Patent Docs

In re Fallaux (Fed. Cir. 2009)

    By Donald Zuhn --

On May 6, the Federal Circuit affirmed a decision by the Board of Patent Appeals and Interferences affirming the final rejection of U.S. Application No. 10/618,526 for obviousness-type double patenting.  Appellants Frits Jacobus Fallaux, Robert Cornelis Hoeben, Alex Jan Van Der Eb, Abraham Bout, and Domenico Valerio are the named inventors on the '526 application (U.S. Patent Publication No. 2005/0260596), which is directed to an isolated adenovirus packaging cell comprising nucleic acid sequences encoding the adenovirus E1A and E1B gene products but lacking a nucleic acid sequence encoding adenovirus pIX.  Following the examiner's final rejection of the '526 application for obviousness-type double patenting in view U.S. Patent Nos. 6,340,595 and 6,413,776, Appellants appealed the rejection to the Board of Patent Appeals and Interferences, which affirmed the examiner's determination.

The '526 application, which was filed on July 11, 2003, claims the benefit of the following applications:

• U.S. Application No. 08/793,170, filed March 25, 1997, which issued as U.S. Patent No. 5,994,128 on November 30, 1999;
• U.S. Application No. 09/334,765, filed June 16, 1999, which issued as U.S. Patent No. 6,238,893 on May 29, 2001;
• U.S. Application No. 09/506,548, filed February 17, 2000, which issued as U.S. Patent No. 6,602,706 on August 5, 2003;
• U.S. Application No. 10/125,751, filed April 18, 2002, which issued as U.S. Patent No. 7,105,346 on September 12, 2006; and
• U.S. Application No. 10/219,414 (U.S. Patent Publication No. 2003/0104626), filed June 5, 2003.

The patents asserted in the double patenting rejection (i.e., the '595 and '776 patents) are related to the '526 application by way of a single common inventor:  Abraham Bout.  The '776 patent was filed on June 12, 1998 and issued on July 2, 2002, and the '595 patent was filed on July 21, 1999 and issued on January 22, 2002.  In rejecting the '526 application, the examiner applied the one-way test for obviousness-type double patenting.  During prosecution, Appellants argued that the two-way test for obviousness should have been applied.  The examiner, however, determined that Appellants had not provided evidence that the issuance of the '595 and '776 patents before the issuance of the '526 claims was not due to administrative delay on the part of the U.S. Patent and Trademark Office, and further, that the '526 claims could have been introduced (and then allowed) in any of the '526 application's four priority applications that had already issued.

On appeal to the Board, Appellants again argued for the two-way test, but the Board affirmed, determining that the '526 claims could have been filed during prosecution of the '170 application, which issued as the '128 patent before either of the patents asserted in the double patenting rejection.  Thus, the Board concluded that it was Appellants, and not the Patent Office, that dictated the rate of prosecution of the '526 claims.

In affirming the Board's decision, the Federal Circuit first noted that the two-way test for obviousness-type double patenting is a narrow exception to the general rule of the one-way test.  Quoting In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998), the Court also noted that the two-way test:

arose out of the concern "to prevent rejections for obviousness-type double patenting when the applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing, rejecting the basic application although it would have been allowed if the applications had been decided in the order of their filing."

As a result, "[t]he two-way test is only appropriate in the unusual circumstance where, inter alia, the United States Patent and Trademark Office (PTO) is 'solely responsible for the delay in causing the second-filed application to issue prior to the first'" (citing Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 n.7 (Fed. Cir. 2001) (quoting Berg, 140 F.3d at 1437)).

In the instant appeal, the Federal Circuit concluded that:

[Appellants] did not show -- nor is there any evidence to suggest -- that the PTO shared any responsibility for the delay.  There is no dispute that the specification of the '170 application would have supported the ['526] claims.  Nonetheless, [Appellants] elected to prosecute other applications and delay filing the ['526] application until six years after the '170 application was filed.

Thus, the Court found that there was substantial evidence to uphold the Board's finding that the entire delay was attributable to Appellants.

In re Fallaux (Fed. Cir. 2009)
Panel: Circuit Judges Schall, Archer, and Moore
Opinion by Circuit Judge Moore

Revision of Procedures Relating to Amending PCT Applications

    By Christopher P. Singer --

In a notice published in the Federal Register on Wednesday, July 1, 2009 (74 Fed. Reg. 31372), the U.S. Patent and Trademark Office published rule changes relating to amendment practice in PCT applications, which took effect on July 1, 2009.  The revision is specific to 37 C.F.R. § 1.485 (corresponding to amended PCT Rule 66.8), which will be amended to recite:

The applicant may make amendments at the time of filing the Demand.  The applicant may also make amendments within the time limit set by the International Preliminary Examining Authority for reply to any notification under § 1.484(b) or to any written opinion.  Any such amendments must be made in accordance with PCT Rule 66.8.

Under the prior PCT Regulations relating to amendment procedure, applicants were required to submit replacement pages for only those pages that contained revisions.  Under the new Regulations, applicants are required to submit a complete set of the claims when any amendment is made to one or more claims.

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 in the News - 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