Patent Docs

House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period

    By Donald Zuhn --

On Friday, the House Committee on Energy and Commerce approved a health care reform bill by a narrow three-vote margin (31-28).  The bill (H.R. 3200), entitled "America's Affordable Health Choices Act," was originally introduced in the House on July 14, 2009 by Rep. John Dingell (D-MI).

According to a statement released by the Committee, the bill will "build on what works in today's health care system, makes important insurance market reforms to protect consumers, encourages competition among insurance plans to improve choices for patients, and expands access to quality, affordable health care for all Americans."  Committee Chairman Henry Waxman (D-CA) called the passage of the bill "a historic moment for the House of Representatives and a defining moment for our country," adding that the bill "will deliver the results the nation's health care system so desperately needs:  lower costs, better quality, and broader coverage."  Chairman Waxman said that he hoped that the House would pass the bill when it returns from recess.  The Energy and Commerce Committee's bill will be merged with provisions reported by the Committees on Ways and Means and Education and Labor for consideration by the full House of Representatives.

The Committee also announced a series of mark-ups to the bill that were introduced prior to the Committee's vote.  One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March.  In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed.  The amendment was passed by the Committee by a comfortable 41-11 margin.  Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA).  The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors).

The Committee's passage of H.R. 3200 marked the second victory this month for organizations, trade groups, and companies seeking a longer (12 to 14-year) exclusivity period.  On July 14, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee approved -- by a 16-7 vote -- an amendment providing a 12-year exclusivity period for biologic drug makers (see "Senators Hatch and Enzi Champion 12-Year Data Exclusivity in Senate").

In a statement released by the Biotechnology Industry Organization (BIO), BIO President and CEO Jim Greenwood observed that "[t]he strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow," and contended that the Eshoo-Inslee-Barton amendment "strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation."  Mr. Greenwood noted that the amendments approved this month in both the House and Senate Committees had the support of the ALS Association, Alliance for Aging Research, Association of American Universities, National Venture Capital Association, AIDS Institute, National Minority AIDS Council, Children's Tumor Foundation, National Kidney Foundation, and Vietnam Veterans of America.

ACI Maximizing Pharmaceutical Patent Lifecycles Conference

American Conference Institute (ACI) will be holding its 10th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 7-8, 2009 in New York, NY.  The conference will allow attendees to:

• See how a new global legal paradigm for pharmaceutical patent life cycles is being shaped by forces in the U.S. and abroad;
• Understand the interplay between Patent Reform and Follow-on Biologics legislation and how these pending laws will dramatically alter pharmaceutical patent life cycle strategies;
• Determine when secondary patents should be pursued in light of KSR's progeny and Kubin;
• Learn to properly calculate PTA via Wyeth v. Dudas and avoid A and B period overlap dilemmas;
• Examine how Bilski may affect pharmaceutical method claims;
• Incorporate precedents from leading Paragraph IV cases involving declaratory judgments, inequitable conduct and double patenting into your life cycle strategies;
• Assess the impact of skinny labeling and carve-outs on Orange Book listing determinations;
• Decipher the FDA's new interpretations of pre- and post- MMA exclusivity and make sense of new rulings on forfeiture determinations;
• Navigate the new boundaries of the safe harbor as set by Proveris; and
• Explore pharmaceutical patent life cycle strategies for emerging markets.

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

• The endgame re-invented:  Preparing for an emerging pharmaceutical patent paradigm;
• Patent reform and the pharmaceutical industry:  Anticipating and adapting to change;
• Follow–on biologics:  Understanding the role of patents in health care reform and related consequences for life cycle strategies;
• Wyeth v. Dudas:  Revisiting patent term adjustment calculations;
• Overcoming obviousness:  An analysis of the post-KSR treatment of primary and secondary patents and finding new ways to extend patent life;
• In re Bilski:  Exploring its implications for pharmaceutical method claims;
• Eye on the Federal Circuit and District Courts:  Life cycle lessons derived from Paragraph IV litigation;
• Promoting competition in the pharmaceutical industry;
• The European Commission pharmaceutical sector inquiry - Main findings and policy recommendations;
• Rethinking life cycle strategies for established and emerging international markets:  Focus on Europe and Asia;
• A new look at Orange Book listings, delistings and related challenges;
• Update on FDA activities relative to pharmaceutical patent life cycles;
• Exclusivity:  Modes, methods and new interpretations; and
• Re-exploring the safe harbor:  Learning to navigate the potential limits and boundaries of Proveris.

A pre-conference workshop, entitled "Hatch-Waxman Boot Camp -- A Primer on IP Basics and Regulatory Fundamentals" will be held on October 6, 2009.  This workshop will offer presentations on the following topics:

• Understanding pre-commercialization concerns relative to small molecules and biologics;
• Exploring the link between the FDA approval process and the patenting of drugs and biologics;
• Patent and IP overview for drugs and biologics:  Hatch-Waxman, trade dress, and more;
• Patent and non-patent exclusivity;
• Bioequivalence and the "same active ingredient" vis-à-vis patentability; and
• Exploring pharmaceutical patent extensions:  Patent term adjustment and patent term restoration.

Two additional master classes will be offered on October 9, 2009.  One of the master classes, entitled "New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World," will focus on brand name drugs, and the other master class, entitled "Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters," will focus on generic drugs.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.

The registration fees are $2,195 (conference only), $3,090 (conference plus workshop), $2,695 (conference plus one master class), $3,590 (conference plus workshop and both master classes), and $1,395 (workshop alone).  Those registering on or before September 21, 2009 will receive a $200 discount (for all but the workshop alone), and those registering on or before August 7, 2009 will receive a $300 workshop (for all but the workshop alone).  ACI will also provide a $200 discount off the standard price to all Patent Docs readers who reference the discount code "The Media Partner Discount" when registering.  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.

Patent Docs is a media partner of ACI's Maximizing Pharmaceutical Patent Lifecycles conference.

Ex parte Competitive Technologies, Inc. (B.P.A.I. 2009)

Board Finds Metabolite Claim to be Patentable

    By Kevin E. Noonan --

The most significant non-decision from the Supreme Court in recent memory is Justice Breyer's dissent over the Court's decision to dismiss its granted certiorari petition (as improvidently granted) in the Laboratory Corp. v. Metabolite Laboratories, Inc. case regarding the patent-eligibility of this claim:

13.  A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:  assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

The bases for the dissenters' objections to the patentability of this claim has been discussed in prior Patent Docs posts (see "The Supreme Court, In re Bilski and the Lingering Question of Labcorp v. Metabolite").  Today, the Board of Patent Appeals and Interferences issued its decision in an appeal from a final rejection of this claim in reexamination, reversing the Examiner's assertion that the claim was unpatentable for obviousness.

The ex parte reexamination, Control No. 90/008,305, of U.S. Patent 4,940,658 was requested on October 23, 2006, and claims 13, 15-17 and 33 were finally rejected for obviousness over the following references:

•  Refsum et al., "Radioenzymic Determination of Homocysteine in Plasma and Urine," Clinical Chemistry 34: 624-28 (1985), cited for teaching methods for determining homocysteine levels in plasma by converted total homocysteine to radiolabeled S-adenosylhomocysteine and then quantifying;

•  Kass, "Cytochemical Detection of Homocysteine in Pernicious Anemia and in Chronic Erythremic Myelosis," American Journal of Clinical Pathology 67: 53-56 (1977), cited for teaching chemical methods of homocysteine detection in permicious anemia to detect B12 deficiency, but which test showed cross-reactivity with Coenzyme A;

•  Wilcken et al., "Homocysteinemia, Ischemic Heart Disease, and the Carrier State for Monocystinuria," Metabolism 32: 363-70 (1983), cited for teaching homocysteine detection in a twin study showing different folate and B12 levels consistently detected from RBCs; and

•  Westhyyzen et al., "Plasma amino acids and tissue methionine levels in fruit bats (Rousettus aegyptiacus) with nitrous oxide-induced vitamin B12 deficiency," British Journal of Nutrition 53: 657-62 (1985), cited for showing in correlation between plasma methionine levels and vitamin B12 deficiency.

The Examiner rejected the claims in reexamination for obviousness, citing the Refsum reference as the primary reference (showing a method for detecting plasma homocysteine) combined with the other references showing a correlation with vitamin deficiency.  It would have been obvious to combine the teachings of these references, according to the Examiner, "[b]ased on the correlation between the elevated levels of homocysteine (free and/or complexed) in blood and urine samples with deficiency of cobalamin or folate taught by Kass, Wilcken . . . and Westhuyzen."

Saith the Board:  We disagree.  The panel first stated the principle, enunciated in KSR International Co. v. Teleflex Inc., requiring "some articulated reasoning with some rationale underpinning to support the legal conclusion of obviousness" (550 U.S. 398, 418 (2007)).  Here, the Board opined that the claimed invention requires assaying for "total" homocysteine, which comprises four species (homocysteine, homocystine, homocysteine-cysteine disulfides, and protein-homocysteine mixed disulfides), based on specific findings of fact, and correlating elevated levels with folate and/or vitamin B12 deficiency (without discriminating between the two).  The panel then distinguished the cited secondary references (which the Examiner used to establish the correlation between elevated homocysteine levels and vitamin deficiency) from the claimed invention.  According to the Board, Kass teaches a chemical reaction test that measures not only homocysteine (and not "total" homocysteine) but also Coenzyme A and further distinguishes between B12 and folate deficiency (contrary to the claimed invention).  The Board further opined that the ordinarily skilled worker would not have "reasonably" read the Wilcken reference as teaching a correlation between elevated total homocysteine levels and either folate or B12 deficiency, since neither twin was reliably deficient in either folate or B12.  The Westhuyzen reference does suggest a correlation between elevated plasma homocysteine and B12 deficiency, the Board conceded, but only detects homocysteine, not total homocysteine, and there is no evidence that the detected increased in homocysteine would "necessarily mean an increase in 'total' homocysteine."  In addition to these deficiencies, the Board found that none of the cited references show any correlation between plasma homocysteine levels and folate deficiency.

The Board then held that "[t]he Examiner has failed to provide a sufficient factual basis to support her conclusion of obviousness i.e. that the applied prior art teaches or suggests all of the claim limitations" (phraseology applying -- but not rigidly applying -- the traditional TSM test remaining as one option under KSR and the Patent Office Guidelines for implementing the KSR decision).

This decision cannot be appealed by the third-party requester, and at least with regard to claim 13 provides no basis for appeal by the patentee (since the patentability of this claim was affirmed in unamended fashion by the Board's decision).  It is unlikely that this determination would change Justice Breyer's mind, in any event, since he is on record as believing that:

Even were I to assume (purely for argument's sake) that claim 13 meets certain general definitions of process patentability, however, it still fails the one at issue here:  the requirement that it not amount to a simple natural correlation, i.e., a "natural phenomenon."  See Flook, supra, at 588, n. 9 (even assuming patent for improved catalytic converter system meets broad statutory definition of patentable "process," it is invalid under natural phenomenon doctrine); Diehr, 450 U. S., at 184–185 (explaining that, even if patent meets all other requirements, it must meet the natural phenomena requirement as well).

At most, respondents have simply described the natural law at issue in the abstract patent language of a "process."  But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.  Cf. id., at 192 (warning against "allow[ing] a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection").  One might, of course, reduce the "process" to a series of steps, e.g., Step 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly.  But one can reduce any process to a series of steps.  The question is what those steps embody.  And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered.  In my view, that correlation is an unpatentable "natural phenomenon," and I can find nothing in claim 13 that adds anything more of significance.

The Board's decision properly addresses the legal flaw in Justice Breyer's reasoning, as explicated by Judge Rich in In re Bergy:  the question of patent eligibility is distinct from whether an invention satisfies the statutory requirement for patentabity.  The Board has affirmed that Claim 13 is patentable; perhaps the Supreme Court will use its review of In re Bilski to address the question of whether the claim is also patent-eligible.

Ex parte Competitive Technologies, Inc. (B.P.A.I. 2009)
Panel: Administrative Patent Judges Spiegel, Adams, and Delmendo
Opinion by Administrative Patent Judge Spiegel

Fish & Richardson Catches Error in Patent Office's PTA Calculation

    By Sydney Kokjohn --

Fish & Richardson and its pharmaceutical client Japan Tobacco Inc. recently discovered another error in the U.S. Patent and Trademark Office's method of calculating patent term adjustment ("PTA").  On January 8, 2009, Fish & Richardson filed an Application for Patent Term Adjustment under 37 C.F.R. § 1.705(d) (see Application).  In addition to arguing that additional patent term was due in light of Wyeth v. Dudas, 580 F. Supp. 2d 138 (D.D.C. 2008) (see Patent Docs post), Fish & Richardson argued that the Patent Office was incorrectly calculating "B-delay" (delay for failure to issue a patent within three years of the actual filing date of the application) for U.S. national stage applications.  The Patent Office was using the date on which an international applications fulfilled the requirements of 35 U.S.C. § 371 as the filing date for calculation of B-delay.  But 37 C.F.R. § 1.702(b) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to issue a patent within three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application."  Section 371(b) states that subject to § 371(f), "the national stage shall commence with the expiration of the applicable time limit under article 22 (1) or (2), or under article 39 (1)(a) of the [PCT]."  Fish & Richardson pointed out that the time at which the national stage is commenced under section 371(b) and PCT Articles 22(1), 22(2), and 39(1)(a), and thus the "actual filing date" for purposes of calculating B-delay, is thirty months from the priority date of the international application.

While Fish was not successful with its Wyeth argument, the Patent Office did grant Japan Tobacco additional patent term for B-delay, indicating that B-delay should be calculated based on the date on which the national stage commenced, not the date on which the requirements of § 371 were fulfilled as it had previously determined (see Decision).  But the PTO's new PTA calculation method is not always beneficial for the applicant.  Fish & Richardson has indicated on its website that applicants may also be granted too much patent term adjustment if they fulfill the § 371 requirements, but do not expressly request early processing of the national stage application under § 371(f) (see Correct Method for Measuring "B Delay" for 371 National Stage Applications).  Under this section, an applicant may expressly request that the national stage be commenced as long as the requirements of § 371(c) have been met.  If the applicant does not expressly request commencement of the national stage, § 371(b)'s thirty month date will be the date used in B-delay calculations even if the applicant met the requirements of § 371(c) prior to that date.  In this situation, the applicant will be granted less patent term under the new calculation.

Note also that "A-delay" for failure to mail a notification under 35 U.S.C. § 132 or a notice of allowance under 35 U.S.C. § 151 is still calculated from the date of fulfillment of the requirements of § 371 (see 35 U.S.C. § 154(b)(1)(A)(i)(II) and 37 C.F.R. § 1.702(a)(1)).  Interestingly, however, A-delay is not affected by late submission of a fee and/or oath in a filing under 35 U.S.C. § 111(a).  37 C.F.R. § 1.702(a)(1) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to . . . [m]ail at least one of a notification under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 not later than fourteen months after the date on which the application was filed under 35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 in an international application."  The filing date for purposes of § 111(a) and A-delay is "the date on which the specification and any required drawing are received in the [Patent Office]" (see 35 U.S.C. § 111(a)(4)).  An applicant may lose patent term if he fails to respond to the notice of missing parts within three months, but the late filing of an oath or fee in an application filed under § 111(a) does not affect that calculation of A-delay for failure to issue an action or notice of allowance within fourteen months.  The late filing of any of the requirements under § 371(c), however, does affect the calculation of A-delay.  Thus, a discrepancy remains between the calculation of A-delay for applications under § 111(a) and the calculation for U.S. national stage applications.

Patent practitioners should remember that under 37 C.F.R. § 1.704(b), "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request."  The three-month period applies to replies to all notices and actions, including those in which the shortened statutory period is less than three months, such as restriction requirements and notices of missing parts.

In sum, this decision provides another reason for patent practitioners to request additional patent term for many U.S. national stage filings and suggests that such petitions are likely to be more successful than petitions filed pursuant to the Wyeth decision.  In addition, patent practitioners should carefully analyze all rules regarding patent term adjustment in order to maximize patent term.

Patent Docs thanks Fish & Richardson for alerting the patent community to this issue.

Senate Judiciary Committee Hears from Director Nominee

    By Donald Zuhn --

Today, the Senate Judiciary Committee heard testimony from David Kappos (at right), the Obama Administration's nominee for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.  While the hearing was mostly uneventful, Senator Arlen Specter (D-PA) provided an interesting line of questioning when he asked Mr. Kappos to explain how he would balance his new obligations as Director with his old loyalties to IBM.  When Mr. Kappos responded by saying that he would recuse himself from matters that specifically involved IBM, Sen. Specter inquired about global decisions Mr. Kappos might make as Director that could ultimately benefit IBM while disadvantaging other applicants.  Sen. Specter noted that the Federal Circuit had recently granted a request for an en banc hearing in Tafas v. Dudas, and that the parties had jointly sought a stay "to see what attitude [Mr. Kappos] might have."  Depending on Mr. Kappos' "attitude" regarding the case, Sen. Specter (at left) contended that "IBM would be benefitted one way and other companies would be benefitted the other way," and asked Mr. Kappos how he would handle this "more subtle and sophisticated issue."  Mr. Kappos responded by saying his role, if confirmed as Director, would be to "do[] the right thing for the American people and the United States of America," and like other individuals who had left the private sector for a governmental position, he would "put my previous role behind me and focus on doing the right thing for the United States of America -- in the Tafas case and the Bilski case and everything else on a policy level."

The questioning from other Senators was less challenging.  Senate Judiciary Chairman Patrick Leahy (D-VT) (at right) asked Mr. Kappos whether he would work with Congress to advance patent reform.  Mr. Kappos replied that securing passage of a patent reform bill was a top priority (albeit one of many "top" priorities).  Senator Orrin Hatch (R-UT) provided a nice endorsement of Mr. Kappos' nomination, saying that the nominee was the type of person who could "keep us at the forefront of innovation."  Sen. Hatch also told the nominee that he was "very impressed that you're willing to do this."

Senator Jeff Sessions (R-AL) asked Mr. Kappos whether the application backlog and pendency could be reduced with the annual threat of fee diversion.  Mr. Kappos informed the Committee that he was opposed to fee diversion, and noted that while the USPTO was "one of the few places where a user community will readily step up and say we don't mind paying whatever it costs," the user community's response will be quite different if fees are diverted (as Patent Docs has reported before, fee diversion has not been a problem for the past few years).  Senator Amy Klobuchar (D-MN) told Mr. Kappos that the Committee "believe[s] your nomination is a good thing for this country," and asked him how efficiency and morale could be improved in the USPTO.  Mr. Kappos proposed to raise morale by completely remaking the count system, which he said "needs to be fixed."  Mr. Kappos stated that "as I understand it, the examining corps hates the count system the way it is," and "the applicant community . . . hates the count system the way it is because it results in dysfunctional behavior."  He informed the Committee that Secretary of Commerce Gary Locke had specifically asked him to fix the count system.

All told, Mr. Kappos listed four priorities during the hearing, including advancing the Senate patent reform bill (S. 515), reducing the application backlog, creating a "sustainable, long-term funding model" for the USPTO (which would require passage of S. 515 and its provisions to end fee diversion and allow the Director to set fees), and remaking the count system.

Chairman Leahy concluded the hearing by noting that the record would be held open for one week to allow Committee members to submit additional questions.

A webcast of the hearing can be viewed here, a copy of Mr. Kappos' written testimony can be found here, and Chairman Leahy's statement regarding the hearing can be found here.

Senate Judiciary Committee to Consider Kappos Nomination on Wednesday

    By Donald Zuhn --

On Wednesday, the Senate Judiciary Committee will hold a hearing on several nominations, including that of David Kappos for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.  The Committee, which is scheduled to begin the hearing at 10:00 am (EST), will also be considering nominees for the Eleventh Circuit and the South Dakota District Court.  A webcast of the hearing can be accessed here.

In preparation for the hearing, the Committee has made available three letters it received in connection with Mr. Kappos' (at left) nomination.  The letters were sent by the American Intellectual Property Law Association (AILPA), the Intellectual Property Owners Association (IPO), and Henry Nothhaft, the President and CEO of Tessera.  In its letter, the AIPLA states that:

Mr. Kappos has been a member of AIPLA for nearly 20 years and has served as a member of the AIPLA Board of Directors for the last three years.  Based on our own experience with him over this period, we know Mr. Kappos to have a rich and varied experience in intellectual property law and policy, and we believe him to be well qualified to serve in the position to which he has been nominated.

The AIPLA also noted that it had previously advised the Obama Administration that "a new USPTO Director must be an individual of the highest caliber who is experienced and is a highly respected leader in whom Congress and the community of intellectual property owners, businesses, and international communities can place their full confidence," and that it "believe[s] that Mr. Kappos' experience more than meets this standard."

The letter sent by the IPO also provides an endorsement of Mr. Kappos, stating that:

Mr. Kappos has an exceptional record in intellectual property law and significant experience in industry as a manager.  He has worked within IPO and other associations to improve IP practice and communications with the USPTO.  He meets all the qualifications that IPO set out recently in letters to the Obama Administration for the position for which he has been nominated.

Finally, in the letter sent by Mr. Nothhaft, the Tessera CEO notes that while "the [USPTO] is underfunded, overburdened, and faces huge hurdles in hiring and retention," Tessera supports the nomination and is "hopeful that Mr. Kappos can quickly address these issues to further strengthen the USPTO."  Mr. Nothhaft also offers the Committee a list of recommendations for improving the USPTO, including adopting rules that prevent fee diversion and incentivize the issuance of quality patents, revising the fee structure to take into account the increasing complexity of many patent applications and perhaps charge higher fees for quicker prosecution outcomes, being more proactive in conducting interviews, and attracting and retaining a high-quality quality workforce (perhaps by creating virtual regional offices).

In addition to the letters in support of Mr. Kappos' nomination, the Committee has made available the nominee's responses to the Committee's background questionnaire, as well as links to the publications and other documents listed on the questionnaire.

Follow-on Biologics News Briefs - No. 6

    By Donald Zuhn --

BIO CEO Cites Letters from Patient Groups Supporting Longer Exclusivity Period

Last week, BIO President and CEO Jim Greenwood (at right) noted that a number of patient groups had joined BIO in seeking passage of a follow-on biologics bill providing a minimum of 12 years of data exclusivity.  Mr. Greenwood also provided links to a July 13th letter sent to Sen. Ted Kennedy (D-MA) by the AIDS Institute, Community Access National Network, CAEAR Foundation, and National Minority AIDS Council; a July 16th letter sent to Rep. Anna Eshoo (D-CA) by the ALS Association; and a July 16th letter sent to Rep. Eshoo by the Alliance for Aging Research.  The AIDS Institute et al. letter states that:

Since 1987, approximately 32 drugs have been developed to treat HIV/AIDS.  These innovations have turned what was once a terminal illness into a potentially chronic, manageable condition.  Technology, research, and innovation have expanded the horizon of possibilities for saving lives.  . . .  All of these life-saving drugs were developed with private investment and it is our opinion that this was only possible because pharmaceutical and biotechnology companies were able to recoup their investment in the extensive clinical research and clinical trials required to make these drugs available to the people that need them.

As a result, the groups "strongly urge [Congress] to include a period of data exclusivity relative to biologics of 12 years."

The letter from the ALS Association provides an endorsement for Rep. Eshoo's follow-on biologics bill (H.R. 1548).  (Note:  As of Tuesday, Rep. Eshoo's bill has the backing of 139 co-sponsors to 14 for Rep. Waxman's competing bill.)  The ALS Association also informed Rep. Eshoo that it backed the follow-on biologics bill that had been adopted by the Senate HELP Committee earlier this month.  The ALS letter contends that "any biosimilars legislation . . . must foster innovation," and therefore, the group supports a regulatory pathway providing a 12 year period of data exclusivity.

Finally, the Alliance for Aging Research also announced its support for the follow-on biologics regulatory pathway being proposed by Rep. Eshoo.

Rhode Island Biotech Supports 12-Year Data Exclusivity Period

On Sunday, The Providence Journal reported on the efforts of the Rhode Island BioGroup and the New England Biotech Association to sway public opinion towards a follow-on biologics regulatory pathway providing 12 years of data exclusivity.  As part of those efforts, the two trade groups have been running radio spots and full-page newspaper ads.  While noting that the possibility of securing patent protection often gets lost in the discussion about data exclusivity, the article incorrectly reports that "[t]he 20-year clock on a drug patent begins to tick down as soon as a company files with the FDA for approval."

Momenta Pharmaceuticals Supports Shorter Exclusivity Period

Last Friday, Mass High Tech posted an article regarding the decision by Cambridge-based Momenta Pharmaceuticals Inc. to support a shorter data exclusivity period.  The biologic drug manufacturer has written to Congress to advocate for shorter protections for biologics.  According to the MHT report, Momenta's efforts are related to the company's development of a technology platform it says can help make generic versions of the drugs -- the platform provides a series of analytic tools to help determine and reproduce exactly how a biologic was made.

BioWorld Today Columnist Says Exclusivity Issue Is Needlessly Thwarting Debate

Karl Thiel, writing earlier this month in BioWorld Today, argues that the White House proposal of seven years of data exclusivity "seems reasonable" in view of Europe's 8-10 year exclusivity period.  Mr. Thiel explains that "we require less exclusivity here because our patent system is stronger and fills the gap more effectively."  While acknowledging that he doesn't know "what the right number is," Mr. Thiel says that data exclusivity is "an issue that's frankly been blown out of proportion," since "[e]xclusivity runs concurrent to patent life after all."  He adds that "in most cases, it's not going to matter whether it's five or seven or 12 years, because the patent protection will supersede the exclusivity period, at least if you have good lawyers."

University of Pittsburgh v. Hedrick (Fed. Cir. 2009)

For Stem Cells, It Seems That Conception Is Enough

    By Kevin E. Noonan --

On Thursday, the Federal Circuit affirmed a District Court determination that the University of Pittsburgh had established, by clear and convincing evidence, that four inventors had been improperly named in U.S. Patent No. 6,777,231 and granting judgment correcting inventorship under 35 U.S.C. § 256.  In doing so, the Court's decision raised a paradox with regard to conception of biological inventions (albeit while not making any new law in the process).

The facts of the case, as set forth in the Patent Docs report on the District Court decision, illustrate the influence patenting can have on academic collaboration.  As granted, the '231 patent named Adam J. Katz, Ramon Llull, William J. Futrell, Marc H. Hedrick, Prosper Benhaim, Hermann Peter Lorenz, and Min Zhu as inventors, with Katz, Llull, and Futrell having assigned their rights to the University of Pittsburgh and the remaining named inventors assigning their rights to the Regents of the University of California.

The District Court found that Dr. Katz had isolated adipose-derived stem cells, and that Drs. Katz and Llull conceived that these cells could be induced to differentiate into cells from multiple mesodermal lineages, "including bone, cartilage, fat and muscle."  The Court credited evidence from laboratory notebooks that Drs. Katz and Llull showed their adipose-derived stem cells could differentiate into several different cell types, including adipose cells, nerve cells, and muscle cells.  According to the District Court's Findings of Fact, Dr. Katz also "appreciated" the capacity of these adipose-derived stem cells for self-renewal.  The Court found that the earliest date of conception for the invention claimed in the '231 patent was 1996, a date several years before work began at UCLA.

The Federal Circuit recited the following facts which are relevant to the panel decision:

• The Pittsburgh inventors (Katz and Llull) discovered in 1996 that certain cells from adipose tissue could de-differentiate into fibroblast-like cells and back again to adipose-like cells.

• In 1997, these researchers "explored the idea" that these cells could "transdifferentiate" into other cell types, including bone, cartilage, and muscle, and that Dr. Katz's laboratory notebooks showed experiments on different media formulations that could induce adipose-derived cells to differentiate into bone, muscle, fat, cartilage, and nerve cells; however, these notebooks also established that this differentiation was "not scientifically certain," but the cells were observed to change into muscle and fat cells and maybe into nerve cells.

• At that time, they recognized from the work of others that mesenchymal stem cells can do this too, but these isolated by others from bone marrow.

• "By April 1997, they [the Pittsburgh inventors] had the firm and definite idea that the cells were human, could be genetically modified, secreted hormones, and contained cell-surface bound intracellular signaling moieties, all properties known at the time to scientists in the field."

• A UCLA scientist (Hedrick) was on a one-year fellowship to Dr. Katz's laboratory in 1997, but was not named on a grant proposal on adipose-derived stem cells submitted at that time or in laboratory notebooks on these stem cells.

• Dr. Hedrick did write his own proposal on using these cells.

• An invention disclosure was submitted to the University of Pittsburgh naming the Pittsburgh inventors and Hedrick, stating the invention was isolated cells that could be induced to transform into fat, bone, cartilage, and muscle cells.

• When Dr. Hedrick returned to UCLA after his fellowship in Dr. Katz's lab, he formed the Regenerative Bioengineering and Research ("REBAR") laboratory with the other UCLA inventors.

• Dr. Hedrick and the REBAR group worked on the same cells as the Pittsburgh group, and "determined that the adipose-derived cells were distinct from the prior art bone marrow-derived mesenchymal stem cells because they responded differently to induction media.  They also identified various media to induce differentiation in the cells, and identified the presence of an enzyme that is indicative of stem cells in a heterogeneous stromal vascular fraction population.  In late 1999 and early 2000, the REBAR lab successfully cloned single adipose-derived cells."

• In March 1999, a provisional patent application was filed by the University of Pittsburgh that named Hedrick as well as the Pittsburgh inventors; a second provisional application was filed in October 1999 naming the same inventors.

• In February 2000, Dr. Hedrick submitted an invention disclosure to UCLA for adipose tissue-derived stem cells, and included the nerve cell embodiments even though he "had not conducted any nerve differentiation experiments."

• In March 2000, an International Patent Application was filed by Pittsburgh naming all the Pittsburgh and UCLA inventors; this is the application that issued as USP 6,777,231.

The '231 patent was granted with the following claims:

1.  An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

2.  An isolated, adipose-derived multipotent cell that differentiates into cells of two or more mesodermal phenotypes.

3.  An isolated adipose-derived stem cell that differentiates into two or more of the group consisting of a fat cell, a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

4.  An isolated adipose-derived stem cell that differentiates into a combination of any of a fat cell, a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

5.  A substantially homogeneous population of adipose-derived stem cells, comprising a plurality of the stem cell of claim 1, 3 or 4.

6.  The adipose-derived stem cell of claim 1, 3 or 4 which can be cultured for at least 15 passages without differentiating.

7.  The adipose-derived stem cell of claim 1, 3 or 4 which is human.

8.  The cell of any of claim 1, 3 or 4 which is genetically modified.

9.  The cell of any of claim 1, 3 or 4, which has a cell-surface bound intercellular signaling moiety.

10.  The cell of any of claim 1, 3 or 4, which secretes a hormone.

The Federal Circuit's opinion, by Judge Mayer joined by Judges Rader and Bryson, considered two questions:  claim construction and inventorship.  Regarding claim construction, the Court affirmed the District Court's determination that the claim term "adipose-derived" had its plain meaning as "derived from fat tissue," and rejected the construction proposed by the REBAR inventors that the term should mean "species of stem cell distinct from the mesenchymal stem cell that is obtainable from bone marrow tissue."  The REBAR inventors had determined that adipose-derived stem cells were distinct from mesenchymal stem cells from bone marrow, and thus their construction excluded such bone-marrow derived stem cells that may have migrated to adipose tissue.  The District Court had agreed that the specification distinguished bone marrow from adipose tissue derived stem cells, but only with regard to culture conditions and not that the cells represent "separate species."  The District Court was not persuaded that the different culture and isolation conditions necessitated that the adipose derived stem cells are different from bone marrow-derived mesenchymal stem cells.  The Federal Circuit agreed, and opined that neither the specification (where the term was not expressly defined) nor the prosecution file history supported REBAR inventors' construction.  Specifically with regard to the file history argument, the REBAR inventors contended that an amendment proposed by the Pittsburgh inventors (to recite "adipose-derived" in the claims) was a disclaimer of mesenchymal stem cells isolated from fat that would read on prior art stem cells.  The panel noted, however, that this amendment was never submitted, since the inventors submitted instead a paper from the REBAR group showing that the cells were different.  The panel refused to find a disavowal of subject matter under these circumstances:

A wide chasm exists between the weak inference from the summary that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term.

Turning to inventorship, the panel recited the following fundamental principles:

An inventor need not know that his invention will work for conception to be complete.  Price v. Symsek, 988 F.2d 1188, 1196 (Fed. Cir. 1993).  . . .  He need only show that he had the complete mental picture and could describe it with particularity; the discovery that the invention actually works is part of its reduction to practice.  Id.  In a joint invention, each inventor must contribute to the joint arrival at a definite and permanent idea of the invention as it will be used in practice.  Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 1229 (Fed. Cir. 1994).

In this panel's view, the district court had applied these principles properly:

The district court correctly applied this law, finding clear and convincing evidence that Katz and Llull conceived of each claim of the invention through contemporaneous corroboration before the arrival of Hedrick at Pittsburgh in July 1997.  It found that they had recorded that their cells could transdifferentiate into multiple mesodermal lineages including bone, cartilage, fat and muscle in laboratory notebooks, letters, a January 1997 invention disclosure for their Auto-Cell Separator, the February 1997 document "What's So Great About Fat?," and the inference that Katz would have only conducted his muscle induction experiment on the cells to confirm his belief that they could differentiate into muscle instead of adipocytes.  They had recorded that their isolated cells transdifferentiated into cells resembling a nerve cell in April 1997, as was recorded in a letter to a colleague requesting his help with electrophysiological techniques.  While not scientifically certain that they were observing a nerve cell, they did have the firm and definite idea that nerve cells were present, and ordered further confirming tests.  Claims 1, 2, 3, and 4 require an isolated adipose-derived stem cell that can differentiate into two or more mesodermal phenotypes, including specifically a fat cell, a bone cell, a cartilage cell, a nerve cell, a muscle cell, or a combination of these.  Thus, the entire invention as described by claims 1, 2, 3, and 4 had been conceived and corroborated through these disclosures.

The panel also opined that other limitations recited in the claims, such as the requirement for a substantially homogeneous population of cells (claim 5), the capacity of the cells for self-renewal (claim 6), that the cells must be human (claim 7), could be genetically-modified (claim 8), secreted hormones (claim 9), and contained cell-surface bound intracellular signaling moieties (claim 10) were all "grasped" by Drs. Katz and Llull by April 1997 (at a time prior to Dr. Hedrick beginning his fellowship), at least in part because the scientists in the field recognized that stem cells had these features and capacities.

The panel rejected the REBAR inventors' contentions that the Pittsburgh inventors' research was "inconclusive," "highly speculative," and not fully realized until their owen contribution to the work.  Citing Coleman v. Dines, 754 F.2d 353 (Fed. Cir. 1985), the REBAR inventors argued that an inventor must "know" that the invention contained every limitation of each claim at the time of conception.  The panel characterized these assertions as a "misapprehension of what it means to 'know' the limitations of the claims."  The District Court found that Katz's laboratory notebooks sufficiently described to those skilled in the art how to isolate the cells from adipose-tissue, at which point they would be in possession of the invention, and the Federal Circuit agreed.  Specifically, the Court stated that:

Knowledge in the context of a possessed, isolated biological construct does not mean proof to a scientific certainty that the construct is exactly what a scientist believes it is . . . .  Proof that the invention works to a scientific certainty is reduction to practice . . . .  The determinative inquiry is not whether [the inventor's] disclosure was phrased certainly or tentatively, but whether the idea expressed therein was sufficiently developed to support conception of the subject matter.  In re Jolley, 308 F.3d 1317, 1324 (Fed. Cir. 2002).  . . .  Evidence need not always expressly show possession of the invention to corroborate conception, and a court may properly weigh evidence that a claimed attribute is merely an obvious property of a greater discovery at issue.  Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 1231 (Fed. Cir. 1994).

This determination is consistent with well-established law regarding conception.  For example, in Burroughs Wellcome Co. v. Barr Labs, Inc., the Burroughs Wellcome defendants argued that for an invention in an "uncertain or experimental discipline, where the inventor cannot reasonably believe an idea will be operable until some result supports that conclusion," conception occurs only when there is experimental confirmation that the invention works for its intended purpose.  The Federal Circuit was clear, stating: "[b]ut this is not the law.  An inventor's belief that his invention will work or his reasons for choosing a particular approach are irrelevant to conception.  Id., citing MacMillan v. Moffett, 432 F.2d 1237, 1239, 167 U.S.P.Q. 550, 552 (CCPA 1970)."  This is sufficient for conception, unless there is evidence of subsequent experimental failure:  "[a] conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.  Id. at 1229, citing Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1387, 181 U.S.P.Q. 453, 457-58 (CCPA 1974)."

However, this decision, and the well-established reasoning behind it, does lead to at least an anomaly if not an outright paradox when it comes to biological inventions.  Here, the inventors "conceived" of a stem cell derived from adipose tissue that could be induced to differentiate into bone, muscle, fat, and nerve tissue on the basis of (1) isolating cells that could de- and transdifferentiate; (2) some but admittedly inconclusive evidence that these cells could be induced to differentiate under certain experimental conditions; and (3) the "a definite and permanent idea" of adipose-derived stem cells.  In contrast, other biological inventions, such as nucleic acids, have been held to require simultaneous conception and reduction to practice, in view of their inherent complexity (see Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991)).  It seems anomalous that cells, which are inherently more complex than nucleic acids should be capable of being conceived more easily and to require less knowledge about their properties (except what can be "definitely and permanently" fixed in the mind of the inventor (and corroborated by documentary evidence).  Perhaps an answer to the paradox is that this case is limited to determining who should be named as inventors, i.e., who conceived of the invention.  Unlike the situation in an interference, neither the District Court nor the Federal Circuit address when the Pittsburgh inventors could describe the cells sufficiently or produce and differentiate them reliably, activities both courts classified as being part of reduction to practice and hence irrelevant to the question before them (see, e.g., Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005)).  The Federal Circuit's decision made abundantly clear that the rubrics for deciding inventorship in the relatively complex biological arts are no different than for any other art, and that conceiving the existence of a cell like a stem cell is enough (so long as subsequent attempts to reduce the invention to practice do not contradict this presumption).

University of Pittsburgh v. Hedrick (Fed. Cir. 2009)
Panel: Circuit Judges Mayer, Rader, and Bryson
Opinion by Circuit Judge Mayer

Could the "New Rules" Nightmare Finally Be Over?

    By Kevin E. Noonan --

Hal Wegner has shared with Patent Docs papers filed by the Department of Justice (DOJ) on Friday, asking the Federal Circuit to defer proceedings on its en banc review of the panel decision in Tafas v. Doll.  The basis for this request is to give Under Secretary-designate David Kappos the opportunity to consider what action should be taken in the case.  The motion was filed as a joint motion of the DOJ and plaintiffs Dr. Triantafyllos Tafas and GlaxoSmithKline.

Appellants' brief is currently scheduled to be due on August 5th, with appellees' brief due 20 days thereafter and Appellants' reply 7 days after that date.  Oral argument is scheduled for October 7th.  The joint motion asks that "briefing and oral argument" be stayed until 60 days after the Senate confirms the Kappos appointment as Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.  In the event that the Office wishes to continue with en banc review, the motion asks for 30 days from the end of this 60 day term for the Appellants' brief to be due, with the same relative timing for following briefs as are now scheduled.

The brief in support of the joint motion states that the stay is requested to "give the new Director, if confirmed, an opportunity to examine the rules at issue in this case and determine what course the USPTO should take in the future with respect to those rules, including whether to rescind the rules."  While rescission of this rules package is a hopeful prospect, it should not be forgotten that the panel decision was in the main favorable to the Office, holding that three out of the four challenged rules were within the Office's procedural rulemaking authority (see Patent Docs post).

Assuming the new Kappos regime in the Patent Office is committed to working with, rather than against, its customers and their representatives in the patent bar, this action may be the first step towards restoring the historical amity between the Office and its constituents.

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.

King Pharmaceuticals Inc. et al. v. Sandoz Inc.
2:09-cv-03587; filed July 21, 2009 in the District Court of New Jersey

• Plaintiffs: King Pharmaceuticals Inc.; King Pharmaceuticals Research and Development, Inc.; Elan Corp., PLC.; Elan Pharma International Ltd. 
• Defendant: Sandoz Inc.

Infringement of U.S. Patent No. 6,066,339 ("Oral Morphine Particulate Formulation," issued May 23, 2000) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of King's Avinza® (morphine sulfate extended release capsules, used for the once-daily treatment of moderate-to-severe chronic pain).  View the complaint here.

Taro Pharmaceuticals North America, Inc. et al. v. Synerx Pharma, LLC et al.
2:09-cv-03569; filed July 20, 2009 in the District Court of New Jersey

• Plaintiffs: Taro Pharmaceuticals North America, Inc.; Taro Pharmaceuticals U.S.A., Inc.
• Defendants: Synerx Pharma, LLC; Karalex Pharma, LLC; DPT Laboratories, Ltd.

Infringement of U.S. Patent No. 7,560,445 ("Process for Preparing Malathion for Pharmaceutical Use," issued July 14, 2009) based on defendants' manufacture and sale of a generic version of Taro's Ovide® (malathion lotion, used to treat head lice).  View the complaint here.

Pioneer Hi-Bred International, Inc. v. Nelson et al.
1:09-cv-01246; filed July 17, 2009 in the Central District of Illinois

• Plaintiff: Pioneer Hi-Bred International, Inc.
• Defendants: Ivan L Nelson; Thomas M Nelson

Infringement of U.S. Patent Nos. 7,034,211 ("Soybean Variety XB34D04," issued April 25, 2006) and 7,169,979 ("Soybean Variety XB35C06," issued January 30, 2007) based on defendants' use of cleaned and saved soybean seed from earlier purchased soybean seed.  View the complaint here.

Bone Care International LLC et al. v. Sandoz Inc.
1:09-cv-00524; filed July 16, 2009 in the District Court of Delaware

• Plaintiffs: Bone Care International LLC; Genzyme Corp.
• Defendant: Sandoz Inc.

Infringement of U.S. Patent No. 5,602,116 ("Method for Treating and Preventing Secondary Hyperparathyroidism," issued February 11, 1997) following Sandoz's filing of an ANDA to manufacture a generic version of plaintiffs' Hectorol® (doxercalciferol, used to treat secondary hyperparathyroidism in patients with chronic kidney disease).  View the complaint here.

Alcon Research Ltd. v. Barr Laboratories Inc.
1:09-cv-00512; filed July 14, 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), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999), 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 Barr's filing of an ANDA to manufacture a generic version of Alcon's Travatan Z® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Allergan Inc. et al. v. Watson Pharmaceuticals Inc. et al.
1:09-cv-00511; filed July 13, 2009 in the District Court of Delaware

• Plaintiffs: Allergan Inc.; Allergan USA Inc.; Allergan Sales LLC; Endo Pharmaceuticals Solutions Inc.; Supernus Pharmaceuticals Inc.
• Defendants: Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida; Watson Pharma, Inc.

Infringement of U.S. Patent No. 7,410,978 ("Once Daily Dosage Forms of Trospium," issued August 12, 2008) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Allergan's Sanctura XR® (trospium, used to treat overactive bladder).  View the complaint here.

AlphaVax, Inc. v. Novartis Vaccines and Diagnostics, Inc.
1:09-cv-11176; filed July 10, 2009 in the District Court of Massachusetts

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Novartis in the interference between U.S. Patent Application No. 10/683,781 ("Alphavirus RNA Replicon Systems," filed October 10, 2003), assigned to AlphaVax and U.S. Patent No. 6,015,694 ("Method for Stimulating an Immune Response Utilizing Recombinant Alphavirus Particles," issued January 18, 2000), assigned to Novartis.  View the complaint here.

River's Edge Pharmaceuticals, LLC v. Brookstone Pharmaceuticals, LLC et al.
0:09-cv-01777; filed July 10, 2009 in the District Court of Minnesota

• Plaintiff: River's Edge Pharmaceuticals, LLC
• Defendants: Brookstone Pharmaceuticals, LLC; JR Nutraceuticals, Inc.

Infringement of U.S. Patent No. 6,979,468 ("Oral Composition and Method for the Treatment of Inflammatory Cutaneous Disorders," issued December 27, 2005) based on defendants' manufacture and sale of its Nicotinamide Zinc Oxide, Cupric Oxide, Folic Acid Tablets product, comparable to plaintiff's Nicotinamide ZCF (immediate release form of nicotinamide in combination with a sustained release form of zinc, used to treat inflammatory skin conditions such as acne rosacea and acne vulgaris).  View the complaint here.

Eurand, Inc. et al. v. Anchen Pharmaceuticals, Inc. et al.
2:09-cv-04931; filed July 9, 2009 in the Central District of California

• Plaintiffs: Eurand, Inc.; Cephalon, Inc.; Anesta AG
• Defendants: Anchen Pharmaceuticals, Inc.; Anchen, Inc.

Infringement of U.S. Patent No. 7,387,793 ("Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued July 17, 2008), licensed to Cephalon, following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Cephalon's Amrix® (cyclobenzaprine hydrochloride, used for relief of muscle spasm associated with acute, painful musculoskeletal conditions).  View the complaint here.

Novartis Vaccines and Diagnostics, Inc. v. Doll
1:09-cv-01201; 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.

Conference & CLE Calendar

July 29, 2009 - Pharmaceutical Antitrust Initiatives and Developments in the U.S. and Abroad*** (American Conference Institute) - 1:00-2:30 PM (EST)

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

August 4, 2009 - Venue in Patent Litigation:  New Strategies after Genetech and TS Tech USA (Strafford) - 1:00-2:30 PM (EST)

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

September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL

September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD

September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

September 17, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY

September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD

September 30-October 1, 2009 - Biotech Patents*** (American Conference Institute) - Boston, MA

October 14, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA

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

ACI Biotech Patents Conference

American Conference Institute (ACI) will be holding its 11th Advanced Forum on Biotech Patents on September 30 to October 1, 2009 in Boston, MA.  The conference will allow attendees to:

• Adopt a practical approach to incorporating follow-on biologics into your current patent strategies;
• Implement best practices for avoiding § 112 and § 103 rejections in light of Kubin, Ariad, and KSR for patenting biotech inventions including gene sequences;
• Establish effective strategies to overcome charges of inequitable conduct;
• Uncover ways to overcome increasing rejections related to diagnostic and treatment claims and integrate Bilski and related precedents into current strategies;
• Design global patent strategies that take into account developing standards abroad and patent harmonization efforts;
• Identify and utilize key European patent litigation strategies; and
• Optimize freedom to operate assessments.

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

• Preparing for the inevitable enactment of follow-on biologics legislation and adopting a practical approach to integrating FOB's into your patent strategies;
• Politics and patents:  Reassessing your patent strategy in light of current changes;
• Uncovering current trends and predicting future changes facing biotech patent practitioners;
• What's patentable?  The impact of Bilski and related precedents to diagnostic testing and treatment claims in the biotech patent industry -- to be presented in part by Patent Docs author Kevin Noonan;
• Deciphering the impact of In re Kubin on application of § 103 obviousness requirements;
• Strategies for patenting biotechnology inventions with evolving § 112 jurisprudence;
• Cultivating proactive prosecution strategies to overcome charges of inequitable conduct;
• Developing global biotech patent strategies and indentifying key rule changes in foreign patent offices;
• Spotlight presentation:  European biotech patent law;
• Tactics for breaking through the challenges associated with antibody patent prosecution; and
• Freedom to operate assessments for the biotech industry.

An additional master class entitled: "Drafting Successful Patent Applications for Biotechnology Inventions" will be offered on October 2, 2008.  The master class will provide attendees with the tools they need to draft strong applications that will be well positioned to withstand future challenges.

The agenda for the Biotech Patents conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.

The registration fee ranges from $2,195 (conference) to $2,795 (conference plus master class).  Those registering on or before August 21, 2009 will receive a $200 discount.  ACI will provide a $400 discount off the standard price to all Patent Docs readers who reference the discount code "MBHB" when registering.  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.

Patent Docs is a media partner of ACI's Biotech Patents conference.

Venue in Patent Litigation CLE

Strafford will be offering a CLE seminar entitled: "Venue in Patent Litigation:  New Strategies after Genentech and TS Tech USA" on August 4, 2009 from 1:00-2:30 PM (EST).  The CLE will examine the latest case law developments on patent venue, discuss the evolving venue standards in patent litigation, and offer strategies for pursuing and defending motions to transfer venue.  In particular, the speakers will address the following topics:

I.  New case law and its aftermath
    A.  28 U.S.C. § 1404(a)
    B.  In re Genentech Inc. (Fed. Cir. May 22, 2009)
    C.  In re TS Tech USA Corp. (Fed. Cir. Dec. 29, 2008)
    D.  Venue issues and declaratory judgments
II.  Factors impacting selection of venue   
    A.  Perceived biases for or against a particular party or class of parties
    B.  Speed to disposition
    C.  Winning percentages for parties
    D.  Percentage of transfers out
    E.  Local patent rules in a particular district
    F.  Court’s experience in handling patent cases
    G.  Likelihood of summary judgment being granted
III.  Best practices for pursuing and defending motions to transfer venue
    A.  Plaintiffs' strategies
    B.  Defense strategies
IV.  Patent reform and venue

The registration fee for the seminar is $297 ($362 for those desiring CLE credit).  Those interested in registering for the seminar, can do so here.

Bristol-Myers Squibb to Acquire Medarex

    By Sherri Oslick --

On Wednesday Bristol-Myers Squibb and Medarex, Inc. announced that they have entered into a definitive merger agreement by which Bristol-Myers Squibb will acquire Medarex for $2.4 billion.  With Medarex holding approximately $300 million in net cash and marketable securities, the purchase prices is effectively about $2.1 billion.  Under the agreement, Bristol-Myers Squibb will commence a cash tender offer on or about July 27, 2009 to purchase all of the outstanding shares of common stock for $16.00 per share, and the companies expect the tender offer to close approximately 30 days after its commencement.

Under the agreement, Bristol-Myers Squibb will acquire rights to ipilimumab, currently in Phase III clinical trials for the treatment of metastatic melanoma, as well as Phase II studies for the treatment of lung cancer and Phase III studies for the treatment of adjuvant melanoma and hormone-refractory prostate cancer.  Bristol-Myers Squibb will also acquire Medarex's UltiMAb Human Antibody Development System®, Medarex's Antibody-Drug Conjugate technology, rights to seven antibodies in clinical trials under Medarex's sole sponsorship and three other antibodies being developed jointly by Bristol-Myers Squibb and Medarex (including ipilimumab), and royalties based on a percentage of sales for SIMPONI™, STELARA™ and ILARIS®.

For additional information regarding the merger agreement, please see:
• Bristol-Myers Squibb's press release
• Medarex's press release

Additional Disclaimer:  MBHB represents Bristol-Myers Squibb on certain matters.  To the extent that this post contains any opinions, the opinions would be of Dr. Oslick and not Bristol-Myers Squibb or MBHB.