Patent Docs

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.

Abbott Laboratories v. Zydus Pharmaceuticals (USA), Inc.
3:07-cv-05821; filed December 6, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,511,678 ("Controlled Release Formulation of Divalproex Sodium," issued January 28, 2003), 6,528,090 (same title, issued March 4, 2003), 6,713,086 (same title, issued March 30, 2004), and 6,720,004 (same title, issued April 13, 2004) following a paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Abbott's Depakote® ER (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches).  View the complaint here.

Human Genome Sciences Inc. v. Immunex Corp. et al.
1:07-cv-00780; filed November 30, 2007 in the District Court of Delaware

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Immunex (now Amgen) in the interference between U.S. Patent Application 09/378,045 ("Receptor That Binds TRAIL"), assigned to Immunex and U.S. Patent No. 6,872,568 ("Death Domain Containing Receptor 5," issued March 29, 2005), assigned to Human Genome Sciences.  View the complaint here.

Sepracor Inc. et al. v. Anchen Pharmaceuticals, Inc.
3:07-cv-05737; filed November 30, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

Schering Corporation v. Anchen Pharmaceuticals, Inc.
2:07-cv-07840; filed November 30, 2007 in the Central District of California

Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).  View the complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Apotex Inc. et al.
1:07-cv-00779; filed November 29, 2007 in the District Court of Delaware

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued on December 25, 2001), following a paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of plaintiff's Zymar® (gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis).  View the complaint here.

Sun Pharmaceutical Industries, Limited v. Eli Lilly and Company
2:07-cv-15087; filed November 29, 2007 in the Eastern District of Michigan

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) in conjunction with Sun's filing of an ANDA to manufacture a generic version of Eli Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.  As reported here, Eli Lilly had filed suit against Sun in the Southern District of Indiana; the case was voluntarily dismissed without prejudice by Eli Lilly.

Conference & CLE Calendar

December 13, 2007 - Pharmaceutical and Biotech Patent Law: Recent Developments (Practising Law Institute)

January 4-8, 2008 - 25th Annual National CLE Conference (law Education Institute, Inc.) - Vail, CO

January 9, 2008 - Patent Claim Construction (Law Seminars International) - San Francisco, CA

January 25-26, 2008 - Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets (Law Seminars International) - San Francisco, CA

January 30-February 1, 2008 - Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY***

February 15, 2008 - Patent Claim Construction (Law Seminars International) - Chicago, IL

February 25-26, 2008 - Pharma/Biotech Patent Claim Drafting and Prosecution (American Conference Institute) - New York, NY***

February 25-26, 2008 - Strategic Intellectual Property Planning (American Conference Institute) - Scottsdale, AZ

March 30-April 1, 2008 - Advanced Courses (Patent Resources Group) - Bonita Springs, FL

April 3-5, 2008 - Advanced Courses (Patent Resources Group) - Bonita Springs, FL

***Patent Docs is a media sponsor of this conference or CLE.

PRG Offers Advanced IP Courses

The site for the Patent Resources Group (PRG) Advanced Courses this Spring is in Bonita Springs, FL.  The usual courses will be offered, including:  Chemical Patent Practice; Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, Litigation & Licensing; and a new course entitled FDA Orange Book and Listable Small Molecule Patent Practice.  A number of other courses relating to licensing, patent drafting, and litigation are also available.  A complete course listing can be found on the PRG website.  CLE credit is available for these comprehensive courses.  Some of the courses are offered March 30 to April 1, 2008, while others are offered April 3-5, 2008.  A one-day course entitled Inequitable Conduct Under Current Federal Circuit Law is offered April 2, 2008.

BIO Issues Statement Regarding USPTO Performance Report

    By Donald Zuhn --

On Monday, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released a statement regarding the 2007 Performance and Accountability Report issued by the U.S. Patent and Trademark Office on November 15th (see "USPTO Announces "Record Breaking" 2007 Performance").  At the time of the report's release, the Patent Office stated that the report's numbers "reveal historic improvement in the quality of patent and trademark reviews and subsequently the quality of issued patents and registered trademarks."

According to Mr. Greenwood (at left), the report shows a high number of new patent applications and issuances in 2007 and "marked improvement in the quality of patents issued, demonstrating a more rigorous process of patent examination."  In view of the report's findings, Mr. Greenwood urges the Senate, which is considering its own patent reform bill (see "Senate May Act on Patent "Reform" Bill in the New Year"), to "tread carefully and deliberately when considering patent reform."  Mr. Greenwood contends that the Patent Office report "undermine[s] the calls for draconian 'reforms' to the patent system," and argues that the report clearly indicates that "the fundamentals of our current system are sound, and improving over time."  Mr. Greenwood also contends that patent reform proposals that "encourage infringement and weaken the certainty and predictability of patents must be rejected," since "[s]uch proposals would discourage investment in innovative industries such as biotech, in which it often takes more than a decade and hundreds of millions of dollars to bring a product to market."

For additional information on this topic, please see:

• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007

Genentech Beset with Avastin® Woes

    By Kevin E. Noonan --

For the past several months, Genentech has been assailed by ophthalmologists and patients over its decision to ban compounding pharmacies from reformulating its anticancer drug Avastin® (bevacizumab, a monoclonal antibody) to be used for treating neovascular or "wet" age-related macular degeneration (AMD), a condition that if untreated leads inexorably to blindness (see "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration").  This use of Avastin® is an off-label use; Genentech makes a related drug, Lucentis® (ranibizumab injection), that has been approved for AMD treatment.  The choice of the off-label use is related to the cost differential between the drugs:  Avastin® treatment costs from $20-60 per dose, while Lucentis® treatments cost $2,000/dose.  Since neither drug is a cure for AMD, patients require maintenance doses substantially for the remainder of their lives.  The cost differential is due to both differences in cost (Avastin® is priced at only $600/vial) and because it is injected into the eye at such small doses (0.1cc) that each vial can deliver 30 doses ($20/dose).

Although initially defending their decision (see "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration"), more recently the company has responded in a more conciliatory way to the outrage, protests, and threats of political and legal action from its customers and their physicians (see "Age-related Macular Degeneration Patients Get a (Limited) Reprieve").  For example, the company recently postponed the deadline for its compounding pharmacy ban from November 30th to the end of the year.  It has also taken steps to explain its position to organized ophthalmology groups like the American Society of Retinal Specialists (ASRS) and American Association of Ophthalmologists (AAO), particularly with regard to the relationship between its ban and FDA concerns over sterility and packaging of the reformulated Avastin®, and concerns that Avastin® had not been "designed, manufactured or approved" for the off-label use.

While these latest actions have been applauded by these organizations, the decision to ban compounding formulary from diluting Avastin®, and the original handling of the decision and how it was presented to the AMD community, prompted threats of political action.  It seems that despite its efforts to recoup lost goodwill, Genentech now faces just this kind of political action.  On October 18th, Senator Herb Kohl (D-WI) (at left), Chairman of the Senate's Special Committee of Aging, sent a letter to Kerry Weems, Acting Administrator of the Center of Medicare and Medicaid Resources regarding the proposed ban.  Citing an October 12th Wall Street Journal article on the topic, Senator Kohl termed Genentech's decision "troubling," particularly since he understood the action was taken to boost sales of Genentech's Lucentis®.  The Senator cited a particular portion of the Journal article that predicted an increase of from $1 billion to $3 billion per year in Medicare costs due to the ban, and stated that any action that would impose such increased costs on American taxpayers concerned him.  Senator Kohl also cited testimony from another physician's group, Physicians for Clinical Responsibility, regarding Genentech's lack of cooperation with a National Eye Institute study comparing the efficacy of AMD treatment between Lucentis® and Avastin®.

The Senator was clear about what he wanted:  he asked Administrator Weems to provide the answers to two questions:

1.) How much has Medicare spent on Lucentis and Avastin during the period 2005-present?

2.) What measures, if any, have CMS officials taken to explore the reduction of expenditures on expensive drugs such as Lucentis by using alternative treatments such as Avastin?

Senator Kohl ended his letter by saying that saving taxpayer dollars was of the "utmost importance," implying further action if he and his committee did not receive satisfactory answers.

And if that weren't enough bad news, on Monday the Food and Drug Administration's Oncologic Drugs Advisory Committee released a report that showed that even though Avastin® slowed the spread of metastatic breast cancer in the breast cancer sufferers in the study, it did not increase overall survival times.  At the same time, including Avastin® with more conventional breast cancer chemotherapeutic treatments, such as paclitaxel, increased (by 20%) the incidence of serious side effects, including heart attack, stroke, bleeding, and other complications, including six deaths in 363 study subjects.  An advisory committee voted 5-4 yesterday against approval of Avastin® for combination chemotherapy in breast cancer.  Although the final decision will be made by FDA, the agency typically follows the advice of its advisory committees, which are made up of physicians and other experts.  It is thus possible that Genentech's problems over the Avastin®/Lucentis® situation are far from over.

For additional information on this topic, please see:

• "Age-related Macular Degeneration Patients Get a (Limited) Reprieve," November 7, 2007
• "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration," October 21, 2007
• "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration," June 6, 2007
• "Retinal Specialist on the Avastin®/Lucentis® Controversy," February 23, 2007
• "Lower Doses of Genentech's Avastin® Effective in Treating Lung Cancer," February 23, 2007

USPTO News: USPTO e-Commerce Update

    By Christopher P. Singer --

PDX Program

In an e-Commerce alert notice sent by e-mail today, December 5, 2007, the USPTO provides a number of tips for completing a successful priority document exchange (PDX) request.  Throughout the past year, the USPTO began exchanging priority documents electronically with the EPO and JPO through secure electronic connections at no cost to applicants.  Since the time this PDX program began, a number of requests have been filed incorrectly (and thus denied) because Applicants are not authorizing release of a copy of unpublished U.S. applications.  The USPTO encourages that applicants file the Form PTO/SB/39 with the USPTO in order to authorize release of unpublished U.S. applications, and provide a checklist for successful filing:

• Log into EFS-Web as a Registered e-Filer.
• Certify your identity.
• A request can be made at the time of filing a new application or as a follow-on document.  If you are filing a follow-on document, select "Existing application/patent" on the filing type selection screen following log in.
• After selecting "Existing application/patent," enter the Application Number and Confirmation Number in the appropriate fields.
• To authorize the USPTO to electronically transmit Official Priority Documents to the EPO or JPO and enter them into the file wrapper, attach a completed Form PTO/SB/39 on the Attach Documents screen in EFS-Web.  Form PTO/SB/39 must be signed in accordance with 37 C.F.R. § 1.14(c).  See 37 C.F.R. § 1.14(h)(2).  The form can be found here.
• Select "Priority Documents" from the Category drop-down list.
• Select "Authorization to Access Application by Trilateral Office" from the Document Description drop-down list.
• Click "Upload and Validate" button.
• Review your documents and select "Continue."
• There are no fees associated with requesting priority documents.  If there are no other fees due, proceed and click "Submit."

Alternatively, Form PTO/SB/39 can be faxed to the Central Fax number at 571-273-8300 or mailed to: Commissioner of Patents, P.O. Box 1450, Alexandria VA 22313-1450.  More information about the PDX program can be found here.

EFS-Web 1.2

The USPTO has provided a link describing the new enhancements made to EFS-Web with the 1.2 release last month.  Enhancements include a fillable cover sheet for provisional applications, an enhanced pay fees page which lists fees based on the particular type of filing, pop-up warnings when attaching problematic documents, and a link to the Electronic Patent Assignment System (ePAS) which allows certain data fields in ePAS to be pre-populated using information from EFS-Web.

Document Descriptions

The Office again is stressing the importance of choosing the correct document description when filing using EFS-Web.  One "quick hint" you can use while filing is clicking on the blue "i" information icon found near Document Descriptions, when attaching a document.  A new window will open with a list of all available document descriptions.  The official USPTO business process description for each document type is provided to help proper indexing of documents.  A complete list of document descriptions can be found here.  Additional help on how to index your documents can be found here.

Why Does Flu Season Happen in Winter?

    By Kevin E. Noonan --

It is always surprising to non-scientists when they discover how little we know about the answers to some fundamental questions.  Everyone knows, of course, the paradox that "we can land a man on the moon, but we can't prevent the common cold."  More esoterically, Dr. J.R. Powell at Yale University once published a paper with his mentor, Theodosius Dobzhansky, asking the simple question:  "How far do fruit flies fly?" about the common genetic lab animal, Drosophila.  But recently the answer to a more pertinent question was established by workers in New York:  why does flu season occur in winter?   

This is a question that has vexed researchers for decades, even as the phenomenon has been well established:  on either side of the equator, the flu strikes in wintertime, and in the tropics (which have no "winter") there isn't much flu or flu season at all.  Anecdotal explanations, such as crowding indoors amongst school children, were unsatisfactory in light of similar crowding in autumn with little influenza infection.  Efforts towards establishing an answer experimentally have been thwarted by the absence of a convenient laboratory animal with which to conduct a study, since the ideal candidate, the human population, is properly off-limits.

Which is where persistence, perspicacity, and serendipity come in.  Dr. Peter Palese (at left), a renowned microbiologist and flu researcher, has the answer, which is elegant in its simplicity, and he got it from a hint found in reports dating from the infamous 1918 "Spanish flu" pandemic that killed millions.  As reported today by Gina Kolata of The New York Times (herself a renowned popular science writer), Dr. Palese noticed that an American Medical Association report from 1919 about the flu epidemic at Camp Cody in New Mexico mentioned that all the guinea pigs (of all things) died shortly after the influenza outbreak, and that necropsy showed their deaths were the result of pneumonia.  Dr. Palese tested guinea pigs for influenza infection and found, remarkably, that they are susceptible to infection with the virus and could spread it from one animal to another (a key difference with mice, who get the flu but can't pass it to other mice). 

Having "found" his experimental animal, the experiments themselves were straightforward.  Dr. Palese and his colleagues tested the effects of environmental temperature and humidity on the frequency of influenza infection in these guinea pigs.  They found that viral transmission decreased as the temperature and humidity increased, and that the best conditions for transmission were when the air was cold (41°F) and dry (20% humidity) - just the conditions that occur in the temperate zones during winter.  This also confirms that, unlike cold viruses that spread from direct physical contact between individuals, the flu is spread through the air like a medieval miasma.  The virus is suspended in water droplets from coughs and sneezes and persists suspended in air longer under cold and dry conditions, according to Dr. Palese. 

It is not clear that this new information suggests anything about how to avoid the flu (Dr. Palese recommends getting a flu shot) other than providing a reason to ensure that indoor temperature and humidity is not allowed to plummet in winter in a misguided effort to save heating costs in public institutions or to avoid "mollycoddling" youngsters.  It does suggest that there may be more harm than good in avoiding dramatic changes in temperature as children go from outdoors to indoors in winter, since it is certainly likely that human transmission is influenced by population density, and crowded schools are a great place to transmit airborne viruses.  But besides these possible practical consequences, Dr. Palese's work can be seen as a satisfying answer to another nagging question about the world.  There is a benefit to answering these questions, the benefit of reducing even incrementally our vast ignorance about the natural world, that makes the answer, and the story behind the answer, sufficient in itself for celebration.

For those interested in the details, Dr. Palese's report was originally published in the October 19th issue of PLoS Pathogens.

Biovail and Watson Settle Cardizem® Suit

    By Sherri Oslick --

Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, and Watson Pharmaceuticals, Inc., have announced that they have reached a settlement agreement in Biovail's lawsuit against Andrx Pharmaceuticals, Inc., a subsidiary of Watson.  The lawsuit was filed following a paragraph IV certification as part of Andrx's filing of an ANDA to manufacture a generic version of Biovail's Cardizem® LA (diltiazem), which is used to treat hypertension and for the management of chronic stable angina.

Under the terms of the settlement, Watson, which has been awarded an exclusive license to the patents covering Cardizem® LA, will not enter the market until April 1, 2009.  At that time, Biovail will receive a royalty based on Watson's sales of its generic diltiazem.  Other details of the settlement agreement, which is subject to court approval, have not been disclosed.

For additional information regarding the settlement, please see:

• Biovail's press release
• Watson Pharmaceuticals' press release

Oracle Healthcare Acquisition and Precision Therapeutics Announce Merger

    By Donald Zuhn --

Oracle Healthcare Acquisition Corp. and Precision Therapeutics, Inc. announced today that the companies have entered into a merger agreement.  Precision Therapeutics, Inc. is a privately-owned life sciences company based in Pittsburgh, PA that focuses on the development and commercialization of tests for use in individualizing cancer therapy.  Oracle Healthcare Acquisition is a publicly-traded special purpose acquisition company based in Greenwich, CT, which was formed in 2005 for the purpose of acquiring an operating business in the healthcare industry.

Under the merger agreement, Precision Therapeutics, Inc. will be the surviving corporation, and Oracle Healthcare Acquisition will change its name to Precision Therapeutics Corp. and operate as a subsidiary of Precision Therapeutics, Inc.  The combined company will be based in Pittsburgh.  Further details concerning the merger can be found in the companies' statement.

Precision Therapeutics President and CEO Sean McDonald stated that the merger "would provide the financial resources to capitalize on the progress we have made in commercializing our ChemoFx test."  ChemoFx® is a chemoresponse test that uses a patient's tumor cells to assess the patient's likelihood of responding to various cancer drugs, or drug combinations.  The test measures both the sensitivity and resistance of a patient's tumor cells to single or multiple chemotherapeutic agents, thereby allowing for the formulation of an optimal therapy choice for the patient.  According to Precision Therapeutics' website, ChemoFx® is currently being used to analyze fifteen different solid tumors, including breast, ovarian, endometrial, colorectal, genitourinary, head and neck, lung, brain, pancreas, and hepato-biliary.

Precision Therapeutics' patent portfolio includes seven U.S. patents and four U.S. patent application publications.

Court Sets Summary Judgment Schedule in New Rules Case

    By Kevin E. Noonan --

Gene Quinn from the PLI blog reports today that Judge Cacheris has set the briefing schedule for summary judgment motions in the challenge to the claims and continuation rules enjoined by the Court on October 31st (see Patent Docs report).  All parties must file summary judgment motions and any briefs in support of those motions by December 20th (see Court's Order).

This deadline also applies to any amicus briefs to be filed in support of either party.  Opposing briefs are due on January 22, 2008, and reply briefs due on February 1, 2008.  The hearing on motions is scheduled for February 8th, but GSK counsel has informed the Court that it is scheduled for trial in another matter on that day.  Thus, the Court's Order schedules an alternative date of the first Friday following February 15th that the Judge has available for the hearing.

In view of this schedule, it is possible that there will be a decision in late winter or early spring.  It is unlikely that the matter will go to trial, since there will be no discovery and it is difficult to see what issues remain for trial.  Since it can be expected that the losing party will appeal, it is conceivable that the ultimate fate of the "new rules" will not be determined until next summer.

For additional information on this topic, please see:

• "No Discovery in New Rules Case," November 27, 2007
• "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)," October 31, 2007
• "USPTO Late to Its Own Party," October 31, 2007
• "GSK Secures Injunction," October 31, 2007 (includes links to Court's Order and Opinion)
• "Senator Schumer Sends a Signal," October 30, 2007
• "GSK TRO/Preliminary Injunction Hearing," October 29, 2007
• "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules," October 25, 2007
• "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
• "Hooray! - (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect," August 30, 2007

Patent Profile: Vaccinex Announces Issuance of European Patent Covering ActivMAb® Antibody Discovery Technology

    By Donald Zuhn --

Last Friday, Vaccinex, Inc. announced that it had been granted European Patent No. 1 340 088.  According to the statement released by Vaccinex, the '088 patent covers the Rochester, New York-based company's ActivMAb® antibody discovery technology platform, which can be used for the discovery and development of new monoclonal antibody therapies, and which Vaccinex has used to identify four of its lead therapeutic antibodies.

Vaccinex President and CEO Dr. Maurice Zauderer stated that "[t]his European patent, and related patents already awarded in the United States and elsewhere, underscores the novelty of our discovery technology, which gives Vaccinex important advantages over competitors in the area of therapeutic antibodies."  Vaccinex estimates that the market for antibody therapies in 2007 will be $25 billion, and projects the market to reach $43 billion by 2012.

Vaccinex describes its ActivMAb® technology as allowing for the direct selection of high-affinity, fully human antibodies using a unique vaccinia virus-based vector to express antibodies in mammalian cells, thereby providing extremely high levels of combinatorial diversity of immunoglobulin heavy and light chains.  A video outlining Vaccinex' antibody technology can be viewed here.  Representative independent claim 1 of the '088 patent recites:

1.  An in vitro method of selecting polynucleotides which encode an antigen-specific immunoglobulin molecule, or antigen-specific fragment thereof, comprising:

(a)  introducing into a population of eukaryotic host cells capable of expressing said immunoglobulin molecule a first library of polynucleotides encoding, through operable association with a transcriptional control region, a plurality of first immunoglobulin subunit polypeptides, each first immunoglobulin subunit polypeptide comprising:

(i)  a first immunoglobulin constant region selected from the group consisting of a heavy chain constant region and a light chain constant region,
(ii)  an immunoglobulin variable region corresponding to said first constant region, and
(iii)  a signal peptide capable of directing cell surface expression or secretion of said first immunoglobulin subunit polypeptide;

(b)  introducing into said host cells a second library of polynucleotides encoding, through operable association with a transcriptional control region, a plurality of second immunoglobulin subunit polypeptides, each comprising:

(i)  a second immunoglobulin constant region selected from the group consisting of a heavy chain constant region and a light chain constant region, wherein said second immunoglobulin constant region is not the same as said first immunoglobulin constant region,
(ii)  an immunoglobulin variable region corresponding to said second constant region, and
(iii)  a signal peptide capable of directing cell surface expression or secretion of said second immunoglobulin subunit polypeptide, wherein said second immunoglobulin subunit polypeptide is capable of combining with said first immunoglobulin subunit polypeptide to form an immunoglobulin molecule, or antigen-specific fragment thereof;

(c)  permitting expression of immunoglobulin molecules, or antigen-specific fragments thereof, from said host cells;
(d)  contacting said immunoglobulin molecules with an antigen; and
(e)  recovering those polynucleotides of said first library which express immunoglobulin molecules, or antigen-specific fragments thereof, specific for said antigen.

Senate May Act on Patent "Reform" Bill in the New Year

    By Kevin E. Noonan --

Breda Lund, writing in the November 28th edition of The Generic Line, reports that the Senate may consider its version of the patent "reform" bill, S. 1145, during the next session of the 110th Congress when it convenes next January.  According to Ms. Lund, Matthew Sandgren, counsel to Senator Orrin Hatch (R-Utah), spoke on the likelihood of Senate consideration at the Center for Business Intelligence (CBI) "Forum on Effective Patent, Intellectual Property and Trademark Strategies" earlier this month.

Ranking members of both parties, including Senator Hatch and Senator Patrick Leahy (D-Vt.) are "intent" on bringing the bill to a vote, Mr. Sandgren (at left) said.  Although the bill has been successfully voted out of the Judiciary Committee, it will not come to the floor for a vote until several "outstanding issues" have been addressed.  These include post-grant review, inequitable conduct, changes in how damages are calculated, elimination of the "best mode" requirement, and granting the U.S. Patent and Trademark Office substantive rulemaking authority (lack of the power to be granted by the latter provision is one basis for Judge Cacheris' injunction imposed on October 31st blocking implementation of the "new rules" concerning continuations and claim limits promulgated by the Office on August 21st; see Patent Docs report).  Each of these provisions is also a part of the corresponding bill already passed by the House (H.R. 1908) (see "Patent 'Reform' Bill Passes House of Representatives").

There are several differences between the House and Senate bills.  For example, the Senate bill grants a "second window" of post-grant review, while the House version does not.  The House bill eliminates "best mode" while the Senate version does not, and there are differences, and disagreements, between how the House and Senate bills change apportionment of damages.  Mr. Sandgren asserts that Senator Hatch is "the champion on inequitable conduct reform," and that differences between the House and Senate versions of the bill with regard to inequitable conduct must be resolved.

Most heartening to patent applicants is the prediction by Mr. Sandgren that the provisions expanding the Office's substantive rulemaking powers will likely be removed from the final version of the bill.  If true, Office management will have one less avenue for imposing its misguided "new rules" in whatever form they may take after Judge Cacheris makes his final determination.  And removal of these provisions will make it more difficult (if not impossible) for the Office to prevail, either before Judge Cacheris or the Federal Circuit, with its argument that it has such substantive rulemaking authority already.

A useful comparison between the House and Senate bills can be found at the Intellectual Property Owners Association (IPO) website.

For additional information on this topic, please see:

• "The Wall Street Journal Gets It Half Right," November 5, 2007
• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
• "Patent 'Reform' Bill Passes House of Representatives," September 9, 2007
• "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
• "Patent Reform Bill to Be Delayed?" June 12, 2007
• "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007

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.

Novartis Vaccines and Diagnostics, Inc. v. United States Department Of Health and Human Services et al.
1:07-cv-02138; filed November 27, 2007 in the District Court of the District of Columbia

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to defendants in the interference between U.S. Patent 6,531,276 ("Methods for Detecting Human Immunodeficiency Virus Nucleic Acid," issued March 11, 2003), assigned to Novartis, and U.S. Patent Application No. 06/693,866 ("Cloning and Expression of HTLV III DNA), assigned to DHHS.  View the complaint here.

Schering Corporation v. Anchen Pharmaceuticals, Inc.
3:07-cv-05649; filed November 27, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).  View the complaint here.

Lonza Group AG v. Northwest Biotherapeutics, Inc.
8:07-cv-03177; filed November 27, 2007 in the District Court of Maryland

Infringement of U.S. Patent Nos. 5,122,464 ("Method for Dominant Selection in Eucaryotic Cells," issued June 16, 2992), 5,591,639 ("Recombinant DNA Expression Vectors," issued January 7, 1997), 5,658,759 (same title, issued August 19, 1997), 5,770,359 ("Recombinant DNA Sequences, Vectors Containing Them and Method for the Use Thereof," issued June 23, 1998), 5,827,739 (same title, issued October 27, 1998), 5,879,936 ("Recombinant DNA Methods, Vectors and Host Cells," issued March 9, 1999), 5,891,693 (same title, issued April 6, 1999), and 5,981,216 ("Transformed Myeloma Cell-Line and a Process for the Expression of a Gene Coding for a Eukaryotic Polypeptide Employing Same," issued November 9, 1999) based on Northwest's manufacture, use, and sale of its DCVax® products, including DCVax®-Prostate, used to treat prostate cancer.  View the complaint here.

Aventis Pharmaceuticals Inc. et al. v. Wockhardt Limited et al.
2:07-cv-05647; filed November 26, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,113,942 ("Pharmaceutical Composition for Piperidinoalkanol Compounds," issued September 5, 2000), 5,855,912 (same title, issued January 5, 1999), and 5,738,872 (same title, issued April 14, 1998) following a paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Aventis' Allegra (fexofenadine hydrochloride) and Allegra-D® 12 Hour (fexofenadine hydrochloride/ pseudoephedrine) (both used to treat allergies).  View the complaint here.

King Pharmaceuticals, Inc., et al. v. Teva Pharmaceuticals USA, Inc.
2:07-cv-05618; filed November 21, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,061,722 ("Cis-Endo-2-Azabicyclo-[3,3,0]-Octane-3-Carboxylic Acids, A Process For Their Preparation, Agents Containing These Compounds and Their Use," issued on October 29, 1991), following a paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of King's Altace® (ramipril, used to lower cardiovascular risk and to treat hypertension).  View the complaint here.

Norway to Join EPO in 2008

    By Robert Dailey --

Norway will become the 33rd member of the European Patent Organization on January 1, 2008.  Therefore, any European patent applications filed on or after January 1, 2008 may designate Norway as a contracting state.

No retroactive designations will be permitted.  Nevertheless, the EPO will accord applications filed in December 2007 a filing date of January 1, 2008, if the applicant expressly makes such a request.

This also means that European patents for Norway may issue from PCT applications filed on or after January 1, 2008.  For PCT applications filed prior to that date, however, any resulting European "national phase" patents will not provide patent protection in Norway.  In those instances, applicants will still need to prosecute a separate national phase application in Norway.

Official notice from the EPO Official Journal can be found here.  The EPO Journal will provide further details on Norway's implementing legislation.