Patent Docs

Biotech/Pharma Docket

    By Suresh Pillai --

Beckman Asks for Dismissal in Patent Dispute with Sequenom

Following the completion of a Markman hearing in a dispute with Sequenom Inc. concerning patents covering genotyping methods, Beckman Coulter has asked the District Court to dismiss its complaint.  In the lawsuit, Beckman Coulter had contended that Sequenom willfully infringed Beckman's patented GenomeLab SNPstream Genotyping System, covered by U.S. Patent Nos. 5,888,819, 6,004,744, and 6,537,748.  All three patents-in-suit are owned by Orchid Cellmark, Inc. (the second named plaintiff in the suit) and are the subject of a licensing agreement between Orchid and Beckman.  In the suit, Beckman sought a permanent injunction, damages, and attorney fees.  Following the filing of the suit, Sequenom filed counterclaims seeking dismissal of the case, asserting that the patents-in-suit were invalid and unenforceable.

Last week, however, the parties filed a joint motion in the U.S. District Court for the Southern District of California in which they asked the Court to dismiss Beckman's claims with prejudice and to dismiss Sequenom's claims without prejudice, leaving the door open for Sequenom to reassert the invalidity and unenforceability of the patents-in-suit at some future date.  The District Court granted the joint motion and dismissed the case.

Ninth Circuit Court of Appeals Refuses to Lift Monsanto Injunction

The U.S. Court of Appeals for the Ninth Circuit refused Monsanto's motion to lift an injunction that prevents the company from selling its patented Roundup Ready alfalfa seed prior to completion of environmental impact studies on how use of the product may affect neighboring crops.  The original lawsuit was filed in 2006 by environmental groups and a consortium of conventional seed companies, led by Geertson Seed Farms, and sought to force the United States government to rescind its 2005 approval of the Monsanto Roundup Ready product pending a complete environmental study.  In their complaint, the plaintiffs claimed that the danger of cross pollination of Roundup Ready crops could contaminate wildtype alfalfa fields.  The plaintiffs also asserted that overuse of the Monsanto product could give rise to resistant "super weeds" or could contaminate ground water.

A District Court judge agreed with the plaintiffs.  In a 2007 ruling, the Court ruled that the USDA had failed to address the concerns raised by the plaintiffs and granted the plaintiffs an injunction pending completion of a complete USDA environmental study.  Although the USDA originally joined with Monsanto in the original action, the USDA did not join Monsanto in its petition for a rehearing.  Following two affirmations of the lower court ruling, the Ninth Circuit denied Monsanto's request and refused to accept any future petitions for rehearing.  Following the latest Ninth Circuit decision, Monsanto's only possible source of recourse is the United States Supreme Court.

Jury Awards Record $1.67 Billion Verdict to Centocor in Humira Infringement Suit

On Monday, a jury found that Abbott Laboratories had willfully infringed two patents covering Humira®, owned by Centocor, Inc., and awarded Centocor $1.67 billion in damages.  The damages awarded were based upon the jury's conclusion that Centocor had suffered $1.168 billion in lost profits.  In addition to lost profits, the jury awarded Centocor an additional $504 million as a reasonable royalty.  This award appears to be the largest patent infringement award in history.

The patents-in-suit, U.S. Patent Nos. 7,070,775 and 7,276,239, cover recombinant A2-specific TNFα-specific antibodies.  Humira® is widely used in the treatment of various forms of arthritis and recently received FDA approval to be used in the treatment of Crohn's disease.  Centocor originally filed suit in 2007 (see "Court Report," April 23, 2007, and "Biotech/Pharma Docket," June 8, 2009), claiming that Abbott willfully infringed upon both Centocor patents.

EBI Patent Term Adjustment Suit Stayed Pending Outcome of Wyeth v. Dudas

The current case of EBI Food Safety BV v. Doll has been stayed pending the outcome of Wyeth v. Dudas.  EBI Food Safety originally filed suit in April, claiming that the U.S. Patent and Trademark Office calculation of patent term adjustment for its issued patent, U.S. Patent No. 7,438,901, was erroneous in that it deprived EBI of one year of patent protection.  EBI claimed that the patent term adjustment method used in Wyeth should be the correct method for calculating patent term.  Under this method, the EBI patent term should be adjusted to 703 days; EBI is seeking to have the new term reflected within the terms of the patent itself.

The stay is the latest in a series of stays in pending lawsuits where the central issue is whether the USPTO correctly calculated patent term adjustment.  All of the suits have been stayed pending a final outcome of Wyeth.  As reported on Patent Docs, Wyeth is currently under appeal after a D.C. District Court granted Wyeth's motion for summary judgment on the grounds that the USPTO used an erroneous method to calculate patent term adjustment.

FierceBiotech Announces "Fierce 15" for 2009

    By Christopher P. Singer --

FierceBiotech published its annual "Fierce 15" list of what it considers to be among the most promising of the up-and-coming companies in the biotechnology industry.  FierceBiotech, a daily biotech industry news and article provider, has been publishing the Fierce 15 since 2003.  The companies below (listed alphabetically) were named to the Fierce 15 for 2009.  The brief description of each company on this year's list has been adapted from information taken from each company's website.

Achaogen develops small molecule therapeutics to treat multi-drug resistant bacterial infections, which cause hundreds of thousands of deaths worldwide each year.  The company is developing next-generation aminoglycosides called, "neoglycosides."  Achaogen's lead compound, ACHN-490, has displayed efficacy in research and nonclinical studies against systemic infections caused by multi-drug resistant (MDR) Gram-negative bacteria (e.g., E. coli and K. pneumoniae) and MRSA.  The compound entered a Phase 1 clinical trial in early 2009.

Agios Pharmaceuticals is a biopharmaceutical company focusing on cancer metabolism, providing an understanding of how cancer cells become addicted to using more nutrients than normal cells to ensure their survival and growth.  Agios is developing a deep pipeline of drug candidates that disrupt the growth and survival of cancer.  The company's initial focus is on cancer, particularly targeting three key metabolic pathways:  glycolysis (sugar metabolism), fatty acid metabolism, and autophagy (self-metabolism), but the company's platform will also be applicable to other therapeutic areas including autoimmune, inflammatory, and neurological diseases.

Aileron Therapeutics is a biopharmaceutical company developing a new class of drugs called Stapled Peptides.  This new class of drugs represents the first general solution for modulating intracellular protein-protein interactions, which have been identified as critical control points for most human diseases.  Aileron's approach provides an opportunity to exploit potentially thousands of currently "undruggable" targets with applications in all human diseases.  Aileron's Stapled Peptides are structured into an alpha-helical shape via an optimized cross-linking chemistry, mimicking the structure found at the interface of many protein-protein interactions.  The resulting Stapled Peptide drugs are endowed with unique properties, including efficient cell penetration, high affinity binding to large target protein surfaces, and excellent stability within the body.

BioVex is a biotechnology company focusing on the development and commercialization of biological treatments for cancer and the prevention of infectious disease.  The company's lead cancer technology platform, OncoVEXGM-CSF, is a first-in-class oncolytic, or cancer destroying, virus technology.  OncoVEXGM-CSF works by replicating and spreading within solid tumors (leaving healthy cells unaffected), causing the death of cancer cells, and through stimulating the immune system to destroy uninjected metastatic deposits.  BioVex's second major program is a vaccine for genital herpes, ImmunoVEXHSV2, which provides complete protection in animal models of the disease.  The vaccine has been authorized to commence clinical testing in the UK.

Calistoga Pharmaceuticals is developing oral medicines targeting selected isoforms of the PI3 kinase pathway to improve the health of patients with cancer and inflammatory diseases.  Calistoga Pharmaceuticals has a portfolio of proprietary compounds selectively targeting the isoforms of the PI3 kinase pathway.  The pipeline includes a p110δ (delta) selective PI3 kinase inhibitor under clinical evaluation in patients with hematologic malignancies; a p110δ and p110β (beta) inhibitor under preclinical evaluation for the treatment of patients with solid tumor malignancies; and a p110δ selective PI3 kinase inhibitor advancing toward Phase 2 for treatment of patients with inflammatory diseases.

Clovis Oncology (website under development) has assembled a management team from Pharmion (purchased by Celgene) and a group of investors that are willing to provide $145 million in capital to fund Clovis, which is planned to follow a model similar to Pharmion's.  The Clovis team will likely select five or six candidate cancer therapeutics from several developers and attempt to shepherd them toward regulatory approval.

Heptares Therapeutics is a drug discovery company focusing on novel small-molecule drugs targeting G-protein-coupled receptors (GPCRs), the largest family of druggable targets.  The company has developed a technology for making purified, stabilized, and functional GPCRs (known as StaRs™, Stabilised Receptors), overcoming a major limiting factor to the development of new drugs targeting this group.  Heptares' StaR platform is based on science from the MRC Laboratory of Molecular Biology (Cambridge, UK) and enables the company to engineer and purify GPCRs in stable and functional conformations that retain their drug-binding characteristics.  For the first time, contemporary drug discovery approaches, such as crystallization and structure-based design, biophysical analysis of ligand interactions, and fragment screening can now be applied to GPCRs.  This unique approach is expected to radically improve the chances of finding drugs to previously intractable targets and will enable the development of safer and more selective therapeutic agents.

Ironwood Pharmaceuticals is focused at the interface of pharmacology and chemistry.  The company's programs have a pharmacologically validated mechanism along with robust readouts that are predictive of clinical outcomes.  This methodology allows Ironwood to rapidly iterate between in vivo models and chemistry to efficiently find lead molecules with clinical promise.  Linaclotide, is Ironwood's first-in-class compound, and is being evaluated in a comprehensive Phase 3 clinical program for the treatment of irritable bowel syndrome with constipation and chronic constipation.  The company's pipeline of clinical candidates focuses on areas such as gastrointestinal and cardiovascular diseases, pain, and inflammation.

iZumi Bio is focusing on the application of cellular reprogramming, including the scientific breakthrough of induced pluripotent stem (iPS) cell technology for drug discovery.  Because iPS cells have stem-cell-like properties, such as self-renewal and pluripotency (i.e., the ability to self replicate indefinitely and to differentiate into a variety of cell types), iPS cells are considered to be of great potential for providing insights into disease mechanisms, preclinical drug testing, and cell-based therapy.  In addition, iPS cells avoid the ethical issues specific to human embryos and human embryonic stem cells.  iZumi Bio's technology involves creating disease-relevant model systems from reprogrammed cells obtained in a non-invasive manner (i.e., skin cells) from patients with known disease.

KaloBios focuses on monoclonal antibody technology, using a proprietary platform to develop first-in-class human antibody therapeutics.  The company has multiple programs that were in seven Phase 1 or 2 clinical trials in 2008-09, including an anti-infective for Pseudomonas aeruginosa infections being tested in cystic fibrosis and in intensive care patients on a ventilator; two molecules being evaluated in inflammatory conditions, such as rheumatoid arthritis and asthma; and a molecule in preclinical development for oncology.  KaloBios' Humaneering™ technology offers advantages over other methods of human antibody creation in terms of immunogenicity, potency, and manufacturing yields.

Pacific Biosciences is developing a transformative DNA sequencing platform -- a single molecule real time (SMRTTM) technology that provides long reads, low costs, and fast cycle times.  The technology allows for the observation of natural DNA synthesis by DNA polymerase as it occurs.  The two key innovations behind the technology include the SMRT chip, which enables observation of individual fluorophores against a dense background of labeled nucleotides by maintaining a high signal-to-noise ratio; and phospholinked nucleotides, which produce a completely natural DNA strand through fast, accurate, and processive DNA synthesis.

Portola Pharmaceuticals is focused on therapeutics that target cardiovascular, inflammation, and oncology indications.  Portola has a preclinical pipeline that includes molecules such as a FXa inhibitor antidote to address potential bleeding issues from use of a FXa inhibitor; a Syk and JAK inhibitor program developing compounds for the treatment of rheumatoid arthritis and certain cancers; and an aspirin replacement therapy for aspirin intolerant patients.  Portola also has two compounds in Phase II clinical development in the area of thrombosis:  betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant, and elinogrel is formulated as an i.v. and oral antiplatelet agent that is a direct-acting, reversible P2Y12 ADP receptor antagonist.

Proteon Therapeutics is developing a line of first-in-class pharmaceuticals for the treatment of renal and vascular diseases.  Proteon possess unique knowledge of tissue remodeling mechanisms that allows it to develop its pipeline of therapeutics focusing on vascular access for hemodialysis and peripheral arterial disease (PAD).  The company's first candidate molecule (PRT-201) is in development for the improvement of blood flow following vascular surgery procedures.

VaxInnate is developing novel vaccines targeted against pandemic and seasonal influenza.  VaxInnate holds proprietary toll-like receptor technology which allows for rapid production and development of its fusion vaccines.  These fusion vaccines also allow for the development of compositions that can generate an immune response to conserved regions of viral proteins that typically exhibit low immunogenicity, which may lead to a product that can be effective against a wider variety of strains and pandemic viruses.

Zafgen develops novel therapeutics for the treatment of obesity.  Zafgen's research and development is based upon recent studies that demonstrate that the nature of adipose tissue, or fat cells, is a significant determinant of obesity, and that adipose tissue plays an active role in the disease.  The company targets adipose vasculature in an attempt to shrink fat cells and help to maintain a more lean body composition.

For additional information regarding this topic, please see:
• "FierceBiotech Announces the 'Fierce 15' Biotech Companies for 2008," June 25, 2008

Follow-on Biologics News Briefs - No. 4

    By Donald Zuhn --

IPO Continues to Support 14-Year Exclusivity Period

The Intellectual Property Owners Association (IPO), reporting on last week's announcement that the White House believes a 7-year data exclusivity period "strikes the appropriate balance between innovation and competition," reminded its members today that the IPO Board adopted a resolution in September 2008 supporting legislation that "promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population" (see "Follow-on Biologics in the News - No. 1" for the complete text of the IPO resolution).

More on OMB Letter to Rep. Waxman

According to a Bloomberg report, the letter sent by Office of Management and Budget (OMB) officials to Rep. Henry Waxman (D-CA) last week in which the White House backed a 7-year data exclusivity period (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics"), also called the 7-year period a "generous compromise."  The report speculated that this choice of language was likely influenced by President Obama's request earlier this year that Congress pass follow-on biologics legislation providing an exclusivity period "generally consistent" with that provided for small molecule therapeutics under the Hatch-Waxman Act.  Bloomberg also reported that the letter from the OMB stated that the White House was conducting "a serious review of FDA's existing authorities" to ensure that the agency can quickly begin approving follow-on biologics once legislation is passed.

The report also included a statement from Amgen Inc. spokesperson David Polk, who contended that "[w]ithout a fair and sustainable cycle of investment and returns in innovative R&D, biotech discovery will be stifled," adding that the company looked forward to working with Congress on follow-on biologics legislation that "strikes a necessary balance."

Japan Approves First Follow-on Biologic

On the same day that the White House delivered its follow-on biologics letter to Rep. Waxman, a Reuters report noted that Japan had approved its first follow-on biologic, Somatropin, a generic version of human growth hormone from Novartis AG's generic unit Sandoz.  Somatropoin, a biosimilar of Pfizer Inc.'s Genotropin, has been approved in Japan for the same range of diseases as Genotropin, including the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency.  In Europe and the U.S., the drug has already been approved as Omnitrope (see "Congressional Fact-finding on Follow-on Biologics" and "Three New Biosimilars Pass EMEA Test").

San Jose Mercury News Backs Eshoo Bill

In an editorial in last Wednesday's edition of the San Jose Mercury News, the Silcon Valley newspaper voiced support for Rep. Anna Eshoo's (D-CA) follow-on biologics bill (H.R. 1548), which provides up to 14.5 years of data exclusivity and currently has 108 co-sponsors.  Rep. Henry Waxman's (D-CA) competing bill (H.R. 1427) provides up to 5.5 years of data exclusivity and has 12 co-sponsors.  In discussing its endorsement of the Eshoo bill, the editorial states that:

Legislation in Congress could determine whether [biotech] research goes forward or stalls in Silicon Valley and other biotech centers.

The issue is essentially patent protection:  the length of time companies have to at least try to recover the $1 billion or more in investment it can take to bring one of these drugs to market.  For each biologic breakthrough, other companies are waiting to introduce biosimilars -- basically, generics -- at lower prices.

The dilemma goes to the heart of President Barack Obama's goal for comprehensive health care reform: Can the nation continue to spark health care innovation at the same time it guarantees access to affordable medical care, including medication?  Can it save the billions of dollars a year we know is wasted in the current system without undercutting incentives for excellence?  Health care reform will fail if it stalls research and medical progress.  When Congress takes up regulation of biosimilars later this year, it needs to shore up the incentive for promising biologics research.

The editorial calls the Eshoo bill "smart, science-based legislation that puts a premium on patient safety and encouraging further innovation."  Noting that "[h]olding down cost is a worthwhile goal," the newspaper argues that "these medicines won't exist in the first place if research dries up, or if safety issues crop up with the biosimilars."  As for lowering costs, the editorial contends that
"as their use increases and more new drugs come onto the market to attack debilitating diseases, savings will kick in."

Teva Unveils "Man on the Street" Videos

As part of Teva's "Year of Affordable Healthcare" campaign, which the company describes on the campaign's website as "a nationwide call for increased access to affordable healthcare for American citizens [that] coincides with the 25th anniversary of the landmark Hatch-Waxman Act," Teva has released the first in a series of "man on the street" videos in which Washington, DC residents were asked to comment on U.S. healthcare, and particularly on the need for follow-on biologics.

USPTO Initiates Patent Prosecution Highway Pilot Program with Finland Patent Office

    By Christopher P. Singer --

In June 29, 2009 press release, the U.S. Patent and Trademark Office announced that it has agreed with the National Board of Patents and Registration of Finland (NBPR) to establish a Patent Prosecution Highway (PPH) program.  As mentioned in prior posts regarding other participant Offices, the motivation behind the PPH is to leverage fast-track patent examination in participant offices so that applicants can obtain corresponding patents faster and more efficiently in each participant country.  PPH agreements are cooperative initiatives that streamline the patent system and promote expeditious, inexpensive, and high-quality patent protection throughout the world.  The U.S.-Finnish PPH is the USPTO's tenth PPH program among various foreign patent and trademark offices.  The pilot period will begin on July 6, 2009, and continue for a period of one year.  Additional information regarding participation in the PPH program in Finland can be found at the at bot the USPTO website and the NBPR website.

Court Report

    By Sherri Oslick --

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

Dey, L.P. et al. v. Teva Parenteral Medicines, Inc. et al.
1:09-cv-00087; filed June 23, 2009 in the Northern District of West Virginia

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

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

University of Iowa et al. v. Abbott Laboratories et al.
3:09-cv-00099; filed June 22, 2009 in the Southern District of Iowa

• Plaintiffs: University of Iowa; University of Iowa Research Foundation
• Defendants: Abbott Laboratories; Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd.

Infringement of U.S. Patent Nos. 5,168,062 ("Transfer Vectors and Microorganisms Containing Human Cytomegalovirus Immediate-Early Promoter-Regulatory DNA Sequence," issued December 1, 1992) and 5,385,839 (same title, issued January 31, 1995) based on Abbott's manufacture and sale of its Humira® (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis).  View the complaint here.

Medicis Pharmaceutical Corp. v. Glenmark Generics Inc., USA et al.
2:09-cv-03010; filed June 16, 2009 in the District Court of New Jersey

• Plaintiff: Medicis Pharmaceutical Corp.
• Defendants: Glenamrk Generics Inc., USA; Glenmark Generics Ltd.

Infringement of U.S. Patent Nos. 6,765,001 ("Compositions and Methods for Enhancing Corticosteroid Delivery," issued July 20, 2004) and 7,220,424 (same title, issued May 22, 2007) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of plaintiff's Vanos® (fluocinonide cream, used to relieve inflammation and itching caused by certain skin conditions that respond to corticosteroids).  View the complaint here.

Conference & CLE Calendar

June 29-30 - Product and Pipeline Enhancement for Generics (Marcus Evans) - Washington, DC

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

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

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

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

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

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

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

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

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

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

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

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

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

White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics

    By Donald Zuhn --

Reuters reports that the White House sent a letter to Rep. Henry Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, on Thursday stating that a follow-on biologics regulatory pathway providing a 7-year data exclusivity period would "strike[] the appropriate balance between innovation and competition."  According to the Reuters report, the letter was signed by Peter Orszag, Director of the Office of Management and Budget (OMB), and Nancy-Ann DeParle, director of the Office of Health Reform.

Three follow-on biologics bills have been introduced in the 111th Congress so far:  H.R. 1427, which was introduced by Rep. Waxman on March 11 and which provides up to 5.5 years of data exclusivity; H.R. 1548, which was introduced by Rep. Anna Eshoo (D-CA) on March 18 and which provides up to 14.5 years of data exclusivity; and S. 726, which was introduced by Sen. Charles Schumer (D-NY) on March 26 and which is the Senate companion to H.R. 1427.  With respect to the two House bills, a search of thomas.gov indicates that H.R. 1427 currently is backed by 12 co-sponsors and H.R. 1548 enjoys the support of 107 co-sponsors.

According to the Reuters report, Rep. Waxman (at left) stated that the Obama administration "has made clear that the president does not support the lengthy monopoly periods sought by the drug industry and instead wants a bill, as I do, that will bring real competition and will not unduly prolong the monopolies on biotech drugs."

In a statement issued by the Biotechnology Industry Organization (BIO), President and CEO Jim Greenwood said that while BIO "continues to support strongly the development of a pathway for the review and approval of biosimilars," the organization was "extremely concerned that the seven years of data exclusivity called for by the administration in the letter points to a risky short cut to biosimilars."  He added that BIO "believe[s] this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer's and HIV/AIDS as well as unmet medical needs," and that "any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures."

Mr. Greenwood (at left) stated that BIO "continue[s] to believe that fourteen years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances."  He also noted that the bill providing such a period, H.R. 1548, enjoyed the support of more than 100 House co-sponsors as well as the support of "more than 105 patient advocacy, physician, academic and innovator groups."

Mr. Greenwood said that BIO was "disappointed the administration chose to base its policy upon the Federal Trade Commission (FTC) report," which he argued "was based upon highly selective assumptions and has been rejected by many members of Congress as fundamentally flawed" (see "No One Seems Happy with Follow-on Biologics According to the FTC").  The BIO release asserts that "[f]ollowing the recommendations in the report will place at risk the more than 7.5 million high wage, high-quality American jobs supported by the biotech industry and jeopardize our nation’s global competitive advantage in biomedical innovation."

For additional information on this and other related topics, please see:
• "Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation," June 21, 2009
• "AEI Believes Advantages of Longer Data Exclusivity Period Outweigh Disadvantages," June 18, 2009
• "No One Seems Happy with Follow-on Biologics According to the FTC," June 14, 2009
• "Uncertain Future for Waxman Follow-on Biologics Bill," June 9, 2009
• "CHI CEO on Patent Reform and Follow-on Biologics Legislation," April 28, 2009
• "Follow-on Biologics in the News - No. 3," April 27, 2009
• "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation," April 22, 2009
• "Third Follow-on Bioligics Bill Introduced in 11th Congress," April 1, 2009
• "Second Follow-on Biologics Bill Is Introduced in House," March 18, 2009
• "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," Sptember 18, 2008

Is Venezuela the new Thailand?

    By Kevin E. Noonan --

A great deal has been written over the past week about Venezuela's new patented drug policy.  Last Saturday, President Hugo Chavez (at right) announced that his government would "shake up" Venezuela's intellectual property laws, particularly with respect to patents on medicines.  As reported by Reuters and the Associated Press, Sr. Chavez drew a distinction between "a song [which] is intellectual property" and "an invention or scientific discovery [that] should be knowledge for the world, especially medicine."  In characteristically dramatic fashion, he went on to say "[t]hat a laboratory does not allow us to make a medicine because they have a patent, no, no, no."

The details and scope of the policy (besides a general intent to prevent foreign, predominantly Western, drug companies from enforcing patents in Venezuela) was not announced.  However, Commerce Minister Eduardo Saman (at left), formerly head of Venezuela's patent agency (SAPI), said that the revised policies "should be compatible with the international treaties that we have signed and respect and honor."  He justified the new policies by saying that "[p]atents have been a barrier to production, and we cannot allow them to be barriers to medicine, to life, to agriculture."

A contrary view was voiced by Edgar Salas, president of the Venezuelan pharmaceutical business chamber, who predicted that preventing foreign pharmaceutical companies from enforcing patents in Venezuela would result in these companies refusing to import their drugs into the country.  For a country that imports most of its pharmaceuticals this could be a huge problem.  On the other hand, Venezuela's position as an oil producer gives it significant leverage in obtaining goods from abroad.  For example, in 2002, the U.S. alone exported $4.4 billion in goods to Venezuela and yet the country ran a trade surplus, exporting $15.1 billion (mostly from the sale of oil) to the U.S.

This latest move by Sr. Chavez is keeping with his anti-capitalist, anti-Western policies and rhetoric, and thus should come as no surprise.  The "international treaties" referenced by Sr. Saman include, of course, the Trade-related Aspects of Intellectual Property Rights (TRIPS) provisions of the General Agreement on Tariffs and Trade (GATT), and Venezuela's participation in the World Trade Organization (WTO), under the 1994 Marrakesh Agreement.  Venezuela was one of the earliest nations in the Organization, becoming a member on January 1, 1995.  Sr. Chavez has threatened to leave the Organization, accusing it of neocolonialism and imposing trading practices unfair to developing nations.  And a blanket ban on permitting or enforcing pharmaceutical patents would be a violation of TRIPS.

But TRIPS in practice has not been the panacea for drug patents that its drafters might have intended (see "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries"; "Worldwide Drug Pricing Regime in Chaos"; "More on the Global Drug Patenting Crisis").  This outcome is due in large part to WTO member countries taking advantage of treaty provisions that permit (or can be co-opted to permit) nationalistic interpretations like Sr. Chavez now proposes.  For example, TRIPS itself permits treaty signatory nations to include provisions for compulsory licenses in the face of extreme medical emergencies.  The WTO adopted the Doha Declaration of 2001 that has reduced the consequences for disrespecting foreign patent rights even further.  Specifically, the Declaration provides:

Article 4.  The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.
    In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

Article 5.  Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:
    (a) In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.
    (b) Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.
    (c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.
    (d) The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.

Article 6.  We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.

Several developing countries have used the compulsory licensing provisions of TRIPS as modified by the Doha Declaration to grant compulsory licenses for anti-AIDS drugs (see "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries").  Thailand has gone even further, imposing compulsory licenses for drugs such as Plavix® that do not readily fall within the definition of drugs for treating a public health crisis or national emergency (see "Thailand Continues Its Compulsory Licensing Practices").  So it is unlikely that Venezuela will be unable to fashion a justification for whatever policies it adopts that will permit Sr. Chavez to fulfill his commitment to abolish drug patents in his country while permitting Sr. Saman to maintain that those policies "respect and honor" the "international treaties that [Venezuela has] signed."

Venezuela thus becomes the latest example of a developing country able to use the provisions of GATT and the auspices of the WTO to receive the benefits of reduced tariffs on their exports while avoiding the political repercussions of enforcing drug patents owned by foreign nationals.  Even without Sr. Chavez's anachronistically Marxist rhetoric, it is hard to fathom a political leader of a country like Venezuela staking political power on protecting foreign interests.  Patent protection in any country will be enforced only when such protection benefits the society itself, suggesting that Western patent holders would be better served to support local industries that could partner with them to make the case for patent rights with their governments (see "A Modest Proposal Regarding Drug Pricing in Developing Countries").  Sadly, with few exceptions, Western pharmaceutical companies have not availed themselves of such opportunities.  As a consequence, the political calculus strongly favors leaders like Sr. Chavez, and we can expect similar actions, with luck devoid of the florid rhetoric, from other developing countries until the situation changes.

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

• "Recent Developments in Pharmaceutical Patenting and Compulsory Licensing of Pharmaceutical Patents in Developing Countries," July 8, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008
• "Thailand Continues Its Compulsory Licensing Practices," March 11, 2008
• "More on the Global Drug Patenting Crisis," August 14, 2007
• "EU Trade Commissioner Sends Warning Letter to Thailand," August 13, 2007
• "Pharma Sanity Lacks Global Reach," July 13, 2007
• "Worldwide Drug Pricing Regime in Chaos," May 9, 2007
• "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries," May 1, 2007
• "A Modest Proposal Regarding Drug Pricing in Developing Countries," May 2, 2007

Autogenomics, Inc. v. Oxford Gene Technology Ltd. (Fed. Cir. 2009)

    By Donald Zuhn --

Last month, the Federal Circuit affirmed the judgment of the District Court for the Central District of California granting Defendant-Appellee Oxford Gene Technology's motion to dismiss for lack of personal jurisdiction.  Oxford filed the motion to dismiss after Plaintiff-Appellant Autogenomics filed suit against Oxford seeking a declaratory judgment of invalidity, unenforceability, and non-infringement with respect to U.S. Patent No. 6,054,270.

The '270 patent, which is owned by Oxford, relates to oligonucleotide microarrays for the analysis of polynucleotides.  Oxford is a British biotechnology company that is organized under the laws of England and Wales; which is not registered to do business in California; and which has no California facilities, assets, employees, or agents.  Autogenomics, meanwhile, is a biotechnology company that is organized under the laws of California, and which uses microarray technology in its business.

In July 2007, Autogenomics filed a declaratory judgment action against Oxford asking the California District Court to find claims 9 and 10 of the '270 patent invalid or unenforceable, and not infringed.  In support of the District Court having personal jurisdiction over Oxford, Autogenomics alleged that Oxford had several contacts with California, including:

• Licensing negotiations between the parties -- In 2006, Oxford contacted Autogenomics regarding the '270 patent, and Autogenomics expressed an interest in licensing the patent.  Autogenomics, however, believed eleven references raised "serious issues with regard to novelty and obviousness."  Oxford asserted that the '270 patent was valid over the references, and two Oxford representatives subsequently traveled to California to meet with representatives of Autogenomics.  The parties were unable to agree on license terms.

• Licenses -- Oxford entered into non-exclusive licenses with about ten California companies.

• Agilent agreement -- Oxford and Agilent Technologies (a California company) entered into "a collaborative agreement giving [Oxford] access to Agilent's microarray platform, confirming [Oxford] as an Agilent Certified Service Provider, and appointing Agilent as an OEM supplier for [Oxford] designed microarrays."

• Conferences -- Oxford attended three conferences in California between 2003 and 2007.

• Sales -- Oxford sold 20 microarrays to a California company in April 2006.

• Publication -- Oxford published an application note, describing a microarray product, on the Nature.com website.

Oxford responded to Autogenomics' suit by filing a motion to dismiss, contending that the District Court lacked general or specific personal jurisdiction over it.  The District Court granted Oxford's motion, ruling that it lacked general jurisdiction because Oxford's contacts with California were insufficient to be the equivalent of having a physical presence within the state, and that it lacked specific jurisdiction because the declaratory judgment action did not arise from or relate to most of the contacts alleged by Autogenomics.  The District Court also denied Autogenomics' request to conduct jurisdictional discovery.  Autogenomics appealed these determinations to the Federal Circuit.

A divided panel, with Judge Moore writing for the majority, determined that the District Court had correctly ruled that it lacked general or specific personal jurisdiction over Oxford, and that the District Court did not abuse its discretion in denying jurisdictional discovery to Autogenomics.  With regard to general personal jurisdiction, the majority found that Oxford lacked the types of contacts with California that qualify as "continuous and systematic general business contacts."  In particular, the majority noted that Oxford has no actual physical presence or license to do business in California, and that it was not reasonable to infer, as Autogenomics had suggested, that Oxford's conference booths were, in effect, "mobile offices."  The Federal Circuit determined that "ultimately, [Oxford's participation in] four conferences over five years constitute only sporadic and insubstantial contacts."  Stating that "[a]ll of the contacts alleged by Autogenomics, even in combination, are insufficient evidence of continuous and systematic contacts," the majority concluded that the District Court lacked general personal jurisdiction over Oxford.

As for specific personal jurisdiction, the majority began by discussing the Court's 2008 decision in Avocent Huntsville Corp. v. Aten Int'l Co., noting that:

Avocent explained that the contacts material to the specific jurisdiction analysis in a declaratory judgment action are not just any activities related to the patent-at-issue.  Rather, the relevant activities are those that the defendant "purposefully directs . . . at the forum which relate in some material way to the enforcement or the defense of the patent."  Id. at 1336.  Thus, courts must examine the jurisdictional facts for conduct whereby the patentee "may be said to purposefully avail itself of the forum and to engage in activity that relates to the validity and enforceability of the patent."  Id.

Thus, in accord with Avocent, "only enforcement or defense efforts related to the patent rather than the patentee's own commercialization efforts are to be considered for establishing specific personal jurisdiction in a declaratory judgment action against the patentee."  While the majority was also "concerned that foreign patentees like Oxford may engage in significant commercialization and licensing efforts in a state while benefiting from the shelter of the Avocent rule," the Court noted that it was "nonetheless bound by Avocent."  That being said, the majority observed that under 35 U.S.C. § 293, "[j]urisdiction over foreign patentees like Oxford continues to be available in the United States District Court for the District of Columbia."

With respect to the facts of the instant case, the majority disagreed with Autogenomics' contention that the Agilent agreement was sufficient to establish specific jurisdiction over Oxford, stating that "there is nothing in evidence, nor would it be a reasonable inference, to suggest that this agreement involves the '270 patent or is 'analogous to a grant of a patent license.'"  The Federal Circuit also concluded that Autogenomics' argument that Oxford had granted an exclusive license to Incyte Pharmaceutics Inc. (a California company), in view of the numerous non-exclusive licenses that Oxford had granted, "cannot be a reasonable inference."  The majority therefore determined that the District Court also lacked specific personal jurisdiction over Oxford.

In the last portion of the opinion, the majority dispensed with Autogenomics' final argument:  that the District Court abused its discretion in denying Autogenomics's request for jurisdictional discovery.  The Federal Circuit noted that "[i]n this case, there is no denial of a motion for jurisdictional discovery for us to review because there was no formal motion for jurisdictional discovery."  The Court also noted that "Autogenomics did not make . . . a showing that further discovery would elucidate the facts necessary to prove that the court had personal jurisdiction," adding that "[o]nly now, on appeal, does Autogenomics explain how discovery could help establish the court's jurisdiction."  The majority concluded, therefore, that the District Court acted within its discretion by denying Autogenomics' request for jurisdictional discovery.

Judge Newman (at left) begins her dissent by declaring that "[t]he Federal Circuit again restricts United States parties from access to our courts when a United States patent is owned by a foreign entity."  With respect to Oxford's contacts with California, Judge Newman noted that:

Oxford owns several United States patents, including the patent that is the subject of this declaratory action, and is exercising its United States patent rights through approximately ten licensees in California.  Autogenomics states that Oxford has entered into a manufacturing venture with the California company Agilent, whereby Agilent serves as a California-based supplier of microarrays designed by Oxford.  Oxford's employees have personally exhibited the Oxford technology at trade shows in California and publicized the availability of licenses for Oxford's United States patents.  The record shows sale of Oxford microarray products to at least one customer in California.  Oxford employees traveled to California and negotiated with Autogenomics in that forum.  In addition, California is the primary site of Autogenomics' business, the forum in which the accused infringing activities are conducted, and in which Oxford's threatened enforcement of its patent would occur.

Judge Newman also noted that "[n]o other forum has been asserted by Oxford to be more convenient; indeed, the entire relationship between Oxford and Autogenomics has been in the California forum, which is a primary locus of the biotechnology industry in which both parties are engaged."  With regard to the majority's reliance on Avocent (where Judge Newman also dissented) she stated that "if Avocent is read to bar this suit, it is in conflict with precedent of this court and the Supreme Court."  As for the majority's statement that Autogenomics could bring suit in the District of Columbia, Judge Newman stated that:

It is not explained why a California plaintiff should have to resort to a distant forum, which is not alleged to have meaningful contacts with either party, to resolve a dispute that centers upon actions by both the plaintiff and the foreign patentee in the state of California.  I take note that Oxford has not suggested transfer to the District of Columbia; the Oxford position is that it cannot be sued.

Autogenomics, Inc. v. Oxford Gene Technology Ltd. (Fed. Cir. 2009)
Panel: Circuit Judges Newman and Moore and District Judge Gettleman
Opinion by Circuit Judge Moore; dissenting opinion by Circuit Judge Newman

Biotech/Pharma Docket

    By Suresh Pillai --

Caraco Motion for Summary Judgment in Prandin® Case Denied

The U.S. District Court for the Eastern District of Michigan has denied a motion for summary judgment brought by Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. (the majority shareholder of Caraco) in their patent suit with Novo Nordisk over Prandin®, a drug for the treatment of diabetes.  Novo Nordisk originally filed suit in 2005 following Caraco's ANDA filing with the U.S. Food and Drug Administration in which Caraco sought to market a generic version of Prandin®.  The patent-in-suit, U.S. Patent No. 6,677,358, covers a method for treating Type II diabetes using repaglinide in combination with metformin.  In 2007, following the filing of the suit, the FDA granted tentative approval to Caraco to manufacture and market a generic repaglinide product.  In 2008, however, Caraco submitted an amended ANDA in which, Novo claimed, Caraco stipulated to infringement of the '358 patent.

In December 2008, Caraco filed its motion for summary judgment, contending that an FDA ruling that Caraco need not reference the Novo patented repaglinide-metformin combination at launch effectively nullified Caraco's stipulation of infringement of the '358 patent.  While the District Court disagreed with Caraco's contention, the Court did not issue a written opinion.

Injunction Granted in Crescendo Suit Against Ethicon

The U.S. District Court for the Southern District of Ohio has granted a temporary injunction sought by Ethicon Endo-Surgery Inc. (a subsidiary of Johnson & Johnson) that prevents a former Ethicon employee from selling or licensing patent applications for ultrasonic surgical blade technology in the wake of a jury awarding the company $2.1 million in damages.  In the original suit, a jury found the employee and former inventor at Ethicon, Jean M. Beaupre, in breach of an invention assignment agreement entered into between the inventor and his former employer -- Beaupre had assigned U.S. Patent Publication Nos. 2006/0100652 and 2007/0016236, and a provisional application ("Balanced ultrasonic curved blade") to Crescendo Technologies LLC.  Beaupre had worked for Ethicon for eight years prior to founding Crescendo.  The jury also found Crescendo liable for tortious interference.

Although the jury awarded damages to Ethicon, it failed to determine which party owns the rights to the applications-in-suit.  The temporary injunction will remain in effect until the District Court has determined ownership.

Summary Judgment Awarded in Sanofi-Aventis Eloxatin® Generic Suit

The U.S. District Court for the District of New Jersey has awarded summary judgment to generic drug drug manufacturers Sandoz, Inc., Mayne Pharma Inc., Teva Pharmaceutical Industries Ltd., and Hospira Inc. in their patent infringement dispute with Sanofi-Aventis US LLC over Eloxatin®, a colon cancer drug.  Sanofi originally filed suit in 2007, alleging that the generic drug companies had infringed U.S. Patent No. 5,338,874, Sanofi's patent covering HPLC-derived oxaliplatin, the active ingredient in Eloxitan® (see "Court Report," July 30, 2007).  Sanofi had licensed this patent to another plaintiff in the suit, Debiopharm SA.  Sanofi's suit followed Sandoz's ANDA filing with the FDA in which Sandoz sought to manufacture and market generic Eloxatin®.  Included in the ANDA was a Paragraph IV certification stating that both the '874 patent and another Sanofi patent, U.S. Patent No. 5,716,988, were invalid and noninfringed.  Sanofi then filed suit, disputing the claim, and the generic manufacturers filed their motion for summary judgment.

The District Court concluded that the patents-in-suit were not infringed because the products made by the defendants were not derived from the method of production disclosed in the '874 patent.  However, the Court denied the defendants' motion for summary judgment of invalidity on the grounds that, in light of the noninfringement finding, such a determination would be moot.

Kappos Nomination Supported by Industry and Patent Groups

    By Donald Zuhn --

Last Thursday, the White House announced that President Obama had selected David Kappos (at right), the Vice President and Assistant General Counsel of Intellectual Property Law at IBM, to head up the U.S. Patent and Trademark Office.  In the days since that announcement, a number of patent organizations and trade groups have released statements commenting on Mr. Kappos' nomination.  While many of these organizations ordinarily find it difficult to agree on almost any patent-related issue, they seem to have reached consensus on President Obama's selection -- and the news is good for Mr. Kappos who, once confirmed, will take over as Undersecretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.

In a statement released last Friday, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood commended President Obama for "making a strong choice in his nomination of David Kappos," adding that the organization believed Mr. Kappos would "bring a thoughtful perspective to the Department of Commerce and the USPTO."  Mr. Greenwood noted that Mr. Kappos "has a long history of industry experience, providing a point of view and insights we have always thought to be highly valuable in this position."  Mr. Greenwood stated that BIO looked forward to working with Mr. Kappos in the coming years, and urged the Senate "to move quickly" to consider Mr. Kappos' nomination, since the Office "needs a confirmed leader as soon as possible."

The Coalition for Patent Fairness, which has been at odds with BIO on a number of patent-related issues, released its own statement regarding the Kappos nomination on Friday.  The CPF applauded President Obama's selection of Kappos, contending that "Mr. Kappos has the background and experience needed to lead the U.S. Patent Office at a time when it faces significant operational challenges in an ever-evolving competitive global marketplace."  The CPF also stated that it looked forward to the opportunity to work with Mr. Kappos, concluding that the group "support[ed] President Obama's call for reforms to the US patent system that will spur innovation and job creation."

The Intellectual Property Owners Association (IPO), where Mr. Kappos currently serves as Vice President of the Board of Directors (the second highest position in the association), issued a statement congratulating Mr. Kappos on his selection.  Praising the President for the nomination, IPO Executive Director Herb Wamsley stated that "Dave Kappos is exceptionally well qualified to lead the USPTO during this time of difficult challenges for the agency."

The Innovation Alliance, a coalition of small and medium-sized technology companies, issued a press release congratulating Mr. Kappos on his nomination.  The group stated that it "look[ed] forward to working with [Mr. Kappos] in what will be a very difficult, but important effort to revitalize the PTO, which all agree is under funded and overburdened," taking the opportunity to request that Congress provide the Patent Office with the funds it needs "to upgrade its technology, improve the patent application process, and attract and retain professional talent."  The Innovation Alliance pledged to "work with Mr. Kappos, the Administration and Congress in achieving these goals, and making sure that our nation's strong patent protections continue to work for all sectors of the U.S. economy," and urged the Senate "to move forward with a speedy confirmation."

The Coalition for 21st Century Patent Reform called Mr. Kappos' nomination "very welcome news for our Coalition members and all innovators, researchers and manufacturers."  In its statement, the group asserted that Mr. Kappos "will be an advocate for inventors and the protection of the nation's patents and advancements," adding that his appointment would also be "beneficial for the continued progress" of the Senate patent reform bill (S. 515).

Biotech Director at EPO Discusses European Patent Practice - Part II

    By Bradley Crawford --

In the first post in this series, background information from Mr. Enrique Molina Galan's  presentation at BIO 2009 was reported.  The focus of this post is on the second part of his talk, where Mr. Molina Galan described the European Patent Office's role in fostering innovation.

In his talk, Mr. Molina Galan noted the need for balancing the needs of innovators with those of the public, and the need to balance patent protection against disclosure.  In particular, he mentioned the incentive to innovate, the return on investment, and better market position on one hand are weighed against the sharing of knowledge, which can lead to "innovation leaps" in the other.  As he made clear, the key to ensure the right balance is for the European Patent Office to apply high standards, which is entirely consistent with the mission statement of the European Patent Office:

As the Patent Office for Europe, we support innovation, competitiveness and economic growth across Europe through a commitment to high quality and efficient services delivered under the EPC.

Quality can be fostered by the applicant via submission of an enabling disclosure, an undisputed inventive contribution, and claim scope that is commensurate with the contribution to the relevant art.  These will lead to the granting of a patent with a high presumption of validity.  Quality can be fostered by the European Patent Office via the use of highly skilled examiners, thorough and consistent procedures, comprehensive search documentation, and rigorous controls coupled with a commitment to improve.  Efficiency can be fostered by minimizing procedural delays, minimizing legal uncertainty as early as possible, and handing the ever increasing workload.

After briefly discussing the European Patent Grant Procedure, a slide entitled "fate of the biotech applications from search to grant" was shown (slide shown below).  This slide shows that for every 100 biotech EP applications that were searched, about 70 proceeded to examination.  Of the 70 that were examined, 35 were granted, 30 were abandoned or withdrawn, and 5 were refused.  Mr. Molina Galan stated that this last number was showing a slight increase.  Two of the initial hundred applications were the subject of an opposition after grant.  The end results of the opposition were as follows:  about a third of the oppositions were rejected, about a third of the patents were revoked, and in about a third of the cases, the patent was maintained in amended form.

As mentioned above, the European Patent Office's workload has been increasing.  According to Mr. Molina Galan, the gap between the number of new applications and the number of finished applications is currently growing at a rate of 37,500 applications per year; it would take 750 examiners, working at full capacity to handle this work load.  Of course, each year, an additional 750 examiners would have to be hired in order to handle this ever increasing workload.

In an effort to align patent quality standards to the needs of today's society, the European Patent Office has instituted a "Raising the Bar" campaign.  Legislative measures supporting this initiative and aimed at improving the quality of the incoming patent applications and streamlining the grant proceedings will take effect on April 1, 2010.  The key features of those amendments to the Implementing Regulations to the EPC are as follows.

Early enforcement of the EPC Rules on the admissible number of independent claims per category:

• When appropriate, the search can be restricted to one independent claim per category.
• If a meaningful search is not possible, the applicant will be invited to clarify the subject matter to be searched.
• Examination will be limited to the searched subject matter.
• A response to the search opinion issued by the EPO will become mandatory.
• Amendments and their basis in the application as filed shall be clearly identified.
• Applicants will have fewer opportunities to amend the claims on their own initiative.  Further amendments with the consent of the examining division remain possible.
• The sanction for not observing the respective time limits will, as a rule, be the deemed a withdrawal of the application.  The available remedy is further processing or, in a few cases, re-establishment of rights.

The European Patent Office is also instituting a new rule regarding the deadline for filing a divisional application.  Under the current rules, a divisional may be filed at any time before the European patent is granted.  Under the new rules, all divisional applications must be filed either within a period of two years from the first communication by the examining division in respect of the earliest application for which such a communication has been issued or within two years of receiving a lack of unity objection.

As previously mentioned, the new rules take effect on April 1, 2010.  However, the European Patent Office has yet to finalize its rules regarding the day to day implementation of the above rules.  In the next post in this series, possible results and consequences of the new rules will be discussed.

Patent Docs thanks Mr. Molina Galan for his time, the comments that he provided regarding the above post, and for granting permission to make the slides from his BIO 2009 presentation publicly available.  To view the slides, click here.

Committee Publishes National Model Patent Jury Instructions

    By Sherri Oslick --

Assembled by Chief Judge Paul R. Michel (at right) of the United States Court of Appeals for the Federal Circuit, a committee comprising litigators and judges from across the nation has prepared and published model jury instructions for patent infringement cases based on the experience of those both on the bench and in the bar.  The model jury instructions have not been endorsed by the CAFC, nor were they intended to be "official" model jury instructions.  Rather the committee's focus was "to benefit from the collective experience of both judges and attorneys who [were] interested in creating an easier to understand and streamlined set of model jury instructions."

Committee members include:  Kenneth C. Bass III (Senior Counsel with Sterne, Kessler, Goldstein & Fox, P.L.L.C., Washington, D.C., now deceased), Donald R. Dunner (Partner with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, D.C.), Pamela Banner Krupka (Krupka Law Group, P.C., Los Angeles, California), Roderick R. McKelvie (Partner with Covington & Burling LLP, Washington, D.C.), Teresa Stanek Rea (Partner with Crowell & Moring, Washington, D.C.), Judge Patti B. Saris (U.S. District Court Judge, District of Massachusetts), Judge T. John Ward (U.S. District Court Judge, Eastern District of Texas), and Judge Ronald M. Whyte (U. S. District Court Judge, Northern District of California).  The committee is chaired by Edward R. Reines (Litigation Partner with Weil, Gotshal & Manges LLP, Redwood Shores, California).

In preparing the model jury instructions, the committee reviewed and drew from the work of others, including that of the committees for the Northern District of California, The Federal Circuit Bar Association, the AIPLA, and the District of Delaware.  Public comments from federal judges, inventors, attorneys, law firms, corporations, bar groups, and trade associations were also taken into consideration, including comments from the American Bar Association Section of Intellectual Property Law, Federal Circuit Bar Association, and Intellectual Property Owners Association.

The National Patent Jury Instructions may be downloaded here, in either PDF or Microsoft Word format.  They will be updated in a timely manner to incorporate new developments in the law.

The Genetics of Complex Behaviors: It Really Isn't That Simple

    By Kevin E. Noonan --

Early last week, the Journal of the American Medical Association published a study ("Interaction Between the Serotonin Transporter Gene (5-HTTLPR), Stressful Life Events, and Risk of Depression") by Neil Risch at the University of California, San Francisco and colleagues at the National Institutes of Mental Health, Johns Hopkins University, Yale University School of Medicine, the Rockefeller University, the University of Pittsburgh School of Medicine, and Virginia Commonwealth University that showed no statistically-significant link between depression and the short HTT allele.  The study provided a statistical meta-analysis of data accumulated for 14,250 participants from 14 separate studies from the medical literature and a second meta-analysis of 10,943 participants from 10 of these studies.  These results were contrary to the results published by Avshalom Caspi and collaborators (including Terrie E. Moffitt (at right), Knut Schmidt Nielsen Professor, Departments of Psychology and Neuroscience, Psychiatry and Behavioral Sciences, and Institute for Genome Sciences and Policy, Duke University) that individuals bearing at least one copy of a specific genetic polymorphism in a serotonin transporter gene were more susceptible to depression as a consequence of environmental (life) stressors (see Caspi et al., 2003, "Influence of Life Stress on Depression:  Moderation by a Polymorphism in the 5-HTT Gene," Science 301: 386-89).

Dr. Moffitt has graciously provided us with three points in rebuttal to the conclusions of the Risch study, set forth in her own words:

1.    The JAMA article ignores the wider body of scientific evidence.  In the past 6 years, extensive research in experimental neuroscience using both animals and humans has validated the original report by showing that 5-HTTLPR short allele-carriers are excessively vulnerable to stress.  Experimental studies that expose human participants to stressors in the laboratory show that individuals having the 5-HTTLPR short genotype have greater stress responses on measures of cognitive reactivity (e.g., Beevers et al., 2007, J. Abnorm. Psychol. 116: 208-12; Fox et al., 2009, Proc. Biol. Sci. 276: 1747-51), hormonal  reactivity (e.g., Chen et al., 2009, Psychoneuroendocrinology 34: 681-86; Gotlib et al., 2008, Biol. Psychiatry. 63: 847-51), physiological reactivity (e.g., Lonsdorf et al., 2009, Psychol. Sci. 20: 198-206) and reactivity in the brain's emotion-circuitry (e.g., Hariri et al., 2006, Arch. Gen. Psych. 62: 146-52; Canli et al. 2006, Proc. Natl. Acad. Sci. U.S.A. 103: 16033-38).  This vulnerability of 5-HTTLPR S carriers has also been confirmed in animal research (e.g., Carola et al., 2008, Biol. Psychiatry. 63: 840-46; Barr et al., 2004, Biol. Psych. 55: 733-38; Kalin et al., 2008, Mol. Psychiatry. 13: 1021-27, online at DOI: 10.1038/mp.2008.37; Watson et al., 2009, PLoS One, published online January 14, 2009).  Further validation comes from studies which have shown that 5-HTTLPR Short allele carriers are vulnerable not only to depression, but also to other mental-health problems caused by stress, including PTSD and anxiety (e.g., Gunthert et al., 2007, Psychosom. Med. 69: 762-68; Kilpatrick et al., 2007, Am. J. Psychiatry. 164: 1693-99).

2.    The selection of studies for meta-analysis clearly fails to represent the pool of papers in the literature.  4 out of 17 positive replications were included (24%) but 6 out of 9 published negative
studies (67%), a bias that violates a basic requirement of the meta-analysis method to examine a representative sample of the existing literature.  Further, the article opted not to analyze several well-designed studies of individuals exposed to stress.  For example, studies of children who are victims of abuse (e.g., Cicchetti et al., 2007, Dev. Psychopathol. 19: 1161-80; Kaufman et al., 2004, Proc. Natl. Acad. Sci. U.S.A. 101: 17316-21) and patients suffering hip fractures, strokes and coronary heart disease (Kohen et al., 2008, Arch. Gen. Psychiatry. 65: 1296-302; Lenze et al., 2008, Amer. J. Geriatric Psych. 13: 428-32; Otte et al., 2007, Am. J. Psychiatry. 164: 1379-84) have reported positive findings for this "GxE" hypothesis.  Several other positive replications from studies with very strong research designs were omitted from the meta-analysis as well (Kendler et al., 2005, Arch. Gen. Psych. 62: 529-35; Drachmann-Bukh et al., 2009, J. Affect. Disord. 2009 Mar. 30 (e-publ. ahead of print at doi:10.1016/j.jad.2009.02.023); Lazary et al., 2008, Biol. Psychiatry. 64: 498-504).

3.    Within the smaller subset of studies in the meta-analysis, there is important heterogeneity.  The article says this heterogeneity was not statistically significant.  However, we have learned that the test fell just short of statistical significance.  One obvious characteristic that varies widely across studies in the meta-analysis is measurement quality.  As one example, meta-analysis gives more mathematical weight to studies with the largest samples.  But in this case the big studies had to collect their data through telephone calls or self-complete postal questionnaires, which are known to be weak methods of measuring life events and depression.  Not surprisingly, these big studies with weak measures tended not to find positive results, tilting the meta-analysis toward a null finding.  In the existing literature of tests of this GxE hypothesis, 13 studies have replicated the finding, using measures collected in face-to-face clinical assessments, and 10 studies failed to replicate the finding, using measures collected via phone or postal questionnaires.  This clear methodological pattern was ignored in the meta-analysis.  This is one example of heterogeneity could have been followed up in a meta-analysis, there may be others.

Dr. Moffitt concluded her response to Dr. Risch's work by noting that "[w]hat is needed is not less research into gene-environment interaction, as Risch et al. recommend, but more research of better quality, and a more thorough and thoughtful evaluation of it."

Dr. Moffitt has extensive experience in studying the biological basis of complex behaviors, and in addition to her Duke University appointment is also Professor of Social Behaviour and Development, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, London and Associate Director, Dunedin Multidisciplinary Health and Development Research Unit, Dunedin School of Medicine, Dunedin, New Zealand.

This controversy illustrates one of the many pitfalls frequently faced by academic inventors motivated by the dual (and occasionally conflicting) needs of disseminating the results of their studies as rapidly as possible and protecting the intellectual property aspects of their work to maximize the likelihood that it can be commercialized (and not merely expropriated by others based on its disclosure in the academic literature).  As a result, often the research is not as developed as it might be if it were developed by a commercial concern initially.  This situation presents particular challenges to university technology transfer offices and their clients, university faculty and university administrations.  It is an imperfect system, which motivates some to say there is a flaw in the basic premise of promoting university patenting under the Bayh-Dole regime.  However, the alternative (not protecting university-generated inventions) is indeed worse, since then the public stands no chance of seeing the fruits of these labors helping to finance the next generation of technologies.

Court Report

    By Sherri Oslick --

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

Sepracor Inc. et al. v. Synthon Pharmaceuticals, Inc. et al.
5:09-cv-00264; filed June 17, 2009 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a Paragraph IV certification as part of Synthon's filing of an ANDA to manufacture a generic version of UCB's XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis).  View the complaint here.

Pfizer Inc. et al. v. Mylan Inc. et al.
1:09-cv-00441; filed June 15, 2009 in the District Court of Delaware

Pfizer Inc. et al. v. Mylan Inc. et al.
1:09-cv-00079; filed June 15, 2009 in the Northern District of West Virginia

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,969,156 ("Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)," issued October 19, 1999), 6,087,511 ("Process for the production of amorphous [R-(R*,R*)]-2-(4-fluorophenyl)- β,δ -dihydroxy-5-(1-methylethyl )-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid) calcium salt (2:1)," issued July 11, 2000), and 6,274,740 (same title, issued August 14, 2001) based on Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease).  View the Delaware complaint here.

Public Patent Foundation, Inc. v. McNeil-PPC, Inc.
1:09-cv-05471; filed June 15, 2009 in the Southern District of New York

False marking based on McNeil's marking of certain Tylenol® products indicating that these products are covered by certain of U.S. Patent Nos. 4,820,522 ("Oral Sustained Release Acetominophen Formulation and Process," issued April 11, 1989), 4,968,509 (same title, issued November 6, 1990), 5,004,613 (same title, issued April 2, 1991), 5,658,589 ("Subcoated Simulated Capsule-Like Medicament," issued August 19, 1997), 5,436,026 ("Discharge and Transfer System for Apparatus for Gelatin Coating Tablets," issued July 25, 1995), 5,228,916 ("Apparatus for Creating a Gelatin Coating," issued July 20, 1993), and 5,679,406 ("Tablet Dipping Systems for Apparatus for Gelatin Coating Tablets," issued October 21, 1997), some of which are expired.  View the complaint here.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. Sandoz, Inc.
2:09-cv-02863; filed June 4, 2009 in the District Court of New Jersey

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

Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

    By Kevin E. Noonan --

As reported last week by FierceBiotech, EvaluatePharma, a market forecasting firm specializing in the life sciences sector, released its prediction on the future of the pharmaceutical industry.  According to EvaluatePharma, six of the top ten selling drugs by 2014 will be biologics.  Today, half of the top ten best-selling drugs are conventional small molecule drugs, as shown in the table below; in terms of sales, these drugs account for about 61% of the revenues garnered by the top ten best-selling drugs.

Top 10 Drug Products by Sales in 2008

EvaluatePharma predicts this situation will change dramatically by 2014:  as shown below, seven out of the top ten best-selling drugs will be biologic drugs.  Moreover, biologics drugs are predicted to account for a 75% of the revenues, an almost 2-fold increase in the relative contributions of biologic drugs to the sector.

Top 10 Drug Products by Sales in 2014

The reason for this expected change is generic competition for small molecule drugs that will be off-patent by 2014, including current best-sellers Nexium®, Lipitor®, Plavix®, Advair® and Diovan®.  The report also notes that "anti-cancer antibodies appear set to easily become the most valuable therapeutic class of drug."  The report also notes that some traditional Big Pharma companies stand to benefit from their association (partnering) or acquisition of biotechnology companies, with Roche being a clear example as purveyors of three of the top ten predicted best-selling drugs in 2014 (Avastin®, Rituxan® and Herceptin®) representing about one third of the revenues from these drugs.  Notably absent from the list are companies like Pfizer and GlaxoSmithKline that today have drugs in the best-selling top ten.  Accordingly, EvaluatePharma suggests that it may behoove such companies to pursue small and mid-sized biotech companies, particularly now during the economic downtrend that has reduced the valuations of these biotech companies.

These results are consistent with other reports.  Biologics sales currently are around $75 billion, with 22 biologics drugs breaking the $1 billion "blockbuster" drug barrier in 2007.  These revenues can only be expected to increase, and much of this cost can be expected to be borne by government under Medicare, Medicaid, and other programs, particularly since many biologic drugs are directed to end-of-life diseases like cancer.  Senator Schumer, in a press release issued in conjunction with the introduction of his follow-on biologics bill in the Senate (S. 726) estimated that the bill "would save federal programs like Medicare and Medicaid at least $10 billion dollars by bringing needed competition to the marketplace" (see "Third Follow-on Biologics Bill Introduced in 111th Congress").  This estimate is consistent with a Congressional Budget Office report, stating that implementation of a follow-on biologics regulatory scheme would save health programs such as Medicare and Medicaid about $8.1 billion over the 2010–2019 period, as well as reduce costs for private health insurance plans and lower insurance premiums for employers by almost 0.2% by 2019 (see "BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on 'Troubling Assumption'").

While these numbers pale in comparison with the monies expended by the Federal government over the past several months, they bring to mind Senator Everett Dirksen's famous (perhaps apocryphal) aphorism that "A billion here, a billion there, and pretty soon you're talking real money."  These numbers provide more than adequate political motivation for follow-on biologics legislation, making it all the more critical that interested observers make sure their Congressional representatives know precisely what is at stake in this debate.

News from Abroad: Utility under Canadian Patent Law and the Doctrine of Sound Prediction

    By Ariadni Athanassiadis, Catherine Lemay, and Claire Palmer --

In Canada, for subject matter to be patentable, it must be novel, inventive, and have utility.  A patent will fail for lack of utility if it can be shown that "the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do" (Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., (1981) 56 CPR (2d) 145 (S.C.C.)).  At the time a patent is applied for, the inventor must be in a position to establish utility, "on the basis of either demonstration or sound prediction" (Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 2007, 2002 SCC 77).

As is often the case for both biotechnology and pharmaceutical inventions where working examples demonstrating promised utility are not available at the time of filing, the doctrine of sound prediction, as established by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation Ltd., must be relied on to support the utility of the invention.

To meet the test for "sound prediction," there must be:

(i)    a factual basis for the prediction;

(ii)    an articulable and "sound" line of reasoning from which the desired result can be inferred from the factual basis, and

(iii)    proper disclosure.

With respect to the first requirement, the factual basis from which utility can be soundly predicted may be provided by way of examples but there is no requirement to do so.  Nor is there any requirement to establish the factual basis with human clinical trial data.  In fact, in Apotex Inc. v. Wellcome Foundation Ltd., the factual basis was provided by way of in vitro examples.

A recent Canadian Federal Court of Appeal decision in Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, has examined the sound prediction doctrine and sets a troubling precedent with regard to inclusion of performed clinical trial data in pharmaceutical applications in order to satisfy the third prong of the test relating to disclosure.

On March 25, 2009, the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a lower court decision pursuant to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") in favor of Apotex for its raloxifene hydrochloride drug (generic  version of EVISTA7).  The PM(NOC) Regulations are Canada's version of a Hatch-Waxman-type regime linking the approval of generic drugs under the Canadian Food and Drugs Act and Regulations with the Canadian Patent Act.

The patent at issue, Canadian Patent No. 2,101,356 ('356 patent) is directed to the use of a group of compounds (including raloxifene) in the treatment or prevention of osteoporosis and for inhibiting bone loss in a human.  The patent specification disclosed four examples of in vivo rat studies and a fifth example of an anticipated study on a group of post-menopausal women where certain results were expected.  In its Notice of Allegation, Apotex alleged that the rat studies disclosed in the '356 patent did not provide a factual basis for a sound prediction; specifically, that it could not be soundly predicted that the results obtained from in vivo testing in rats would demonstrate utility in humans.  According to Apotex, the inventors had not demonstrated that raloxifene HCl could be used as a treatment for the prevention of osteoporosis and/or bone loss in humans and that, while the disclosure mentioned that a clinical trial in healthy post-menopausal women was underway to confirm this, the results of the study were not reported in the '356 patent.

The first instance trial judge agreed with Apotex and held that the '356 patent lacked proper disclosure as required by the sound prediction test articulated in Apotex Inc. v. Wellcome Foundation Ltd.  Of relevance was an abstract published by Eli Lilly before the Canadian filing date of the '356 Patent, but after its U.S. priority date which described a study (referred to as the Hong Kong study) conducted on a group of post-menopausal women demonstrating that raloxifene showed promising skeletal anti-resorptive properties.  The Court ruled that, although there was a good basis for a prediction as of the priority date of the application based on the in vivo rat studies described in the application, and a sound line of reasoning as of the Canadian filing date based on the Hong Kong study, the third prong of the test had not been met as the Hong Kong study itself was not disclosed in the '356 patent.  Eli Lilly argued that the Hong Kong study abstract was available to the public at the Canadian filing date and that, as such, sufficient disclosure to satisfy the third prong of the test had been made.  However, this was rejected by the trial judge who, as mentioned above, ruled that the disclosure must be in the patent, not elsewhere.

On appeal, Eli Lilly argued, inter alia, that the trial judge had committed a legal and factual error as recent case law on the issue of sound prediction had established that there was no requirement that the underlying data supporting a sound prediction be disclosed in the patent.  The Federal Court of Appeal disagreed with Eli Lilly and confirmed that a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction was required in sound prediction cases.  According to the Court, "when a patent is based on a sound prediction, the disclosure must include the prediction.  As the prediction was made sound by the Hong Kong study, this study had to be disclosed."

It is unclear from the decision why both the trial level and appeal Courts found (and Eli Lilly's counsel accepted) that the particular Honk Kong study was necessary to provide a sound line of reasoning, i.e., that in vivo data in rats alone was not sufficient to provide both the factual basis and the sound line of reasoning.  Eli Lilly appears to have simply argued its case on the basis that the doctrine of sound prediction did not require that the study be actually disclosed in the application.  Perhaps it should have gone still further and argued that the judge had erred in finding that it was the testing in humans that made the prediction sound.  In the vast majority of cases, when a patent application is filed, no such human clinical trial data is available; therefore, it is typical for applicants to support their sound predictions with in vitro or animal in vivo data only.

Therefore, this case should not be taken as establishing a requirement to provide human clinical trial studies in support of a sound prediction.  As mentioned above, in the Apotex Inc. v. Wellcome Foundation Ltd. case itself, the factual basis had been established by in vitro data only.  However, if an applicant does have human clinical trial studies available prior to filing its Canadian patent application (as was the case for Eli Lilly in the case at hand), then it would be advisable for the applicant to include the results of the studies in the patent application.

For more information regarding the Doctrine of Sound Prediction please contact Ariadni Athanassiadis (aathanassiadis@mbm.com), Catherine Lemay (clemay@mbm.com) or Claire Palmer (cpalmer@mbm.com).

Conference & CLE Calendar

June 21-23, 2009 - IP Business Congress (Intellectual Asset Management magazine) - Chicago, IL

June 22-27, 2009 - Innovation Week 2009 (U.S. Patent and Trademark Office) - Arlington, VA

June 29-30 - Product and Pipeline Enhancement for Generics (Marcus Evans) - Washington, DC

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

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

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

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

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

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

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

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

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

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

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

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

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

Corporate Intellectual Property Conference

The Law Bulletin Publishing Company will be holding its 4th Annual Corporate Intellectual Property Conference on July 15, 2009 in Chicago, IL.  The conference will address the following topics:

• Protecting and leveraging IP assets in a down economy;
• Update on major case law affecting IP;
• Licensing IP assets:  Strategies for success;
• Damages: Valuation and presentation; and
• Copyright and trademark issues.

Additional information regarding the conference can be found here (although a program for the conference is not yet available).  The registration fee for the conference is $99.  Those registering before July 1, 2009 will receive a $20 discount off the registration fee.  Those interested in registering for the conference can do so here.

Generic Pharmaceuticals Conference

Marcus Evans has announced its 2nd Annual Product and Pipeline Enhancement for Generics conference on "Formulating a Concrete Plan for Sustainability in the Rapidly Changing Global Generic Pharmaceutical Market."  The conference, to be held on June 29-30, 2009 in Washington, DC, will offer presentations on the following topics:

• Ensuring the sustainability of the generics industry;
• Devising a risk-balanced patent strategy to mitigate potential lawsuits;
• Recent developments in the law impacting Hatch-Waxman litigation;
• Integrating your patent and regulatory strategies;
• Comprehending the factors involved in a profitable IP strategy;
• Best practices for navigating the global biogenerics terrain;
• Important considerations when breaking into the biogenerics market;
• Encouraging a tighter focus on innovative projects through strong project execution;
• Focusing on core competencies to overcome shrinking innovator pipelines;
• The impact of the globalization of the pharmaceutical industry;
• Achieving global success in the generics industry through strategic partnering;
• Securing your supply chain through strong API relationships;
• Understanding the global healthcare climate to ensure an accurate pricing strategy;
• Insight on changing standards in generics regulation;
• Developing a specialty product strategy to ensure a prosperous portfolio; and
• Avoiding the commoditization of your generic products.

A brochure for this conference can be requested here.  The registration fee for the conference is $2,500.  Those interested in registering for the conference can do so here.