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President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)

One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something...more

10/30/2014 - Biotechnology Harvard University Inter Partes Reexamination Patent Infringement Patent Litigation Patents Pharmaceutical Patents

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

10/9/2014 - Amgen Biosimilars Biotechnology Patent Litigation Patents

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

8/14/2014 - Biologics Biosimilars Biotechnology FDA Pharmaceutical PHSA Prescription Drugs

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

7/1/2014 - AMP v Myriad Biotechnology Guidance Update Mayo v. Prometheus Patent-Eligible Subject Matter Patents Public Comment SCOTUS USPTO

Sherry Knowles Speaks Truth to the Power of the PTO on ยง 101 Guidelines

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more

5/2/2014 - AMP v Myriad Biotechnology GlaxoSmithKline Mayo v. Prometheus Patent Litigation Patents Pharmaceutical SCOTUS Section 101 USPTO

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

4/16/2014 - Biotechnology Patent Infringement Patent Litigation Patents Pharmaceutical

Amicus Briefs Urging Reversal Filed in Ariosa Inc v. Sequenom, Inc.

The San Diego Intellectual Property Law Association (SDIPLA) is one of two groups that have filed an amicus curiae brief urging reversal of the District Court's summary judgment decision in Ariosa Inc v. Sequenom, Inc. (The...more

3/7/2014 - Biotechnology Patent Infringement Patent Litigation Patents

Patenting Necessary for Continued Innovation in Biotech/Pharma Industries, Academics Conclude

Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more

2/12/2014 - Bayh-Dole Act Biotechnology Innovation Patent Applications Patents Pharmaceutical Universities

More Q&A from Webinar on Top Patent Law Stories of 2013

On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more

1/24/2014 - 23andMe America Invents Act AMP v Myriad Biotechnology Bowman v Monsanto FTC v Actavis Innovation Act Life Sciences Monsanto Myriad Patent Infringement Patent Litigation Patent Reform Patent Trolls Patents Pharmaceutical SCOTUS

University of Pittsburgh v. Cellerix (PTAB 2013)

The Patent Trial and Appeals Board (PTAB), a creation of the Leahy-Smith America Invents Act that replaced the Board of Patent Appeals and Interferences (BPAI) overruled the Reexamination Unit's decision that the claims of...more

12/11/2013 - Biotechnology Life Sciences Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents Stem cells

Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing

On July 19th, Myriad Genetics amended its complaint against Ambry Genetics to include claims to its patents relating to colon cancer predictive genetic diagnostic testing (amended complaint). ...more

10/24/2013 - Biotechnology Genetic Testing Myriad Patent Infringement Patent Litigation Patents

BIO Urges Rehearing En Banc in Fresenius v. Baxter Int'l.

In a case that raises important issues of perhaps Constitutional dimensions (at least in Circuit Court Judge Newman's view), the Biotechnology Industry Organization (BIO) urged the Federal Circuit to rehear the panel decision...more

9/10/2013 - Biotechnology Fresenius Patent Infringement Patent Litigation Patents USPTO

Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine

The Supreme Court, in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), has in recent years focused the requirements for pleadings under the Federal Rules of Civil Procedure...more

8/29/2013 - Ambry Antitrust Litigation Bad Faith Biotechnology Counterclaims DNA Federal Rules of Civil Procedure Genetic Materials Myriad Noerr-Pennington Doctrine Patents Twombly/Iqbal Pleading Standard

Novozymes A/S v. DuPont Nutrition Biosciences APS (Fed. Cir. 2013)

It has long been a practice in prosecuting a patent application to keep a continuation application pending during the term of any granted patent. This practice is advantageous because it permits the patentee to pursue...more

7/26/2013 - Biotechnology Litigation Strategies Patent Applications Patent Litigation Patents

In re Adler (Fed. Cir. 2013)

Ever since the Supreme Court handed down its decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), both the U.S. Patent and Trademark Office and the courts have found it easier to render a decision that a claimed...more

7/25/2013 - Biotechnology Inventions Patent Applications Patents SCOTUS USPTO

Organic Seed Growers & Trade Ass'n v. Monsanto Co. (Fed. Cir. 2013)

Somewhat lost in the hubbub over the Supreme Court's ruling in AMP v. Myriad was the Federal Circuit's decision, just a few days earlier, in Organic Seed Growers & Trade Ass'n v. Monsanto Co. That case is the latest windmill...more

7/5/2013 - Biotechnology Farms Food Supply Genetically Engineered Seed Infringement Monsanto Organic Organic Seed Growers & Trade Assn Patents

The Myriad Case and "Gene" Patents: Much Ado about Nothing?

The biggest concern of the biotechnology industry caused by the impending Supreme Court decision in the AMP v. Myriad Genetics case is the threat to existing patents having claims to isolated human DNA (and the DNA from other...more

5/15/2013 - AMP v Myriad Biotechnology DNA Gene Patenting Human Genes Myriad Patents

It Ain't Necessarily So Down on the Farm: Not All Farmers Agree with Farmer Bowman in Bowman v. Monsanto

The "conventional wisdom" surrounding the Bowman v. Monsanto case now before the Supreme Court on certiorari is that it is "David v. Goliath," the salt-of-the-earth farmer versus the corporate monolith, and an example of the...more

2/1/2013 - Biotechnology Bowman v Monsanto Farms Genetically Engineered Seed Infringement Patent Exhaustion Patents SCOTUS Seeds

BayhDol25 Files Amicus Brief in Bowman v. Monsanto

"Happy families are all alike; every unhappy family is unhappy in its own way." - Leo Tolstoy, Anna Karenina A great many amicus briefs have been filed in support of affirmance of the Federal Circuit's decision in Bowman...more

1/31/2013 - Bayhdol25 Biotechnology Bowman v Monsanto Licenses Patents Royalties Seeds

Is It Time for Myriad to Concede in AMP v. Myriad for the Good of the Biotechnology Industry?

The Supreme Court's grant of certiorari over the question "Are human genes patentable" had raised for many the specter of an uninformed generalist court rendering a decision containing dicta that would negatively affect...more

1/24/2013 - Biotechnology DNA Human Genes Myriad Patent-Eligible Subject Matter SCOTUS

Spread of Laboratory-generated Antibiotic Drug Resistance in Chinese Rivers

A generation ago, Jeremy Rifkin famously convinced the Cambridge city council to ban genetic engineering in that city, using the fear of "tinkering" with nature and producing a "superbug" that would hurt the public health and...more

12/28/2012 - Biotechnology China Drug-Resistant Recombinant DNA

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