Patent Law

Janssen Pharaceutica, N.V. v. Apotex, Inc. (Fed. Cir. 2008)

Posted on September 11, 2008
By Kevin E. Noonan -- Over the past year, the Federal Circuit has addressed on many occasions the scope of the "case or controversy" requirement for a court to have jurisdiction under Article III of the Constitution. Several of these decisions have been directed to the proper jurisdictional scope of declaratory judgment actions filed in ANDA cases, where a generic drug company has filed its ANDA on a drug having at least one patent listed by the innovator in the FDA Orange Book...

Carnegie Mellon University v. Hoffman-La Roche Inc. (Fed. Cir. 2008)

Posted on September 10, 2008
By Donald Zuhn -- On Monday, the Federal Circuit affirmed a finding on summary judgment by the District Court for the Northern District of California that the asserted claims of U.S. Patent Nos. 4,767,708 and 5,126,270 and certain asserted claims of U...

In re Swanson (Fed. Cir. 2008)

Posted on September 09, 2008
By Kevin E. Noonan -- Re-examination, whether ex parte under 35 U.S.C. § 302-307 or inter partes under 35 U.S.C. § 311-318, is a procedure intended to provide an alternative to patent litigation, which Congress characterized as being expensive and inefficient in passing legislation establishing these two routes of post-grant challenge (see H...

Court Report

Posted on September 08, 2008
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. Glaxo Group Ltd. et al. v. Lupin Ltd. et al.1:08-cv-00551; filed August 29, 2008 in the District Court of Delaware Infringement of U...

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New Attack on Patenting in The New York Times

Posted on September 08, 2008
By Kevin E. Noonan -- The New York Times seems to have an unending supply of pundits willing to support its anti-patent agenda, as has been noted on this blog before (see below). The latest example is an article in this Saturday's paper, entitled "When Academia Puts Profit Ahead of Wonder," by Janet Rae-Dupree...

Isis Pharmaceuticals Adds to Crooke RNAi Patent Estate

Posted on September 05, 2008
By Donald Zuhn -- Isis Pharmaceuticals, Inc. announced today that the U.S. Patent and Trademark Office has issued notices of allowance for U.S. Application Nos. 10/281,312 and 10/281,297. According to the company's press release, the two allowances "significantly expand" the scope of Isis' Crooke patent estate -- a family of patents based on the research of Dr...

BIO Discusses Legislative Accomplishments

Posted on September 04, 2008
By Kevin E. Noonan -- Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO) and Joshua Boger, Ph.D., Chairman of BIO's Board and President and CEO of Vertex Pharmaceuticals Inc...

USPTO News: USPTO and UKIPO Extend Patent Prosecution Highway Pilot Program

Posted on September 04, 2008
By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office announced that the Patent Prosecution Highway (PPH) pilot program with the United Kingdom Intellectual Property Office (UKIPO), which was initiated on September 4, 2007, would be extended until further notice...

Tafas v. Dudas Update

Posted on September 03, 2008
By Sherri Oslick -- Patent Docs readers anxiously awaiting GSK/Tafas' brief will have to wait a little longer. On August 14, the parties jointly moved to modify the briefing schedule; the motion was granted today (September 2). The schedule as it now stands is as follows:? September 24, 2008: Appellees' briefs due ? October 15, 2008: Appellants' reply brief and joint appendix due By an additional joint motion, also granted today, oral arguments will be scheduled on the December 2008 argument calendar...

USPTO News: Patent Office Seeking Volunteers to Test Continuing Education System

Posted on September 02, 2008
By Donald Zuhn -- In an e-Commerce e-Alert distributed on Friday, the U.S. Patent and Trademark Office announced that it was seeking up to 1,000 registered practitioners to help with a pilot test of the Office's new online Continuing Education for Practitioners (CEP) system...

Court Report

Posted on September 01, 2008
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. Sanofi-Aventis et al. v. Apotex, Inc. et al.3:08-cv-04320; filed August 27, 2008 in the District Court of Delaware Infringement of U...

Conference & CLE Calendar

Posted on September 01, 2008
September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA September 22-23, 2008...

2008 World Stem Cell Summit

Posted on August 30, 2008
The Genetics Policy Institute will be holding the 2008 World Stem Cell Summit on September 22-23 in Madison, WI. The Summit, which is being hosted by the University of Wisconsin Stem Cell & Regenerative Medicine Center and WiCell Research Institute, will bring together researchers, clinicians, business pathfinders, key policy-makers, regulators, advocates, and experts in law and ethics to give presentations, share information, and chart the future of regenerative medicine...

USPTO News: Patent Office Puts End to Submission of Duplicate Copies of Forms

Posted on August 29, 2008
By Christopher P. Singer -- In an August 27, 2008 notice, the U.S. Patent and Trademark Office (USPTO) announced that it is changing certain forms to remove language that requests a duplicate copy of the form be submitted for fee processing purposes. Previously, the duplicate copy of forms that contained an authorization to charge fees to a deposit account allowed for faster processing, because hardcopy paper application files were maintained in one area of the Office, while fee processing was done in another area of the Office...

ABA Issues Opinion on Outsourcing

Posted on August 28, 2008
By Donald Zuhn -- On Monday, the American Bar Association (ABA) Standing Committee on Ethics and Professional Responsibility released a statement regarding a new ethics opinion (Formal Opinion 08-451), which concludes that U.S. lawyers can outsource legal and nonlegal work provided that they adhere to ethics rules regarding competence, supervision, protection of confidential information, reasonable fees, and not assisting in the unauthorized practice of law...

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2008)

Posted on August 27, 2008
By Kevin E. Noonan -- We may have reached the high-water mark on the expansion of the inequitable conduct doctrine. Recent decisions from the Federal Circuit seem to signal a retrenchment in the Court's treatment of the doctrine, and its willingness to affirm district court judgments finding inequitable conduct, particularly in the context of summary judgment decisions...

Patent Profile: Helix BioMedix Announces Issuance of Patent for Antimicrobial Peptide

Posted on August 26, 2008
By Donald Zuhn -- Helix BioMedix, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,407,940, which is directed to hexapeptides that exhibit antimicrobial activity against infections caused by a variety of pathogens...

Conference & CLE Calendar

Posted on August 24, 2008
September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA September 23-24, 2008...

Biotech/Pharma Lobbying Scoreboard - Second Quarter Update

Posted on August 22, 2008
By Donald Zuhn -- Regular Patent Docs readers have likely noticed that we have been paying close attention to the lobbying efforts of various players in the biotech/pharma industry. Our interest in the lobbying expenditures of these companies and organizations stems from the push by Congress over the past year to pass patent reform and follow-on biologics legislation...

ACI Pharma/Biotech Collaborative Agreements Conference

Posted on August 22, 2008
American Conference Institute (ACI) will be holding its 11th Advanced Forum on Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements from November 12-14, 2008 in New York. The conference will allow attendees to: ? Leverage intellectual property and draft favorable exclusivity provisions;? Anticipate the potential impact of M&A activity on your transaction;? Negotiate co-development rights;? Protect rights relating to future developments and improvements;? Evaluate viable compensation structures;? Minimize risks through partner selection and due diligence;? Ensure effective alliance management;? Negotiate hotly contested issues with universities; and? Avoid the top pitfalls of international deals...

In re Omeprazole Patent Litigation (Fed. Cir. 2008)

Posted on August 21, 2008
By Kevin E. Noonan -- The Federal Circuit today affirmed AstraZeneca's latest victory in its long-running battle against generic drug companies who filed ANDAs for its (former) blockbuster drug, Prilosec®. The Court affirmed in toto the decisions of Judge Barbara S...

Prasco, LLC v. Medicis Pharmaceutical Corp. (Fed. Cir. 2008)

Posted on August 19, 2008
By Kevin E. Noonan -- The Supreme Court has spent the past few years issuing decision after decision circumscribing the Federal Circuit's Congressionally-mandated authority over U.S. patent law, pursuant to its plenary powers under Article III of the Constitution...

Court Report

Posted on August 17, 2008
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. Janssen Pharmaceutica N.V. et al. v. Sandoz, Inc. 1:08-cv-00511; filed August 13, 2008 in the District Court of Delaware Infringement of U...

UK High Court Invalidates HGS Neutrokine-alpha Patent

Posted on August 15, 2008
By Donald Zuhn -- Earlier this month, several European news outlets reported on a decision by the UK High Court of Justice declaring a Human Genome Sciences (HGS) patent disclosing the nucleotide and amino acid sequence of Neutrokine-alpha, a novel member of the TNF ligand superfamily, to be invalid...

USPTO News: USPTO Announces Revisions to Patent Fees

Posted on August 14, 2008
By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Thursday, August 14, 2008, the U.S. Patent and Trademark Office announced that certain patent fee amounts are being adjusted to reflect fluctuations in the Consumer Price Index (CPI) for financial year 2009...

Congressional Fact-finding on Follow-on Biologics

Posted on August 14, 2008
By Kevin E. Noonan -- The Subcommittee on Health of the House of Representatives' Committee on Energy and Commerce recently solicited comments and information on so-called "follow-on biologics" (FOBs) from stakeholders and other interested parties. The Subcommittee on Health's letter, signed by Subcommittee chairman Frank Pallone, Jr...

Insmed's Follow-on Biologics Campaign Continues

Posted on August 14, 2008
By Donald Zuhn -- Earlier this year, we reported on the campaign undertaken by Insmed Inc., a biopharmaceutical company based in Richmond, VA, to raise national awareness about the importance of establishing a regulatory pathway in the U.S. for follow-on biologics...

Patent Profile: Ulysses Pharmaceuticals Announces Issuance of Patent for Novel Class of Antibiotics

Posted on August 13, 2008
By Donald Zuhn -- Ulysses Pharmaceuticals announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,410,974, which is directed to a class of compounds that exhibit antibiotic activity against a wide spectrum of microorganisms, including organisms that are resistant to multiple antibiotic families (the so-called "superbugs")...

Senate Patent Reform Legislation -- One Old Bill and One New Bill

Posted on August 12, 2008
By Donald Zuhn -- Last Tuesday, CongressDaily reported that Senate Judiciary Chairman Patrick Leahy (D-VT) (at right) and ranking member Arlen Specter (R-PA) have indicated that patent reform will be a top priority for the new session. Coalition for Patent Fairness lobbyist Steve Elmendorf told the publication that he expects to begin working in earnest early next year to help push the Senate bill through, and predicted that it was "highly probable" that a bill would pass in the 111th Congress, given the Democratic leadership's support of the House bill, which passed in September 2007...

Once Again, The New Yorker Gets It Wrong on Patents -- Update

Posted on August 11, 2008
Last week, Patent Docs posted an article by Kevin Noonan (see "Once Again, The New Yorker Gets It Wrong on Patents") regarding "The Permission Problem," an article by James Surowiecki that appears in the August 11th edition of The New Yorker. Over the weekend, Mr...

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