Patent Docs

MPEG LA Announces Formation of Gene Patent Pool

    By Donald Zuhn --

In a press release issued earlier this month, MPEG LA, LLC announced that it was launching an initiative to enhance the availability of gene patents for diagnostic testing.  MPEG LA, which describes itself as the world's leading packager of patent pools for standards and other technology platforms, would accomplish this objective by creating a new gene patent pool.  Currently, MPEG LA has formed patent pools for MPEG-2, ATSC, AVC/H.264, VC-1, MPEG-4 Visual, MPEG-2 Systems, 1394, and MPEG-4 Systems, so the company would be venturing outside of consumer electronics-related pools for the first time in creating the gene patent pool.

MPEG LA notes that it neither owns nor uses the patents in its pools, but rather seeks to create markets for patents that maximize profits for the patent holders and make utilization of patents affordable for manufacturers, consumers, and other users.  According to the company's press release, the new gene patent initiative will address "the market's need for nonexclusive access to patents for diagnostic genetics tests leading to personalized medical solutions that save lives and reduce healthcare costs."  While MPEG LA President and CEO Larry Horn described diagnostic genetics testing as "hold[ing] great promise as a driver of precision therapy," he noted that patent thickets and restrictive licensing arrangements threaten the delivery of such tests.  Pointing to the recent decision in Association for Molecular Pathology vs. U.S. Patent and Trademark Office, Mr. Horn contended that a solution that "balances social cost and open access with innovation incentive" was needed.

MPEG believes that by aggregating patent rights for existing and emerging tests that may lead to personalized treatment for diseases and disorders such as hereditary hearing loss in infants, breast cancer, ovarian cancer, cardiovascular disease, and Lynch syndrome, and licensing these patents nonexclusively for diagnostic use, it can assist laboratories, testing companies and researchers in obtaining the rights they need to design comprehensive diagnostic genetics tests, and as a result, make such tests widely available through multiple channels at affordable prices.

NVCA Report Shows First Quarter Drop in Venture Funding

    By Donald Zuhn –-

On Friday, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its latest MoneyTree Report on venture funding.  The study, conducted with PriceWaterhouseCoopers based on data from Thomson Reuters, indicates that venture capitalists invested $4.7 billion in 681 deals in the first quarter of 2010, a 9% decrease in dollars and 18% increase in deals as compared to the fourth quarter of 2009.  After adjusting its fourth quarter numbers, the NVCA determined that $5.2 billion had been invested in 832 deals, as opposed to its initial determination that $5.1 billion had been invested in 794 deals.  While the NVCA report indicated that both the dollars and deals were down from the fourth quarter of 2009, the NVCA noted that the numbers for the first quarter of 2010 were higher than for the same quarter in 2009, when $3.4 billion was invested in 635 deals.


It was a case of good news, bad news for the Life Sciences sector (biotechnology and medical devices) in the first quarter.  On the bad news side, Life Sciences investing dropped to $1.3 billion in 160 deals for the first quarter, which constituted a 26% drop in dollars and a 21% decrease in deals as compared with the fourth quarter of 2009.  On the good news side, Tracy Lefteroff of PricewaterhouseCoopers noted that "Life Sciences continues to be the number one sector for VC investing, with biotechnology being the absolute single-industry leader in dollars invested over the past four quarters."  In particular, the biotech sector drew $825 million in 99 deals in the first quarter.  However, these numbers still represented a 24% decrease in dollars (down from $1.1 billion in the fourth quarter) and a 14% drop in deals (down from 115 deals in the fourth quarter).

NVCA President Mark Heesen said that "[d]espite a great deal of economic uncertainty in the first quarter, the venture capital industry moved forward with a more active start than it did in 2009, which bodes well for the remainder of the year."  He expected venture funding to increase moderately throughout the remainder of 2010, in part because of the passage of health care reform legislation.

Additional information regarding the latest report can be found here.

For additional information on this and other related topics, please see:

• "VentureDeal Report Shows 65% Increase in Fourth Quarter Biotech Venture Funding," March 16, 2010
• "NVCA Report Shows Slight Drop in 4Q Venture Funding and Sharp Decline for 2009," January 24, 2010
• "Biotech/Pharma Companies Look to Market for Capital," December 29, 2009
• "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009
• "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
• "Investors Saw Biotech Rebound Coming," August 17, 2009
• "Is Biotech/Pharma Beginning to Bounce Back?" August 12, 2009
• "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009
• "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009

Court Report

    By Sherri Oslick --

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

Biovail Laboratories International SRL v. Paddock Laboratories, Inc.
0:10-cv-01571; filed April 15, 2010 in the District Court of Minnesota

Infringement of U.S. Patent Nos. 7,569,610 ("Modified Release Formulations of a Bupropion Salt," issued August 4, 2009), 7,572,935 (same title, issued August 11, 2009), 7,649,019 (same title, issued January 19, 2010), 7,563,823 (same title, issued June 21, 2009), 7,553,992 (same title, issued June 30, 2009), and 7,671,094 ("Bupropion Hydrobromide and Therapeutic Applications," issued March 2, 2010) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Biovail's Aplenzin ER (bupropion, used to treat depression).  View the complaint here.

Abbott Laboratories et al. v. Teva Pharmaceutical Industries Ltd. et al.
1:10-cv-00302; filed April 14, 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.

Bayer Schering Pharma AG et al. v. Teva Pharamceuticals USA, Inc. et al.
1:10-cv-00299; filed April 13, 2010 in the District Court of Delaware

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

Infringement of U.S. Patent No. 7,696,206 ("2-phenyl Substituted Imidazotriazinones as Phosphodiesterase Inhibitors," issued April 13, 2010) as part of Teva's filing of an ANDA to manufacture a generic version of plaintiffs' Levitra® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.

Baker v. Bayer Aktiengescellschaft Corp. et al.
2:10-cv-02271; filed April 13, 2010 in the Western District of Tennessee

• Plaintiff:  Charles R. Baker
• Defendants:  Bayer Aktiengescellschaft Corp. d/b/a Bayer AG; Bayer Corp.; Bayer Healthcare, LLC; Bayer Healthcare Pharmaceuticals, Inc.

False marking based on Bayer's marking of certain of its Baytril®, Cipro®, Ciprodex®, Fludara®, Legend®, and Proleukin® products indicating that these products are covered by one or more of U.S. Patent Nos. 4,670,444 ("7-amino-1-cyclopropyl-4-oxo-1, 4-dihydro-quinoline-and naphthyridine-3-carboxylic acids and antibacterial agents containing these compounds," issued June 2, 1987), 4,844,902 ("Topically applicable formulations of gyrase inhibitors in combination with corticosteroids," issued July 4, 1989), 4,357,324 ("Prodrug derivatives of 9beta-D-arabinofuranosyl-2-fluoroadenine," issued November 2, 1982), 4,808,576 ("Remote administration of hyaluronic acid to mammals," issued February 28, 1989), 4,530,787 ("Controlled oxidation of microbially produced cysteine-containing proteins," issued July 23, 1985), 4,569,790 ("Process for recovering microbially produced interleukin-2 and purified recombinant interleukin-2 compositions," issued February 11, 1986), 4,604,377 ("Pharmaceutical compositions of microbially produced interleukin-2," issued August 5, 1986), 4,748,234 ("Process for recovering refractile bodies containing heterologous proteins from microbial hosts," issued May 31, 1988), 4,572,798 ("Method for promoting disulfide bond formation in recombinant proteins," issued February 25, 1986), 4,853,332 ("Structural genes, plasmids and transformed cells for producing cysteine depleted muteins of biologically active proteins," issued August 1, 1989), and 4,959,314 ("Cysteine-depleted muteins of biologically active proteins," issued September 25, 1990), all of which are expired.  View the complaint here.

Baker v. Novartis Pharmaceuticals Corp. et al.
2:10-cv-02272; filed April 13, 2010 in the Western District of Tennessee

• Plaintiff:  Charles R. Baker
• Defendants:  Novartis Pharmaceuticals Corp.; Novartis Animal Health US, Inc.; Novartis Opthalmics, Inc.

False marking based on Novartis' marking of certain of its Denegard®, Milbemite®, and Ocupress® products indicating that these products are covered by one or more of U.S. Patent Nos. 4,278,674 ("Substituted 14-desoxy-mutilin compositions," issued July 14, 1981), 4,547,520 ("5-Oxime derivatives of milbemycins and veterinary and agricultural use thereof," issued October 15, 1985), 3,910,924 ("3,4-Dihydrocarbostyril derivatives and a process for preparing the same," issued October 7, 1975), and 4,309,432 ("Compositions for treating glaucoma containing a carbostyril," issued January 5, 1982), all of which are expired.  View the complaint here.

Baker v. Bausch & Lomb, Inc.
2:10-cv-02273; filed April 13, 2010 in the Western District of Tennessee

False marking based on Bausch & Lomb's marking of certain of its Xibrom® products with U.S. Patent No. 4,910,225 ("Locally administrable therapeutic composition for inflammatory disease," issued March 20, 1990) which is expired.  View the complaint here.

Baker v. Glaxosmithkline Healthcare, LP et al.
2:10-cv-02274; filed April 13, 2010 in the Western District of Tennessee

• Plaintiff:  Charles R. Baker
• Defendants:  Glaxosmithkline Healthcare, LP; Glaxosmithkline, LLC

False marking based on GSK's marking of certain of its Alli® products with U.S. Patent No. 4,598,089 ("Leucine derivatives," issued July 1, 1986) and its NicodermCQ ® products with U.S. Patent No. 5,004,610 ("Subsaturated nicotine transdermal therapeutic system," issued April 2, 1991), which are expired.  View the complaint here.

Warner Chilcott Co., LLC et al. v. Mylan Pharmaceuticals Inc.
1:10-cv-00059; filed April 9, 2010 in the Northern District of West Virginia

• Plaintiffs:  Warner Chilcott Co.; Hoffmann-La Roche Inc.
• Defendant:  Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007), licensed to Warner Chilcott, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Once-a-Month Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis).  View the complaint here.

Astrazeneca Pharmaceuticals LP et al. v. Anchen Pharmaceuticals, Inc. et al.
3:10-cv-01835; filed April 8, 2010 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
• Defendants:  Anchen Pharmaceuticals, Inc.; Anchen, Inc.

Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

The Fantastical Economics of the Gene Patenting Debate

    By Kevin E. Noonan --

At least since William Shockley's crackpot racial theories had their brief moment in the public discourse, it has been evident that merely achieving a Nobel Prize is not a guarantee of Solomonic wisdom, particularly outside the recipient's field of expertise.  Or perhaps it is just a reflection of the human reality that the fickle finger of genius touches even the most brilliant of us serendipitously and cannot be counted as a birthright of any constancy -- strokes of genius perhaps being more like strokes of lightening than we would care to admit.

This is particularly true of fields like economics, where the complexities of the subject matter (and the difficulties is fashioning meaningful "controls") frequently render conclusions that differ from reality -- if it were different, we could just transport the Fed to the University of Chicago's economics department and be done with it.  But all too often, economic predictions and even analyses fall short, not due to anything other than the impossibility of accuracy in describing these aspects of the world around us.

These characteristics of economic analysis come to mind in considering Professor Joseph Stiglitz's (at right) op-ed piece in Friday's Wall Street Journal, purportedly making "The Case Against Gene Patents."  (The Professor is joined by another Nobelist, John Sulston (below), chair of the Institute for Science, Ethics and Innovation at the University of Manchester; his Nobel was for medicine, awarded in 2002.)  Professor Stiglitz, who is at Columbia University, won the Nobel Prize in 2001 for his work on information assymetry.  He was Chair of the President's Council of Economic Advisors under President Clinton, and in addition to the Nobel, has won the John Bates Clark Medal (1979) and is "one of the most frequently-cited economists in the world" according to the University of Connecticut's Department of Economics.

And yet, Professor Stiglitz falls into the same errors that far lesser pundits and polemicists have been prey to in the gene patenting debate.  Of course, the Professor was part of the ACLU "team" that won a summary judgment verdict from a District Court judge last month, so he is hardly unbiased on the issue.  But he does make some idiosyncratic errors that illustrate how far afield from reality the anti-gene patenting folks are willing to go.

First, he states that "Myriad [has] had total control over the BRCA1 and BRCA2 genes since the 1990s.  No other companies have been able to do research on the genes without Myriad's permission."  Partially true, with regard to companies -- it should come as no surprise that patents prevent competing commercial activity.  But this is hardly total control, since extensive basic research has been done on these genes since Myriad (and their licensor, the University of Utah) were granted the patents.  And there are extensive commercial uses for the genetic information that could have been pursued by companies without infringing.  What other companies have not been able to do is practice the patented invention.

He then states that genes "contain the most fundamental information about humanity -- information that should be available to everyone."  As they are -- the information is not patented.  It has been a consistent theme of the ACLU and their friends that Myriad has somehow hijacked an individual's genes, when the fact is that gene patents do nothing of the sort.

Speaking as an economist, Professor Stiglitz then purports to introduce "a deeper understanding of the economics and science of innovation" that, he says, "leads to exactly the opposite conclusion" asserted by gene patent proponents, viz. that "private companies will not engage in genetic research unless they have the economic incentives created by the patent system."  Unfortunately, he then misconstrues the fundamental societal benefit conferred by the patent system -- not incentives to innovate, and not even incentives to commercialize, but the requirements for disclosure that are fundamental to the patent grant.  Again misunderstanding the difference between the patented article -- an isolated nucleic acid encoding a specific protein -- and the information content comprising the sequence, Professor Stiglitz asserts that patents "not only prevent the use of knowledge in ways that would most benefit society, they may even impede scientific progress."  His basis for this statement?  "Every scientific advance is built on those that came before it.  There is still a great deal to learn about our genes, particularly how they contribute to disease.  Gene patents inhibit access to the most basic information."

Once again, actually that is simply not the case.  Not only is there no evidence to support the statement that gene patents have impeded genetic research, there is copious evidence to the contrary -- the almost 8,000 basic scientific references that have been published since the Myriad patents at issue in the ACLU lawsuit were granted.  So the "patents impede scientific progress" argument does not seem to have benefited from the Professor's deeper understanding of either economics or science.

The next issue the Professor raises is the potential "patent thicket" that might arise in an era of personalized medicine when an individual's genetic information may be commonly obtained, at least for genetic loci identified as being involved in the etiology of common diseases.  Here he has a point, but it is a prospective one -- that era is not yet upon us, for one, and the types of claims invalidated by the District Court are not the ones that will impact personalized medicine.  The invalidated claims were, in large part, directed to the isolated genes themselves.  These claims were targets because they had sufficient potential political impact -- they supported the "don't patent my genes" campaign mounted by the ACLU to provide the background drumbeat of support from media and "grassroots" outlets, they could be easily fashioned into a "message" with great emotional impact, and they were the types of claims that are the bedrock of the biotechnology industry.

However, it is unlikely that any of these claims are infringed in performing the types of genetic testing either as performed by Myriad for the BRCA1 and BRCA2 genes, or that would be implicated in personalized medicine.  That is because these claims have the following structure (illustrated for BRCA1 but in common with most other claims to isolated genes):

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. [U.S. Patent No. 5,747,282]

In order to be infringed, this claim requires that the full-length BRCA1 gene be isolated, and that it encode the polypeptide identified by SEQ ID NO: 2.  For personalized medicine, on the other hand, the identification of disease-related polymorphisms in BRCA1 (or any other gene) will not require isolation of the full-length gene.  Instead, the polymorphic site will be identified, and only that fragment of the gene will need to be interrogated.  However this is done, it will not infringe a gene claim like claim 1 of the '282 patent unless the entire, full-length gene is isolated.  For economic if not scientific reasons, this will simply not be done because it doesn't need to be.

The Professor argues that in the brave new world of personalized medicine, "free sharing of information about genes will be vital to understanding the role of these variations in human disease and other traits" (emphasis added).  That, of course, is the world we have today, since the unpatentability of genetic information (and the patentability of isolated genes) has resulted in a free-flow of information from universities and governmental and non-governmental research institutes.  In short, there is no incentive to suppress this information, since the aspects that are patentable -- isolated genes -- can be protected.  Indeed, in view of the disclosure requirements of U.S. patent law -- specifically 35 U.S.C. § 112 -- such full and complete disclosure is required (said disclosure requirements not being an aspect, for example, of scientific research papers).  So as things now stand (before the ACLU took up the anti-gene patenting torch), "the basic data" of our genes is "freely available to everyone to interpret and develop."  What is not permitted -- during the temporary existence of a patent -- is commercial activity in competition with the patent holder or her licensee.

Of course, cost comes into the equation, and the fact that some women are not able to afford the Myriad test.  But those costs are not completely the consequence of the tests being patented, and any unavailability of the tests is more the result of the lunacy of permitting insurance companies instead of doctors to decide who does (and who does not) get needed care.  The Professor asserts that "[p]atents are also not necessary for ensuring that genetic tests come to market" based on the representations of  "[o]ther labs" that they are prepared to provide the test for "a few hundred dollars" rather than what Myriad charges.  This is not surprising -- these "other labs" didn't have to incur the start-up costs and attract the investors at a time when the success of Myriad's test was not assured.  It is always easier to copy than to innovate and commercialize, and the ex post facto reasoning that these "other labs" can now provide these tests more cheaply ignores the frank reality that the patent system provides for that -- these labs, and every other lab, will be able to enter the marketplace unfettered by Myriad's patent rights when the patents expire, sometime in 2014.

Professor Stiglitz saves some of the best (or worst) flights of fancy until the end of the piece.  The consequence of less private investment in commercializing the fruits of genetic research by banning patents would result in "a slight slowdown in private research expenditures," he says, which "can and should be made up for by an increase in public expenditures."  Governmental control over the means for production was tried, famously and unsuccessfully, in the 20th Century, and a non-existent limitation on genetic information hardly justifies trying that experiment again, particularly in a field like healthcare that is so important to everyone.  The uproar over this administration's healthcare initiative -- which hardly substituted private with public control over the healthcare system -- should convince dispassionate observers that the "public option" is not a viable one.

He also states that genes "are an example of 'basic knowledge'" like mathematical theorems, again neglecting the tangible/intangible, patent-eligible/ineligible distinction between genetic information and isolated genes.  He compares patenting genes to patenting Alan Turing's "mathematical insights," which if patented might have "greatly delayed" the development of the modern computer according to the Professor.  In this he neglects the unfortunate facts that Turing's insights were made in the 1950's, while the personal computer was developed in the 1970's - 80's.  Moreover, even if patented, Turing's patents would have expired 15-20 years before Steve Jobs and Bill Gates created the personal computer revolution; an equally likely case might be made that patent protection would have provided the incentive to commercialize the personal computer more rapidly by companies like IBM and Xerox.

His conclusion shows how badly Professor Stiglitz has assessed the reality of biotechnology innovation:

It's true that knowledge cannot be produced without cost, but there is a proven alternative:  government- and foundation-supported research in universities and research laboratories.

For over a generation, this is precisely what has happened:  universities and research institutes have performed the basic scientific research, and the potential to protect the practical applications of that research through patenting have provided the incentives (and the economic benefits to those universities and research institutes) for companies to commercialize them.  This partnership has propelled the U.S. to the forefront of biomedicine, providing biologic drugs and diagnostic methods for important and previously-intractable diseases.  The industry has in some ways been a victim of these successes:  the uninformed and willfully misinformed see these beneficial consequences and misunderstand or misrepresent the critical importance of patenting in its historical development.  Professor Stiglitz characterizes the District Court's decision as a "critical achievement"; in ways only an economist can be, he is completely wrong, and the evidence of the past 30 years provides ample evidence of that fact.

"Colbert Report" Enters Gene Patenting Fray

    By Donald Zuhn --

On last Thursday's "Colbert Report," host Stephen Colbert turned his attention to the Association of Molecular Pathology v. U.S. Patent and Trademark Office case that was decided on March 29.  Pointing to the result in the BRCA1/2 gene patent case, Mr. Colbert said he had found "a reason to be disappointed in the Federal benchwarmers," and noted that the decision would be "a huge blow to the biotech industry."  The Comedy Central comedian said that he was "furious at the ACLU," and instead was "with Kevin Noonan here . . . the man who defended Myriad's right to patent the genes."  By defending Myriad, Mr. Colbert was referring not to the District Court litigation, but rather Dr. Noonan's appearance on "60 Minutes" earlier this month (see "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story").  Mr. Colbert then played the portion of Dr. Noonan's interview in which he argues that patents are necessary in order to promote investment.  Now, Patent Docs is well aware that the "Colbert Report" is a satire of news shows that can be found on a certain conservative cable network, and that there is a possibility that Mr. Colbert may actually side with the plaintiffs and the ACLU.  However, when one strips away the jokes, the segment still makes a good case for gene patenting (or at least a better case than "60 Minutes") -- other than the part about 401 Man Seed knock-offs, of course.

The "Colbert Report" segment on gene patenting can be viewed below:

The Colbert Report	Mon - Thurs 11:30pm / 10:30c
Formula 01 Liquid Genetic Material
www.colbertnation.com
Colbert Report Full Episodes Political Humor Fox News

Conference & CLE Calendar

April 19-21, 2010 - Intellectual Property Counsels Committee (IPCC) Spring Conference & Meeting (Biotechnology Industry Organization) - New Orleans, LA

April 22, 2010 - "Bio-Similars: The New Litigation Landscape" (Intellectual Property Owners Association) - 2:00 - 3:00 PM (EST)

April 23-24, 2010 - 12th Comprehensive PCT Seminar (Franklin Pierce Law Center & World Intellectual Property Organization) - Concord, NH

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

April 27-28, 2010 - Corporate IP Counsel Summit (World Research Group) - New York, NY

April 29, 2010 - 26th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) - New York, NY

May 3-6, 2010 - 2010 BIO International Convention (Biotechnology Industry Organization) - Chicago, IL

May 11, 2010 - Law Symposium on Intellectual Property (George Washington University Law School, Howrey LLP & Cornerstone Research) - Washington, DC

May 18, 2010 - "The Role of Patent Agents in Intellectual Property in the Changing Economy" (Intellectual Property Law Association of Chicago) - Chicago, IL

May 20, 2010 - "The Federal Circuit: A National Court of Appeals: Approaching 30 Years" (U.S. Court of Appeals for the Federal Circuit) - Washington, DC

May 24-25, 2010 - Hatch-Waxman Boot Camp*** (American Conference Institute) - San Diego, CA

May 24-26, 2010 - Pharmaceutical & Biotech Patent Litigation Strategies*** (Pharma IQ) - London, England

May 26-27, 2010 - 7th International Forum on Freedom to Operate (C5) - Munich, Germany

June 11, 2010 - "The Future of U.S. Patent Law: An In-Depth Discussion on the Congress, the Courts, and the USPTO" (Patent Resources Group) - Alexandria, VA

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

PRG Looks at the Future of Patent Law

Patent Resources Group (PRG) will be offering a one-day conference on "The Future of U.S. Patent Law:  An In-Depth Discussion on the Congress, the Courts, and the USPTO" on June 11, 2010 from 9:00 AM to 4:30 PM at Buchanan Ingersoll and Rooney PC in Alexandria, VA.  According to the PRG website, the in-depth panel discussion will bring together some of the best minds in patent law to inform, discuss, and debate the future of U.S. patent law, with the event comprising brief lectures, lively panel discussions, and audience participation.  Among the topics to be discussed are U.S. patent reform, ideas and approaches to improve pendency and efficiency at the USPTO, and the latest developments in, and tensions between, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit.

The discussion will be moderated by Professor Michael Meurer of Boston University and co-author of "Patent Failure:  How Judges, Bureaucrats, and Lawyers Put Innovators at Risk," and include the following panelists:  Professor Michele Boldrin of the Department of Economics at Washington University in St. Louis, and co-author of "Against Intellectual Monopoly"; Tom Irving of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Patrick C. Keane of Buchanan Ingersoll & Rooney PC; and Samuel C. Miller, III of Buchanan Ingersoll & Rooney PC.

The registration fee for the event is $395.  Those interested in registering for the event, can do so here.

IPLAC Panel Discussion on Role of Patent Agents

The Intellectual Property Law Association of Chicago (IPLAC) will offer a panel discussion entitled:  "The Role of Patent Agents in Intellectual Property in the Changing Economy" on May 18, 2010 from 1:00 to 4:00 PM (CDT) at the John Marshall Law School in Chicago, IL.  The panel discussion, which is being sponsored by IPLAC's Patent Agents Committee in conjunction with the John Marshall Law School, will feature Heather Gerard, a Patent Liaison at Promega Corp.; Troy Groetken of McAndrews Held & Malloy LTD; Dr. Angeline-Rose Babel, a Patent Agent at McAndrews Held & Malloy LTD; David J. Bremer, a Patent Agent at Sabre Technical Services Corp.; and Bob Smith, an Attorney Search Consultant at Keith Ross & Associates, Inc.  The registration fee for the panel discussion is $5 (IPLAC members and students) or $10 (all other attendees).  Those interested in registering for the panel discussion, can obtain a registration form here.

C5 Freedom to Operate Forum

C5 (UK) will be holding its 7th International Forum on Freedom to Operate on May 26-27, 2010 in Munich, Germany.  The conference will provide practical advice on the biggest challenges facing freedom to operate (FTO) assessments, including:

• How to effectively manage the FTO process to ensure the lowest cost, the highest value, and the lowest risk;
• The latest EPO, U.S., and European national case law on claim interpretation and validity;
• The newest developments with SPC's and the pediatric exemption;
• When to buy a patent and when to license to best clear the developmental path;
• The latest on gene and research tool patenting and how it affects the FTO process; and
• How to manage a patent thicket.

In particular, C5 faculty will offer presentations on the following topics:

• Cost effective and high value FTO assessment strategies:  From searching to data retention;
• Patent validity and FTO search interpretation;
• How to thin patent thickets;
• Focus on U.S. developments;
• Update on the law of SPCs and how they affect FTO;
• Targeted patent and IP acquisition;
• Gene patenting and brave new worlds in FTO:  Where are we now in Europe?
• Privilege and confidentiality;
• Updates in patent claim construction in the context of FTO;
• Changes in U.S. Law:  Method patents and legislative reform; and
• Supporting evidence in patent applications.

An additional workshop will be offered from 2:15 to 4:45 pm on May 27, 2010.  The workshop, entitled "Reading and Analyzing Claims in Patents and Patent Applications for Establishing FTO" will provide information and insights for effectively establishing FTO.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee is £1898 ($2,831.15) for the conference and workshop and £1399 ($2,149.33) for the conference alone.  Those interested in registering for the conference can do so here, by calling +44 (0) 20 7878 6888, by faxing a registration form to +44 (0) 20 7878 6896, or by e-mailing registrations@C5-Online.com.

MedPointe Healthcare, Inc. v. Kozachuk (Fed. Cir. 2010)

    By Donald Zuhn --

On April 6, the Federal Circuit, in MedPointe Healthcare, Inc. v. Kozachuk, affirmed a decision of the District Court for the District of New Jersey enforcing a settlement agreement regarding the transfer of ownership of U.S. Patent Nos. 5,728,728, 5,942,540, and 6,515,019, which are directed to clinical uses of the drug Felbamate to treat neurological indications.  The three patents issued from applications that were filed by Defendant-Appellant Dr. Walter Kozachuk eighteen months after he left the employ of Carter-Wallace, Inc., the predecessor of Plaintiff-Appellee MedPointe Healthcare, Inc.  During his employment at Carter-Wallace, Dr. Kozachuk supervised clinical studies of Felbamate.  Under the terms of Dr. Kozachuk's employment agreement with Carter-Wallace, he agreed to assign to Carter-Wallace and its successors any and all inventions, discoveries, or improvements made, discovered, or conceived by him during his employment.

In April of 2004, MedPointe brought suit against Dr. Kozachuk, claiming ownership of the '728, '540, and '019 patents based on Dr. Kozachuk's breach of his employment agreement and duty of loyalty, and seeking to correct the patents' inventorship under 35 U.S.C. § 256.  In May of 2008, the parties participated in a settlement conference before a magistrate, and following four hours of negotiations, placed the terms of a settlement agreement on the record.  The terms included a $60,000 payment by MedPointe to Dr. Kozachuk; a transfer of all right, title, and interest in Dr. Kozachuk's patents to MedPointe; an agreement to arbitrate disputes over Dr. Kozachuk's ownership of a pending U.S. patent application; and a reservation of rights by MedPointe with respect to foreign patents or patent applications.  Shortly after the conference, MedPointe's counsel provided Dr. Kozachuk with a draft Settlement Agreement and Release and draft Assignment, but Dr. Kozachuk refused to sign the documents.  MedPointe responded by filing a motion to enforce the settlement agreement, and the District Court, adopting the findings and conclusions of the magistrate, ordered Dr. Kozachuk to execute the settlement documents and imposed sanctions for MedPointe's attorneys' fees and costs incurred enforcing the settlement.

On appeal, Dr. Kozachuk argued that he did understand the proceedings in May of 2008 and had no intention of settling, the settlement terms were unconscionable in that they required him to transfer patents assertedly worth millions of dollars for $60,000, and the settlement agreement was unenforceable because his attorney coerced him into settling by adopting a negative assessment of the case and threatening to withdraw as counsel.  MedPointe countered that the transcript of the settlement conference and Dr. Kozachuk's e-mails and sworn statements demonstrated that the parties agreed to the essential terms of a settlement at the May 2008 conference, there was no evidence that the $60,000 exchange for the transfer of Dr. Kozachuk's three patents was unconscionable, and there was no evidence that Dr. Kozachuk's counsel intended to (or did) pressure him into settling by threatening to withdraw.

In an opinion issued per curiam, the Federal Circuit agreed with MedPointe, rejecting all three of Dr. Kozachuk's arguments.  In response to Dr. Kozachuk's assertion that he did understand the settlement proceedings and had no intention of settling, the panel stated that "[t]he transcript of the proceedings clearly evinces both parties' intent to settle the suit brought by MedPointe on specific terms," noting that "[a]t no time did Kozachuk ask for clarification or in any way indicate that he did not understand that he was agreeing to a settlement on the terms stated by MedPointe's counsel."  The panel also rejected Dr. Kozachuk's argument that the settlement terms were unconscionable, determining that although Dr. Kozachuk contended that the '728, '540, and '019 patents were worth millions of dollars, he presented no evidence to establish their worth.  Lastly, the panel rejected Dr. Kozachuk's argument that his attorney's behavior coerced him into accepting the settlement, stating that "it strains credibility to think that Kozachuk, who had already retained new counsel once during the litigation and who worked with sophisticated business advisors, felt that he had no choice but to settle because his counsel indicated a desire to withdraw in light of their disagreements over the merits of the case."  The panel also noted that to the extent that Dr. Kozachuk was claiming inadequate representation by counsel, "it is well-established that a party is bound by the actions of his counsel and may not after the fact disavow counsel’s actions on his behalf."

Medpointe Healthcare, Inc. v. Kozachuk (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Gajarsa, and Moore
Per curiam opinion

USPTO Seeking Nominations for Public Advisory Committee Members

    By Sarah Fendrick --

In a notice published in the Federal Register (75 Fed. Reg. 15417), the U.S. Patent and Trademark Office (USPTO) announced that it is seeking nominations for three members to both the Patent and Trademark Public Advisory Committees.  The Public Advisory Committees serve to review the policies, goals, performance, budget, and user fees of the USPTO.  Each elected member will serve a term of three years.  Committee members must have "substantial backgrounds and achievement in finance, management, labor relations, science, technology, and office automation."  35 U.S.C. § 5(b)(3).

Nominations must be postmarked or electronically transmitted on or before June 11, 2010, and should be sent (along with the nominee's resume) by e-mail to PPACnominations@uspto.gov (for the Patent Public Advisory Committee); by facsimile to the Chief of Staff's attention at 571-273–0464; or by regular mail to the Chief of Staff's attention, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, Post Office Box 1450, Alexandria, Virginia 22313–1450.

GSK Senior Vice President to Start IP Consulting Firm

    By Donald Zuhn --

Sherry Knowles, Senior Vice President, Global Patents for GlaxoSmithKline has announced that she will be leaving GSK in June to start a consulting firm that will focus on IP management, business development, and monetizing assets in the area of pharmaceuticals, biopharmaceuticals, and medical devices.  Ms. Knowles (at right), who has led Global Patents at GSK since 2006, played a significant role in the successful challenge to the claims and continuation rules published by the U.S. Patent and Trademark Office in August of 2007, helping to secure a preliminary injunction enjoining the rules on Halloween in 2007, which injunction was made permanent by the U.S. District Court for the Eastern District of Virginia on April 1, 2008.  Last fall, the USPTO finally rescinded the controversial rules package before the Federal Circuit was to rehear GSK's and Dr. Tafas' appeal en banc.  Ms. Knowles has also been centrally involved in developing GSK's Knowledge Pool for the treatment of neglected tropical diseases in least developed countries.

Managing IP Magazine named Ms. Knowles one of the ten most influential people in Intellectual Property in 2008, and earlier this year, the New Jersey Intellectual Property Lawyers Association awarded Ms. Knowles, as the representative of GSK, the Jefferson Medal for exceptional contribution to Intellectual Property.  In February, Ms. Knowles published an article in the journal Science on "Fixing the Legal Framework for Pharmaceutical Research" (see "Takings' by Congress and the Courts").

Commenting on her upcoming move, Ms. Knowles told Patent Docs that she has thoroughly enjoyed her tenure at GSK and has been "very impressed with the caliber and devotion of the GSK staff in creating and protecting the market for new medicines."  She said she plans to continue her "strong support for the innovator community to help create an environment that fosters and protects investment."  Ms. Knowles noted that she will continue to lead Global Patents until June, and will continue to consult with GSK, subject to availability and the company's needs, after she departs.

For additional information regarding this and other related topics, please see:

• "'Takings' by Congress and the Courts," April 1, 2010
• "GSK Announces 'Open Innovation' Strategy to Combat Neglected Tropical Diseases," February 3, 2010
• "Alnylam to Donate RNAi Patents to Patent Pool," August 10, 2009
• "'New Rules' Officially Rescinded," October 8, 2009
• "Managing Intellectual Property Releases MIP 50," July 28, 2008
• "No April Fool's Joke -- Tafas and GSK Win on Summary Judgment," April 1, 2008
• "GSK Secures Injunction," October 31, 2007

In re Suitco Surface, Inc. (Fed. Cir. 2010)

    By Kevin E. Noonan --

It is a bedrock principle of patent practice that the U.S. Patent and Trademark Office gives the terms of claims under examination their broadest reasonable construction.  The rationale is that, in this way, the applicant has the opportunity to argue or amend the claims to be as broad as the prior art permits, and precludes the applicant from expanding beyond these limits the scope of granted claims it asserts against accused infringers.  Regardless of the soundness of this practice as a policy matter, as applied by the Office it can (and frequently does) exceed the boundaries of reasonableness:  the Office frequently takes a position regarding the scope of a claim term that is completely unreasonable.  As one example, the Office has, on occasion, determined that essentially any nucleic acid can hybridize with any other, since the complexity of almost any sequence contains short stretches of sequence found in many other sequences; such reasoning is then applied to reject any claim depending on specific hybridization.

The practice of construing claim terms unreasonably arose in an opinion handed down from the Federal Circuit today, In re Suitco Surface, Inc.  Patentees appealed final rejection in an ex parte reexamination based on anticipation.  The Federal Circuit, in an opinion by Judge Rader joined by Judges Prost and Moore, vacated and remanded the Office's grounds of rejection based, in part, on the unreasonable construction of claim terms that expanded their scope to encompass the prior art.

Reexamination was on U.S. Patent No. 4,994,514, which claimed a "floor finishing material" used on "floor surfaces [made] of wood, linoleum, terrazzo, [or] concrete," particularly as used on bowling lanes and athletic courts.  Representative claim 4 is in Jepson claim format (with emphasis added):

4.  On a floor having a flat top surface and an improved material for finishing the top surface of the floor, the improvement comprising:
    at least one elongated sheet including a uniform flexible film of clear plastic material having a thickness between about one mil and about twenty-five mils and
    a continuous layer of adhesive material disposed between the top surface of the floor and the flexible film, the adhesive layer releasably adhering the flexible film onto the top surface of the floor.

The opinion notes that the underlined claim terms had been construed during a prior litigation:  "material for finishing" to mean "a material that makes more durable the underlying surface of the floor, and is applied for that purpose," and "uniform flexible film" to mean "the material must be of a uniform thickness, and excludes material in which there are any variations in thickness."  The Federal Circuit in an appeal from grant of summary judgment against the patentee, disagreed, saying:

The text of claim 4 leaves little ambiguity as to the meaning of "material" - namely, at least one elongated sheet of a uniform flexible film of clear plastic having a thickness between about one and about twenty-five mils.  What remains in dispute is the precise meaning of the phrase "for finishing."  In the context of claim 4, "finishing" clearly refers to providing a clear, uniform layer on the top surface of a floor.  Significantly, there is no indication in claim 4 as to what level of durability, if any, the "finish" layer must have.  Thus, claim 4 implies a broad meaning for the term "finishing," which is consistent with the dictionary definition of "finish."  See, e.g., Webster's Ninth New Collegiate Dictionary 464 (1984) (defining "finish" as "the final treatment or coating of a surface," but not identifying any specific properties).

The District Court granted summary judgment a second time on remand, based on the "uniform flexible film" limitation.  The Federal Circuit again disagreed, based on whether the accused infringing article was required to have a uniform thickness throughout.  During the second remand, the defendant 3M (an amicus here) filed the ex parte reexamination request which resulted in a stay of the remand litigation and, ultimately, this appeal.  Claims 4-8 were finally rejected as being anticipated by U.S. Patent No. 3,785,102 to Amos and U.S. Patent No. 4,543,765 to Barrett, these rejections being the subject matter of this appeal.  (A third rejection, based on U.S. Patent No. 4,328,274 to Tarbutton was not appealed.)

Briefly, the Amos reference teaches "a floor covering pad comprising a plurality of plastic sheets connected together by a plurality of adhesive layers . . . designed to be used right before entry into a clean room or a hospital bay to remove dirt from the shoes or wheels of incoming traffic."  Each of the plurality of sheets is exposed one at a time and allowed to function to remove dirt until the adhesive on the sheet is filled, and then the sheet is removed and the next sheet is exposed and so forth.  The Barrett reference teaches "the use of a clear plastic film connected to a floor with an adhesive layer" to "temporarily protect a floor during construction."

During the reexamination, the examiner asserted rejections based on anticipation by these references, and the Board affirmed.  The Board construed the two relevant claim terms more broadly that the District Court:  the term "material for finishing the top surface of a floor" was construed to mean "requiring a material that is structurally suitable for placement on the top surface of a floor."  Thus, any layer placed above a floor fulfilled this requirement, "regardless of whether it was the top or final layer."  The term "uniform flexible film" was construed by the Board to mean "including, for example, a flexible film having the same thickness throughout, as well as a flexible film having the same textured surface throughout."  Suitco challenged the Board's decision affirming the asserted rejections based on these constructions, particularly asserting that none of the prior art cited the "uniform" limitation.

The Federal Circuit's opinion acknowledged the practice before the Office that claim terms are to be given "their broadest reasonable construction consistent with the specification," citing In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007), saying that its inquiry was thus whether the Board's construction was "reasonable," citing In re Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997).  Applying these principles, the Court directly held that the Office's construction of the term "material for finishing" was unreasonable:

The express language of the claims requires a "material for finishing the top surface of the floor."  '514 patent col.7 ll.67-68 (emphases added).  A material cannot be finishing any surface unless it is the final layer on that surface.  Otherwise, the material would not be "finishing" the surface in any meaningful sense of the word.

The PTO's proffered construction ignores this reality by allowing the finishing material to fall anywhere above the surface being finished regardless of whether it actually "finishes" the surface.  Indeed, according to the PTO, the finishing surface need only be "structurally suitable for placement on the top surface of the floor" -- i.e., several layers can be placed on top of the "finishing" layer.  If the PTO's construction were accepted, a prior art reference with carpet on top of wood, on top of tile, on top of concrete, on top of a thin adhesive plastic sheet anticipates the claims in question because an adhesive plastic sheet falls at some point in the chain of layers.  This construction does not reasonably reflect the plain language and disclosure of the '514 patent.

The problem, according to the Court, is that the Office has ignored the part of the standard that limits the bounds of what is "reasonable" to what is consistent with the specification:  the rubric is not merely that claims must be given "their broadest reasonable construction" but that they be given "their broadest reasonable construction consistent with the specification" (emphasis added).  Moreover, claims are to be read "in light of the specification as it would be interpreted by one of ordinary skill in the art," citing In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990).

The opinion particularly rejects the Office's reliance upon and justification of its construction because the patentee used the term "comprising" in the claim.  "The broadest-construction rubric coupled with the term 'comprising' does not give the PTO an unfettered license to interpret claims to embrace anything remotely related to the claimed invention," according to the opinion.  Citing Schriber-Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940) (perhaps on the panel's mind after its extensive citation in the en banc Ariad v. Eli Lilly appeal), the Court held that the Office must always construe claims "in light of the specification and the teachings of the underlying patent."  Here, both the "express language of the claim and the specification" mitigated against the Office's construction, and "require the finishing material to be the top and final layer on the surface being finished."

This opinion certainly provides ammunition for applicants facing unreasonable interpretations of claim terms during prosecution.  It will be interesting to see whether the Office adopts the Federal Circuit's restrictions on unfettered claim interpretation, or continues with its occasional flights of fancy in construing claim terms during prosecution.

In re Suitco Surface, Inc. (Fed. Cir. 2010)
Panel:  Circuit Judges Rader, Prost, and Moore
Opinion by Circuit Judge Rader

USPTO Launches Ombudsman Pilot Program

    By Sarah Fendrick --

Last week, the U.S. Patent and Trademark Office announced the launch of a new ombudsman pilot program that will provide patent applicants with more assistance with application processing problems.  The new pilot program allows applicants experiencing problems during processing to contact an ombudsman representative.  The ombudsman representative will call the applicant within one day for assistance in resolving the problem.  The problems raised will be tracked and used to construct a website that provides answers to commonly encountered issues.  Additional information regarding the pilot program can be found in a notice the Office published in the Federal Register (75 Fed. Reg. 17380).

In an Office press release announcing the launch, USPTO Director David Kappos stated that the "program is a direct response to feedback we've received from members of the patent community who have told us that they need a dedicated resource they can turn to when they have concerns about the prosecution of their application."  Director Kappos added that the Office was "always striving for ways to improve the quality and efficiency of patent examinations, and we believe this initiative is an important step forward on both these fronts."

Applicants can contact an ombudsman representative through the Ombudsman Pilot Program webpage.  While the pilot program is being made available to provide additional assistance, existing resources still remain available to patent applicants.

For additional information regarding this topic, please see:

• "USPTO Proposes Patents Ombudsman Pilot Program," November 12, 2009