Patent Docs

PRG Advanced Patent Courses

Patent Resources Group (PRG) will be holding its next group of Advanced Courses between April 11-17, 2010 in Bonita Springs, Florida.  Among the courses being offered are:

• ANDA Litigation: Critical Issues and Winning Strategies - April 14

• Fundamental Building Blocks for Creating and Enforcing the FDA Orange Book Listable U.S. Patent - April 15

• Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman and Litigation - April 15-17

• Chemical Patent Practice - April 11-13

• Comprehensive PCT Practice: How to Master Its Challenges - April 11-13

• Claim and Specification Drafting for a Single EPO/USPTO Patent Application - April 14-15

• Crafting & Drafting Winning Patents - April 11-13

• Federal Circuit Law (2008-2010) - April 11-13

• Obviousness in the Wake of KSR -- What Has and Has Not Changed - April 14

• Art and Science of Patent Searching - April 11-13

• "Designing Around" Valid U.S. Patents - April 15-17

• Patent Opinions, Strategy & Tactics - April 14

• Due Diligence Investigations - April 11-13

• Patent Infringement Litigation - April 15-17

• Patent Claim Interpretation - April 14

• Drafting Patent License Agreements - April 11-13

• Reexamination and Reissue Practice - April 15-17

• When, Why and How to Effectively Appeal to the USPTO Board of Patent Appeals and Interferences - April 14

• The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents - April 15-17

A syllabus for each course can be downloaded by clicking on the course title above.  The registration fee for each course is $995 (one day courses), $1,995 (two day courses), or $2,195 (three day courses). Those interested in registering for any of the courses can do so here.

BIO Sends Letter on SACGHS Report to HHS Secretary Sebelius

    By Donald Zuhn --

Last week, the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) issued its long-awaited report on gene patents.  While the report, entitled "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," indicates that gene patents and licensing practices concerning such patents have not had an adverse impact on patient access to genetic tests, it nevertheless includes a number of controversial recommendations.  The most controversial of these recommendations is a proposal to exempt gene patents from infringement liability.

On Thursday, the day before the report was issued, the Biotechnology Industry Organization (BIO) held a press conference to express concern about the report's recommendations (see "BIO Comes out Swinging against SACGHS Report").  Appearing at the press conference with BIO President and CEO Jim Greenwood were former Senator Birch Bayh, co-author of the Bayh-Dole Act; Dr. Brian Stanton, a member of the SACGHS Task Force on Intellectual Property and Access to Genetic Testing; Dr. Jim Davis, Executive Vice President, General Counsel and Secretary of Human Genome Sciences, Inc.; and Dr. Jon Soderstrom, the Managing Director of the Office of Cooperative Research at Yale University.

On Friday, BIO issued a press release noting that it had sent a letter to Health and Human Services Secretary Kathleen Sebelius (at right) regarding the "potentially harmful" recommendations of the SACGHS Report.  Joining Mr. Greenwood on the letter were representatives from the Association of University Technology Managers (AUTM); BayBio; Genetic Alliance; the Fox Chase Cancer Center; the Wisconsin Alumni Research Foundation (WARF); the WiSys Technology Foundation; Alkermes; Alnylam Pharmaceuticals; Bavarian Nordic Inc.; Bayer Corp.; Celera Corp.; Ceregene, Inc.; Clinical Data, Inc.; Fluidigm Corp.; Genzyme Corp.; GlobeImmune, Inc.; Human Genome Sciences, Inc.; Isis Pharmaceuticals, Inc.; Monsanto Co.; Novartis Oncology; Oncolytics Biotech Inc.; PsychoGenics Inc.; Regulus Therapeutics Inc.; Target Discovery, Inc.; and XDx.

The letter begins by expressing the group's "grave concerns about certain recommendations" in the SACGHS Report and urging Secretary Sebelius to "to reject these recommendations and ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved."  The signatories contend that "collaboration fostered by the Bayh-Dole Act -- and fueled by massive amounts of private investment" has yielded "tangible medicines, diagnostic tests, and other healthcare-related products that are saving lives, improving diagnoses, and alleviating suffering for millions of people worldwide."  The group states that "[t]he critical links in this chain are the availability and enforceability of patents to protect these investments, and a flexible system of technology transfer to foster commercialization."

Declaring that "[i]t is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation," the letter contends that the SACGHS report "contains certain recommendations that we believe would seriously hamper public/private collaborations and the commercialization of publicly-funded research."  The letter states that "[t]hese unprecedented recommendations -- based on limited anecdotal experiences and an internally contradictory evidentiary record -- include exempting from infringement liability the use of gene patents for the purpose of developing and commercializing diagnostic tests, and promulgating regulations that would limit exclusive licensing of federally-funded inventions for genetic diagnostic purposes."  The signatories argue that the report's recommendations "would chill future investment and innovation in this area, and would unfairly upset the investment-backed expectations of current patent owners and licensees," adding that the report's recommendations are "based on claims of a crisis in the current system that does not exist, supported by selective assertions that do not hold up under scrutiny."

The group of concerned organizations and companies states that "[i]n light of the risks of going back to the pre-Bayh-Dole era, no compelling case has been made to warrant the Committee’s recommendations," and concludes the letter by asking Secretary Sebelius to "carefully consider the views and experiences of those who actually bring biomedical innovation to suffering patients, and to look closely at the case studies themselves, before making any decisions with respect to the Committee's recommendations."

USPTO Remains Closed For February 11, 2010

    By Sarah Fendrick --

As a result of two recent blizzards in Washington DC, the city broke a record for annual snowfall on Wednesday that had stood for more than 120 years.  The old record of 54.4 inches, set in 1888-89, has now been surpassed by the 54.9 inches that has fallen this winter.  Last weekend's snowstorm alone dumped almost 18 inches of snow on DC, placing the storm fourth on DC's list of largest snowfalls.  The storm, which some have labeled "Snowmageddon" has resulted in a four-day shutdown of the U.S. Patent and Trademark Office.  As with the first three days of the shutdown, the USPTO will consider February 11, 2010 to be a "Federal holiday within the District of Columbia" under 35 U.S.C. § 21(b) and 37 C.F.R. §§ 1.6, 1.7, 1.9, 2.2(d), 2.195, and 2.196.

Debating Gene Patents - Round Four

    By Donald Zuhn --

In January, the gene patenting debate returned to National Public Radio when WBUR's "On Point" became the fourth NPR program to tackle the issue since last May, when a group of patients, physicians, academic researchers, and medical societies filed suit against the U.S. Patent and Trademark Office and Myriad Genetics, among others, in Association for Molecular Pathology v. United States Patent and Trademark Office (see Patent Docs reports here and here).  The first discussion, involving Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan, occurred in June on WAMU's "The Kojo Nnamdi Show" (see "Gene Patenting Debate Continues").  In August, Kevin Keenan, the Executive Director of the American Civil Liberties Union (ACLU) for San Diego and Imperial Counties; Stacey Taylor, a partner at DLA Piper; and Dr. Leonard Deftos, Professor of Medicine in Residence at the University of California, San Diego, and Adjunct Professor of Law at California Western School of Law, discussed the subject on KPBS's "These Days" program (see "Gene Patenting Debate Continues - Round Two").  And last December, Patent Docs author Dr. Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff, and Daniel Ravicher, the Executive Director of the Public Patent Foundation (PUBPAT), squared off in a third debate on the topic on NPR's "Science Friday" (see "Gene Patenting Debate Continues - Round Three").

In the most recent discussion, Dr. Sauer once again defended gene patenting, while one of the attorneys in the AMP case, Chris Hansen, who is Senior National Staff Counsel with the ACLU, argued against gene patenting.  The debate was moderated by "On Point" host Tom Ashbrook.

Dr. Sauer began the conversation by noting that "DNA molecules with human nucleotide sequences are patentable under the laws of almost all industrialized countries today, and the law has been clear for a long time."  Dr. Sauer indicated that as with natural substances like plant chemicals and antibiotics, patented genes had to be "transformed by human intervention into something that is sufficiently different from the natural state to qualify as something new and useful and man-made."  Demonstrating a grasp of the issue that has often appeared to elude other moderators, Mr. Ashbrook offered that "by the time [a gene has been] patented, it's been extracted and isolated and purified and made something different -- it's not just the handiwork of nature."

Mr. Ashbrook then asked Mr. Hansen to present his argument against the patenting of genes.  Mr. Hansen explained that it has been a long standing principle that while "creations of people" are patentable, "creations of nature," such as E=mc2, gravity, gold, or iron (Mr. Hansen's examples), are not.  According to Mr. Hansen, "a few years ago, the Patent Office veered off and stopped applying that principle, and then started patenting things were in fact products of nature or laws of nature or abstract ideas, and one of the places where they erred was in patenting the human gene."  When asked about the practical problems associated with gene patents, Mr. Hansen noted that he represented four national associations of physicians and pathologists who are willing to offer genetic testing to women throughout the country, but who were prohibited from doing so by Myriad.  He added that many women cannot afford the test being offered by Myriad.

Mr. Ashbrook then asked Dr. Sauer about the implications to the biotech industry if the District Court were to rule for the plaintiffs in the AMP case.  Dr. Sauer responded that the ACLU's lawsuit was "shortsighted" because" in trying to strike at these two particular patents and at this particular company . . . they are striking at all patent holders in biotechnology."  He noted that "patents on isolated and purified DNA substances don't only protect genetic testing technology, which is in the cross hairs in this lawsuit, . . . in many cases gene patents protect not genetic tests, but they protect actual medicines and actual therapeutics, which for their development require an investment of $1 to $2 billion over the course of ten years to reach the marketplace."

Mr. Hansen countered that "the fact that I represent most of the medical establishment of this country . . . would suggest that cries from industry that this [case] is going to hurt patients is probably misguided," adding that "the truth is there are lot of expert geneticists around the country who can do the testing that Myriad does, who can do it cheaper and even better, and Myriad is preventing that from occurring."  He also denied that a favorable decision for the plaintiffs would adversely impact the patenting of therapeutics or therapeutic methods.  Mr. Ashbrook, however, asked whether the biotech industry would develop such therapeutics or methods "without the incentive of owning it and the profit motive imbedded in that."  Mr. Hansen replied that "we know that the incentive here was not necessary for Myriad -- there were several other labs all over the country looking for the BRAC1 and BRAC2 gene; they were all just about as close as Myriad was to finding it."

With respect to Mr. Hansen's assertion that Myriad would not allow other scientists to look at the BRAC1 and BRAC2 genes, and instead had "locked them away for Myriad only," Dr. Sauer noted that it was his understanding that Myriad had never asserted its patents against scientists that do basic research, and further, that thousands of papers on the BRAC1 and BRAC2 genes had been published in the scientific literature since Myriad obtained the patents.  Dr. Sauer also addressed Dr. Hansen's criticism of the cost of Myriad's test by pointing out that a Duke University study had determined that Myriad's test was in fact no more expensive than comparable tests that were either not patented or not exclusively licensed.

While Mr. Ashbrook acknowledged that Myriad's failure to assert the patents and the thousands of published papers didn't "sound like a lock down," Mr. Hansen argued that you had "to distinguish between clinical [work] and research -- there's unquestionably a total lock down on clinical testing."  He also contended that Myriad prohibited basic researchers from divulging BRAC1 and BRAC2 test results to individuals participating in studies, so Myriad was "locking up some degree of the research and locking up all of the clinical practice."

Moving to the call-in portion of the program, Mr. Ashbrook took a call from a researcher who thought gene patenting was "a bad idea."  The caller then attempted to dispel the three "myths" of gene patenting by arguing that gene patents are not profitable, that they stifle innovation, and that gene patents are not necessary for the protection of therapeutics.  While conceding that "it is probably true that basic research doesn't need to be motivated by patents," Dr. Sauer asserted that "patents are critically necessary for . . . transforming the basic discoveries . . . that are done in the universities and research institutions in this country into real life products that benefit patients."

Noting that Dan Ravicher of PUBPAT had stated that the goal of the AMP litigation was to invalidate all gene patents, Mr. Ashbrook asked Mr. Hansen to discuss the likely impact of such a result on therapeutic development.  Mr. Hansen replied that the invalidation of all gene patents would have "a very positive impact," and contended that there would be "an explosion of scientific interest in [previously patented genes]," and "an explosion of new techniques, new treatments, [and] new drugs."

Taking a break from listener calls, Mr. Ashbrook introduced Dr. Wendy Chung to the program.  Mr. Ashbrook noted that Dr. Chung, who is the director of clinical genetics at Columbia University and a plaintiff in the AMP case, was also gene patent holder.  In response to the implication, Dr. Chung explained that for her, the biggest issue in the case was not the validity of the patents themselves, but rather the exclusive licensing of these patents.  She argued that there should be mechanisms by which universities and diagnostic companies interested in developing genetic tests could deal with gene patents by securing non-exclusive licenses.  Detecting that Dr. Chung's motivation for participating in the case differed from that of the ACLU and PUBPAT, Mr. Ashbrook asked whether gene patents encouraged innovation.  Somewhat surprisingly, Dr. Chung acknowledged that gene patents "act as a carrot" by incentivizing public and private research.  Noting that "it seems like you see both sides," Mr Ashbrook asked Dr. Chung why she nevertheless agreed to be a plaintiff in the case, to which she again responded that the problem was with the licensing, rather than the issuance, of the BRAC1 and BRAC2 patents.  Mr. Ashbrook inquired as to whether there was a "middle ground," and Dr. Chung suggested patent pools and non-exclusive licenses as two alternatives to a prohibition on gene patenting.

On the subject of licensing, Dr Sauer noted that a recent poll of BIO's members indicated that exclusive licenses were generally preferred, particularly where the licensed technology was going to be used in the development of a therapeutic product, but that non-exclusive licenses were granted in some cases.  As for Dr. Chung's "middle ground," Mr. Hansen offered that "we're certainly open to virtually any option that would change the current situation."

Mr. Hansen concluded the discussion by predicting that there would be "a vast increase in the amount of genetic research that takes place and a vast increase in the number of new tests and new drugs that are developed" if the plaintiffs in the AMP case receive a favorable decision from the District Court.  However, Dr. Sauer suggested that if the District Court finds for the plaintiffs, "we will lose the significant incentive to develop products like recombinant human growth hormone, insulin, erythropoietin, and other new therapies that we haven't even thought of today for the benefit of patients who are still waiting [for such therapies]."

Patent Office Remains Closed for February 10, 2010

    By Sarah Fendrick --

The U.S. Patent and Trademark Office remains closed today, February 10, 2010, due to weather.  The USPTO will consider February 10, 2010 to be a "Federal holiday within the District of Columbia" under 35 U.S.C. § 21(b) and 37 C.F.R. §§ 1.6, 1.7, 1.9, 2.2(d), 2.195, and 2.196.

For additional information regarding this topic, please see:

• "USPTO Closed on Monday and Tuesday, February 8-9, 2010," February 9, 2010

USPTO Closed on Monday and Tuesday, February 8-9, 2010

    By Sarah Fendrick --

On Monday and Tuesday, February 8-9, 2010, the U.S. Patent and Trademark Office was closed due to weather.  As a result of the closing, the USPTO will consider each of Monday and Tuesday, February 8-9, 2010 to be a "Federal holiday within the District of Columbia" under 35 U.S.C. § 21(b) and 37 C.F.R. §§ 1.6, 1.7, 1.9, 2.2(d), 2.195, and 2.196.  Thus, according to a USPTO notice issued earlier today, any action or fee due on either February 8-9, 2010 (or the preceding Saturday (February 6, 2010) or Sunday (February 7, 2010)) will be considered as timely for the purposes of, e.g., 15 U.S.C. §§ 1051(b), 1058, 1059, 1062(b), 1063, 1064, 1126(d), or 35 U.S.C. §§ 119, 120, 133, and 151, if the action is taken, or the fee paid, on the next succeeding business day on which the USPTO is open.

Any paper or fee properly deposited in the Express Mail Service of the USPS on Monday, February 8, 2010, or Tuesday, February 9, 2010, with a "date-in" of February 8-9, 2010, on the Express Mail mailing label will be considered filed as of the "date-in."

Correspondence transmitted electronically to the USPTO will be considered filed in the USPTO on the date the USPTO received the complete electronic transmission.  Correspondence submitted through the patent Electronic Filing System will still receive the date as indicated on the Acknowledgement Receipt and Trademark Electronic Application System filings will still receive the date indicated in the e-mail confirmation sent at the time of a successful filing.

Court Report

    By Sherri Oslick --

A note to our readers:  In an effort to catch up with recently filed biotech and pharma cases following a brief hiatus, Patent Docs presents this additional installment of Court Report.

Teva Women's Health, Inc. v. Lupin, Ltd. et al.
2:10-cv-00603; filed February 3, 2010 in the District Court of New Jersey

• Plaintiff:  Teva Women's Health, Inc.
• Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 7,320,969 ("Oral Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology," issued January 22, 2008) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Teva Women's Health's (formerly Duramed) Seasonique® (levonorgestrel/ethinyl estradiol, used as oral contraception).  View the complaint here.

Sepracor, Inc. v. Teva Parenteral Medicines, Inc. et al.
1:10-cv-00746; filed February 1, 2010 in the Southern District of New York

• Plaintiff:  Sepracor, Inc.
• Defendants:  Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 6,472,563 ("Formoterol Tartrate Process and Plymorph," issued October 29, 2002), 6,720,453 ("Formoterol Tartrate Polymorph," issued April 13, 2004), and 7,145,036 (same title, issued December 5, 2006) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Sepracor's Brovana® (arformoterol tartrate, used to treat bronchoconstriction in patients with chronic obstructive pulmonary disease).  View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Roxane Laboratories, Inc.
2:10-cv-00534; filed January 29, 2010 in the District Court of New Jersey

• Plaintiffs:  Endo Pharmaceuticals Inc.; Penwest Pharmaceuticals Co.
• Defendant:  Roxane Laboratories, Inc.

Infringement of U.S. Patent No. 5,958,456 ("Controlled Release Formulation (Albuterol)," issued September 28, 1999) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.

Warner Chilcott Co., LLC et al. v. Sandoz Inc.
2:10-cv-00511; filed January 28, 2010 in the District Court of New Jersey

• Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott (US), LLC; Mayne Pharma International Pty. Ltd.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used to treat a variety of bacterial infections).  View the complaint here.

Patent Profile: Fate Therapeutics to Receive First U.S. Patent for Induced Pluripotent Stem Cell Technology

    By James DeGiulio --

This week, Fate Therapeutics of San Diego, CA was issued a Notice of Allowance for U.S. Application No. 10/997,146 (U.S. Patent Application Publication No. 2008/0280362), titled "Methods for Reprogramming Somatic Cells."  With a priority date of November 26, 2003, the application is believed to contain the earliest allowed claims in the United States for induced pluripotent stem cell technology.  Upon issuance, the invention by Rudolf Jaenisch, M.D. (below left), founding member of the Whitehead Institute for Biomedical Research and scientific founder of Fate Therapeutics, will cover methods for generating pluripotent stem cells and compositions for identifying agents that enable the reprogramming of human somatic cells.

The application first describes the need for alternative methods of generating human pluripotent cells without using embryos, oocytes, or nuclear transfer technology and how reprogrammed somatic cells can enable autologous cell therapy, including the treatment of neurological diseases.  The application describes novel methods of reprogramming somatic cells by introducing certain pluripotency genes, such as Oct4, Nanog, or Sox2.  The application further covers compositions used in screening for agents to generate these pluripotent cells, including genes, classes of small molecules, or pluripotency proteins.  The application's lone Example describes the generation of a transgenic mouse by integration of an inducible Oct-4 gene and the resulting enhanced stem cell populations.

After a series of amendments, including an examiner's amendment, twelve total claims were allowed, including three independent claims:

17.  A primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, wherein the cell additionally comprises an exogenously introduced nucleic acid encoding a pluripotency protein and operably linked to at least one regulatory sequence, wherein the endogenous pluripotency gene is a gene that is expressed in a pluripotent embryonic stem cell, is required for the pluripotency of the embryonic stem cell, and is downregulated as the embryonic stem cell differentiates, and wherein the pluripotency protein is a protein expressed in a pluripotent embryonic stem cell, and is downregulated as the embryonic stem cell differentiates.

36.  A primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, wherein the first endogenous pluripotency gene encodes Oct4 or Nanog, and wherein the cell additionally comprises an exogenously introduced nucleic acid encoding Oct4, Nanog, or Sox2 and operably linked to at least one regulatory sequence.

38.  A composition comprising:
    (i)  a primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, and additionally comprising an exogenously introduced nucleic acid encoding Oct4, Nanog, or Sox2 and operably linked to at least one regulatory sequence; and
    (ii)  a candidate agent of interest with respect to its potential to reprogram a somatic cell, wherein the first endogenous pluripotency gene encodes Oct4 or Nanog.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at degiulio@mbhb.com.

Newsweek = Newspeak on Gene Patenting

    By Kevin E. Noonan --

Newsweek has always been Avis to Time Magazine's Hertz -- evidenced by an increasing difference in subscriptions (3.3 million versus 1.97 million on 2009).  So it isn't surprising that the magazine needs to do something to tweak its readership, even if that something is to distort its reporting on an important issue.  Which is, of course, what Newsweek has done on its science news page in the February 15th issue, in an article cleverly entitled "Who Owns Your DNA?"

The article, by "Science Editor" Susan Begley (at left), is of course not a science story but a legal one.  This is something Ms. Begley expressly acknowledges ("I defer to others on the legal merits here").  But that, of course, doesn't stop her from repeating many of the most egregious falsehoods in the debate, starting with the first sentence:

Ever since the first human gene was patented in 1982, there's been a near-universal "What??!!" when people hear that it's legal for someone to own the rights to our DNA.

Of course, no one owns anyone's DNA (something even the most vociferous participants in the debate acknowledge except, of course, the ACLU who use the lie emblazoned on buttons to inflame the passions of their constituents).  And Ms. Begley is careful to acknowledge the source of the lie, the late author Michael Crichton who (in)famously expressed these views on the Op-Ed page of the New York Times at the same time he was selling a book about the evils of gene patenting (perhaps Ms. Begley was concerned about infringing Mr. Crichton's copyright).

But she is not done, however, next reporting that the "scientific issues . . . have become serious enough in the past few years to call into question whether gene patents, meant to promote research, instead impede it, with no offsetting benefits."  Ms. Begley, unlike the rest of the news industry, seems not to have lost the "Search" button on her computer -- she acknowledges that "[t]housands of BRCA papers have been published, and in surveys few scientists say patents are an obstacle to research."  But she has an answer for that:  "But few isn't none."  And who are those none that she quotes?  None other than the plaintiffs in the ACLU suit.  Now, since Ms. Begley isn't a lawyer she can't be held to legal standards, but even a reporter should realize that the plaintiffs are not particularly reliable for refuting the overwhelming evidence that scientific research has not been impeded, such as the hundreds of researchers who have published thousands of research papers on the BRCA1 and BRCA2 genes since the patents at issue in the ACLU suit were granted.

Being facially even-handed, Ms. Begley quotes Rick Marsh, Myriad's general counsel that "Myriad 'has never told someone they cannot do [noncommercial] research on BRCA,'" and that "'[t]he notion that Myriad has hindered research is incorrect.'"  But rather than exploring whether two of the plaintiffs, Arupa Ganguly and Haig Kazazian, may have been performing research directed towards commercial applications (thus explaining why they, and they alone, have received a "cease and desist" letter from Myriad, and what may make them different from those hundreds of other BRCA1 and BRCA2 researchers), she reports that Dr. Ganguly was "scared off" from doing research by the letter and that Dr. Kazazian thinks gene patents "inhibit biomedical research."  That's their position and they're sticking to it, of course, but while understandable in a brief, only a writer with an unstated bias would report these sentiments uncritically.

The same could be said for a quote from another plaintiff, Dr. Wendy Chung of Columbia University, who alleges that there has been no testing to study the "normal variation" of mutations in the population.  That would come as quite a surprise to the research group (Haffty et al.) at the Department of Radiation Oncology at the Cancer Institute of New Jersey, whose paper "Breast cancer in young women (YBC): prevalence of BRCA1/2 mutations and risk of secondary malignancies across diverse racial groups" reported (in the October 2009 issue of the Annals of Oncology):

BACKGROUND: Despite significant differences in age of onset and incidence of breast cancer between Caucasian (CA), African-American (AA) and Korean (KO) women, little is known about differences in BRCA1/2 mutations in these populations.  The purpose of this study is to evaluate the prevalence of BRCA1/2 mutations and the association between BRCA1/2 mutation status and secondary malignancies among young women with breast cancer in these three racially diverse groups.  METHODS:  Patients presenting to our breast cancer follow-up clinics selected solely on having a known breast cancer diagnosis at a young age (YBC defined as age <45 years at diagnosis) were invited to participate in this study.  A total of 333 eligible women, 166 CA, 66 AA and 101 KO underwent complete sequencing of BRCA1/2 genes.  Family history (FH) was classified as negative, moderate or strong.  BRCA1/2 status was classified as wild type (WT), variant of uncertain significance (VUS) or deleterious (DEL).  RESULTS:  DEL across these three racially diverse populations of YBC were nearly identical:  CA 17%, AA 14% and KO 14%. The type of DEL differed with AA having more frequent mutations in BRCA2, compared with CA and KO.  VUS were predominantly in BRCA2 and AA had markedly higher frequency of VUS (38%) compared with CA (10%) and KO (12%).  At 10-year follow-up from the time of initial diagnosis of breast cancer, the risk of secondary malignancies was similar among WT (14%) and VUS (16%), but markedly higher among DEL (39%).  CONCLUSIONS:  In these YBC, the frequency of DEL in BRCA1/2 is remarkably similar among the racially diverse groups at 14%-17%.  VUS is more common in AA, but aligns closely with WT in risk of second cancers, age of onset and FH.

Perhaps someone should explain the inhibitory effects on breast cancer research occasioned by the Myriad patents to these researchers.  Ms. Begley's bias is revealed at the end of the article:

The justification for patents is that they encourage innovation: make a discovery, reap the financial rewards.  But I have real doubts that this applies in genetics.  Discoveries, not dollars, are what motivate most geneticists.  (I have criticized that before: because scientists care so little about turning basic discoveries into useful treatments, they have dropped the ball when it comes to helping patients.)  If being first, not being rich, is what drives gene researchers, it is hard to see why society should tolerate patents on human genes that act as even the slightest brake on discovery.

Ms. Begley should realize that she, and society, can't have it both ways -- either we want treatments and diagnostic testing for diseases or we don't.  These treatments and tests are developed by companies, not universities, and companies require investment, if only to maximize the likelihood that the treatments will work and the diagnoses will be reliable.  While discoveries would still occur in the absence of patents, commercialization would not, and Ms. Begley should consider those realities if she thinks scientists have "dropped the ball" when it comes to helping patients.  She says her goal is for basic research to help patients; if so, Ms. Begley should think long and hard about whether that aim is consistent with stories like hers directed instead to selling more copies of Newsweek.

Court Report

    By Sherri Oslick --

A note to our readers:  In an effort to catch up with recently filed biotech and pharma cases following a brief hiatus, Patent Docs presents this additional installment of Court Report.

Eli Lilly and Company v. Fresenius Kabi Oncology PLC
1:10-cv-00147; filed February 4, 2010 in the Southern District of Indiana

Infringement of U.S. Patent Nos. 4,808,614 ("Difluoro Aantivirals and Intermediate Therefore," issued February 18, 1989) and 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.

Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
1:10-cv-00085; filed February 3, 2010 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Pfizer Pharmaceuticals LLC; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.; CP Pharmaceuticals International CV
• Defendant:  Mylan Pharmaceuticals Inc.

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

Celsis In Vitro, Inc. v. Xenotech, LLC et al.
1:10-cv-00681; filed February 1, 2010 in the Northern District of Ilinois

• Plaintiff:  Celsis In Vitro, Inc.
• Defendants:  Xenotech, LLC; Sekisui Chemical Co. Ltd.; Sekisui Medical Co. Ltd.

Infringement of U.S. Patent No. 7,604,929 ("Cellular Compositions and Methods for Their Preparation," issued October 20. 2009) based on defendants' manufacture and sale of hepatocyte products, such as CryoXTreme, as well as providing in vitro drug testing services using pooled cryopreserved hepatocytes.  View the complaint here.

Alcon Research, Ltd. et al. v. Sandoz Inc.
1:10-cv-00106; filed January 27, 2010 in the Southern District of Indiana

• Plaintiffs:  Alcon Research, Ltd.; Alcon Laboratories, Inc.; Alcon Pharmaceuticals, Ltd.; Kyowa Hakko Kirin Co., Ltd.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997), 6,995,186 ("Olopatadine Formulations for Topical Administration," issued on February 7, 2006), and 7,402,609 (same title, issued July 22, 2008) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Alcon's Pataday® (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis).  View the complaint here.

Abbott Laboratories et al. v. Teva Pharmaceutical Industries Ltd. et al.
1:10-cv-00057; filed January 22, 2010 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA Inc.

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

Takeda Pharmaceutical Co. et al. v. Aurobindo Pharma Ltd. et al.
2:10-cv-00319; filed January 19, 2010 in the District Court of New Jersey

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Takeda Pharmaceutical Company Limited et al. v. Aurobindo Pharma Limited et al.
1:10-cv-00247; filed January 13, 2010 in the Southern District of New York

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the New Jersey complaint here.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. Lupin Pharmaceuticals, Inc. et al.
2:10-cv-00322; filed January 15, 2010 in the District Court of New Jersey

• Plaintiff:  Ortho-McNeil-Janssen Pharmaceuticals, Inc.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Ortho Tri-Cyclen Lo® (norgestimate and ethinyl estradiol, used for oral contraception).  View the complaint here.

Court Report

    By Sherri Oslick --

A note to our readers:  Patent Docs apologizes to our readers for the recent Court Report hiatus.  This Court Reporter was away at trial and has just now been able to come up for air.  We will catch our readers up in the next few postings.  Patent Docs thanks our readers for their patience.

Novartis AG v. Kappos
1:10-cv-00164; filed January 29, 2010 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. 7,569,337 ("Coumarins Useful as Biomarkers," issued August 4, 2009).  View the complaint here.

Cephalon, Inc. et al. v. Sandoz Inc.
1:10-cv-00175; filed January 26, 2010 in the District Court of Colorado

• Plaintiffs:  Cephalon, Inc.; Cephalon France
• Defendant:  Sandoz Inc.

Cephalon Inc. et al. v. Sandoz Inc.
1:10-cv-00055; filed January 22, 2010 in the District Court of Delaware

• Plaintiffs:  Cephalon, Inc.; Cephalon France
• Defendant:  Sandoz Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,297,346 ("Pharmaceutical Formulations of Modafinil," issued November 20, 2007), RE37,516 ("Acetamide Derivative Having Defined Particle Size," issued January 15, 2002), and 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the Colorado complaint here.

Purdue Pharma Products LP et al. v. Anchen Pharmaceuticals Inc.
8:10-cv-00103; filed January 22, 2010 in the Central District of California

• Plaintiffs:  Purdue Pharma Products LP; Napp Pharmaceutical Group LTD
• Defendant:  Anchen Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,591,452 ("Controlled Release Formulation," issued January 7, 1997) and 6,326,027 (same title, issued December 4, 2001) following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of plaintiffs' Ryzolt® (controlled-release tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the complaint here.

Cephalon, Inc. v. Kappos
1:10-cv-00131; filed January 22, 2010 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. 7,566,805 ("Modafinil Compositions," issued July 28, 2009).  View the complaint here.

Purdue Pharma Products LP et al. v. Lupin Ltd. et al.
1:10-cv-00049; filed January 21, 2010 in the District Court of Delaware

• Plaintiffs:  Purdue Pharma Products LP; Napp Pharmaceutical Group Ltd.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,254,887 ("Controlled Release Tramadol," issued July 3, 2001) and 7,074,430 ("Controlled Release Tramadol Tramadol [sic] Formulation," issued July 11, 2006) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiffs' Ultram® ER (tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the complaint here.

Galderma Laboratories LP et al. v. Tolmar Inc.
1:10-cv-00045; filed January 21, 2010 in the District Court of Delaware

• Plaintiffs:  Galderma Laboratories LP; Galderma SA; Galderma Research and Development SNC
• Defendant:  Tolmar Inc.

Infringement of U.S. Patent No. 7,579,377 ("Administration of 6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic Acid for the Treatment of Dermatological Disorders," issued August 25, 2009) following a Paragraph IV certification as part of Tolmar's filing of an ANDA to manufacture a generic version of Galderma's Differin® gel (adapalene, used in the topical treatment of acne vulgaris).  View the complaint here.

Pfizer Inc. et al. v. Teva Parenteral Medicines Inc. et al.
1:10-cv-00037; filed January 15, 2010 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Pharmacia Corp.; Pharmacia & Upjohn Co.; Pharmacia & Upjohn LLC; Pharmacia & Upjohn Co. LLC; C P Pharmaceuticals International CV
• Defendants:  Teva Parenteral Medicines Inc.; Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 5,688,792 ("Substituted Oxazine and Thiazine Oxazolidinone Antimicrobials," issued November 18, 1997) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Pfizer's Zyvox® (linezolid, used to treat bacterial infections).  View the complaint here.

Boram Pharm. Co. Ltd. v. Life Technologies Corp.
1:10-cv-00031; filed January 14, 2010 in the District Court of Delaware

Infringement of U.S. Patent No. 7,319,001 ("High Throughput System for Producing Recombinant Viruses Using Site-Specific Recombination," issued January 15, 2008) based on Life Technologies' manufacture and sale of its BaculoDirect Baculovirus Expression System under its Invitrogen brand.  View the complaint here.

Daiichi Sankyo Inc. et al. v. Impax Laboratories Inc.
1:10-cv-00032; filed January 14, 2010 in the District Court of Delaware

• Plaintiffs:  Daiichi Sankyo Inc.; Genzyme Corp.
• Defendant:  Impax Laboratories Inc.

Infringement of U.S. Patent Nos. 5,607,669 ("Amine Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4, 1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus).  View the complaint here.

USPTO Budget Request for FY 2011 and Perspectives from the Patent Community

    By Christopher P. Singer --

On February 1, 2010, the U.S. Patent and Trademark Office issued a press release announcing President Obama's $2.3 billion budget request for the USPTO for fiscal year 2011.

According to the statement, the amount of the budget request is intended to support and achieve the strategic objectives of the five-year plan for the USPTO as mapped out by Director Kappos and Commerce Secretary Locke.  Specific goals include reducing application pendency and the existing application backlog, improving patent quality, enhancing IP protection and enforcement, and upgrading the Office's IT infrastructure and tools in order to achieve total electronic processing in patents and trademark IT systems.  As first steps, the PTO plans to make progress toward these goals by restructuring management and workflow processes and hiring 1,000 patent examiners (search for positions here in each of fiscal year 2011 and 2012, specifically targeting former patent examiners and current IP professionals to increase initial examiner productivity.

The USPTO will continue to provide additional details concerning its five-year plan later this year.  The breakdown of the FY 2011 $2.3 billion budget includes forecasting almost $2.1 billion in fee collections, with the remainder (about $224 million) to come from interim fee increases.  The press release also notes that a section of the budget request relates to the administration's continuing support of "granting the USPTO fee-setting authority [rather than Congress] as a significant part of a sustainable funding model that would allow the director to propose and set fees in a manner that better reflects the actual cost of USPTO services."

On Tuesday, the Intellectual Property Owners Association (IPO) paid particular attention to the fee setting authority provision of the budget, noting in one of its "Daily News" items that, "the USPTO would be authorized to raise existing statutory fees in 2011 by rule with no limits specified."  The item clarified further that the IPO has consistently opposed prior proposals that would allow the USPTO to set its own fees.  IPO Executive Director Herb Wamsley (at left) was quoted in the article and characterized the fee-setting provision as "a blank check for the USPTO to raise fees that would open the door to increases far higher than 15 percent."

On Wednesday, Hal Wegner (at right) put the focus on the IPO's commentary concerning the proposed budget in his widely-read e-mail newsletter, stating that in order for real improvement to be made in the USPTO, the patent community would need to support the Administration in its many efforts, including "fee flexibility in the coming year."  In his criticism of the IPO's comments against the proposed budget, he noted that the patent community can play an important role in providing constructive criticism and simple suggestions to help improve Office procedures, "but it is yet another matter to fail to support important initiatives so necessary for fixing a broken system."

While it may well be that there is no real need to shift the fee setting authority from Congress to the USPTO, it also seems very unlikely that the agency would necessarily abuse such authority if it was granted.  In light of the effect that the recession has had on the Office's revenue, the administration should be well aware that applicants are fully prepared to make decisions based on economic necessity.  Further, we can look to the recent example of the interim fix the PTO has provided to patentees for requesting PTA reconsideration in certain patents based on the recent Wyeth decision.  The Office has provided a simple form for making the request.  And, rather than attempting to associate the request with a processing fee such as outlined in 37 C.F.R. § 1.705 ($200), the Office requires no fee for filing the request.  So it would seem that the current administration is not simply driven by maximizing fees and exploiting every revenue opportunity.

USPTO Extends Period for Public Comment and Period of Effectiveness for Recent Programs

    By Sarah Fendrick --

The U.S. Patent and Trademark Office has extended the time for public comment for two recent Office initiatives and has extended the period of effectiveness for a third Office initiative.

Extension of Period for Comments on Enhancement in the Quality of Patents

In December 2009, the USPTO published a notice in the Federal Register seeking public comment on the enhancement in quality of patents.  Specifically, the Office solicited public comment with respect to potential methods that may be employed by applicants and the USPTO to enhance the quality of issued patents, to identify appropriate indicia of quality, and to establish metrics for the measurement of the indicia.  The USPTO recently extended the deadline for public comment until March 8, 2010.

Written comments can be sent to patent_quality_comments@uspto.gov or can be submitted by mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kenneth M. Schor and Pinchus M. Laufer.

Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals; Extension of Comment Period on Potential Modifications to Final Rule

At the end of 2009, the USPTO published an advance notice of proposed rule making on potential modifications to rules governing practice before the Board of Patent Appeals and Interferences (BPAI) in ex parte patent appeals.  The USPTO has now extended the deadline for the public to submit comments on the potential rule modifications.  The new deadline is 5 p.m. (EST) on February 26, 2010.

Written comments on potential modifications to the final rule should be sent by electronic mail message over the Internet addressed to BPAI.Rules@uspto.gov or by mail addressed to:  Mail Stop Interference, Director of the United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Linda Horner, BPAI Rules.

Extension of the Patent Application Backlog Reduction Stimulus Plan

The USPTO has extended the patent application backlog reduction stimulus plan on a temporary basis.  Under this program, a small entity applicant may have an application accorded special status for examination if the applicant expressly abandons another copending unexamined application.  The plan has been extended until June 30, 2010.  After that deadline, the USPTO will consider whether to open the program to all applicants or discontinue the program altogether depending on the results.

For additional information on these topics, please see:

• "USPTO to Hold Public Meeting on January 20th to Discuss Appeals Rules Changes," January 13, 2010
• "USPTO Requests Comments on Enhancement of Patent Quality," December 13, 2009
• "USPTO Implements Patent Application Backlog Reduction Stimulus Plan," December 7, 2009

Conference & CLE Calendar

February 9, 2010 - Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality (Technology Transfer Tactics) - 1:00 - 2:30 PM (EST)

February 17-18, 2010 - Biotech & Pharmaceutical Patenting (IIR) - Munich, Germany

February 24-25, 2010 - 2nd Expert Forum on ITC Litigation & Enforcement (American Conference Institute) - New York, NY

March 1-2, 2010 - 4th Annual Patent Law Institute (Practising Law Institute) - New York, NY

March 2-4, 2010 - 6th Annual Biosimilars Conference (Visiongain) - Boston, MA

March 17-18, 2010 - 18th Forum on Biotech Patenting (C5) - Munich, Germany

March 18-19, 2010 - 4th Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - Washington, DC

March 22-23, 2010 - 4th Annual Patent Law Institute (Practising Law Institute) - San Francisco, CA

March 24-25, 2010 - FDA Boot Camp*** (American Conference Institute) - New York, NY

March 30, 2010 - "The Bilski Decision: Expert Strategies to Manage Its Impact on University IP" (Technology Transfer Tactics) - 1:00 - 2:30 PM (EST)

April 7-10, 2010 - 25th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) - Arlington, VA

April 27-28, 2010 - 4th Annual Paragraph IV Disputes*** (American Conference Institute) - New York, NY

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