Patent Law

Federal Circuit Grants Stay in Tafas v. Kappos

Posted on August 21, 2009
By Donald Zuhn -- On July 24, the Department of Justice (DOJ) filed a joint motion with Plaintiffs-Appellees Dr. Triantafyllos Tafas and GlaxoSmithKline seeking to stay briefing and oral argument in Tafas v. Kappos (previously Tafas v. Doll) until 60 days after the U...

ACI Paragraph IV on Trial Conference

Posted on August 21, 2009
American Conference Institute (ACI) will be holding its 2nd Annual Paragraph IV on Trial conference on November 12-13, 2009 in New York, NY. At this conference, Hatch-Waxman litigators experienced in representing both generic and innovator drug manufacturers will immerse attendees in a live, two-day, interactive mock trial of a Paragraph IV case based on a real-life fact pattern derived from an ANDA filing...

The Milwaukee Journal Sentinel Gets It Right about Patents

Posted on August 20, 2009
By Kevin E. Noonan -- Published articles in the popular press rarely report accurately about patents and the patent system. That's why it is unexpected, remarkable, and incredibly timely that the Milwaukee Journal Sentinel published not one but two in-depth articles about patents and the U...

Follow-on Biologics News Briefs - No. 8

Posted on August 20, 2009
By Donald Zuhn -- President Obama Wants to Speed Up Introduction of Generic Drugs In a health care town hall meeting held in Portsmouth, NH last week, President Obama told attendees that he wanted to speed up the introduction of generic drugs into the marketplace...

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By Suresh Pillai -- Settlement

Posted on August 19, 2009
By Suresh Pillai -- Settlement Announced in University of Iowa Dispute with Amgen The University of Iowa Research Foundation (UIRF) has announced a settlement in its dispute with Amgen Inc. over alleged patent infringement of two UIRF patents covering a cytomegalovirus promoter used in the design and manufacture of a number of marketed vaccines and therapeutics...

Investors Saw Biotech Rebound Coming

Posted on August 18, 2009
By Donald Zuhn -- Last week, the Biotechnology Industry Organization (BIO) and Thomson Reuters released the results of an investor perception study conducted earlier this year that correctly forecast a rebound for the biotech industry. A 37-page report outlining the result of the study can be obtained here...

BIO CEO Makes Case for 12-Year Data Exclusivity Period

Posted on August 17, 2009
By Donald Zuhn -- Last week, CNBC anchor Joe Kernen challenged Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood over the wisdom of implementing a follow-on biologics (FOB) regulatory pathway that provides innovator biologics manufacturers with 12 years of exclusivity...

Court Report

Posted on August 17, 2009
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. Astrazeneca LP et al. v. Breath Ltd. 1:09-cv-04115; filed August 12, 2009 in the District Court of New Jersey ? Plaintiffs: Astrazeneca LP; Astrazeneca AB ? Defendant: Breath Ltd...

Conference & CLE Calendar

Posted on August 17, 2009
August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments...

CBI Pharmaceutical Congress on Paragraph IV Disputes and Settlements

Posted on August 15, 2009
The Center for Business Intelligence (CBI) will be holding its 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes and Settlements on October 22-23, 2009 in Philadelphia, PA. The conference will cover issues relevant to both brand and generic companies during two days of presentations and panel discussions on litigation strategies, statutory guidelines, current cases, and their landmark decisions...

BIO IPCC Fall Conference

Posted on August 15, 2009
The Biotechnology Industry Organization (BIO) will be holding its Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting on October 26-28, 2009 in Washington, DC. The semi-annual IPCC conference will once again be open to the public...

PLI Patent Litigation 2009

Posted on August 15, 2009
Practising Law Institute (PLI) will be holding five sessions of its Patent Litigation 2009 seminar this fall in San Francisco (September 21-22), McLean, VA (October 5-6), Chicago (October 15-16), Atlanta (November 9-10), and New York (November 16-17)...

BIO Files Amicus Brief in Bilski

Posted on August 14, 2009
By Kevin E. Noonan -- The Biotechnology Industry Organization (BIO) filed an amicus brief with the Supreme Court last week in Bilski v. Doll, the appeal from the Federal Circuit's en banc decision establishing the "machine or transformation" test as the exclusive test for patent eligibility of process claims...

New Director to Be Sworn in on Thursday

Posted on August 13, 2009
By Donald Zuhn -- The U.S. Patent and Trademark Office has announced that on Thursday at 12:30 pm (EST), U.S. Secretary of Commerce Gary Locke will administer the oath of office to David Kappos (at right), the new Under Secretary of Commerce for Intellectual Property and Director of the USPTO...

Is Biotech/Pharma Beginning to Bounce Back?

Posted on August 13, 2009
By Donald Zuhn -- It has not been a great year for the biotech/pharma industry. In February, BIO President and CEO Jim Greenwood noted that almost a third of BIO's membership had less than six months of cash on hand, 45% had less than one year of cash remaining, and only 10% of the 370 publicly-traded biotechnology companies reported a positive income (see "BIO Meets the Press")...

Biotech/Pharma Docket

Posted on August 12, 2009
By Suresh Pillai -- Jury Finds AGA Guilty of Infringement in Medtronic Dispute A jury in the U.S. District Court for the Northern District of California has ruled that AGA Medical Corp. infringed Medtronic Inc.'s patents for blood vessel occlusion devices, and has ordered AGA to pay Medtronic $57 million...

Patent Profile: Cytori Receives Notice of Allowance for Use of Adipose-Derived Stem Cells in Bone Disorders

Posted on August 12, 2009
By Mark Chael -- Recently, Cytori Therapeutics, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for claims directed to prosthetic devices seeded with adipose-derived stem cells. According to the press release, these claims are related to the use of Cytori's Celution® System for the treatment of bone diseases...

Alnylam to Donate RNAi Patents to Patent Pool

Posted on August 11, 2009
By Donald Zuhn -- Last month, Alnylam Pharmaceuticals announced that it would contribute more than 1,500 of its RNA interference (RNAi) patents to the patent pool established by GlaxoSmithKline earlier this year. Alnylam is known for the development of therapeutics based on RNAi for the treatment of respiratory syncytial virus (RSV) infection, liver cancer, hypercholesterolemia, Huntington's disease, and TTR amyloidosis...

USPTO Office of PCT Legal Administration Mailing List

Posted on August 11, 2009
By Mark Chael -- For the benefit of our readers, we would like to remind you that the Office of PCT Legal Administration at the U.S. Patent and Trademark Office maintains a mailing list "to notify PCT customers, via e-mail, of updates to the forms and other information on [its] pages...

Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)

Posted on August 10, 2009
Common Sense, Perhaps, But Whose? By Kevin E. Noonan -- The Supreme Court in KSR International Co. v. Teleflex Inc. established a standard (such as it is) of "common sense" in evaluating whether an invention is obvious. If the Court had been careful to follow the statute, it might have stressed more carefully that the answer to the question "whose common sense" must be the person of ordinary skill in the art...

Court Report

Posted on August 09, 2009
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. Sandoz Inc. v. Boehringer Ingelheim Pharma GmbH & Co. KG et al. 1:09-cv-01444; filed July 31, 2009 in the District Court of the District of Columbia ? Plaintiff: Sandoz Inc...

Conference & CLE Calendar

Posted on August 09, 2009
August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments...

ACI Patent Opinion Writing Boot Camp

Posted on August 08, 2009
American Conference Institute (ACI) will be holding its Patent Opinion Writing Boot Camp on October 28-29, 2009 in Philadelphia, PA. The conference will allow attendees to: ? Identify how Seagate has altered opinion practice and the new standard for willful infringement; ? Clarify business objectives to determine the ultimate purpose of the opinion and the anticipated audiences; ? Formulate a pre-drafting strategy which accounts for the preparation, timing, and scope of the opinion; ? Understand how the opinion letter fits into the overall IP strategy; ? Incorporate new invalidity opinion strategies from evolving legal standards concerning written description and enablement;...

Exergen Corp. v. Wal-Mart Stores, Inc. (Fed. Cir. 2009)

Posted on August 07, 2009
Has Inequitable Conduct Met Its Match? By Kevin E. Noonan -- There have been clear indications for some time that certain members of the Federal Circuit believe that the Court's inequitable conduct jurisprudence has gone astray from the "a high bar" Judge Rader (at right) believes the Court's earlier case law requires for establishing this affirmative defense...

Follow-on Biologics News Briefs - No. 7

Posted on August 06, 2009
By Donald Zuhn -- California Healthcare Institute Applauds Eshoo-Inslee-Barton Amendment Last Friday, the House Committee on Energy and Commerce passed a health care reform bill by a close 31-28 vote (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period")...

Gene Patenting Debate Continues - Round Two

Posted on August 05, 2009
By Donald Zuhn -- Gene patenting. It's a topic that Public Radio just can't seem to get enough of this summer. In June, Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan discussed the topic on WAMU, Washington, DC's leading public radio station (see "Gene Patenting Debate Continues")...

Biotech/Pharma Docket

Posted on August 04, 2009
By Suresh Pillai -- Settlement Announced in Ethyol® Infringement Suit Sun Pharmaceutical Industries, Ltd. and Medimmune LLC have announced a settlement of their patent dispute regarding Sun's manufacture and marketing of a generic version of the Medimmune drug Ethyol®, a cancer therapy drug...

Efficient Delivery of siRNA

Posted on August 04, 2009
By Kevin E. Noonan -- A research paper in the June 2009 edition of Nature Biotechnology (Eguchi et al., 2009, "Efficient siRNA delivery into primary cells by a peptide transduction domain?dsRNA binding domain fusion protein," Nature Biotechnology 27: 567-71) describes a new system for introducing short interfering RNAs (siRNAs) into mammalian cells that may help this technology become practicable for therapeutic uses...

Patents and Data Exclusivity: It Ain't Necessarily So

Posted on August 03, 2009
By Kevin E. Noonan -- The most troublesome point of contention in the follow-in biologics (FOBs) debate has undoubtedly revolved around the term for data exclusivity. In a subject so complex, it may be understandable that there are differing views about the importance of data exclusivity, and whether this is "much ado about nothing" or a vitally-important part of any follow-on biologics regime...

Court Report

Posted on August 03, 2009
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. Juridical Foundation The Chemo-Sero-Therapeutic Research Institute v...

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