Patent Docs

NCHC Sends Letter on Biosimilars to Senate Health Committee

    By Donald Zuhn --

On the same day that BIO CEO Jim Greenwood was briefing the media regarding follow-on biologics legislation in the current Congress, the National Coalition on Health Care (NCHC) was making its position on the legislation known in a letter sent to Senate Committee on Health, Education, Labor, and Pensions (HELP) Chairman Senator Ted Kennedy and the Committee's ranking member, Senator Michael Enzi (R-WY).  The NCHC, which was founded in 1990, describes itself as a non-profit and "rigorously non-partisan" coalition comprised of more than 70 organizations, employing or representing about 150 million Americans, that are working together to improve America's health care.

In its letter, the NCHC notes that biologics are among the most expensive and most important drugs available to patients today, accounting for 25% of all new drug products approved by the FDA and costing on average 22 times more than small molecule drugs.  Stating that "[n]ow, there is an opportunity to yield substantial savings to the health care system by creating a generic pathway for high quality biologics as part of comprehensive health care reform," the Coalition encourages the Senate Health Committee to enact the Senate version (S. 726) of the bill introduced by Rep. Henry Waxman (H.R. 1427).  The NCHC bases its endorsement of S. 726 on the "tremendous success" of the Hatch-Waxman Act, which the Coalition contends has "accelerated" innovation of brand drugs, "as demonstrated by a dramatic increase in research and development spending."  (Amgen Inc. Vice President Stuart Watt would likely disagree with the Coalition's assessment of the impact of Hatch-Waxman, which he asserted earlier this year had resulted in less innovation, pharma company consolidation, and a shift in investment from pharma companies to biotech companies; see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation").

Not surprisingly, the NCHC letter focuses on the issue of exclusivity for innovator biologics.  Noting that "[s]ome of the bills that have been introduced would provide that innovator biologics would be entitled to 12-14 years of exclusivity [i.e., the Eschoo bill, H.R. 1548]," the Coalition "urge[s the Committee] to oppose generic biologics legislation that contains excessive periods of exclusivity or that contains other unnecessary and significant barriers to generic, biologic competition."  In support of its plea to the Committee to reject double-digit exclusivity, the NCHC cites to the recent FTC report on biosimilars (see "No One Seems Happy with Follow-on Biologics According to the FTC").  The NCHC letter concludes that "[t]he five year period of exclusivity provided in H.R. 1427 follows the Hatch-Waxman model and is the appropriate period of exclusivity," and suggests that "[a]n unnecessarily long period of exclusivity would . . . diminish the incentives for other companies to continue innovating, actually resulting in less innovation over time."

Patent Docs thanks a reader for alerting us to the NCHC letter.

Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period

    By Kevin E. Noonan --

Yesterday, Senator Ted Kennedy (D-MA) proposed that innovator biologic drugmakers should be given up to 13.5 years of data exclusivity in any follow-on biologics legislation to be considered by Congress this session.  As reported by Catherine Larkin at Bloomberg.com, the Senator's proposal was introduced as a "placeholder" that could be adopted, modified, or discarded after other Senators have the opportunity to introduce their own amendments to biosimilars legislation being prepared by the Senate Committee on Health, Education, Labor, and Pensions.  Two of the three follow-on biologics bills introduced in the current Congress (H.R. 1427 and S. 726) provide for no more than 5.5 years of data exclusivity to innovator biologics companies, a term most industry representatives (including, inter alia, AEI, BIO, the IPO and, notably, the only peer-reviewed study by an academic; see "Follow-on biologics: data exclusivity and the balance between innovation and competition") have assailed as being inadequate to protect biotechnology innovation (see "Docs at BIO: 'Perfect Storm' Super Session").

The Senator's proposal comes in the face of a flurry of recommendations recently sent to the Senate's Health, Education, Labor and Pensions committee (which Senator Kennedy chairs), including a letter from the AARP, a letter from the Office of Management and Budget (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics") and a report from the Federal Trade Commission (see "No One Seems Happy with Follow-on Biologics According to the FTC"), all of which urged shorter data exclusivity periods.  As reported by Patent Docs yesterday, BIO CEO James Greenwood contends that a 12-year period, agreed to as recently as the last Congress, was a minimum term sufficient to protect innovation (see "BIO CEO Provides Update on Follow-on Biologics Legislation").  And industry leaders have stated publicly that any data exclusivity period shorter than 12 years would be bad for innovation and compromise patient health (see statement by Audrey Philips, Johnson and Johnson Executive Director for Biotechnology Policy in a Bloomberg.com report and comments by Stuart Watt, Vice President and Law & Intellectual Property Officer at Amgen Inc. in "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation").

Even proponents admit that follow-on biologic drugs may yield no more than a 10-30% reduction in biologic drug costs.  While this represents significant savings for government programs like Medicare and Medicaid, the cost reductions have potential risks, including increased adverse patient events (i.e., increased morbidity and mortality) and dangers to biotechnology innovation; see "Docs at BIO: Patent Reform Super Session").  The importance of setting an appropriate data exclusivity period is highlighted by predictions that biologics drugs will become predominant market leaders over the next 5 years (see "Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation").

The Senate health committee has set no dates for hearings or further action on biosimilars legislation, and Congressman Waxman has been unable to move H.R. 1427 out of his committee in the face of Congresswoman Eshoo's competing (and more heavily-supported) bill, H.R. 1548 (see "Uncertain Future for Waxman Follow-on Biologics Bill").

BIO CEO Provides Update on Follow-on Biologics Legislation

    By Donald Zuhn --

During a Wednesday afternoon teleconference, Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO), discussed a recent "flurry of activity" surrounding follow-on biologics legislation currently being debated in Congress.  Noting that the Senate Committee on Health, Education, Labor, and Pensions had reported follow-on biologics legislation providing 12 years of data exclusivity in the last Congress (S. 1695), Mr. Greenwood (at right) conceded that BIO had started hearing last Thursday that agreement on the 12-year period was "unraveling."

Mr. Greenwood suggested that there were three reasons for the Committee's change on data exclusivity.  First, he noted that the AARP recently sent a letter to Congress indicating that the organization would not support any healthcare reform legislation that provided double-digit data exclusivity for follow-on biologics.  In its letter, the AARP also backed companion bills introduced in the House by Rep. Henry Waxman (H.R. 1427) and Sen. Charles Schumer (S. 726), which provide up to 5.5 years of data exclusivity.  According to a letter published in the Waxahachie Daily Light, a version of the AARP letter sent to Rep. Michael Burgess (R-TX) states that:

AARP understands that the pharmaceutical and biotechnology industries have said that H.R. 1427/S.726 would undermine their ability to recoup the costs of drug development.  However, there is little to support such an argument.  In fact, based on U.S. drug sales alone, many top selling biologics have recouped their manufacturer’s initial investment several times over in the last six years -- often within a single year.  It is these drugs, according to a recent Federal Trade Commission (FTC) report, that will face generic competition, and not those that have relatively low sales.  In addition, the FTC has concluded that brand name manufacturers will continue to reap substantial profits even after generic versions enter the market.

AARP also understands that it has been asserted that H.R. 1427/S.726 will undermine manufacturers' efforts to research and develop new life-saving medications.  Yet, the FTC recently concluded that five years without generic competition is adequate to support continued innovation, and that a twelve to fourteen year exclusivity period actually negatively impacts innovation.

Mr. Greenwood next pointed to a letter sent to Rep. Waxman on June 25 by OMB officials Peter Orszag and Nancy-Ann DeParle stating that a follow-on biologics regulatory pathway providing a 7-year data exclusivity period would "strike[] the appropriate balance between innovation and competition" (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics").  Finally, he listed the report issued by the Federal Trade Commission (FTC) in early June indicating that no data exclusivity was needed (see "No One Seems Happy with Follow-on Biologics According to the FTC").

Mr. Greenwood suggested that the AARP and OMB letters and FTC report had caused some members of the Senate Committee to retreat from the 12-year period.  Instead, the Committee appears to have settled on 9 years of data exclusivity with 3 additional years for supplemental applications establishing a "significant therapeutic advance for patients" (e.g., a new indication).  The BIO CEO called the 9-year + 3-year provision "very bad language as far as we're concerned," adding that BIO continued to support the 12-year provision of S. 1695.  As for the possibility of securing legislation with a 12-year data exclusivity period, Mr. Greenwood noted that "it looks to us like Republicans will hold on that, and we're hoping to have enough Democrats to prevail."  However, he also noted that "the issue is far from resolved," and that a number of amendments have been filed by members of the Committee, including one by Sen. Barbara Mikulski (D-MD) that provides a 10-year + 1-year fallback option -- that Mr. Greenwood said parallels biosimilar exclusivity in Europe -- in case the 12-year period of S. 1695 fails to garner sufficient support.  Despite her amendment, Mr. Greenwood was counting Sen. Mikulski among the Committee's Democratic members (along with Sen. Kay Hagan (D-NC)) who continue to support a 12-year period of data exclusivity, ading that BIO was "continuing to work other swing Democrats."

As for a timetable for resolution of the issue, Mr. Greenwood suggested that "this battle could play out Friday," and that BIO had "from now until then to round up our votes."  Mr. Greenwood also mentioned that in an Op-Ed piece in Wednesday's edition of The Hill, Democratic National Committee chairman Dr. Howard Dean (at left) backed the House bill (H.R. 1548) introduced by Rep. Anna Eshoo (D-CA) in March and the Senate bill (S. 1695) introduced in the last Congress.  In his article, Dr. Dean contends that:

A commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years.  A shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures.  Most firms would be unable to recoup their investments in new medicines, which ordinarily top $1 billion and involve 15 years of research and development.  If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures.

During the question and answer portion of the briefing, Mr. Greenwood explained why a 12-year data exclusivity period was needed.  In particular, he noted that because biologics are large and complex molecules, it is possible for generic companies to "engineer around" an innovator's patent by producing a biosimilar that is dissimilar enough from the innovators' molecule so as to not infringe the innovator's patent, but similar enough that the FDA could approve the biosimilar using clinical data accumulated by the innovator.  Mr. Greenwood noted that the ability of the FDA to approve such biosimilars would hinge on the text of the legislation passed by Congress, but that if the legislation was "written the wrong way," such approvals would become possible.  Under the above scenario, Mr. Greenwood contended that a generic company could begin competing with an innovator company very quickly, and that this would "completely deflate the incentive" for the innovator to invest in the development of biologics.  Mr. Greenwood concluded that "in order to create a legislative pathway for biosimilars, we need to have a proxy . . . for patent protection, and that's data exclusivity."

WIPO Becomes Priority Document Exchange Participant Office

    By Christopher P. Singer --

On June 30, 2009, the U.S. Patent and Trademark Office sent out an e-Commerce e-Alert announcing that the World Intellectual Property Organization (WIPO) is now participating in the Priority Document Exchange (PDX) program.  WIPO is the fourth foreign patent office (including Korea, Japan, and Europe) to join the PDX program with the USPTO.  When filing applications in participant Offices, applicants can request that any priority documents be exchanged, at no cost, between the Offices (e.g., USPTO and WIPO).  WIPO's PDX service can be accessed through it's Priority Document Access Service (DAS) website.  Applicants filing applications that claim priority from an earlier application can rely on a copy of the priority document accessible via DAS, rather than providing a certified copy separately to each Patent Office.

More information regarding participation in the PDX program can be found at the USPTO's PDX website, and WIPO has posted FAQs regarding the program.  Additional questions concerning PDX or the DAS programs can be directed to the Patent EBC Customer Service Center by phone (866-217-9197 or 571-272-4100) or e-mail to PDX@uspto.gov.

Biotech/Pharma Docket

    By Suresh Pillai --

Stanford Graduate Student Adds Claims to Suit against Mentor and Professor over Patent Inventorship

Christopher Sclimenti, a former graduate student in the laboratory of Stanford University faculty member Michele Calos, has amended his suit against both Stanford and his former mentor, claiming that Dr. Calos plagiarized Dr. Sclimenti's Ph.D. dissertation and laboratory notebooks as part of providing support for patent applications based upon Dr. Sclimenti's work.  Dr. Sclimenti originally filed suit in September 2008, alleging breach of contract and correction of inventorship on U. S. Patent Nos. 6,808,925 and 7,141,426.  His amended complaint adds claims of intentional misrepresentation, copyright infringement, defamation, negligence, and unjust enrichment.

Dr. Sclimenti's claims stem from his allegations that, sometime in July 2002, Stanford University improperly removed Dr. Sclimenti as a named co-inventor on the '925 patent application.  According to Stanford, this happened around the time that it amended certain claims in order to satisfy patentability requirements.  However, Dr. Sclimenti's attorney contends that the removal occurred at or around the time that Stanford was in the midst of negotiating a licensing agreement for the applications with Poetic Genetics.  Poetic Genetics, in turn, was founded by Dr. Calos in 2002 as a vehicle for commercializing gene therapies based upon the patents' subject matter.  Dr. Sclimenti contends that he was wrongly removed as an inventor on the patents in order to deny him royalties from the licensing of the patents.

Both the '925 patent (issued in 2004) and the '426 patent (issued in 2006) name Dr. Calos as the sole inventor and Stanford University as the sole assignee.  The amended complaint also includes new allegations that Stanford and Dr. Calos have filed an additional family of patent applications naming Dr. Calos as sole inventor yet citing Dr. Sclimenti's research.  The amended complaint identifies numerous passages within the pending applications that appear to be derived from sections of Dr. Sclimenti's dissertation thesis.  [UPDATE: The amended complaint can be viewed here.]

Infosint Infringement Suit over Celexa® and Lexapro® Allowed to Move Forward

The U.S. District Court for the Southern District of New York has rejected a motion from Lundbeck A/S and its partner, Forest Laboratories, Inc., seeking to dismiss certain infringement claims filed by Infosint S/A alleging infringement of Infosint's patent, U.S. Patent No. 6,458,973.  The '973 patent covers a process for producing 5-carboxyphthalide, an intermediate chemical generated during the manufacture of citalopram, one of the active ingredients in both Celexa® and Lexapro®, two of defendants' antidepressant drugs.  In its complaint, Infosint alleged that Lundbeck and Forest Labs infringed upon the process claimed in the '973 patent.  Lundebeck and Forest Labs counterclaimed that Infosint infringed Lundbeck's patent, U.S. Patent No. 6,403,813, which discloses a process for creating the same intermediate compound as the '973 patent (see "Court Report," July 30, 2007).

In their latest attempt to secure a dismissal, Lundbeck and Forest Labs argued that the method employed by their chemical supplier in the manufacture of the compound did not meet a claim limitation of the '973 patent, namely, that the chemical mixture used in the process be heated to 120-140 degrees Celsius.  The District Court, however, refused to dismiss the infringement claims against Lundbeck and Forest Labs, holding that the only evidence in support of their assertion -- an unsigned photocopied letter dated from 2007 -- was inadmissible evidence of the temperature at which the defendants' supplier manufactured the compound.  The Court also found the testimony of an Infosint expert to be highly persuasive; the expert testified as to the unlikelihood of creating the compound at the lower temperature on an industrial scale.

Counterclaims Dismissed in Alzheimer's Institute/Mayo Patent Dispute

The U.S. District Court for the Middle District of Florida has dismissed two counterclaims filed by the Alzheimer's Institute of America Inc. (AIA) in its patent dispute with Mayo Clinic Jacksonville.  The original suit began in 2005 as part of an attempt by Mayo to compel arbitration to resolve a licensing dispute with AIA.  AIA granted Mayo a license to use the AIA's transgenic mice, and Mayo collaborated with its partner, Myriad Pharmaceuticals, to generate treatments through the use of the mice and related transgenic cell lines.  AIA objected to Mayo's use of the cell lines, claiming that under the terms of the licensing agreement, Mayo was only allowed to use the mice.  AIA then filed suit for patent infringement, and Mayo sued to compel arbitration of the dispute.  The separate suits were consolidated into a single suit in Florida, and AIA filed counterclaims alleging unjust enrichment, breach of contract, and equitable interest.

AIA argued that its counterclaims arose from the conduct of Mayo in negotiating the licensing agreement that was separate and distinct from their conduct in infringing the patents-in-suit, U.S. Patent Nos. 5,795,963 and 5,455,169.  The District Court, however, disagreed and concluded that AIA's counterclaims did not plead conduct that was separate and independent from AIA's claims under U.S. Patent Law.  Therefore, the Court held that the state law claims were preempted by federal patent law.  The Court dismissed the counterclaims with leave to refile by July 27.

BioMedica's Bid for Interlocutory Appeal to Federal Circuit Denied in TroVax® Suit

The U.S. District Court for the Northern District of California denied Oxford Biomedica Ltd.'s attempt to certify an order for an interlocutory appeal to the Court of Appeals for the Federal Circuit in BioMedica's patent dispute with Bavarian Nordic A/S over the cancer vaccine TroVax®.  Bavarian Nordic filed suit in 2008 (see "Court Report," July 6, 2008), claiming that BioMedica's TroVax® vaccine infringed upon Bavarian Nordic's patented method for delivering recombinant vaccines, covered by Bavarian Nordic's U.S. Patent Nos. 6,761,893, 6,913,752, 7,335,364, and 7,459,270.  BioMedica immediately claimed that Bavarian Nordic's suit was prematurely filed, as TroVax® was still in its development stage at the time of filing.  However, Bavarian Nordic countered that BioMedica's safe harbor argument failed because BioMedica, having entered into a contract with Sanofi-Aventis U.S. valued at $700 million, had already commercialized the TroVax® vaccine (see "Biotech/Pharma Docket," May 21, 2009).

In the latest ruling by the Court, it dismissed BioMedica's request to have the Federal Circuit address two questions that could resolve the suit.  The first question was whether the District Court had proper subject matter jurisdiction, where the suit involved a product currently in FDA clinical trials and a licensing agreement to jointly develop and co-fund the product with intent to commercialize.  The second question was whether such an agreement would be exempt from definitions of infringement.

NIH Releases New Stem Cell Rules

    By Kevin E. Noonan --

Yesterday, the National Institutes of Health released guidelines governing requirements (and limitations) for federal funding of research on human embryonic stem cells.  These rules supersede rules promulgated during the Bush administration that so severely constrained the number of funding-eligible human stem cell lines as to effectively prohibit use of federal funds for this research.  These Guidelines were promulgated by Acting Director Raynard S. Kington, and become effective today, July 7, 2009.  The new Guidelines are expected to make up to 700 existing human embryonic stem cell lines eligible for federal funding, a ten-fold increase over the 69 hESC lines approved under the Bush administration (many of which have been acknowledged to be inappropriate for embryonic stem cell research).

The Guidelines were developed by the Institutes in response to Executive Order 13505, entitled "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells" issued March 9, 2009.  Fulfilling a promise President Obama made during his campaign, the Order was intended to permit the Institutes to "support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law."  The new Guidelines, relating to both intramural and extramural research, "establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law."

The Guidelines are expressly based on the principles that:

1.  Responsible research with hESCs has the potential to improve our understanding of human health and illness and discover new ways to prevent and/or treat illness.

2.  Individuals donating embryos for research purposes should do so freely, with voluntary and informed consent.

Human embryonic stem cells are defined as "cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers," making the distinction that "[a]lthough hESCs are derived from embryos, such stem cells are not themselves human embryos."  The Guidelines establish a new NIH stem cell registry, and stem cells will be eligible for funding if they are listed on the registry or if they comply with Section IIA of the Guidelines.  Cells will be eligible if they are derived from human embryos:

1.  that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose;

2.  that were donated by individuals who sought reproductive treatment (hereafter referred to as "donor(s)") and who gave voluntary written consent for the human embryos to be used for research purposes; and

3.  for which all of the following can be assured and documentation provided, such as consent forms, written policies, or other documentation, provided:

a.  All options available in the health care facility where treatment was sought pertaining to the embryos no longer needed for reproductive purposes were explained to the individual(s) who sought reproductive treatment.

b.  No payments, cash or in kind, were offered for the donated embryos.

c.  Policies and/or procedures were in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s).

d.  There was a clear separation between the prospective donor(s)'s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes.  Specifically:

i.  Decisions related to the creation of human embryos for reproductive purposes should have been made free from the influence of researchers proposing to derive or utilize hESCs in research.  The attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize hESCs should not have been the same person unless separation was not practicable.

ii.  At the time of donation, consent for that donation should have been obtained from the individual(s) who had sought reproductive treatment.  That is, even if potential donor(s) had given prior indication of their intent to donate to research any embryos that remained after reproductive treatment, consent for the donation for research purposes should have been given at the time of the donation.

iii.  Donor(s) should have been informed that they retained the right to withdraw consent for the donation of the embryo until the embryos were actually used to derive embryonic stem cells or until information which could link the identity of the donor(s) with the embryo was no longer retained, if applicable.

e.  During the consent process, the donor(s) were informed of the following:

i.  that the embryos would be used to derive hESCs for research;

ii.  what would happen to the embryos in the derivation of hESCs for research;

iii.  that hESCs derived from the embryos might be kept for many years;

iv.  that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the hESCs, such as who may be the recipients of cell transplants;

v.  that the research was not intended to provide direct medical benefit to the donor(s);

vi.  that the results of research using the hESCs may have commercial potential, and that the donor(s) would not receive financial or any other benefits from any such commercial development;

vii.  whether information that could identify the donor(s) would be available to researchers.

Alternatively (Section IIB), for stem cell lines established prior to promulgation of these Guidelines, eligibility can be established by submitting evidence to a newly-constituted Working Group of the Advisory Committee to the Director showing that "the hESCs were derived from human embryos:  1) that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and 2) that were donated by donor(s) who gave voluntary written consent for the human embryos to be used for research purposes."

The Guidelines expressly prohibit funding of research on human embryonic stem cells or pluripotent cells introduced into a non-human primate blastocyst or animal breeding experiments involving introduction of human stem cells into non-human primate blastocysts.

The Notice reports that the Institutes received around 49,000 comments in response to the request for public comment published on April 23, 2009 in the Federal Register (74 Fed. Reg. 18578).  These comments came from "patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, and private citizens," as well as members of Congress.  The Notice contains a synopsis of these comments, which are included in groups identified as title, terminology and background, financial gain, IRB review, donation and informed consent, and monitoring and enforcement actions, among others.  The Notice describes how the draft guidelines were adapted or modified in response to these comments, or the Institutes distinguished or disputed the assertions in the comments.  Of note is the Institutes' assertions that it expects "that stem cell research materials developed with NIH funds, as well as associated intellectual property and data, will be distributed in accordance with the NIH's existing policies and guidance, including ''Sharing Biomedical Research Resources, Principles and Guidelines for Recipients of NIH Grants and Contracts' and 'Best Practices for the Licensing of Genomic Inventions'" (see NIH Policies & Reports page).  In addition, the Institutes will review de novo the circumstances surrounding development of existing stem cell lines rather than grandfathering these cells, applying ethical principles embodied inter alia in the Guidelines and 45 C.F.R. Part 46 Subpart A (Protection of Human Subjects).

The comments section also addresses the potential limitations on federal funding imposed by the Dickey amendment, wherein "an embryo is defined by Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09 . . . as any organism not protected as a human subject under 45 C.F.R. Part 46 that is derived by fertilization, parthenogenesis, cloning or any other means from one or more human gametes or human diploid cells."  The Guidelines state that:

[s]ince 1999, the Department of Health and Human Services (HHS) has consistently interpreted this provision as not applicable to research using hESCs, because hESCs are not embryos as defined by Section 509.  This long-standing interpretation has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001.  These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo's destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo's destruction, for which federal funding is permitted.

While nicely expressing the distinction, it remains to be seen whether Congress acts to refine the Institutes' understanding of these restrictions, in light of the expansion in the scope of human embryonic stem cells intended by these Guidelines to become eligible for federal funding.

Secretary Locke Appoints Godici to Assess USPTO Challenges

    By Donald Zuhn --

The U.S. Patent and Trademark Office announced today that Secretary of Commerce Gary Locke (at right) has appointed Nicholas Godici "to look at ways to strengthen the management structure of the USPTO and provide an up-to-date assessment of the challenges the office faces."  The USPTO release notes that Mr. Godici will serve as a consultant for 180 days, working with USPTO officials "to identify areas of concern and to assist in the transition to a new director."  Secretary Locke stated that he was "counting on [Mr. Godici] to use his decades of experience to help us strengthen the management of the USPTO and identify the areas most in need of attention by the new director."

According to a profile posted on the USPTO website, Mr. Godici (at left), who is currently an executive advisor at Birch, Stewart, Kolasch & Birch, LLP, worked at the USPTO for 33 years, starting as a patent examiner and eventually serving as Commissioner for Patents from 2000-05.  In 2001, he also served as the Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the USPTO.  Mr. Godici received a bachelor's degree in engineering mechanics from Penn State University and a certificate of advanced public management from the Maxwell School of Citizenship and Public Affairs at Syracuse University.

Patent Docs readers may recall that Mr. Godici was one of two dozen participants to participate in a roundtable discussion on deferred examination hosted by the USPTO in February (see "Patent Office Hosts Roundtable on Deferred Examination: The Proponents").  Mr. Godici was among thirteen roundtable participants who supported (or were at least minimally receptive to) a deferred examination system.  While Mr. Godici did not appear to be a true proponent of deferred examination, he did state that if the USPTO could produce modeling indicating that deferred examination would lead to an 18-month pendency, such a system would be "attractive."  Mr. Godici was also one of ten contributors to a U.S. Chamber of Commerce report issued in December that provided eleven recommendations to the new administration for improving USPTO policies and procedures (see "U.S. Chamber of Commerce Provides Detailed Recommendations to New Administration Regarding USPTO").  (Interestingly, one of the report's eleven proposals was to implement a deferred examination system.)

Federal Circuit Grants En Banc Review in Tafas v. Doll

    By Kevin E. Noonan --

The Federal Circuit today ordered en banc review of Tafas v. Doll, vacating the panel decision of March 20, 2009.  The Court's decision was reported per curiam and Judge Lourie did not participate in the decision to rehear the appeal en banc.

The Court in its order noted that plaintiff-appellees Tafas and Glaxo SmithKline had requested rehearing by the original panel and rehearing en banc (see Patent Docs reports on Tafas Petition and GSK Petition), and that the Court had invited briefing from the U.S. Patent and Trademark Office as appellant and amici.  The Court said that the en banc panel will consider the briefs filed by the parties to date as well as additional amicus briefs, and that the parties could file additional briefs, setting a deadline for appellants' (the USPTO) briefs 30 days from today's order, or August 5, 2009, with appellees Tafas and Glaxo SmithKline's briefs being due 20 days thereafter, on August 26th.

Amici having filed briefs to date include the American Association of Retired Persons (AARP), the Computer and Communications Industry Association, Consumer Watchdog, Essential Action, the Initiative for Medicines, Access and Knowledge, Prescription Access Litigation, Public Knowledge, the Public Patent Foundation, Research on Innovation, and the Software Freedom Law Center (all represented by Dan Ravicher; see "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal"), Amber Wave Systems Corp., the AIPLA, BIO, Dolby Labs, Elan Pharmaceuticals, Inc., Fallbrook Technologies, Inc., General Electric Co., IPO, Intellectual Ventures, Interdigital Communications, LLC, Monsanto Co., Nano-Terra, Inc., the N.Y. IPLA, Pax Streamline, Inc., PhRMA, Ruckus Wireless, Inc., Seven Networks, Inc., Sonic Wall, Inc., Tessera, Inc., the Washington Legal Foundation, the William Mitchell College of Law Intellectual Property Institute (represented by R. Carl Moy), and Arthur Klein, Arti Rai, Craig Nail, John R. Thomas, Katherine Strandburg, Mark Lemley, Mark McKenna, Marshall Leaffer, Michael Risch, Peter Menell, Robin Feldman, Stuart Benjamin, and the Intellectual Property and Administrative Law Professors (all represented by Mark Lemley; see "Law Professors Back USPTO in Tafas v. Dudas Appeal").  Additional briefs, from these or other amici, will be due no later than 7 days after the filing date of the brief for a party whose position the amicus is supporting, or 7 days after the appellant's brief is filed if the amicus is supporting no party, pursuant to Fed. R. App. Pro. 29 and Federal Circuit Rule 32.

What follows constitutes crystal ball-gazing, since the Court's order contained no inkling of the circumstances or rationale that occasioned the Court's decision to rehear the appeal en banc.  The original panel decision (by Judge Prost and joined by Judge Bryson, with Judge Rader dissenting), readers will recall, determined that all of the rules Tafas and GSK objected to were procedural and thus fell within the ambit of the Office's rulemaking authority (see Patent Docs report).  On the other hand, the panel found that proposed Rule 78, which limited the number of continuation applications that could be filed, was contrary to the plain language and meaning of 35 U.S.C. § 120, and thus was void under 35 U.S.C. § 2(b)(2), which required any Patent Office rulemaking not to be "contrary to law."  The effect of the panel's decision was to uphold the District Court's injunction as to Rule 78, which effectively vitiated the other rules.  Indeed, implementing these rules would exacerbate rather than ameliorate the problem that purportedly motivated the rules in the first place, the overwhelming backlog of unexamined applications.

The rehearing en banc could (and probably should) be directed towards establishing firm parameters on the scope of the Patent Office rulemaking authority.  It could also merely reverse the one portion of the decision that went in Tafas/GSK's favor.  What is important to keep in mind is that a rehearing en banc could moot the remaining grounds for objecting to the rules not ruled-upon by the District Court, thus giving a green light for the Office to implement the rules.  There has been no indication that the Obama administration is in favor of these rules (although the presence of Arti Rai as an Obama advisor has given many pause), nor what Director-designate David J. Kappos thinks about the rules.  (In this regard, it may be important to remember that Mr. Kappos filed an affidavit in support of the AIPLA's amicus brief to the district court supporting the Tafas/GSK challenge to the "new rules"; see "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules.")  For now, the best strategy for those who oppose the rules would appear to be filing amicus briefs with the Court.

For additional information regarding this topic please see:
• "GSK Files Petition for Rehearing in Tafas v. Doll," June 4, 2009
• "Tafas Files Petition for Rehearing in Tafas v. Doll," June 3, 2009
• "Tafas v. Doll (Fed. Cir. 2009)," March 22, 2009
• "Law Professors Back USPTO in Tafas v. Dudas Appeal," October 23, 2008
• "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal," August 5, 2008
• "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules," October 25, 2007

Court Report

    By Sherri Oslick --

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

Daiichi Sankyo Co., Ltd. et al. v. Apotex, Inc. et al.
1:09-cv-03997; filed July 2, 2009 in the Northern District of Illinois

Daiichi Sankyo Co. Ltd. et al. v. Apotex Inc. et al.
1:09-cv-00470; filed June 26, 2009 in the District Court of Delaware

• Plaintiffs: Daiichi Sankyo Co. Ltd.; Daiichi Sankyo, Inc.
• Defendants: Apotex Inc.; Apotex Corp.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,340,821 ("Composition and Method for Treating Sjoegren Syndrome Disease," issued August 23, 1994) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Daiichi's Evoxac® (cevimeline hydrochloride, used to treat symptoms of dry mouth in patients with Sjogren's Syndrome).  View the Delaware complaint here.

Alcon Research Ltd. v. Par Pharmaceutical Inc.
1:09-cv-00481; filed July 1, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,510,383 ("Use of Cloprostenol, Fluprostenol and Their Salts and Esters to Treat Glaucoma and Ocular Hypertension," issued April 23, 1996), 5,631,287 ("Storage-Stable Prostaglandin Compositions," issued May 20, 1997), 5,849,792 (same title, issued December 15, 1998), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999), 6,011,062 ("Storage-Stable Prostaglandin Compositions," issued January 4, 2000), 6,503,497 ("Use of Borate-Polyol Complexes in Ophthalmic Compositions," issued January 7, 2003), and 6,849,253 (same title, issued February 1, 2005) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic versions of Alcon's Travatan® and Travatan Z® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Bayer Schering Pharma AG et al. v. Teva Pharmaceuticals USA Inc. et al.
1:09-cv-00480; filed July 1, 2009 in the District Court of Delaware

• Plaintiffs: Bayer Schering Pharma AG; Bayer HealthCare Pharmaceuticals Inc.; Schering Corp.
• Defendants: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 6,362,178 ("2-phenyl Substituted Imidazotriazinones as Phosphodiesterase Inhibitors," issued March 26, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of plaintiffs' Levitra® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.

Apotex Inc v. Eisai Inc. et al.
1:09-cv-00477; filed July 1, 2009 in the Middle District of North Carolina

• Plaintiff: Apotex Inc.
• Defendants: Eisai Inc.; Eisai Co., Ltd.

Declaratory judgment of non-infringement of U.S. Patent Nos. 5,985,864 ("Polymorphs Of Donepezil Hydrochloride and Process for Production," issued November 16, 1999), 6,140,321 (same title, issued October 31, 2000), 6,245,911 ("Donepezil Polycrystals and Process for Producing the Same," issued June 12, 2001), and 6,372,760 ("Stabilized Composition Comprising Antidementia Medicament," issued April 16, 2002) in conjunction with Apotex's filing of an ANDA to manufacture a generic version of Eisai's Aricept® (donepezil hydrochloride, used in the treatment of mild to severe dementia of the Alzheimer's type).  View the complaint here.

Max-Planck-Gesellschaft zur Frderung der Wissenschaften e.V. et al. v. Whitehead Institute for Biomedical Research et al.
1:09-cv-11116; removed July 1, 2009 to the District Court of Massachusetts

• Plaintiffs: Max-Planck-Gesellschaft zur Frderung der Wissenschaften e.V.; Max-Planck-Innovation GmbH; Alnylam Pharmaceuticals, Inc.
• Defendants: Whitehead Institute for Biomedical Research; Massachusetts Institute of Technology; Board of Trustees of the University of Massachusetts

Various claims, including breach of contract and negligence, for misappropriation of "Tuschl II" inventions and inappropriate patent prosecution of "Tuschl I" inventions related to RNAi.  Removed from state court; view the original complaint (filed June 26, 2009) here.

Novartis AG v. Doll
1:09-cv-01202; filed June 30, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,473,761 ("Somatostatin Analogues," issued January 6, 2009).  View the complaint here.

Novartis AG v. Doll
1:09-cv-01203; filed June 30, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,470,709 ("Benzimidazole Quinolinones and Uses Thereof," issued December 30, 2008).  View the complaint here.

Alzheimer's Institute of America, Inc. v. Pfizer, Inc.
4:09-cv-01026; filed June 30, 2009 in the Eastern District of Missouri

Infringement of U.S. Patent Nos. 5,455,169 ("Nucleic Acids for Diagnosing and Modeling Alzheimer's Disease" issued October 3, 1995), 5,795,963 ("Amyloid Precursor Protein in Alzheimer's Disease," issued August 18, 1998), and 6,818,448 ("Isolated Cell Comprising HAPP 6701671 DNAS Sequences" issued November 16,2004) based on Pfizer's use of the patented technology in its Alzheimer's Disease research program and drug development pipeline.  View the complaint here.

Arena Pharmaceuticals, Inc. v. Doll
1:09-cv-01166; filed June 26, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,470,699 ("Trisubstituted Aryl and Heteroaryl Derivatives as Modulators of Metabolism and the Prophylaxis and Treatment of Disorders Related Thereto," issued December 30, 2008).  View the complaint here.

Reckitt Benckiser Inc. et al. v. Tris Pharma, Inc.
3:09-cv-03125; filed June 26, 2009 in the District Court of New Jersey

• Plaintiffs: Reckitt Benckiser Inc.; UCB Manufacturing, Inc.
• Defendant: Tris Pharma, Inc.

Infringement of U.S. Patent No. 5,980,882 ("Drug-resin Complexes Stabilized by Chelating Agents," issued November 9, 1999) following a Paragraph IV certification as part of Tris' filing of an ANDA to manufacture a generic version of Reckitt Benckiser's Delsym® extended release liquid suspension (dextromethorphan polistirex, used to temporarily relieve cough due to minor throat and bronchial irritation).  View the complaint here.

Public Patent Foundation, Inc. v. Glaxosmithkline Consumer Healthcare, L.P.
1:09-cv-05881; filed June 26, 2009 in the Southern District of New York

False marking based on GSK's marking of certain Citrucel® products indicating that these products are covered by certain of U.S. Patent Nos. 4,626,287 ("Process for Preparing Sucrose Encrusted Methylcellulose Particles for Use In Bulk Laxative Compositions," issued December 2, 1986), 4,671,823 ("Sucrose Encrusted Methyl Cellulose Particles for Use In Bulk Laxative Compositions," issued June 9, 1987), and 4,732,917 ("Process For Preparing Sucrose Encrusted Methylcellulose Particles for Use In Bulk Laxative Compositions," issued March 22, 1988), which are expired.  View the complaint here.

Dey LP et al. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00467; filed June 25, 2009 in the District Court of Delaware

• Plaintiffs: Dey, L.P.; Dey, Inc.
• Defendants: Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 6,667,344 ("Bronchodilating Compositions and Methods," issued December 23, 2003), 6,814,953 (same title, issued November 9, 2004), 7,348,362 ("Bronchodilating β-Angonist Composition and Methods," issued March 25, 2008), and 7,462,645 (same title, issued December 9, 2008) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Dey's Perforomist® (formoterol fumarate inhalation solution, used to treat bronchoconstriction in patients with chronic obstructive pulmonary disease).  View the complaint here.

Conference & CLE Calendar

July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY

July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) - New York, NY

July 10, 2009 - Questions of Venue after TS Tech and Genentech (Law Seminars International) - 1:00-2:00 pm (EST)

July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute) - San Francisco, CA

July 15, 2009 - Cost-Effective Patent Strategies (Law Seminars International) - Seattle, WA

July 15, 2009 - Corporate Intellectual Property Conference (Law Bulletin Publishing Company) - Chicago, IL

July 18-21, 2009 - National Association of Patent Practitioners (NAPP) 2009 Annual Meeting - San Diego, CA

July 20, 2009 - Buying, Selling and Licensing Patents: Strategies for Turning Your Patent Portfolios into Revenue Streams (Law Seminars International) - Washington, DC

July 21-22, 2009 - FDA Boot Camp*** (American Conference Institute) - Chicago, IL

July 23-24, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

July 30 - August 4, 2009 - 2009 Annual Meeting (American Bar Association) - Chicago, IL

August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

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