Patent Docs

New Partner for Scripps

    By Jason Derry --

As reported by the San Diego Union Tribune, the Scripps Research Institute and Pfizer Inc. have agreed on a 5 year, $100 million partnership.  The arrangement provides Pfizer the option of licensing up to 47% of the discoveries made at Scripps over the next 5 years, while Scripps receives $20 million per year from Pfizer.  Any of the discoveries Pfizer chooses not to license will then be open for licensing to others.  In addition to the $100 million, Pfizer will pay royalties to Scripps from any profits made through the exercised licenses.  The deal replaces the current partnership between Scripps and Novartis , which continues through 2006.  Final approval of the Scripps-Pfizer agreement is subject to the review of the National Institutes of Health, which provides a majority of Scripps' funding.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

INC Research® to Expand Services in Japan

    By Jason Derry --

North Carolina based INC Research® has announced that Dr. Tetsushi Inada will be its senior liaison officer to Japan.  The appointment is part of INC Research's initiative to expand its clinical expertise services and increase its presence in Asian countries.  INC Research® is a contract research organization that specializes in assisting biotechnology and pharmaceutical companies with clinical development programs.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Dyax and CSIRO to Collaborate in Antibody Discovery

    By Jason Derry --

Dyax Corp. and the Australian national scientific research agency, CSIRO, have announced a collaborative partnership to discover and develop antibodies for treating cancer.  Dyax will provide the antibody libraries and screen for potential clinical leads, while CSIRO will test the leads and work on developing the leads into clinically useful therapeutics.  According to its website, Dyax's mission is to generate biotherapeutics, particularly in the area of immunology and oncology.  In addition, Dyax has entered over 70 revenue-generating collaborative and licensing arrangements involving discovery, affinity separation, diagnostic imaging, and research reagents.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Court Report

    By Sherri Oslick --

About Court Report: Each week we will report briefly on recently filed biotech and pharma patent cases.  A few interesting cases will be selected for periodic monitoring, providing our readers with an opportunity to follow the progress of these cases.

Stratagene California v. Bio-Rad Laboratories Inc. et al.
3:06-cv-02553; filed November 20, 2006 in the Southern District of California

Infringement of U.S. Patent Nos. 6,054,263 ("Thermal Cycler Including a Temperature Gradient Block," issued April 25, 2000) and 5,779,981 (same title, issued July 14, 1998) based on Bio-Rad's manufacture and sale of various thermal cycler devices, and U.S. Patent Nos. 5,288,647 ("Method of Irradiating Biological Specimens," issued February 22, 1994) and 5,395,591 ("Apparatus of Irradiating Biological Specimens," issued March 7, 1995) based on Bio-Rad's manufacture and sale of irradiating devices, including Bio-Rad's GS Gene Linker UV® device.  View the complaint here.

Barr Laboratories Inc. v. Aventis Pharmaceuticals, Inc.
2:06-cv-05605; filed November 21, 2006 in the District Court of New Jersey

Declaratory judgment of invalidity, unenforceability, and noninfringement of U.S. Patent No. 7,138,524 ("Processes for Preparing Anhydrous and Hydrate Forms of Antihistaminic Piperidine Derivatives, Polymorphs and Pseudomorphs Thereof," issued November 21, 2006).  The '524 patent covers a particular crystal form of fexofenadine hydrochloride (Aventis' Allegra®, used to treat allergies), as does U.S. Patent No. 7,135,571 (same title, issued November 14, 2006).  Aventis asserted the '571 patent against Barr in a complaint filed on November 14, 2006 (2:06-cv-00469, ED Texas).  View the complaint here.

Patent Profile: Cytogen's U.S. Patent No. 7,135,457 for Oral Drug Delivery Agents

    By Christopher P. Singer --

In a November 27, 2006 press release Cytogen announced that U.S. Patent No. 7,135,457 issued for oral drug delivery agents that are random peptide compositions that bind to gastro-intestinal tract (GIT) transport receptors.  These agents aid in the transport of active agents from the lumen of mammalian GIT into the circulatory system and/or target active agents to the GIT.  Cytogen is seeking partnerships for oral drug delivery based on its preclinical models as well as successful in vivo delivery results of insulin and leuprolide in animal models.  The company hopes that these delivery agents can be utilized to make more drugs available for oral administration, particularly drugs currently administered via injection.

The '457 patent claims priority to a U.S. Provisional Patent Application filed on May 15, 1997.  Briefly, the patent claims relate to compositions, pharmaceutical compositions, and nano- or microparticles comprising various chimeric or purified proteins, or portions thereof of at least six contiguous amino acids, that mediate binding to the human intestinal peptide-associated transporter, HPT1.  As recited in the claims, the chimeric or purified proteins are bound to various active agents.  Representative independent Claim 1 recites:

1.  A composition comprising a purified protein which specifically binds to the gastro-intestinal tract receptor HPT1 (SEQ ID NO:178), wherein the purified protein is bound to a material comprising an active agent selected from the group consisting of an imaging agent, a drug, and an antigen, and wherein the protein comprises the amino acid sequence of SEQ ID NO:50 or a portion thereof of at least 6 contiguous amino acids that mediates binding to HPT1.

More information regarding this technology as well as Cytogen's other technology platforms can be found at www.cytogen.com.

Bergsma vs. Sutcliffe (B.P.A.I. 2006)

    By Mark Chael --

On November 22, 2006, the Board of Patent Appeals and Interferences (BPAI) at the U.S. Patent and Trademark Office decided a patent interference in favor of Prof. J. Gregor Sutcliffe and colleagues at the Scripps Research Institute related to hypocretins.

Hypocretins are a recently discovered family of neuropeptide hormones comprising Hcrt 1 and Hcrt 2, derived from a common precursor protein.  They are synthesized by neurons located in the hypothalamus and may act in the CNS as neurotransmitters, including possible roles in nutritional homeostasis and narcolepsy, among others.

The interference was originally requested on December 12, 2000, in U.S. Patent App. No. 09/735,138 titled "Hypothalamus-Specific Polypeptides," however the USPTO and the applicants had to come to terms on allowable claims before the interference could be declared, a process which took about three years.

Previously, on December 14, 1999, Drs. Bergsma and Yanagisawa, the junior parties in the interference, were awarded U.S. Patent No. 6,001,963, which is titled "Ligands of the Neuropeptide Receptor HFGAN72."  That patent is assigned on its face to SmithKline Beecham Corporation and the University of Texas Southwestern Medical Center at Dallas.

In the interference, Drs. Bergsma and Yanagisawa filed a concession of priority, thereby prompting the Board to rule in favor of Dr. Sutcliffe and colleagues.  It was also noted by the Board that a settlement agreement existed between the parties and the Board directed the parties' attention to 35 U.S.C. § 135(c) and 37 C.F.R. § 41.205(a).  The Board ordered that the inventors were not entitled to claims 1 and 3 of the '963 patent, which corresponded to the only count in the interference (Count 2).

Bergsma v. Sutcliffe (B.P.A.I. 2006)
Panel: Administrative Patent Judges Schafer, Medley, and Moore
Opinion by Administrate Patent Judge Moore

Delaware Set to Boost Its Economy With Donated Patents

    By Jason Derry --

The Philadelphia Inquirer reported today that Delaware has instituted a new agency to receive donated patents with the goal of inspiring economic growth within the State.  The agency hopes to generate Delaware-based companies through licensing of its available patents.  The agency currently has over 250 patents from DuPont Co. and Hercules Chemical Co., Inc.  The available patents can be viewed here.

In 2001, Wisconsin started The Center for Advanced Technology and Innovation to facilitate economic growth in its state through licensing of donated patents.  The Inquirer reports that four companies have been started through The Center's work.

Patent donation is a great way to reap some benefit from patents that a company owns but doesn't plan to commercialize.  If the company cannot, or does not want to, license such patents, it can donate the patents and receive significant tax benefits.  However, the IRS has recently cracked down on overvaluation of donated patents.  Thus, if you are considering patent donation, be sure to carefully review the valuation requirements.

For more information on patent donation, check out the Special Report on Patent Donations prepared for the Department of Treasury; a law review article by Don Macbean; and a Policy Review prepared by Ron Layton and Peter Bloch for the International Intellectual Property Institute.  In addition, be sure to contact the IRS for the latest requirements.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc. (Fed. Cir. 2006)

    By Donald Zuhn --

In an appeal from a District Court judgment of infringement of U.S. Patent Nos. 5,714,520; 5,731,355; and 5,731,356, the Federal Circuit reversed the District Court's claim construction and finding of literal infringement, and affirmed the District Court's finding of infringement under the doctrine of equivalents.

The patents at issue relate to an improved formulation of a general anesthetic and sedative containing propofol (2,6-diisopropylphenol), in which an antimicrobial agent has been added.  AstraZeneca Pharmaceuticals LP (AstraZeneca), the original assignee of the patents at issue, had discovered that microbial contamination of its propofol composition had led to an increase in post-operative infections, which necessitated that a patient's infusion device be changed at least every 6-12 hours.  The inventors of the patents at issue discovered that by adding preservatives to its propofol composition, the microbial contamination could be retarded such that a patient's infusion device need be changed only once every 24 hours.  In particular, the inventors discovered that the preservative disodium edetate was unexpectedly effective in retarding microbial growth in the propofol composition.  Abraxis Bioscience, Inc. (Abraxis) subsequently acquired all rights to the patents at issue.

Seeking to develop a generic formulation of AstraZeneca's improved propofol composition, ESI Lederle (ESI) began a research effort aimed at identifying an antimicrobial agent that would work as well as the edetate in AstraZeneca's propofol composition.  ESI's research efforts led to the identification of the calcium trisodium salt of diethylenetriaminepentaacetic acid (calcium trisdoium DTPA) as a suitable antimicrobial additive, and ESI was granted U.S. Patent No. 6,028,108 (the '108 patent) for a propofol composition containing calcium trisodium DTPA.  Following issuance of the '108 patent, Wyeth Pharmaceuticals, Inc. (Wyeth), of which ESI was a division, notified AstraZeneca that it was seeking FDA approval for ESI's propofol composition.  AstraZeneca responded by filing a patent infringement action against Wyeth and ESI.  Mayne Pharma (USA), Inc. (Mayne) subsequently acquired the Abbreviated New Drug Application (ANDA) for ESI's propofol composition, and AstraZeneca filed a second patent infringement action against Mayne.  Ultimately, Mayne was substituted for Wyeth and ESI in the first action, and the two actions were consolidated.

In its Markman ruling, the District Court construed three contested terms, including the term "edetate" (i.e., the antimicrobial agent recited in the asserted claims).  The District Court noted that the patentees defined "edetate" in the patents at issue as "EDTA and derivatives thereof," and thus, construed the term "edetate" as meaning "EDTA as well as compounds structurally related to EDTA regardless of how they are synthesized."  Following a bench trial, the District Court determined that Mayne's propofol composition infringed the asserted claims of the patents at issue both literally and under the doctrine of equivalents.

With respect to the District Court's construction of "edetate," the Federal Circuit noted that the District Court had adopted a broad definition of the term "derivatives" in arriving at a construction of "edetate" that encompassed structural analogs of EDTA as well as synthetic derivatives.  The Federal Circuit determined, however, that the instrinsic evidence failed to support a construction of "edetate" that would encompass structural analogs of EDTA.  For example, while the patents at issue list several derivatives of EDTA that are suitable for the invention, the Federal Circuit observed that none of these derivatives are structural analogs.  The Federal Circuit concluded, therefore, that "the listing of EDTA salts as '[p]articular derivatives of use in the present invention,' coupled with the statements regarding the uniqueness of edetate as the only successful antimicrobial agent, and the patentees' description of EDTA salts as advantageous, preferable, and 'exceptional,' limit the term 'derivatives' to EDTA salts or compounds that maintain the EDTA free acid structure."  Thus, the Federal Circuit determined that the District Court had erred in adopting a broad definition of the term "derivatives," and held that "the proper construction of 'edetate' is EDTA and derivatives of EDTA, such as salts, but not including structural analogs."

With respect to the District Court's finding of literal infringement, the Federal Circuit noted that Abraxis had conceded during oral argument that calcium trisodium DTPA is not a salt of EDTA, and further, that calcium trisodium DTPA is not a derivative of EDTA, since it cannot be synthesized from EDTA in a laboratory.  The Federal Circuit concluded that because neither EDTA nor any of its salts or derivatives was present in Mayne's propofol composition, the District Court had erred in finding that Mayne's propofol composition infringed the patents at issue.

In affirming the District Court's finding of infringement under the doctrine of equivalents, the Federal Circuit rejected three arguments proffered by Mayne in support of its position that the District Court had erred in finding that calcium trisodium DTPA was an equivalent of edetate.  Mayne first asserted that the District Court, in applying the function-way-result test, had improperly defined the "way" in which edetate works.  The Federal Circuit, however, agreed with the District Court's determination that the "way" in which both calcium trisodium DTPA and edetate "function" to retard microbial growth is by metal ion chelation.  Mayne next asserted that because the patentees chose to narrowly claim their invention, it was impermissible as a matter of law to extend the meaning of edetate to calcium trisodium DTPA by equivalence.  The Federal Circuit, however, determined that "[c]ontrary to Mayne’s assertion, the inventors did not clearly disavow other polyaminocarboxylates, including DTPA, by claiming edetate," and further that "[t]here is no evidence that the patentees made a clear and unmistakable surrender of other polyaminocarboxylates, or calcium trisodium DTPA in particular, during prosecution."  Finally, Mayne asserted that the lack of known interchangeability between calcium trisodium DTPA and edetate as an antimicrobial agent indicated that the substitution of calcium trisodium DTPA for edetate was a substantial change.  With respect to Mayne's last argument, which the Federal Circuit stated was largely premised on Mayne's ability to secure a patent for its own propofol composition, the Federal Circuit concurred with the District Court's determination that "the separate patentability of Mayne’s generic formula did 'not outweigh the substantial evidence of equivalence between Mayne’s calcium trisodium DTPA and the claimed edetate.'"

Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc. (Fed. Cir. 2006)
Panel: Circuit Judge Lourie, Senior Circuit Judge Plager, and Circuit Judge Rader
Opinion by Circuit Judge Lourie

Patent Profile: U.S. Patent No. 7,125,706 to Introgen Therapeutics, Inc. for Purified Adenoviral Compositions

    By Christopher P. Singer --

In a November 22, 2006 press release, Introgen Therapeutics, Inc. (INGN) announced that it has been awarded U.S. Patent No. 7,125,706, titled "An Improved Method for the Production and Purification of Adenoviral Vectors."  This patent represents the third issued U.S. patent in Introgen's adenoviral vector intellectual property portfolio.  Adenoviral vectors can be used to carry transgenes that encode therapeutic proteins.  Currently, some adenoviral based therapies are in clinical trials for treatment of certain cancers, including cancers of the lung, head, and neck.

In its press release, Introgen states that the ‘706 patent relates broadly to adenoviruses of commercial scale, quantity, and purity, regardless of whether the adenovirus is used as a delivery system for therapeutic genes, used directly as a therapeutic agent, used as a vaccine or vaccine component or simply used for research and development purposes.

The ‘706 patent claims priority through a series of divisional and continuation-in-part applications back to November 20, 1996 (U.S. Provisional Application No. 60/031,329).  The independent claims of the ‘706 patent recite:

1. A recombinant adenovirus composition comprising between 5x10¹⁴ and 1x10¹⁸ viral particles and having less than 50 ng of BSA per 1x10¹² viral particles.
2. A purified recombinant adenovirus composition comprising between 5x10¹⁴ and 1x10¹⁸ adenoviral particles and between about 100 pg and 10 ng of contaminating human DNA per 1x10¹² viral particles.

Introgen’s corporate profile can be found at this link.  More information on Introgen Therapeutics can be found at the company’s website: http://www.introgen.com.

Pfizer and Teva Announce $70M Settlement

    By Christopher P. Singer --

Pfizer and Teva on November 21, 2006 announced that the companies reached an agreement that resolves litigation surrounding the drugs idarubicin and azithromycin, as well as issues relating to epirubicin.  The resolution includes full releases between the parties and directs a payment as large as $70 million from Teva to Pfizer.  The dispute between subsidiary companies Pharmacia (Pfizer) and Sicor (Teva) centered on Sicor’s sale of a generic form of the injectible anti-cancer drug idarubicin HCl (Pharmacia's IDAMYCIN PFS).  Pfizer also filed suit against Teva for its sale of a generic form of the antibiotic azithromycin (Pfizer’s Zithromax).  Under terms of the agreement Teva will continue its sale of generic idarubicin and azithromycin, and has a 2007 option to sell a generic version of epirubicin (Pfizer's ELLENCE), which is used in adjuvant therapy in patients that show evidence of axillary node tumor involvement following resection of primary breast cancer.  Pfizer’s patent coverage of epirubicin is set to expire in August 2007.

$$$ in Applicants' Pockets!

    By Christopher P. Singer --

Last week the United States and European Patent Offices announced that the agencies will begin to exchange priority documents in an electronic format.  This program will impact applicants that have filed an application with the U.S. or European Patent Offices (a "priority document"), and subsequently wish to file a corresponding application in Europe or the U.S. within 12 months of the first filed application.  This document exchange program will be free to applicants.  Currently, the offices charge administrative fees for providing priority documents to the other office.  While this savings may be insignificant relative to the total cost of application filing fees, it is unarguably better than a sharp stick in the eye.

The Offices will begin testing the system in December and intend to be in full-scale operation in January 2007.  More details regarding this announcement can be found at this link.

Abbott Laboratories v. Baxter Pharmaceutical Products, Inc. (Fed. Cir. 2006)

    By Donald Zuhn --

In an appeal from a District Court judgment of validity and noninfringement, the Federal Circuit reversed the District Court's finding of validity, holding the asserted claims in U.S. Patent No. 5,990,176 to be anticipated by the disclosure in U.S. Patent No. 5,684,211.

The '176 patent relates to degradation-resistant compositions of the inhalation anesthetic sevoflurane and processes for preventing the degradation of sevoflurane.  Abbott Laboratories (Abbott), an assignee of the '176 patent, had discovered that its sevoflurane product was being degraded by Lewis acids located on the interior of the containers in which the sevoflurane was being shipped.  This degradation reaction yielded hydrofluoric acid, which is highly dangerous if inhaled.  Abbott also discovered that sevoflurane could be protected from degradation by mixing the sevoflurane with water, which would bind to and deactivate the Lewis acids.  Neither the degradation of sevoflurane by Lewis acids nor the protective effects of water were known in the art at the time of the '176 invention.

Seeking to ship their own sevoflurane product, Baxter Pharmaceutical Products, Inc. and Baxter Healthcare Corp. (Baxter) filed a certification of noninfringement and invalidity of the '176 patent with the FDA, giving rise to the suit with Abbott.  Before the District Court, Baxter argued, inter alia, that the '211 patent disclosed a composition of water-saturated sevoflurane that met all of the limitations of the asserted claims of the '176 patent, and therefore, anticipated the '176 patent.  The District Court, however, determined that because the purpose of the '211 patent was not to produce sevoflurane in its final useable form, the purposes of the '211 and '176 patents were different, and therefore, under Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., the '211 patent did not anticipate the '176 patent.  246 F.3d 1368 (Fed. Cir. 2001) ("Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.").

In rejecting the District Court's application of Bristol-Myers Squibb, the Federal Circuit noted that the purpose-based distinction set forth in that case "is applicable only to process claims [and] does not speak to composition claims."  The Federal Circuit, therefore, determined that the District Court erred by applying Bristol-Myers Squibb to sustain the validity of the composition claims in the '176 patent.  With respect to the process claims in the '176 patent, the Federal Circuit disagreed with the District Court's determination that the processes of the '211 and '176 patents were not directed to the same purpose, finding that "[a]ll of the steps of the '176 patent are disclosed in the '211 patent in furtherance of the same purpose: the delivery of safe, effective sevoflurane anesthetic.  All that is contributed by the method claims of the '176 patent is the recognition of a new property of the prior art process."

The Federal Circuit also rejected Abbott's argument that at the time of the '211 patent, nobody knew that the water-saturated sevoflurane composition disclosed in the '211 patent could resist Lewis acid degradation, stating that "[o]ur cases have consistently held that a reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time."  Noting that the "lack of knowledge [regarding the property of degradation resistance] is wholly irrelevant to the question of whether the '176 patent claims something 'new' over the disclosure of the '211 patent," and finding that the claimed property was inherently present in the '211 patent, the Federal Circuit determined that the '211 patent's disclosure of water-saturated sevoflurane anticipated the claims of the '176 patent.  The Federal Circuit, therefore, reversed the District Court's finding of validity.

Abbott Laboratories v. Baxter Pharmaceutical Products, Inc. (Fed. Cir. 2006)
Panel: Circuit Judge Bryson, Senior Circuit Judge Archer, and Circuit Judge Gajarsa
Opinion by Circuit Judge Gajarsa

New Australia Biotech Regulatory Website

    By Jason Derry--

For companies interested in entering the Australian biotechnology industry, the Australian Government has created a new website related to biotechnology regulatory requirements.  The website, BioRegs Online (www.bioregs.gov.au), was designed to provide easily accessible information to assist companies in devising plans for developing and marketing biotech products.  Specifically, BioRegs Online hopes to facilitate understanding of and compliance with the regulatory requirements in Australia, which will hopefully speed up the approval process for biotech products.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.

Open Source Biotechnology

    By Jason Derry --

Can the open source problem-solving model used in the software community work in the world of science?  The Harvard Business School has published a very interesting interview on this topic (see "Open Source Science: A New Model for Innovation").  In the interview, Karim R. Lakhani, assistant professor at the Harvard Business School, discusses his research relating to whether or not collaborative problem-solving methods should/could be used in the scientific community.  He mentions some of the obvious reasons why scientists and companies generally shy away from asking for outside help with their research, including fear of losing intellectual property rights, fear of divulging scientific or business strategies to potential competitors, and the reluctance to share secrets with others.

However, Lakhani provides solid arguments for why presenting problems to the scientific community can lead to innovative solutions and progress.  For example, Lakhani emphasizes that very often a solution to a problem lies in a separate or intersecting scientific area than the problem itself, and once a person skilled in a different area of science views a problem, a solution becomes clear.  As a specific example to support this observation, Lakhani mentions an instance where a pharmaceutical company was having trouble analyzing unusual toxicology results, until a protein crystallographer viewed the problem offered a solution.  The company, therefore, benefited from someone viewing the problem as a crystallography problem rather than as a toxicology problem.

The biotech community may reap huge benefits from using an open source method of solving problems.  The main concern, of course, is the need to structure licensing agreements or other types of collaborative agreements such that proprietary information is not given away or lost in the process.  If a company does not want to develop such agreements or open source methods on its own, the company InnoCentive has created an environment for open source scientific collaboration using a reward based system.  More information about InnoCentive and its collaborative problem-solving model can be found here.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.