement also credited the Solicitor General's views as being important in the Court's i4i decision, saying that when the parties and amici argue (as they did in i4i) that "commerce as we know it will grind to a halt" if the other parties' views are upheld, the Court looks to the Solicitor General as an "honest broker."  In this regard he noted that the Court "almost routinely" sides with the SG's position, and that since the SG has recently sided with the accused infringer, the Court's decisions have predominantly been against the patentee.  Part of the "differential dynamic" between the Supreme Court and the Federal Circuit is that it is rare for the SG to file an amicus brief in the appellate court, according to Mr. Clement (a comment that should resonate with anyone contemplating a possible Supreme Court decision in AMP v. USPTO).

    Mr. Waxman also mentioned the role of the Solicitor General, and recounted his experience that a great deal of "heated advocacy" occurred within the Executive Branch in an effort to influence the Solicitor General's position.  Typically in patent cases this involves debate between the Patent and Trademark and Copyright Offices on the one hand and the Federal Trade Commission and the Antitrust Division of the Department of Justice on the other; he characterized these as the "liveliest of bloody debates," which occur before the Solicitor files its brief.  He noted a potentially "harmful" effect of this tendency (coupled with the Supreme Court's penchant for relying on the Solicitor as an "honest broker" that reflects the "broad, long-term interests of the U.S."):  while the Supreme Court Justices are not technically trained and do not have a deep understanding of patent law, the lawyers in the Solicitor General's office and the government in general have no expertise in commerce — "people in government tend to be people who have been in government" and not involved in innovation or who have an understanding of how innovation works.  While he credits these people as being "well meaning and smarter and more hard-working than people in commerce," he argued that they lacked the critical expertise in "the market and labs and the venture capital world."

    Judge Michel raised the issue of the role of Congress in defining patent law, and the changes over the past 30 years on the perception of patenting and the economy.  He noted in this regard President Obama's mention of patents in his State of the Union address and elsewhere, and how patent stories have moved from the business section (and obscure positions there) to the front page, so that the Federal Circuit no longer works in "relative obscurity."  Returning to the Supreme Court, Judge Michel noted that the KSR case was the first time the Court had considered obviousness since the late 1960's and that Justice Stevens was the only member of the Bilski Court that had considered subject matter eligibility previously (Parker v. Flook, Diamond v. Chakrabarty, Diamond v. Diehr).  He stated his belief that one possibly positive consequence of the Court's renewed interest in patent cases could be greater familiarity with patent law.

    Mr. Clement responded to Judge Michel's comments by stating that he believed the Court's interest in patent cases is "here to stay" because patents are "too darned important" to be left to the Federal Circuit.  He said that patent reform (while "like the poor is always with us") is important because the Supreme Court decides many patent cases as statutory interpretation cases, frequently finding little support for the Federal Circuit's interpretation of the statute in the statutory language itself.  For a "textually focused" Court, it is easy to overrule the Federal Circuit's more specific rules in favor of the Court's more general standard based on the statutory language.  However, if Congress speaks clearly, the Court may be less likely to rely on 19th Century precedent or language from Justice Cardozo in deciding patent cases according to Mr. Clement.

    In response, Judge Michel noted that the 1952 Patent Act was written very tersely and reads "more like a constitution than a statute," noting the difference between this way of writing a statute and how statutes are written today.  This has led to judicial interpretation of the statute (subject to Supreme Court interpretation and revision), which may be less likely if Congress amends patent law to be more definite.

    Mr. Hungar agreed with these sentiments, and with Mr. Clement's point that the Supreme Court is very confident in construing statutes but is less confident in the patent area, based on the Justices' recognition that their expertise does not lie in either patent law or the real world consequences that may arise from their pronouncements.  This results in a reluctance for bright line rules and a tendency for the Court to "muddy up" Federal Circuit rules that are too restrictive, citing the Court's Bilski decision as an example.  This leads to another of the Court's tendencies, to decide patent cases on a "case-by-case" basis.

    Judge Michel then asked the panel whether the Supreme Court utilized what he called its "constitutional law mode" of decision-making when deciding patent cases, invoking multifactor weighing tests that result in there being no answer to any question until the Court has opined.  He noted that in his view the consequences of this way of addressing patent cases ignore the reality that most of what happens in patenting does not happen in court, but in the real world where clients need guidance with predictability if not certainty about what they can do and what they cannot do.  Mr. Waxman followed up on these thoughts by noting that companies and investors in some industries, like biotechnology, have "substantial lead times" and require equally substantial investment, and that venture capitalists in their amicus brief in i4i voiced their view that they could not function in a world where their patent attorneys could only say "who the hell knows?" about patent validity and viability based on uncertainties introduced by general guidance in Supreme Court opinions.  He said that these actors told the Court that if this were to be the case, they would move to a different technology (or a different country) with all the negative consequences that would entail for American innovation.  He also characterized as "scary" the prospect that "nine unelected Justices" would enunciate specific rules that would apply "for all time," acknowledging that the Justices appreciated their inability to make such universal rules in the face of the inherent uncertainty about where innovation will arise in the future.

    Mr. Hungar raised the point that cases like eBay and MedImmune must be appreciated differently than cases like KSR and Bilski based on how the Court views them.  In the former cases, the Court "gets its mojo back" because it understands the issues — the standard for granting an injunction, when a party is entitled to declaratory judgment jurisdiction — and applies generally applicable standards that apply in all other areas of the law.  In patent law-specific cases, the Court is reluctant to engage in the kind of judicial lawmaking that characterized its explication of the Sherman Act in the last century, because judicial lawmaking is not well suited to making economic policy.  In contrast, the Court has a "serious adverse reaction" to Federal Circuit decisions that apply patent-specific interpretations to standards such as when a prevailing party is entitled to an injunction — "they want none of it."  Mr. Waxman (who represented eBay) noted the incongruity that arose in the eBay case, where both the district court and the Federal Circuit each applied the four-factor test for granting an injunction (albeit coming to different conclusions), in the face of a Supreme Court mandate that the courts apply the four-factor test on remand.  He also said that the consequence of the Court's eBay decision has been "utter confusion" in the district courts and that "untold amounts of money" have been spent in legal fees litigating injunctions in the face of this uncertainty.  He also noted that, perversely, the eBay decision created an incentive for patent holders to sue, if they could, before the International Trade Commission, where the prevailing patentee is entitled to an injunction by statute.  He also said that the Court's eBay decision upset the calculus of damages calculations, because in the absence of the possibility of an injunction, patentees were faced by de facto compulsory licenses.

    In the panel's final topic for discussion, Judge Michel stated his belief that much of what the Supreme Court decides is framed by the language — and rhetoric — of how the questions and arguments are presented to the Court, noting the possibility for disconnect with reality; for example he professed his view that there was never a Federal Circuit "rule" that a prevailing patentee "always" was entitled to an injunction.  In this regard, he discussed the Bilski opinion and the argument that all business method patents were "bad" and how in Prometheus, the same argument was being made regarding diagnostic method patents.  Judge Michel also mentioned Justice Stevens' idea that patent claims should be "deconstructed" to their "core" in deciding questions of patent eligibility, and the theoretical and practical deficiencies of that approach.  Mr. Hungar voiced the view that the Court generally saw beyond (or through) the rhetoric, and Mr. Clement stated his view that the greater frequency of the Court addressing patent issues should result in the Court becoming more adept at appreciating the subtleties in those issues and arguments.

  • By Donald Zuhn

    PPH Logo On Friday, the U.S. Patent and Trademark Office announced that it was revising the requirements for requesting participation in the Patent Prosecution Highway (PPH) programs with seven other patent offices.  The PPH programs being affected by the changes are those between the USPTO and the Canadian Intellectual Property Office (CIPO), IP Australia (IPAU), Japan Patent Office (JPO), National Board of Patents and Registration of Finland (NBPR), Federal Service on Intellectual Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and Trademark Office (SPTO), or United Kingdom Intellectual Property Office (UKIPO).  The USPTO noted that the changes were being made to improve the PPH programs and make them available to a wider range of applicants.

    Under the revisions to the PPH programs, applicants wishing to participate in one of the seven PPH programs in the USPTO based on claims that were determined to be allowable by one of the seven other offices must satisfy the following conditions:

    1.  The U.S. application for which participation in the PPH program is requested and the corresponding application in one of the seven other offices must have the same priority/filing date.  The notices for each of the revised programs (see links below) outline four cases and provide a number of flow chart examples in which this requirement would be satisfied.  Provisional applications, plant applications, design applications, reissue applications, reexamination proceedings, and applications subject to a secrecy order are excluded from participation in the PPH.

    2.  At least one claim has been determined by one of the seven other offices to be allowable/patentable.  The applicant must submit a copy of the allowable/patentable claims (along with an English translation, if necessary, and a statement of translation accuracy).

    3.  All claims on file, as originally filed or as amended, for examination under the PPH must sufficiently correspond to one or more of those claims indicated as allowable by one of the seven other offices.  Claims "sufficiently correspond" where the claims before the USPTO are of the same or similar scope or are narrower in scope than the claims before the other office.

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

    5.  The applicant must file a request for participation in the PPH program and a request that the U.S. application be advanced out of turn for examination under 37 C.F.R. § 1.102(a).

    6.  The applicant must submit a copy of office actions (which are relevant to patentability) from the other office (along with an English translation, if necessary, and a statement of translation accuracy).

    7.  The applicant must submit an information disclosure statement listing the documents cited by the other office and provide copies of any references (except for U.S. patents or U.S. patent application publications).

    8.  The request for participation in the PPH program and all supporting documents must be submitted via the EFS-Web.

    Additional details regarding each of the above requirements, other procedures for the PPH programs, and flow chart examples of applications satisfying revised requirements for PPH participation can be found in pre-OG notices that were issued by the USPTO for each of the revised PPH programs (click on office to view notice): CIPO, IPAU, JPO, NBPR, Rospatent, SPTO, and UKIPO.

    The revisions to these PPH programs took effect on July 15, 2011 and will remain in place for a trial period of one year ending on July 14, 2012 (which can be extended an additional year).  The revisions apply to PPH requests filed on or after July 15, 2011.

    In other PPH news, the USPTO issued OG notices on July 5 for the new PPH-PCT pilot program with the Swedish Patent and Registration Office (PRV) (1368 OG 46) and the new PPH program with the Israeli Patent Office (1368 OG 47) (see "USPTO Expands Patent Prosecution Highway").  The USPTO also issued a pre-OG notice last month for the new PPH-PCT program with the Nordic Patent Institute (NPI) (see "USPTO Expands Patent Prosecution Highway").

  • By Sherri Oslick

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

    Abbott Laboratories et al. v. Watson Pharmaceuticals et al.
    1:11-cv-00607; filed July 8, 2011 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida; Watson Pharma Inc.

    Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.


    Pfizer Inc. et al. v. Apotex Inc. et al.

    1:11-cv-00606; filed July 8, 2011 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Warner-Lambert Co. LLC; CP Pharmaceuticals International CV; Northwestern University
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) and 5,563,175 ("GABA and L-Glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the complaint here.


    Ferring B.V. v. Apotex, Inc. et al.

    3:11-cv-00485; filed July 8, 2011 in the District Court of Nevada

    • Plaintiff:  Ferring B.V.
    • Defendants:  Apotex, Inc.; Apotex Corp.

    Infringement of U.S. Patent No. 7,947,739 ("Tranexamic Acid Formulations," issued May 24, 2011) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Ferring's Lysteda® (tranexamic acid, used to treat heavy menstrual bleeding).  View the complaint here.


    Purdue Pharma L.P. et al. v. Sandoz Inc.

    1:11-cv-04694; filed July 7, 2011 in the Southern District of New York

    • Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Board of Regents of The University of Texas System; Grunenthal GMBH
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent Nos. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002), 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), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Sandoz'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.


    Shire LLC et al. v. Watson Laboratories Inc
    .
    2:11-cv-05565; filed July 6, 2011 in the Central District of California

    • Plaintiffs:  Shire LLC; Shire Development Inc.
    • Defendant:  Watson Laboratories Inc.

    Infringement of U.S. Patent Nos. 7,105,486 ("Abuse-resistant amphetamine compounds," issued  September 12, 2006), 7,223,735 ("Abuse resistant lysine amphetamine compounds," issued  May 29, 2007), and 7,700,561 ("Abuse-resistant amphetamine prodrugs," issued  April 20, 2010) following a Paragraph IV certification as part of Waton's filing of an ANDA to manufacture a generic version of Shire's Vyvanse® (lisdexamfetamine dimesylate, used to treat Attention Deficit Hyperactivty Disorder).  View the complaint here.

  • Calendar

    July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    July 20, 2011 – Are Products of Nature Patentable Subject Matter? (American Bar Association) – 1:00 – 2:30 PM (Eastern)

    July 20-21, 2011 – Advanced Forum on Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – San Francisco, CA

    July 25-27, 2011 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    July 26, 2011 – The New Inequitable Conduct Standard in Patent Litigation: Asserting and Defending Inequitable Conduct Challenges After the Landmark Therasense Decision (Strafford) – 1:00 – 2:30 PM (EDT)

    August 4-7, 2011 – 2011 Annual Meeting (American Bar Association) – Toronto, Ontario

    August 15-19, 2011 – Intellectual Property Law Summer School 2011 (IBC Legal) – Cambridge, UK

    August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

    September 6-7, 2011 – Pharmaceutical Law Academy (IBC Legal Conferences) – London, UK

    September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

    September 14-16, 2011 – 85th Annual Meeting (Intellectual Property Institute of Canada) – Chicago, IL

    September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) – Cape Town, South Africa

    September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

    September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

    September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

    September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NY

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

  • ABA The American Bar Association (ABA) Section of Intellectual Property Law; Criminal Justice Section; Section of Science & Technology Law; Section of Environment, Energy, and Resources; and Center for Continuing Legal Education will be offering a live webinar entitled "Are Products of Nature Patentable Subject Matter?" on July 20, 2011 from 1:00 – 2:30 PM (Eastern).  Lawrence S. Pope (moderator); John L. Hendricks of Hitchcock Evert LLP; Professor Eileen M. Kane, Penn State, Dickinson School of Law; Patent Docs author Dr. Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP; and Jacqueline D. Wright Bonilla of Foley & Lardner LLP, will discuss whether "products of nature" (e.g., genetic material) constitute patentable subject matter, the various approaches to this issue over the last century, and how this issue affects us today.  The panel will also discuss the recent Myriad decision that held that isolated DNA did not qualify as patentable subject matter, including:

    • Providing a summary of the court's holdings and rationale;
    • Analyzing the "products of nature" exception to patentability on which the court relied;
    • Discussing the proper patentability standard to apply to "products of nature"; and,
    • Discussing how that standard might affect patent prosecution and litigation in the biotechnology field.

    The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public (for group fee options, please visit the event website).  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • Boston Skyline The Institute for International Research (IIR) will be holding its 3rd Annual Business of Biosimilars & Biobetters conference from September 19-21, 2011 in Boston, MA.  The conference will allow attendees to:

    • Understand the regulatory and legal implications that may affect your biosimilar profitability;
    • Create strategies to ensure commercialization success;
    • Leverage new manufacturing processes to increase profit; and
    • Delve into scientific considerations including establishing similarity, defining bioequalivance and interchangeability and assess immunogenicity to preserve biosimilar integrity.

    Brochure In particular, IIR's faculty will offer presentations on the following topics:

    Full Day Symposium — September 19:

    • Improve higher-order structure comparability studies;
    • Regulate immunogenicity to decrease unwanted responses and ensure patient safety;
    • Improve cell line development;
    • Streamline testing during the early stages of biosimilar development;
    • Determine clinical trials necessary for biosimilar development;
    • Case study;
    • Identify new tools that aid in biosimilar development; and
    • Guided discussion: If technological advances in manufacturing create a better version of the originator, is the product still a biosimilar?

    Pre-Conference Workshops — September 19:

    • Create or re-assess your emerging market strategy;
    • Biosimilar ip protection and patent litigation strategies for development in the us and abroad; and
    • Biosimilar commercialization primer from compliant market to consumer acceptance.

    Day One of Conference — September 20:

    • Main Street outlook: Current trends and outlook of the biosimilar market around the world;
    • Wall Street outlook: Analyze biosimilars' financial status;
    • Investor outlook: Examine biosimilar development from investors' points of view to better position your biosimilar;
    • Regulatory update of FDA considerations on biosimilars;
    • Implementation of single use technologies in the manufacture of biosimilars;
    • Regional spotlight: Biosimilar development in India;
    • The U.S. abbreviated pathway: The good, the bad and the undefined;
    • Understand the biological, chemical and clinical considerations when establishing similarity;
    • Define bioequivalence and interchangeability;
    • Immunogenicity assessment while preserving desired structural and functional aspects of the biosimilar;
    • Anticipate sales and marketing costs associated with biosimilar product launch;
    • Identify obstacles and opportunities biosimilar manufactures must consider to successfully launch in the future managed care landscape; and
    • Prepare for potential traceability and labeling problems in biosimilar commercialization.

    Day Two of Conference — September 21:

    • Roundtable discussions: Does a global biosimilar opportunity even exist?
    • Increase profitability by considering new biosimilar manufacturing processes;
    • Regional spotlight: Lessons learned from biosimilar development in the established European marketplace;
    • Overcome IP barriers to biosimilar development and commercialization;
    • Regional spotlight: Biosimilar opportunities within the U.S.; and
    • 90-minute intensive: Delve into oncology money-making opportunities.

    The agenda for the Business of Biosimilars & Biobetters conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, descriptions of the scheduled presentations, and registration information can be downloaded link.

    IIR The registration fee for this conference is $2,195 (conference only), $2,595 (conference and one pre-conference workshop), $2,895 (conference and two pre-conference workshops or symposium).  Those registering before July 29, 2011 will receive a $400 discount, and those registering before August 26, 2011 will receive a $300 discount.  Those interested in registering for the conference can do so here, by calling 1-888-670-8200, or by sending an e-mail to register@iirusa.com.

    Patent Docs is a media partner of the Business of Biosimilars & Biobetters conference.

  • New York #2 American Conference Institute (ACI) will be holding its Boston edition of its Life Sciences Business Development & Acquisitions in Emerging Markets conference on September 26-27, 2011 in New York, NY.  ACI faculty will help attendees:

    • Implement strategies that provide commercial entry into lucrative emerging markets;
    • Replenish product pipelines via partnering and co-promotions;
    • Weigh when a partnership is the best entry vehicle vs. a full M&A;
    • Evaluate viable IP protections in developing regions;
    • Minimize risks through effective partner selection and due diligence;
    • Structure transactions to meet both parties' potential objectives;
    • Incorporate what worked in recent deals in India, China and other countries into your negotiations;
    • Integrate your company's product life cycle strategies into your business plan; and
    • Avoid traps that can undermine global collaborations and lead to alliance failures.

    ACI Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Emerging markets outlook: Surveying the fast-changing business landscape and learning from recent deal-making;
    • Identifying the right structure for new deals and negotiating the terms successfully;
    • Maximizing returns by finding the right partner in an emerging market;
    • Discerning what IP protection is available in an emerging market and conducting effective & strategic IP due diligence;
    • Focus session: Successfully implementing a growth strategy in Latin America;
    • Adjusting traditional M&A strategies to capitalize on opportunities in emerging markets;
    • Doing business with an emerging market company seeking access to the U.S. market: cultural, business, and regulatory challenges;
    • Integrating successful life cycle strategies with your business development approach to emerging markets;
    • Overcoming amplified barriers to effective alliance management; and
    • Demystifying the unique legal and regulatory challenges in entering into early stage research partnerships in emerging markets.

    Two post-conference case studies will be offered on September 27, 2011.  The first case study is entitled "Analyzing Winning Agreements Providing Access to the Market in India," and the second case study is entitled "Breaking Barriers and Overcoming Complex Challenges when Negotiating for Commercial Entry in China."

    ACI - American Conference Institute An agenda for the conference can be found here, and a complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee is $2,295 (conference alone), $2,795 (conference and one workshop), or $3,295 (conference and both workshops).  Those registering by August 19, 2011 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

  • By James DeGiulio

    Drug Wholesalers Secure Injunction Blocking Braintree from Terminating MiraLAX Supply

    Braintree Laboratories Direct purchasers of MiraLAX, who have brought a class action suit headed by Rochester Drug Cooperative ("RDC") against drugmaker Braintree Laboratories Inc., were successful in obtaining a preliminary injunction blocking Braintree from terminating its sales to the drug wholesaler plaintiffs.  In the original action, Braintree filed a patent infringement suit against Schwarz Pharma in 2003, after the company submitted an ANDA to manufacture a generic version of MiraLAX.  The suit and prior Paragraph IV filing, which concerned U.S. Patent No. 5,710,183, triggered a 30-month stay on the FDA's approval of Schwarz's ANDA.  Braintree eventually dismissed its claims against Schwarz Pharma, thus waiving the remainder of the 30-month stay, and the ANDA was approved in July 2004.

    Rochester Drug Cooperative In March of 2007, RDC filed this putative class action suit on behalf of drug wholesalers who purchase MiraLAX directly.  RDC claimed that the original ANDA litigation was a ploy to extend Braintree's monopoly on MiraLAX because Braintree knew or should have known the patent it asserted against Schwarz Pharma was invalid.  The plaintiffs claim Braintree engaged in an anti-competitive scheme that allowed it to charge supracompetitive prices for MiraLAX, or polyethylene glycol 3350, and the delay of generic competition caused them to overpay for MiraLAX by millions of dollars.  In lieu of an answer, Braintree filed a motion to dismiss the action, which was denied.  In March 2011, Braintree sent letters to the plaintiffs, stating that they would no longer sell products to them due to their allegedly meritless antitrust litigation.  RDC then moved for a preliminary injunction to force Braintree to continue to supply MiraLAX to the plaintiffs.

    MiraLax On July 7, Judge Sue Robinson issued a memorandum opinion granting the request for a preliminary injunction from plaintiffs RDC, Louisiana Wholesale Drug Co., and Meijer Inc., forcing Braintree to stop its retaliatory action and resume its supplier relationships with the companies.  After Braintree cut off its supply, RDC said the move threatened the plaintiffs' ability to obtain and retain customers, and forced them to switch to other suppliers that charged them higher prices.  Judge Robinson analyzed the four eBay factors, and was persuaded by plaintiff's authority Bergen Drug Company Inc. v. Parke, Davis & Co., 307 F.2d 725 (3d Cir. 1962).  Judge Robinson agreed to issue the injunction, but she said the plaintiffs would have to agree to post a bond for the cost of the litigation.  The plaintiffs have shown only possible harm, not any specific harm, caused by Braintree's decision to terminate its business relationships with the plaintiffs.  This is because ultimate relief sought by the plaintiffs is to be reimbursed for the cost of Braintree's branded MiraLAX product.  Judge Robinson said the plaintiffs must bear the risk of costs going forward if the plaintiffs seek the extra relief of Braintree's continued business.


    Takeda Agrees to Drop Mylan Inc. from Prevacid Patent Litigation, But Mylan Subsidiary Remains

    Takeda Takeda Pharmaceutical Co. Ltd. has agreed to drop Mylan Inc. as a defendant in Takeda's lawsuit over Mylan's generic version of the acid reflux drug Prevacid, but subsidiary Mylan Pharmaceuticals Inc. remains in the suit to litigate the generic maker's position.  Takeda brought suit in May 2011, accusing Mylan of infringing its two patents covering Prevacid, U.S. Patent Nos. 6,328,994 and 5,464,632, by filing an ANDA for a generic version of the drug (see "Court Report – Part II," May 23, 2011).  Ethypharm SA, which owns the '632 patent and licenses it to Takeda, joined Takeda as a plaintiff.  According to the complaint, the plaintiffs claimed the generic's release would cause irreparable harm, and asked the District Court to block approval of Mylan's generic drug.  Takeda also requested that the case be declared exceptional so that Mylan would be forced to cover its attorneys' fees.  After Takeda filed its complaint, Mylan filed counterclaims seeking declaratory judgment that the two patents were invalid and that Mylan's drug did not infringe either patent.

    Mylan #1 On July 11, Judge Joel Pisano signed off on a stipulation dismissing Mylan Inc. as a defendant.  However, the dismissal may not have a significant impact, for Mylan Inc. subsidiary Mylan Pharmaceuticals Inc. remains in the suit.  In exchange for the dismissal, Mylan and Matrix Laboratories agreed to abide by the District Court's final judgment relating to any damages, as well as any court orders against it.  Mylan also agreed to make any documents or information relevant to the alleged infringement and validity of Takeda's patents available for discovery as if the generics maker were still party to the suit.


    Astellas Settles Adenoscan Patent Suit with Sagent and Strides Arcolab

    Astellas After just a few weeks, Astellas Pharma US Inc. has settled a lawsuit against Sagent Pharmaceuticals Inc. and Strides Arcolab Ltd., who were accused of infringing Astellas' patent covering the pharmacologic stress agent Adenoscan.  In June 2011, Astellas and Item Development AB brought suit against Sagent Strides, a joint venture between the two defendant companies, alleging infringement of U.S. Patent No. 5,731,296 (see "Court Report," June 26, 2011).  Astellas was notified in May that Sagent Strides had filed papers seeking FDA approval for an Adenoscan generic.  Sagent Strides asserted that the '296 patent was invalid and unenforceable.  Astellas has vigorously defended the '296 patent, which is set to expire in March 2015, bringing several suits against generic makers seeking to enter the market for its Adenonscan product.  However, Astellas entered into a settlement with Teva in 2007, which provides Teva with a license to market and sell its Adenoscan generic in September 2012.

    On July 11, Judge Mary Cooper signed off on an order dismissing the case against Sagent Strides without prejudice.  The action can be reopened if there is no settlement within 60 days, and the District Court retains jurisdiction over the matter to enforce the terms of the settlement, which were not disclosed.  It is not clear whether the settlement included a provision that would allow Sagent Strides to market and sell its generic Adenoscan product before the expiration of the patent.

  • By Kwame Mensah

    MultiCell Technologies Recently, MultiCell Technologies, Inc. of Woonsocket, RI, a clinical-stage biopharmaceutical company focusing on unmet medical needs for the treatment of neurological disorders, hepatic disease, and cancer, announced that it had been issued U.S. Patent No. 7,935,528, which is related to the isolation and use of human liver stem cells to treat liver disease.  MultiCell Technologies is the worldwide exclusive licensee of the '528 patent, which is assigned to Rhode Island Hospital.

    The '528 patent describes methods to isolate and use human liver stem cells to treat degenerative liver diseases or inherited deficiencies of liver function.  MultiCell Technologies believes that one of the benefits of the claimed methods is that liver stem cells, which differentiate into functional mature hepatocytes, can be used to reconstitute a diseased liver.  This provides a useful alternative approach to whole organ transplants for certain liver diseases.

    W. Gerald Newmin, Chairman and Chief Executive Officer of MultiCell Technologies, stated that the liver stem cells of the '528 patent would help the company "better understand liver stem cell biology, and the role these cells play in chronic liver disease and primary hepatocellular carcinoma."

    Claim 1, which is the lone independent claim of the '528 patent, recites:

    A primary liver stem cell, wherein said stem cell (a) is obtained from normal liver tissue, (b) is isolated from an isolated liver cell cluster comprising a hepatocyte and said stem cell, wherein said hepatocyte and said stem cell are joined by a desmosomal junction, (c) expresses OV6 [an oval cell marker], and (d) does not express OC2 [an oval cell marker], wherein said stem cell comprises a DNA encoding a heterologous protein.