Patent Docs

USPTO Announces Agenda for Next BCP Meeting

As reported earlier this month on Patent Docs, the biotechnology, chemical, and pharmaceutical technology groups at the USPTO will hold the next quarterly meeting next Tuesday, December 4, 2007.  The Patent Office has posted the official announcement which includes the list of topics and speakers:

Morning Session (9:00-noon EST):

• Greeting and Overview
• Invention Secrecy Program -- presenter:  Don Hajec, Director, TC3600
• KSR: Overview -- presenter:  Kathleen Fonda, OPLA
• KSR: Technology Center-Specific Examples of its Application -- presenter:  Jean Witz, QAS, TC1600

Afternoon Session (1:15-4:00 EST):

• Issues in Small Organic Molecules -- presenter:  Michael Hartley, SPE, Art Unit 1618
• 101 Sequence Homology -- presenter:  Dave Nguyen, QAS, TC1600
• Restriction:  Combination/Subcombination -- presenter:  Julie Burke, QAS, TC1600
• Closing Remarks/Discussion

The presentation can be attended in person at Madison East GIPA (Global Intellectual Property Academy) large lecture room on the second floor (600 Dulany Street, Alexandria, VA).  However, in order to attend the meeting in person, you must have confirmed your attendance with Cecilia Tsang by phone (571-272-0562), fax (571-273-0562), or e-mail ([email protected]) by last Tuesday.  The meeting will also be broadcast on-line here using "guest" access, or it can be accessed through the link provided by the USPTO in its announcement.  Additional information (including downloadable copies of presentations and slide shows) relating to this meeting as well as prior BCP meetings can be found here.

ACI Pharma/Biotech Patent Claim Drafting and Prosecution Conference

American Conference Institute (ACI) will be holding a conference on Pharma/Biotech Patent Claim Drafting and Prosecution on February 25-26, 2008 in New York, New York.  The conference will provide information on:

• The status of Tafas v. Dudas and the fate of the U.S. Patent and Trademark Office's claims and continuation rules.
• Analyzing the interplay between critical rules and proposed legislation that impact patent drafting and prosecution strategies.
• Rethinking your view on restrictions and making them work in favor of your patent strategy.
• Employing evolving canons of claim construction to your advantage.
• Ensuring satisfaction of the enablement, written description, and utility requirements.
• Overcoming obviousness rejections in the face of shifting standards.
• Adjusting timing strategies to maximize options in an ever changing statutory and rulemaking environment.
• Drafting claims that cover the proper scope in light of constraints on claim language.

In particular, ACI's faculty will offer presentations on the following topics:

• Emerging patent reforms:  What you need to know now.
• Revisiting restriction practice:  Weighing the cost-benefit of making restrictions work in favor of your patent strategy.
• Innovative approaches for identifying patentable subject matter to optimize protection.
• Evolving canons of claim construction and application -- the post-Philips/Festo world.
• Aligning your patent timing strategies with business objectives in order to maximize your patent lifecycle.
• Avoiding allegations of inequitable conduct when prosecuting patent applications.
• Preventing obviousness rejections post-KSR and its progeny.
• Getting it right the first time:  Best practices for demonstrating utility (to be presented by this Patent Docs author).
• Surviving 35 U.S.C. § 112 rejections:  Written description, enablement and best mode.
• Drafting claims to include varying degrees of scope.
• USPTO speaks.
• Wrap up and interactive strategy session:  Pulling it all together to secure effective coverage of inventions in the current patent environment.

An additional master class entitled: "Perfecting Claim Drafting and Prosecution in Life Sciences Patent Applications" will be offered on February 27, 2008.  The master class will allow conference attendees to apply the lessons learned from the conference's previous sessions to a mock patent drafting scenario.

The agenda for the Pharma/Biotech Patent Claim Drafting and Prosecution conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and master class).  Those registering on or before December 19, 2007 will receive a $300 discount off the registration fee and those registering on or before January 25, 2008 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media sponsor of ACI's Pharma/Biotech Patent Claim Drafting and Prosecution conference.

LEI National CLE Conference (and Skiing!)

Law Education Institute, Inc. (LEI) will be holding the 25th Annual National CLE Conference on January 4-8, 2008 in Vail, Colorado.  The Intellectual Property program of the conference, which will be held at the Vail Marriott Resort and Spa, will offer presentations on a number of topics, including:

• Valuation of intellectual property.
• Declaratory judgment actions after Sandisk.
• KSR and its progeny:  In the courts and the PTO.
• Judges panel:  View from the bench.
• Corporate panel:  Patent issues keeping in-house counsel awake at night.
• Willful infringement and opinions of counsel after Knorr Bremse, Echostar, and In re Seagate.
• Recent patent law developments at the Supreme Court and Federal Circuit.
• PTO rules update.
• Patent legislation update.
• European patent litigation and procuring and enforcing patents in China.

An agenda and list of speakers for the Intellectual Property program of the conference can be found here.  A complete brochure for the Intellectual Property program, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is $729.  Those registering before December 15, 2007 will receive a $100 discount off the registration fee.  Those interested in registering for the conference can do so here or by calling either 1-303-860-0608 or 1-888-860-2531.

ACI Strategic Intellectual Property Planning Conference

American Conference Institute (ACI) will be holding a conference on Strategic Intellectual Property Planning on February 25-26, 2008 in Scottsdale, Arizona.  The conference will share insights on:

• Applying current legal and legislative trends to your IP practices.
• Identifying which IP protections are available.
• Using competitive intelligence to drive market and IP strategy.
• Improving contracting and negotiating practices to ensure maximum protection.
• Managing the flow of proprietary information when employees join and/or leave the company.
• Strategic planning for small businesses.
• Valuing and monetizing assets.
• Best practices in mergers and acquisitions.

In particular, ACI's faculty will offer presentations on the following topics:

• Current legal and legislative trends:  A catalyst or hindrance for maximizing IP protection?
• Aligning strategic IP decision-making with company culture, and projecting potential outcomes.
• Facilitating the creation of an IP strategy.
• Using competitive intelligence to drive market and IP strategy and manage risk.
• Increasing IP leverage and mitigating risks with careful and thorough negotiations and contracting.
• Strategic planning session for small and growth companies.
• The mobile employee:  Managing the flow of IP coming into and out of the company.
• Valuing and monetizing IP assets and knowing when conducting an audit is necessary.
• Controlling the impact of global media networking and the management of IP rights.
• Ensuring best IP strategies in mergers and acquisitions.
• Leveraging and protecting proprietary information overseas:  Conforming company culture to operate on a global scale.

An additional pre-conference workshop entitled: "Covering all the Angles: Creating a Strategic IP Plan from Inception to Implementation (And Everything In Between)" will be offered on February 26, 2008.  The pre-conference workshop will focus on every phase of the strategic IP planning process using a series of hypothetical scenarios to set the stage for the conference.

The agenda for the conference on Strategic Intellectual Property Planning can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and pre-conference workshop).  Those registering on or before December 26, 2007 will receive a $300 discount off the registration fee and those registering on or before January 30, 2008 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Supreme Court Declines to Review CAFC Limits on Certificates of Correction

    By Robert Dailey --

Section 255 of the Patent Act provides a mechanism for correcting typographical or minor errors in an issued patent.

Whenever a mistake of a clerical or typographical nature, or of minor character, which was not the fault of the Patent and Trademark Office, appears in a patent and a showing has been made that such mistake occurred in good faith, the Director may, upon payment of the required fee, issue a certificate of correction, if the correction does not involve such changes in the patent as would constitute new matter or would require reexamination.

In Superior Fireplace Co. v. Majestic Products Co. (Fed. Cir. 2001), the Federal Circuit held (over the dissent of Judge Dyk) that additional requirements apply when the correction would result in any broadening of the claims.  These additional limitations include the following:

• Broadening is evaluated by a text-to-text comparison of the pre-correction claim text to the post-correction claim text, i.e., without consideration of whether the prosecution history demonstrates that the applicant and the PTO had agreed to a narrower meaning of the pre-correction claim term;
• For mistakes "of minor character," the PTO may issue no Certificates that would broaden the claim scope;
• For mistakes "of a clerical or typographical nature," the PTO may only issue Certificates that broaden the claim scope when one of skill in the art, having the intrinsic record at his disposal, would (1) recognize that the mistake has occurred; and (2) know from the intrinsic record how to correct that mistake.

Judge Dyk issued a dissent in the case.  The majority articulated these additional limitations out of a fear that patentees could use Certificates of Correction to obtain changes that would be unavailable under the Reissue provisions of Section 251.  Judge Dyk showed how Sections 255 and 251 could be harmonized without reading the additional limitations into the statutory text.

In the 2007 case of Central Admixture Pharmacy Services, Inc. v. Advanced Cardiac Solutions, P.C., the Federal Circuit had the opportunity to revisit its Superior Fireplace holding.  In the original patent, the patentee had claimed concentration ranges in terms of osmolarity, but had intended to claim the ranges in terms of osmolality.  The PTO issued the Certificate of Correction, which resulted in a 2% downward shift in the claimed concentration ranges.

But the Federal Circuit chose to stand by its precedent.  Because the scope of the corrected claim was not entirely encompassed by the pre-correction claim (i.e., 2% shift), the Court held that this constituted broadening.  Thus, the Superior Fireplace limitations apply.  In this instance, one of skill in the art would not necessarily have recognized that use of "osmolarity" was a mistake, even if claiming concentrations in terms of "osmolality" may have made more sense.  Because the mistake was not apparent on its face, the patentee could not make the change.

Superior Fireplace remains good law, as the Supreme Court has declined to hear the appeal.  Therefore, practitioners are probably advised to avoid using Certificates of Correction for making changes to the claim language.  "Broadening" does not mean that the whole claim is broader; the claim just needs to read on one embodiment that was not previously encompassed.  And when claims are broadened, courts will only uphold a Certificate of Correction when it corrects blatant typographical errors.  So, if you've claimed a concentration range in terms of "miles," use a Certificate of Correction.  Otherwise, use a Reissue.

Patent Profile: Metagenics Awarded Three U.S. Patents For Anti-Inflammatory Compounds

    By Suresh Pillai --

Metagenics, Inc. of San Clemente, California has been awarded U.S. Patent Nos. 7,270,835 ("Compositions that treat or inhibit pathological conditions associated with inflammatory response," issued September 18, 2007);  7,195,785 ("Complex mixtures exhibiting selective inhibition of cyclooxygenase-2," issued March 27, 2007) and 7,205,151 (same title, issued April 17, 2007), three patents that cover discoveries relating to selective kinase response modifiers that have anti-inflammatory properties.  These patents extend to thirty the number of U.S. Patents awarded to both Metagenics, Inc. and its Metaproteomics® Nutrigenomics Research Center subsidiary.

Inflammation via the cyclooxygenase pathway (COX-2) contributes to numerous maladies, including osteoarthritis, reduction of bone mineral density, and autoimmune disease.  COX-2 also plays a housekeeping role within certain cellular pathways; therefore, any treatment targeted to inhibit COX-2-mediated inflammation should not similarly inhibit COX-2-mediated cellular housekeeping.  One method for targeted regulation of COX-2 pathways is through the use of selective kinase response modifiers (SKRMs).  SKRMs inhibit the induction of inflammation via the selective alteration of COX-induced signaling cascade phosphorylation profiles.  The primary benefit of using SKRMs is that, although the inflammation pathways are inhibited, other COX-mediated signaling pathways, including those responsible for normal cellular housekeeping tasks, remain intact.

The '835 patent covers both Metagenics' proprietary compound Luduxin, which consists of rho iso-alpha acids derived from hops, and the use of Luduxin in preserving joint health.  The '785 and '151 patents cover both Metagenics' proprietary compound Tetrase, which consists of tetrahydro-isohumulone (a tetrahydro iso-alpha acid derived from hops), and the use of Tetrase in supporting the management of inflammation.

The '835 patent issued from U.S. Application No. 10/689,856, which was filed on October 20, 2003, and which claims the benefit of Provisional Application No. 60/420,383, filed October 21, 2002.  Independent claim 1 recites:

1.  A method of preserving the health of joint tissues comprising administering to a patient, group consisting of oleanolic acid and ursolic acid, and a component selected from the group consisting of rosemary, an extract derived from rosemary, and a compound derived from rosemary.

The '785 patent issued from U.S. Application No. 10/480,145, which was filed on June 20, 2002.  Independent claim 1 recites:

1.  A method of treating inflammation comprising administering to an animal suffering symptoms of inflammation a pharmaceutical grade extract of hops comprising an effective amount of tetrahydroisohumulone, and an effective amount of essential oils, fats or waxes, wherein said administration provides about 0.01 to 100 mg per kg body weight per day of tetrahydroisohumulone.

The '151 patent issued from U.S. Application No. 09/885,721, which was filed on June 20, 2001.  Independent claim 1 recites:

1.  A composition comprising a pharmaceutical grade extract of hops comprising an effective amount of tetrahydroisohumulone, and an effective amount of at least one component selected from the group consisting of essential oils, fats and waxes, wherein said pharmaceutical grade extract provides 15 to 45 weight % of tetrahydroisohumulone of the composition.

Suresh Pillai, Ph.D., is a molecular biologist and a third-year law student at DePaul University College of Law.  Dr. Pillai was a member of MBHB's 2007 class of summer associates, and is currently working as a law clerk at MBHB.

Exiqon to Acquire Oncotech

    By Jason Derry --

Exiqon A/S and Oncotech Inc. have announced that Exiqon will acquire Oncotech for approximately $45 million.  Oncotech provides diagnostic tests that help physicians optimize treatment regimens for cancer patients.  Exiqon provides a number of products to assist in analyzing gene expression, including microRNA profiling products and services.  Through the acquisition, Exiqon and Oncotech will combine their respective expertise to develop molecular diagnostic tests based on microRNA biomarkers.  The companies expect at least one such test to be available within the coming year.

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

InterMune Buys out License Agreement for Pirfenidone

    By Christopher P. Singer --

In a November 26, 2007 press release, InterMune Inc. announced that it will purchase patent rights to pirfenidone from Marnac, Inc. and KDL GmbH.  This acquisition includes patent rights that InterMune had been licensing from Marnac and KDL as well as other international IP rights relating to pirfenidone that were not part of the prior existing license agreement.  Those additional IP rights include patents that relate to TNF-alpha based activities of pirfenidone.  Currently, pirfenidone is under two large phase 3 clinical trials to determine the safety and efficacy in the treatment of idiopathic pulmonary fibrosis (IPF).  Both the FDA and European Medicines Evaluation Agency (EMEA) have granted pirfenidone orphan drug status for treatment of IPF.

The buyout and purchase does not affect rights to pirfenidone (at left) in Japan, Korea, and Taiwan, which rights remain licensed by Marnac to Shionogi & Co. Ltd.  The terms of the purchase include upfront payments from InterMune totaling $13.5 million, and could include an additional $53.5 million in payments if pirfenidone achieves positive Phase 3 data and is registered in the U.S. and Europe.  All of InterMune's milestone and royalty payments under the prior license agreement are extinguished by this purchase.

Astellas to Acquire Agensys,Inc.

    By Sherri Oslick --

Astellas Pharma Inc. of Tokyo, has announced an agreement between its U.S. subsidiary, Astellas U.S. Holding of Deerfield, IL and Agensys, Inc. of Santa Monica CA under which Astellas will acquire Agensys for $387 million in cash, with up to an additional $150 million dependent upon Agensys' achievement of various milestones.  Agensys is a privately held biotechnology company focused on therapeutic antibody research and development in the area of cancer.

Agensys' portfolio includes 30 proprietary cancer targets to 14 different tumor types, and an antibody targeting prostate, pancreatic, and bladder cancers in Phase Ib clinical trials, and several candidate antibodies in the late preclinical stage.  Agensys develops human monoclonal antibodies through the use XenoMouse®, a human antibody-producing transgenic mouse in-licensed from Abgenix.  Agensys' patent portfolio includes over 100 issued patent or allowed applications and over 300 pending patent applications.

For additional information regarding Astellas' sacquisition of Agensy, please see:

• Astellas' press release
• Agensys' press release

GSK to Acquire Reliant Pharmaceuticals

    By Sherri Oslick --

GlaxoSmithKline of London, UK and Philadelphia, PA and Reliant Pharmaceuticals of Liberty Corner, NJ have announced an agreement under which GSK will acquire Reliant for $1.65 billion in cash.  Reliant is a privately held pharmaceutical company focused on cardiovascular therapeutics.

Reliant's therapeutic portfolio has been developed through in-licensing and development of cardiovascular medicines.  Included in its portfolio is Lovaza (formerly Omacor®; omega-3-acid ethyl esters), which is used to treat adult patients with very high triglyceride levels, and which was launched in 2005 and is licensed (in the U.S. and Puerto Rico) from Pronova BioPharma ASA of Norway.  Lovaza will compliment GSK's primary cardiovascular therapeutic, Coreg CR® (carvedilol phosphate), which is used to treat heart failure and hypertension.

In addition to Lovaza, Reliant's portfolio includes DynaCirc CR® (isradipine) and InnoPran XL® (propanolol hydrochloride), both of which are used to treat hypertension, Rythmol® SR (propafenone hydrochloride), which is used to treat arrhythmia, and Axid® (nizatidine), which is used to treat ulcers  The acquisition is expected to be completed by the end of the year, pending FTC approval.

For additional information regarding GSK's acquisition of Reliant, please see:

• GSK's press release
• Reliant's press release

No Discovery in New Rules Case

    By Kevin E. Noonan --

Gene Quinn from the PLI blog reports today that Judge Cacheris denied from the bench Plaintiffs' motion for discovery in the challenge to the claims and continuation rules enjoined by the Court on October 31st (see "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)").  Patent Office officials, including Director Jon Dudas and Patent Commissioner John Doll will not have to sit for deposition, nor will the Office be required to produce documents or a privilege log for any documents it seeks to withhold.  Plaintiff GlaxoSmithKline (GKS) and Dr. Triantafyllos Tafas have until December 20th to file their summary judgment motions.  While the Court did not explicitly state that amici are under the same deadline, prudence suggests they proceed with the understanding that later-filed briefing may not be considered by the Court.

Although somewhat of a surprise, the "victory" is a double-edged sword for the Office.  On the one hand, they will not be subject to the burden of fighting over privilege logs, something that could be expected in any litigation but would be almost a certainty for this administration.  And Mssrs. Dudas and Doll should be happy to stay out of the witness chair.  However, it will be especially difficult for the Office to assert any additional evidence in support of either their opposition to any GSK/Tafas summary judgment motions or in their own motions.  And as Mr. Quinn notes in his piece, GSK still has its Freedom of Information Act request pending, which may raise the privilege issue.  One possibility (from a reliable source) is that the Office doesn't have any responsive documents; in this scenario, the Office proposed the rules in disregard for the requirement for the kind of agency activities that would have produced documents in the first place.  If that is the case, it would be relevant to GSK/Tafas's argument that the Office violated the statutory mandates of the APA when promulgating the "new rules."

In addition, the absence of discovery should prevent the Office from a "December surprise" of additional information that might be persuasive to Judge Cacheris.  Being limited to the facts as they now exist, it's hard to see how the Office will be able to craft a more compelling argument than the one they asserted in the preliminary injunction hearing.  (Although it will be interesting to see if the Solicitor's office sends someone more senior or better prepared to rebut GSK/Tafas's arguments.)

And for the Grinches in the crowd, remember that some poor junior lawyers will have their holidays ruined preparing the Office's response to plaintiffs' motions.  Since the Office has argued that the entire case should be expedited so the issues can be resolved and the new rules, heaven forbid, be implemented as quickly as possible, it might be hard to get Judge Cacheris to grant an additional time for responding.

For additional information on this topic, please see:

• "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

Alnylam Announces Grant of German RNAi Patent

    By Donald Zuhn --

Alnylam Pharmaceuticals, Inc. announced today that it has received a German patent (DE 10080167) in the "Kreutzer-Limmer I" patent series.  According to the Cambridge, Massachusetts-based RNA interference (RNAi) therapeutics company, the Kreutzer-Limmer I patent series is one of three "fundamental patent" families that Alnylam has exclusively licensed and which the company "believes will be most important in providing competitive advantage and product exclusivity with respect to RNAi therapeutics" (see "Science & Technology - Intellectual Property" at Alnylam's website).  The other two "fundamental patent" series include the Crooke and Tuschl II series of patents.  While the latter two series include U.S. patents (U.S. Patent Nos. 5,898,031; 6,107,094; 7,056,704; and 7,078,196), the Kreutzer-Limmer I series does not include a U.S. patent.

According to Alnylam's statement, the German Kreutzer-Limmer I patent contains 52 claims providing broad coverage of medicaments and uses of small interfering RNAs (siRNAs) of between 15 and 49 nucleotides in length.  Alnylam noted that the Kreutzer-Limmer I series has been licensed to the company's four pharmaceutical collaboration partners, seven biotechnology companies in Alnylam's InterfeRx program, and 15 companies in the research reagent and services market.

Astellas Pharma, King Pharmaceuticals, and Teva Settle Adenoscan® Patent Suit

    By Baltazar Gomez --

Last month, Astellas Pharma Inc., King Pharmaceuticals, Inc., and Teva Pharmaceutical Industries Ltd. announced that U.S. subsidiaries of Astellas, along with Item Development AB and King have signed settlement agreements with respect to U.S. Patent Nos. 5,731,296 and 5,070,877.  The lawsuits involving the '296 and '877 patents were filed against Teva's subsidiaries after the subsidiaries submitted abbreviated new drug applications for a generic version of Adenoscan® (adenosine injection), a pharmacologic stress agent.  Under the terms of the settlement agreement, Teva will be able to launch their generic version of Adenoscan® pursuant to a license in September 2012, or earlier under certain conditions.

Adenoscan® is licensed and sold by Astellas in the U.S. as a pharmacologic stress agent and as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.  Adenoscan shows consistent maximal vasodilation of coronary arteries relative to intracoronary papaverine.  The short half-life of Adenoscan® allows for short-acting pharmacologic effects, making Adenoscan® useful for diagnostic and risk evaluation in coronary artery disease.

Astellas Pharma U.S. Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc.  Astellas is a pharmaceutical company that focuses on the areas of immunology, urology, anti-infectives, cardiovascular, and dermatology.  King Pharmaceuticals, Inc., headquartered in Bristiol, Tennessee, develops novel branded prescription pharmaceuticals and acquires branded products.  Teva Pharmaceutical Industries Ltd., headquartered in Israel, develops, manufactures, and markets generic and human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

For additional information regarding the settlement, please see:

• Astellas' press release
• King Pharmaceuticals' press release
• Teva's press release

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. Banner Pharmacaps Inc.
1:07-cv-00754; filed November 21, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 4,988,731 ("Sodium Hydrogen Divalproate Oligomer," issued January 29, 1991) and 5,212,326 (same title, issued May 18, 1993) following a paragraph IV certification as part of Banner's filing of an ANDA to manufacture a generic version of Abbott's Depakote® (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches).  View the complaint here.

Novartis Vaccines and Diagnostics, Inc. v. Hoffmann-La Roche Inc.
2:07-cv-00507; filed November 19, 2007 in the Eastern District of Texas

Infringement of U.S. Patent No. 7,285,271 ("Antigenic Composition Comprising an HIV gag or env Polypeptide," issued October 23,2007) based on Roche's manufacture and sale of its FUZEON® (enfuvirtide, used to treat HIV infection).  View the complaint here.

Elan Corporation PLC et al. v. Barr Laboratories Inc.
1:07-cv-00736; filed November 16, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Celgene Corporation et al. v. Barr Laboratories, Inc. et al.
2:07-cv-05552; filed November 16, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), and 6,635,284 (same title, issued October 21, 2003), all licensed exclusively to Novartis in certain fields of use, following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
1:07-cv-00731; filed November 15, 2007 in the District Court of Delaware

Declaratory judgment that Impax's Paragraph IV notices are null, void, and without legal effect, that the Court therefore has no subject matter jurisdiction over the claims surrounding the patents at issue, that Impax's notices did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act, and that Impax must serve new Paragraph IV notices upon Endo if and when the FDA accepts Impax's ANDA.  Also, infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.

Teva Pharmaceutical Industries Ltd. et al. v. Apotex, Inc. et al.
3:07-cv-05514; filed November 15, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,699,997 ("Carvedilol," issued March 2, 2004), 6,710,184 ("Crystalline Solids of Carvedilol and Processes for Their Preparation," issued March 23, 2004), 7,056,942 ("Carvedilol," issued June 6, 2006), and 7,126,008 (same title, issued October 24, 2006) based on Apotex's sale and/or manufacture of a generic version of GSK's Coreg® (carvedilol, used to treat congestive heart failure).  View the complaint here.

Allergan, Inc. v. Cayman Chemical Company et al.
8:07-cv-01316; filed November 7, 2007 in the Central District of California

Infringement of U.S. Patent No. 6,262,105 ("Method of Enhancing Hair Growth," issued July 17, 2001) based on defendants manufacture and sale of eyelash growth products with prostaglandin F ("PGF") as the active ingredient (Allergan's Lumigan® ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension, contains a PFG as the active ingredient).  View the complaint here.