Patent Docs

Biotech Venture Funding Sees Second Quarter Rebound

By Donald Zuhn --

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2013.  The report, which is prepared by NVCA and PriceWaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture capitalists invested $6.7 billion in 913 deals in the second quarter, which constituted a 12% increase in dollars and a 2% increase in deals as compared with the first quarter, when $6.0 billion was invested in 896 deals (see chart below, which shows total venture funding from the second quarter of 2009, when the Great Recession ended through the second quarter of 2013; data from MoneyTree Reports; click on chart to expand).

Venture Funding - Q2 2009 to Q2 2013

The biotechnology sector rebounded in the second quarter to place second behind the software sector, with funding increasing by 41% to $1.3 billion and the number of deals rising by 2% to 103.  The software sector once again took the top spot in funding -- with $2.1 billion invested -- marking the fifth straight quarter in which the software sector topped the $2 billion funding level (see chart below, which shows venture funding for the biotech (blue), medicial devices (red), and software (green) sectors since the third quarter of 2009, which was the last quarter in which the biotech sector outpaced the software industry; data from MoneyTree Reports; click on chart to expand).  Medical Device investment dropped by 1% with respect to both dollars and deals, with $543 million being invested in 71 deals.  Overall, eight of the seventeen sectors tracked by the NVCA saw decreases in dollars invested in the second quarter.

Venture Funding by Industry - Q3 2009 to Q2 2013

Biotechnology funding = blue; Medical devices = red; Software = green

With respect to the second quarter results, NVCA president Mark Heesen observed that "[i]n many ways it feels like the late 1990's with information technology driving venture investment and significantly outpacing other sectors when it comes to level of activity and momentum."  He also noted that "[l]ife sciences investment is poised for a slow and steady recovery, provided we can continue to see progress on the regulatory front."

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

• "Biotech Venture Funding Down 33% in First Quarter," April 30, 2013
• "Annual Venture Funding Drops for First Time in Three Years," February 4, 2013
• "Biotech Venture Funding Up 64% in Third Quarter," October 29, 2012
• "Venture Funding in Life Sciences Sector Drops 9% in Second Quarter," July 22, 2012
• "Biotech Venture Funding Drops 43% in First Quarter," May 3, 2012
• "Venture Funding Increased 22% in 2011," February 2, 2012
• "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
• "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
• "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
• "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

• "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

• "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

• "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

• "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
• "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 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.

UCB Inc. et al. v. Aurobindo Pharma Ltd., et al.
1:13-cv-01210; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

UCB Inc. et al. v. Accord Healthcare Inc. et al.
1:13-cv-01206; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

UCB Inc. et al. v. Alembic Pharmaceuticals Ltd. et al.
1:13-cv-01207; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Alembic Pharmaceuticals Ltd.; Alembic Ltd.; Alembic Pharma Ltd.

UCB Inc. et al. v. Amneal Pharmaceuticals LLC et al.
1:13-cv-01208; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Private Ltd.

UCB Inc. et al. v. Apotex Corp. et al.
1:13-cv-01209; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Apotex Corp.; Apotex Inc.

UCB Inc. et al. v. Breckenridge Pharmaceutical Inc. et al.
1:13-cv-01211; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Breckenridge Pharmaceutical Inc.; Vennoot Pharmaceuticals LLC

UCB Inc. et al. v. Glenmark Generics Inc. USA et al.
1:13-cv-01212; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Glenmark Generics Inc. USA; Glenmark Generics Ltd.

UCB Inc. et al. v. Hetero USA Inc. et al.
1:13-cv-01213; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Hetero USA Inc.; Hetero Labs Limited Unit V

UCB Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:13-cv-01214; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

UCB Inc. et al. v. Ranbaxy Laboratories Ltd. et al.
1:13-cv-01215; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Inc.

UCB Inc. et al. v. Sandoz Inc.
1:13-cv-01216; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendant:  Sandoz Inc.

UCB Inc. et al. v ScieGen Pharmaceuticals Inc. et al.
1:13-cv-01217; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  ScieGen Pharmaceuticals Inc.; Bactolac Pharmaceutical Inc.

UCB Inc. et al. v Sun Pharma Global FZE et al.
1:13-cv-01218; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

UCB Inc. et al. v. Watson Laboratories Inc. - Florida et al.
1:13-cv-01219; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Watson Laboratories Inc. – Florida; Watson Pharma Inc.; Actavis Inc.

UCB Inc. et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
1:13-cv-01220; filed July 10, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the Aurobindo complaint here.

Par Pharmaceutical, Inc. et al. v. Takeda Pharmaceutical Co., Ltd. et al.
3:13-cv-03151; filed July 9, 2013 in the Northern District of California

• Plaintiffs:  Par Pharmaceutical, Inc.; Handa Pharmaceuticals, LLC
• Defendants:  Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals North America, Inc.; Takeda Pharmaceuticals America, Inc.; Takeda Pharmaceuticals U.S.A., Inc.

Declaratory judgment of invalidity and/or non-infringement of U.S. Patent No. 8,461,187 ("Multiple PPI Dosage Form," issued June 11, 2013) in conjunction with Par's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease).  View the complaint here.

University of Utah Research Foundation et al. v. Ambry Genetics
2:13-cv-00640; filed July 9, 2013 in the District Court of Utah

• Plaintiffs:  University of Utah Research Foundation; Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche; Myriad Genetics
• Defendant:  Ambry Genetics

Infringement of U.S. Patent Nos. 5,709,999 ("Linked breast and ovarian cancer susceptibility gene," issued January 20, 1998), 5,747,282 ("17Q-linked breast and ovarian cancer susceptibility gene," issued May 5, 1998), 5,753,441 ("170-linked breast and ovarian cancer susceptibility gene," issued May 19, 1998), 5,837,492 ("Chromosome 13-linked breast cancer susceptibility gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), 5,654,155 ("Consensus sequence of the human BRCA1 gene," issued August 5, 1997), 5,750,400 ("Coding sequences of the human BRCA1 gene," issued May 12, 1998), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), and 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007) based on Ambry's offer of laboratory services, including clinical diagnostic and genomic services, including testing and analysis of BRCA1 and BRCA2 genes.  View the complaint here.

Conference & CLE Calendar

July 22, 2013 - IP & Diagnostics Symposium (Biotechnology Industry Organization) - Alexandria, VA

July 22, 2013 - Patent-Eligible Subject Matter After CLS Bank and Ultramercial: Implications of Two Key Federal Circuit Decisions (Law Seminars International) - 3:00 to 4:00 pm (Eastern)

July 24, 2013 - AIA and Patent Prosecution: Navigating the Ethical Grey Areas (Strafford) - 1:00 to 2:30 pm (EDT)

July 28-30, 2013 - 2013 Annual Meeting & Conference (National Association of Patent Practitioners) - San Diego, CA

July 30, 2013 - Are We Innovators, or Are We Trolls: The Slippery Slope of Defining A Patent Troll (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

July 31, 2013 - Battling Patent Trolls: Leveraging New Executive Orders, AIA and Other Tools (Strafford) - 1:00 to 2:30 pm (EDT)

July 31 to August 2, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 5-7, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 8, 2013 - Analyzing and Adapting to the Supreme Court's Myriad Ruling (Technology Transfer Tactics) - 1:00 to 2:00 pm (Eastern)

August 8-11, 2013 - 2013 Annual Meeting (American Bar Association) - San Francisco, CA

August 21, 2013 - Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma Patents (Strafford) - 1:00 to 2:30 pm (EDT)

August 22, 2013 - What are the Implications of CLS Bank Int'l v. Alice Corp. on Computer-Implemented Inventions? (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

September 17-18, 2013 - FDA Boot Camp (American Conference Institute) - Boston, MA

September 18, 2013 - Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls Minimizing Risks of Malpractice Liability and Ethics Sanctions (Strafford) - 1:00 to 2:30 pm (EDT)

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

Webinar on Battling Patent Trolls

Strafford will be offering a webinar/teleconference entitled "Battling Patent Trolls: Leveraging New Executive Orders, AIA and Other Tools" on July 31, 2013 from 1:00 to 2:30 pm (EDT).  Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt and Scott Marks, Senior Intellectual Property Counsel for St. Jude Medical will discuss recent developments and new tools to battle so-called patent trolls, including recent executive orders, the America Invents Act (AIA), and state and congressional action. The panel will discuss the impact of these efforts and offer best practices for combating patent trolls before and during litigation.  The webinar will review the following questions:

• How are the executive orders anticipated to impact patent troll litigation?
• How can counsel act to proactively minimize the threat of patent troll litigation?
• What defense strategies are effective in combatting patent trolls in litigation?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

CLE on Patent-Eligible Subject Matter After CLS Bank and Ultramercial

Law Seminars International (LSI) will be offering a one-hour telebriefing on "Patent-Eligible Subject Matter After CLS Bank and Ultramercial: Implications of Two Key Federal Circuit Decisions" on July 22, 2013 from 3:00 to 4:00 pm (Eastern).  Eric L. Sophir of Dentons will moderate a panel that includes Thomas W. Krause, Special Counsel for Intellectual Property Litigation, Solicitor's Office, U.S. Patent and Trademark Office; Michael B. Chernoff, Director of Legal Services, Patent Operations, Accenture; and Benjamin Lee, Legal Counsel, Twitter.  The panel will assess the implications of the CLS Bank and Ultramercial decisions and provide practical guidance for assessing patent-eligibility of an invention, particularly software and business methods patents.  Among the topics to be covered are:

• Impact of the decisions on applications and challenges to software and business methods patents
• Current test for assessing patent-eligibility under Section 101
• When and how the Abstract Idea Exception may apply
• Strategies for drafting claims for examination at the U.S. Patent & Trademark Office
• Predictions on future handling of this issue by the courts

A Q&A will follow the presentation and last for up to 30 minutes.

The registration fee is $150 per caller and $100 for each additional person on the same line who desires continuing education credit.  Those interested in registering for the telebriefing, can do so here.

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

By Kevin E. Noonan --

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse payment settlement agreements in ANDA litigation.  Such agreements have long been vilified by the Federal Trade Commission and have been the subject of extensive litigation that culminated in a decision by the U.S. Supreme Court last month that mandated these agreements are to be evaluated for antitrust liability under the "rule of reason" (see "Federal Trade Commission v. Actavis, Inc. (2013)").  In its decision the Supreme Court rejected the FTC's position that these agreements should be presumptively illegal or, in the alternative, subject to so-called "quick look" rule of reason assessment.

The study, commissioned by the GPhA and performed by the IMS (Intercontinental Marketing Services) Institute for Healthcare Informatics (an independent research organization with branches in the U.S., China, and India), should provide solid support for parties to such agreements should the FTC come calling with allegations of anticompetitive behavior.  (The likelihood of such inquiries is enhanced by the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-17) that require parties to ANDA settlements to submit these settlements to the FTC for review.)  The bottom line:  settlements of ANDA litigation in 33 different drug molecules resulted in a savings to consumers of $25.5 billion from 2005-2012, and are projected to provide an additional $61.7 billion through patent expiry for patents listed in the Orange Book for these drugs.  About one third ($8.3 billion) of the 2005-2012 total were savings to the Federal government.

The methodology used by IMS calculated the average brand and generic drug costs over time from IMS National Sales Perspective, described as the "industry standard" for pharmaceutical costs that captures 100% of the market; the volume of brand and generic drug activity was calculated from the National Prescription Audit, a measure of "dispensed" prescriptions from retail, long-term care pharmcies and prescription mail services; and dates of brand patent expiry were obtained from the FDA Orange Book.  The GPhA identified 65 molecules subject to ANDA settlement agreements, and 32 of these molecules were excluded from the study because the generic had not yet launched, there was insufficient data for other reasons, or the "calculated" generic price was not less than the branded drug price.

In addition to the cost savings, the study found that generic drugs were brought to market an average of 81 months (6.75 years) before patent expiry (i.e., the date a branded drug maker could have enjoyed the patent "monopoly rents" so often disparaged by the FTC in suits and public statements about these agreements (see "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation").

The GPhA issued the following statement regarding the results from this study:

"For years, opponents of pharmaceutical patent settlements with consideration have stated that settlements create a cost for consumers, the government and others.  This new analysis provides the most current, complete and transparent estimate of the impact of patent settlements on health costs, and it shows that the opposite is true," said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association.  "In particular, the new analysis estimates that patent settlements -- including those with consideration -- have led to billions in savings.  For example, the settlement involving Lipitor alone will save $22 billion over the next four years.  This is critical for lawmakers to understand, because any further restrictions on settlements will put these savings at risk."

The GPhA also noted that Department of Labor statistics show that drug expenditures have declined for the first time in 55 years during the time that branded and generic drug makers have entered into reverse payment settlement agreements.

The IMS Healthcare Institute states that its objectives include "[t]o provide key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information."  While the implications of its results may be disputed because the GPhA commissioned the study, the data speak for themselves.  It seems likely that these statistics will provide objective evidence of pro-competitive consequences of these settlements that both parties (branded and generic) will be able to use (persuasively) when and if the FTC challenges these settlements, either before the Commission or before the courts, or if private parties bring such challenges.  In view of the several bills introduced in this and other Congresses that would render such settlements illegal, it can be hoped that the study is presented to policymakers (in both the legislative and executive branches) so that laws and policies are developed that account for the facts, rather than the presumptions and prejudices, that surround such settlement agreements.

For additional information regarding this topic, please see:

• "Impact of Patent Settlements on Drug Costs: Summary of Findings," July 9, 2013

News from Abroad: Second Referral for the "Broccoli" Patent Case to the Enlarged Board of Appeal

Following the issuance of decision G2/07 in connection with the "Broccoli" patent, which discussed whether plant breeding methods were excluded from patentability as essentially biological processes for the production of plants, the Technical Board of Appeal in proceedings T83/05 have now referred further questions to the Enlarged Board of Appeal, relating to whether the exclusion of Article 53(b) extends to the products of essentially biological processes.

The issue of whether the exclusion of Article 53(b) prohibits the allowability of the patent's product claims was only raised during appeal proceedings and not during opposition proceedings.  However, as the respondent had consented to the examination of the objection and as the objection was relevant to the maintenance of the patent, the Technical Board of Appeal decided to consider it.  Further, similar questions had been referred to the Enlarged Board of Appeal regarding the "Tomato" case, which are currently pending as case G2/12.

The Technical Board of Appeal suggested that the product claims were not excluded under Article 53(b), as the plants were not defined by a multitude of characteristics resulting from a given genotype or combination of genotypes but only by a particular trait, which is not sufficient to define a plant variety without providing further information about the genotype.

However, the essentially biological process claims of the application would cover plants which are produced by the excluded process.  Further, the subject-matter of a product-by-process claim extends to products which are structurally identical to the products produced by the process but are produced by a different process, though no alternative processes are disclosed in the application.  A product claim generally provides protection for the process of making the product and so the product claims discussed in this case would protect any act of making the claimed plants, including those processes excluded from patentability.

In response to this argument, the respondent raised the possibility of including a disclaimer to waive a part of the prerogatives of the owner of a product patent, namely the essentially biological process for producing the plant itself.  This disclaimer was not deemed to be a usual disclaimer (which excludes part of the subject-matter defined in the claim) and the Technical board of Appeal indicated that it was doubtful whether such a disclaimer would be allowed.

The questions to be referred are:

1.  Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts?

2.  In particular:

• (a) Is a product-by-process claim directed to plants or plant material other than a plant variety allowable if its process features define an essentially biological process for the production of plants?

• (b) Is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?

3.  Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC?

4.  If a claim directed to plants or plant material other than a plant variety is considered not allowable because the plant product claim encompasses the generation of the claimed product by means of a process excluded from patentability under Article 53(b) EPC, is it possible to waive the protection for such generation by "disclaiming" the excluded process?

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.

Image of Brassica oleracea var. italica, Location: Maui, Foodland Pukalani (above) by Forest & Kim Starr, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.

Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

By Donald Zuhn --

On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer."  The Bayh-Dole Act, which was enacted in 1980, created a uniform patent policy among the many federal agencies that fund research, enabling small business and non-profit organizations -- including universities -- to retain title to inventions made under federally funded research programs.  In commemorating the Act's 30th anniversary in 2010, the U.S. Patent and Trademark Office noted that "[t]he legislation is credited with the creation of thousands of new companies and billions of dollars of direct benefits to the U.S. economy" (see "USPTO Recognizes 30th Anniversary of Bayh-Dole Act").

As a result of the concern that U.S. taxpayers should not have to pay businesses for inventions that the public has already paid for, legislators added a section to the Act that gave the government "march-in" rights.  Recently, a handful of groups filed a petition with the NIH requesting the agency to exercise these march-in rights over the anti-AIDS drug ritonavir, exclusively sold by Abbott Laboratories (see "Groups Petition for NIH Exercise of March-in Rights over Abbott Laboratories' Norvir®," which includes a discussion of the statute and regulation governing the exercise of the government's march-in rights under the Bayh-Dole Act, as well as a recent history of requests that the government exercise such rights).

In encouraging the NIH to exercise its march-in rights with respect to the Myriad's BRCA test, Sen. Leahy (above right) indicates that:

Myriad's genetic test, which was developed with federally-funded research, is truly important for public health.  Myriad is the only provider of this test because it is covered by patent protection.  Unfortunately, testimony before the United States Patent and Trademark (USPTO) revealed that Myriad does all of this testing in-house, and charges between $3,000 and $4,000.

The letter notes that while the Supreme Court determined last month in Association for Molecular Pathology v. Myriad Genetics, Inc. that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, the Court also held that cDNA is patent eligible because it is not naturally occurring (albeit with the caveat, which the letter does not address, that a "very short series of DNA may have no intervening introns to remove when creating cDNA," and therefore, "a short strand of cDNA may be indistinguishable from natural DNA").  "As a result," Sen. Leahy suggests that "Myriad may continue to be the only company able to provide women with the genetic testing they need to make important health care decisions."

Sen. Leahy explains that because "the Bayh-Dole Act . . . gives the government tools, known as 'march-in rights,' to provide greater access to the subject invention in appropriate situations," "[t]he government can require the patent holder to grant a license to the patent on reasonable terms."  He notes that "[i]f the patent owner refuses, the government can directly license the patent in limited circumstances, including if it 'is necessary to alleviate health or safety needs which are not reasonably satisfied' by the patentee."  Indicating that "Myriad's patents were based in part on federally-funded research," and stating that the health benefits and healthcare cost savings of genetic testing for breast and ovarian cancer are clear, Sen. Leahy expresses "concern[] that the health needs of the public are not reasonably satisfied by the patentee in this situation because testimony presented to the USPTO made clear that many women are not able to afford the testing provided by Myriad."  He therefore encourages the Director to consider using the government's march-in rights with respect to the Myriad's BRCA test.

Interestingly, of the ten patents that Myriad recently asserted against Ambry Genetics (see "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes"), only two (U.S. Patent Nos. 5,747,282 and 5,753,441) are assigned (on their face) to the U.S. government (as well as to Myriad and the University of Utah Research Foundation).  Of the remaining patents, one (U.S. Patent No. 5,709,999) is assigned to Myriad, the Centre de Recherche du Chul (Sainte-Foy, Canada), and the Cancer Institute (Tokyo, Japan); two (U.S. Patent Nos. 5,837,492 and 6,033,857) are assigned to Myriad, Endo Recherche, Inc. (Sainte-Foy, Canada), HSC Research & Development Ltd. (Toronto, Canada), and the Trustees of the University of Pennsylvania; three (U.S. Patent Nos. 5,654,155, 5,750,400, and 6,051,379) are assigned to OncorMed, Inc.; one (U.S. Patent No. 6,951,721) is assigned to Gene Logic Inc.; and one (U.S. Patent No. 7,250,497) is assigned to Myriad alone.  A search of the USPTO's Assignments on the Web for Patents (AOTW-P) database indicates that Myriad assigned the '999, '492, and '857 patents to the University of Utah Research Foundation, and that the '155, '400, '379, and '721 patents are assigned to Gene Logic Inc. and Myriad.

Patent Docs thanks Hal Wegner for alerting the patent community to Sen. Leahy's letter.

New Patent Litigation Bill Introduced in House

By Donald Zuhn --

Last week, Rep. Hakeem Jeffries (D-NY) introduced the "Patent Litigation and Innovation Act of 2013" (H.R. 2639) in the House.  The bill, which would add procedural requirements for patent infringement suits, is related to the "Patent Abuse Reduction Act of 2013" (S. 1013), which was introduced in the Senate in May (see "Congress Continues Efforts to "Reform" U.S. Patent Law").

Like S. 1013, H.R. 2639 would require a party alleging infringement to include in its complaint, counterclaim, or cross-claim an identification of each patent, and each claim of each patent, allegedly infringed, as well as a specific identification of each accused instrumentality alleged to infringe the claim, the party alleging infringement would also be required to provide "a description of the principal business of the party alleging infringement" and to identify co-owners, assignees, and exclusive licensees of the asserted patent.  Unlike the Senate version of the bill, the House version would not require a party alleging infringement to include a list of other complaints (of which the party alleging infringement has knowledge) asserting the same patents; whether the asserted patents are subject to any licensing term or pricing commitments through any agency, organization, standard-setting body, or other entity or community; or the identity of any person having a direct financial interest in the outcome of the action.

In addition, while S. 1013 would limit discovery prior to claim construction "to information necessary for the court to determine the meaning of the terms used in the patent claim, including any interpretation of those terms used to support the claim of infringement," H.R. 2639 would permit a court to stay discovery "if the court determines that a ruling relating to the construction of terms used in a patent claim asserted in the complaint in the action is required."  The House bill also includes provisions for a stay of action against secondary parties, which would allow a court to "grant a motion to stay all or part of the action as to a secondary party with respect to infringement related to a primary party in the same or another action concerning the same apparatus, product, feature, device, method, system, process, function, act, service, or other instrumentality, in whole or in relevant part, of the disputed patent of the primary party" provided that certain conditions are met.

In addition, the House bill provides provisions for sanctions for abusive litigation.  In particular, the legislation would require a court, upon final adjudication of "any civil action arising under any Act of Congress relating to patents," to "include in the record specific findings regarding compliance by each party and each attorney representing any party with each requirement of Rule 11(b) of the Federal Rules of Civil Procedure as to any complaint, responsive pleading, or dispositive motion."

A statement released on Rep. Jeffries' website noted that the new legislation "represents a bipartisan effort to promote American innovation and job creation in the technology ecosystem by addressing the growing problem of abusive patent litigation."  Rep. Jeffries (above left) suggested that the legislation was needed because of "[t]he explosion of patent troll activity [that] diverts resources away from research and development, hinders innovation and stifles entrepreneurship."  Co-sponsor Rep. Blake Farenthold (R-TX) stated that "Americans need to know they are safe from abusive litigation when they buy a product off the shelf and use it for its intended purpose," adding that "[t]he solutions proposed in [H.R. 2639] will deter patent trolls without impeding the rights of responsible intellectual property holders."

After being introduced, the bill was referred to the House Committee on the Judiciary.

Court Report - Part II

By Sherri Oslick --

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

Aptalis Pharma US Inc. et al. v. Mylan Pharamaceuticals, Inc. et al.
3:13-cv-04158; filed July 5, 2013 in the District Court of New Jersey

• Plaintiffs:  Aptalis Pharma US Inc.; Aptalis Pharma Canada Inc.
• Defendants:  Mylan Pharamaceuticals, Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,217,083 ("Mesalamine Suppository," issued July 10, 2012) and 8,436,051 (same title, issued May 7, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Aptalis' Canasa® (mesalamine rectal suppository product, used to treat active ulcerative proctitis).  View the complaint here.

Novartis AG et al. v. Accord Healthcare, Inc. USA et al.
1:13-cv-01013; filed July 3, 2013 in the District Court of the District of Columbia

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
• Defendants:  Accord Healthcare, Inc. USA; Intas Pharmaceutical Ltd.

Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Novartis' Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.

Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA, Inc.
1:13-cv-04606; filed July 2, 2013 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Grunenthal GmbH
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 8,337,888 ("Pharmaceutical Formulation Containing Gelling Agent," issued December 25, 2012) and 8,309,060 ("Abuse-Proofed Dosage Form," issued November 13, 2012) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Alpex Pharma, S.A. et al. v. Zydus Pharmaceuticals USA, Inc. et al.
1:13-cv-04076; filed July 1, 2013 in the District Court of New Jersey

• Plaintiffs:  Alpex Pharma, S.A.; Citius Pharmaceuticals, LLC.; Prenzamax, LLC
• Defendants:  Zydus Pharmaceuticals USA, Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 6,149,938 ("Process for the Preparation of a Granulate Suitable to the Preparation of Rapidly Disintegrable Mouth-Soluble Tablets and Compositions Obtained Thereby," issued November 21, 2000) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Alpex's Suprenza® (phentermine hydrochloride, used to treat obesity).  View the complaint here.

Trivitis, Inc. v. Primus Pharmaceuticals, Inc.
3:13-cv-00352; filed July 1, 2013 in the District Court of Nevada

Infringement of U.S. Patent No. 6,562,864 ("Catechin Multimers as Therapeutic Drug Delivery Agents," issued May 13, 2003) based on Primus' manufacture and sale of its Limbrel product (flavocoxid and citrated zinc bisglycinate, used for the clinical dietary management of the metabolic processes of osteoarthritis).  View the complaint here.

Smith & Nephew, Inc. v. Rea (Fed. Cir. 2013)

By Nicole Reifman --

Last week, in Smith & Nephew, Inc. v. Rea, the Federal Circuit reversed a decision of the Patent Trial and Appeal Board, finding U.S. Patent No. 7,128,744 (the '744 patent), which is owned by Synthes, to be obvious.  Smith & Nephew originally submitted a request for reexamination of the '744 patent, which was granted.  Upon review under reexamination, the Examiner found all of the claims of the patent to be obvious.  Synthes appealed the Examiner's decision to the Patent Trial and Appeal Board, which reversed the Examiner's decision with respect to certain claims (claims 1-23 and 32).  Smith & Nephew then appealed the Board's decision to the Federal Circuit.  Despite the deferential standard of review (substantial evidence) to be applied for a Board decision, the Federal Circuit found claims 1-23 and 32 to be obvious.

Both parties and the Court treated claim 1 as representative for all claims under appeal.  Claim 1 is related to a bone plating system designed to improve the stability of a bone fracture in a long bone.  The claimed system includes a plate with a shaft portion that runs along the outside of a fractured bone, and a flared head portion to accommodate the wider portion of the bone near a joint.  Predrilled holes are formed on both the shaft and the head portions of the plate.  The dispute in the case focused on the structure of the holes in the head portion of the plate; in particular, whether it would have been obvious at the time of the invention to design a bone plate in which all of the holes in the plate's head portion were conically tapered and at least partially threaded, as required by claim 1.

A number of prior art references were applied.  First, the Court found that a prior art Synthes condylar buttress plate disclosed most of the limitations of claim 1 of the '744 patent, including a head portion of a plate with at least three screw holes.  An article by Kenneth Koval and an FDA submission by Synthes (dubbed the K982222 reference) each disclosed modifying the Synthes prior art plate to include partially threaded holes to engage the threads on the head of a locking screw.  A Synthes patent, U.S. Patent No. 5,709,686 (the '686 patent) disclosed anchor holes that were all partially threaded and intended to accommodate either locking screws or compression screws.  Another article, by N.P. Haas, disclosed holes in the head portion of a plate that were both conically tapered and partially threaded; however, unlike the other prior art plates, the Haas plate merely stabilized the femur and did not contact, let alone, compress, bone fragments directly.

The Board found that these prior art references did not teach or suggest the exclusive use of conical, partially threaded holes in a condylar buttress plate because it was not believed that conical, partially threaded holes could be used with non-locking (compression) screws to provide compression against a bone.  The Court held that the Board erred in its analysis, since claim 1 of the '744 patent does not require that the screws drilled into the head holes provide compression ("the patentability of the invention . . . turns on the structure of the holes, not the special nature of the non-locking screw"), and, contrary to Synthes' suggestion that compression is needed in the head portion of the plate, the specification of the '744 patent indicated that locking screws are sometimes used in all of the threaded holes of the head portion of the plate.

The Court also found the Board erred in determining the prior art showed that using a compression screw in a conical, partially threaded hole would cause the screw to undesirably protrude above the line of the plate.  The Court pointed to a chamfer disclosed in the Haas reference that could be used to countersink a screw head so that it does not sit above the top surface of the plate.  The Board had disregarded the Haas chamfer because a drawing in Haas showed the chamfer to be too narrow to prevent protrusion of a compression screw.  The Court held that the Board erred in disregarding the Haas chamfer, and that the chamfer should not be limited to the narrow one shown in the drawing, as chamfers are "conventional features in the art and can be sized to accommodate screw threads of varying heights."  The Court also reasoned that a person of ordinary skill in the art would not have necessarily selected a "rounded-bottom head" that would stick out from the plate, but would have chosen an appropriately shaped screw for the plate holes.

Finally, the Court held that the Board erred in relying on distinguishing the partially threaded, partly conical, holes discussed in the '686 patent from the fully conical threaded holes in the Haas reference for obviousness.  The Court noted that the '744 patent discloses that partially threaded holes, regardless of shape, could provide compression, and held that "a person of skill could adjust a plate hole's geometry -- whether conical, cylindrical, or otherwise -- to fit any standard screw without sacrificing compression."

Thus, the Court held that the motivation to combine the holes in the Haas reference with the prior art condylar plates was there:  the use of threads in all of the holes offers flexibility to the surgeon to choose either locking or non-locking (compression) screws in any of the holes in the head portion of the plate.

The Court additionally held that the Board should have considered two other prior art references that the Board had discounted because the Examiner had not relied on the references in making his rejections.  The fact that the Examiner had incorporated Smith & Nephew's arguments by reference (which included the two references) allowed for Board review of those references.  The Court held that the two references were "clearly probative" regarding whether it was known at the time of the invention that non-locking screws could be used in threaded holes.

Thus, the Court, despite taking a deferential approach to the Board's findings due to the substantial evidence standard of review, concluded that the Board erred in its decision, and reversed the Board's decision for claims 1-23 and 32.  In addressing the deference owed the Board, The Court noted that it did not dispute the Board's resolution of the factual questions of the case, and that the Board's decision was "mainly the result of the [Board's] analytical errors," as discussed above.

Smith & Nephew, Inc. v. Rea (Fed. Cir. 2013)
Panel: Circuit Judges Dyk, Bryson, and Wallach
Opinion by Circuit Judge Bryson

ABA Journal Accepting Nominations for 7th Annual Blawg 100

The ABA Journal has begun work on its 7th annual list of the 100 best legal blogs (or blawgs) and has announced that it is seeking the advice of its readers, via the ABAJournal.com website, on which blogs to include on this year's Blawg 100.  Last year, Patent Docs was honored to be included among five blogs selected in the IP Law category of the Blawg 100 (see "ABA Journal Announces 2012 Blawg 100").

Readers interested in nominating a particular blog for the 7th annual Blawg 100 should use the ABA Journal's blawg 100 amici form.  Additional information about the Blawg 100 can also be found on the blawg 100 amici form.  The form requires that anyone making a nomination provide a name, employer or law school, city, and e-mail address.  The ABA Journal requires this information in order to discourage:

• Bloggers who nominate their own blogs or nominate blogs to which they have previously contributed posts.
• Wives and husbands who nominate their spouses' blogs.
• Employees of law firms who nominate blogs written by their co-workers.
• Public relations professionals in the employ of lawyers or law firms who nominate their clients' blogs.
• Pairs of bloggers who have clearly entered into a gentlemen's agreement to nominate each other.

The ABA Journal, however, welcomes comments (up to 500 words in length) from readers who do not fall into the above categories.

Nominations must be submitted no later than 7:00 pm (ET) on Friday, August 9, 2013.

Court Report - Part I

By Sherri Oslick --

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

UCB Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:13-cv-01148; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

UCB, Inc. et al. v. Zydus Pharmaceuticals (USA), Inc. et al.
1:13-cv-04021; filed June 28, 2013 in the District Court of New Jersey

• Plaintiffs:  UCB, Inc.; UCB Pharma GmbH; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Zydus Pharmaceuticals (USA), Inc.; Cadila Healthcare Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE38,551 (""Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the Teva complaint here.

Pfizer Inc. et al. v Lupin Ltd
1:13-cv-01153; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Lupin Ltd.

Pfizer Inc. et al. v Zydus Pharmaceuticals (USA) Inc.
1:13-cv-01154; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Zydus Pharmaceuticals (USA) Inc.

Pfizer Inc. et al. v Accord Healthcare Inc. USA
1:13-cv-01155; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Accord Healthcare Inc. USA

Pfizer Inc. et al. v. Amerigen Pharmaceuticals Inc., et al.
1:13-cv-01156; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendants:  Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.

Pfizer Inc. et al. v. Amneal Pharmaceuticals LLC
1:13-cv-01157; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Amneal Pharmaceuticals LLC

Pfizer Inc. et al. v. Impax Laboratories Inc.
1:13-cv-01158; filed June 28, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendant:  Impax Laboratories Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder).  View the Lupin complaint here.

Astrazeneca AB et al. v. Mylan Pharmaceuticals et al.
3:13-cv-04022; filed June 28, 2013 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen, Inc.
• Defendants:  Mylan Pharmaceuticals; Mylan Laboratories Ltd.; Mylan, Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 6,875,872 ("Compounds," issued April 5, 2005), 7,411,070 ("Form of S-omeprazole," issued August 12, 2008), 7,745,466 (same title, issued June 29, 2010), 5,948,789 ("Process For Synthesis Of Substituted Sulphoxides," issued September 7, 1999), and 6,926,907 ("Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," issued August 9, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Vimovo® (naproxen and esomeprazole magnesium, used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs)).  View the complaint here.

Merck, Sharp & Dohme Corp. et al. v. Cipla USA, Inc. et al.
1:13-cv-04017; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  Merck, Sharp & Dohme Corp.; Bristol-Myers Squibb Co.
• Defendants:  Cipla USA, Inc.; Cipla Ltd.

Infringement of U.S. Patent Nos. 6,639,071 ("Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one," issued October 28, 2003) and 6,939,964 (same title, issued September 6, 2005) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of BMS' Sustiva® (efavirenz, used to treat HIV infection).  View the complaint here.

Par Pharmaceutical, Inc. et al. v. Breckenridge Pharmaceutical, Inc.
2:13-cv-04000; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Breckenridge Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 6,592,903 ("Nanoparticulate Dispersions Comprising a Synergistic Combination of a Polymeric Surface Stabilizer and Dioctyl Sodium Sulfosuccinate," issued July 15, 2003) and 7,101,576 ("Nanoparticulate Megestrol Formulations," issued September 5, 2006) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients).  View the complaint here.

United States Department of Health and Human Services et al. v. Lupin Ltd.
2:13-cv-04039; filed June 27, 2013 in the District Court of New Jersey

• Plaintiffs:  United States Department of Health and Human Services; Board of Trustees of the University of Illinois
• Defendant:  Lupin Ltd.

Infringement of U.S. Patent No. 7,470,506 ("Fitness Assay and Associated Methods," issued December 30, 2008), licensed to Janssen following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

Conference & CLE Calendar

July 15-16, 2013 - Global Patenting Strategy and Practice (American Conference Institute) - New York, NY

July 15-19, 2013 - Patent Law Summer Intensive (Benjamin N. Cardozo School of Law) - New York, NY

July 16, 2013 - FTC v. Actavis: Practical Implications of the Landmark Supreme Court Decision (Law Seminars International) - 3:00 to 4:00 pm (Eastern)

July 17, 2013 - European biotech patent law update (D Young & Co) - 4:00 am, 7:00 am, 12:00 pm (EDT)

July 17, 2013 - The Myriad Decision: Practical Implications for Biotechnology Companies Protecting IP Assets (Law Seminars International) - 3:00 to 4:00 pm (Eastern)

July 17-18, 2013 - Legal and Regulatory Summit on Generic Drugs (American Conference Institute) - New York, NY

July 22, 2013 - IP & Diagnostics Symposium (Biotechnology Industry Organization) - Alexandria, VA

July 24, 2013 - AIA and Patent Prosecution: Navigating the Ethical Grey Areas (Strafford) - 1:00 to 2:30 pm (EDT)

July 28-30, 2013 - 2013 Annual Meeting & Conference (National Association of Patent Practitioners) - San Diego, CA

July 30, 2013 - Are We Innovators, or Are We Trolls: The Slippery Slope of Defining A Patent Troll (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

July 31 to August 2, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 5-7, 2013 - Advanced Patent Law Seminar (Chisum Patent Academy) - Seattle, WA

August 8, 2013 - Analyzing and Adapting to the Supreme Court's Myriad Ruling (Technology Transfer Tactics) - 1:00 to 2:00 pm (Eastern)

August 8-11, 2013 - 2013 Annual Meeting (American Bar Association) - San Francisco, CA

August 21, 2013 - Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma Patents (Strafford) - 1:00 to 2:30 pm (EDT)

August 22, 2013 - What are the Implications of CLS Bank Int'l v. Alice Corp. on Computer-Implemented Inventions? (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

September 17-18, 2013 - FDA Boot Camp (American Conference Institute) - Boston, MA

September 18, 2013 - Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls Minimizing Risks of Malpractice Liability and Ethics Sanctions (Strafford) - 1:00 to 2:30 pm (EDT)

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