News & Analysis as of

Myriad Disappointments for Biotech, but Hope Remains

CAFC extends the reach of subject-matter ineligibility under Myriad - Following Myriad Genetic’s 2013 loss at the Supreme Court (Ass’n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), herein “Myriad...more

Make Sure You Own the Patent You Think You Do.

The biotechnology industry has a long history of successfully licensing and litigating university technology. That trend looks to be continuing, even as other industries have taken aim at limiting patent enforcement. Ten U.S....more

Court Report -- Part II: November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more

Patent Update for IT and Biotech Companies: New Pieces to the Patent Puzzle

In This Presentation: - PATENT ELIGIBLE SUBJECT MATTER: LIFE IN SOFTWARE/IT AFTER ALICE CORPORATION V. CLS BANK (AND OTHER RECENT 101 DECISIONS) - A Brief History with respect to Software and Biz...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

During a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsels Committee (IPCC) fall conference, which took place this week in Nashville, TN, the U.S. Patent and Trademark Office provided a...more

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

Examination of Myriad-Mayo Guidance Comments -- University Community Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Success Protecting Intellectual Property in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO

For a drug discovery start-up, patent protection of the intellectual property underlying the commercialization pursuit is critically important. If the company is a university or research institution spin-out that obtained...more

Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium

Last month, at the Biotechnology Industry Organization (BIO) IP & Diagnostics Symposium in Alexandria, VA, Sherry Knowles of Knowles IP Strategies addressed the impact of the U.S. Patent and Trademark Office's Myriad-Mayo...more

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

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Full Federal Court confirms isolated nucleic acids are patentable in Australia

• The Full Federal Court has unanimously confirmed that isolated nucleic acids, either DNA or RNA, are patentable in Australia. • The decision is in contrast to the recent decision of the US Supreme Court, which held a...more

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Court Report -- Part II: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc. 2:14-cv-05423; filed August 28, 2014 in the District Court...more

Court Report - August 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Aptalis Pharmatech Inc. et al. v. Apotex Inc. et al. 1:14-cv-01038; filed August 11, 2014 in the District Court of...more

Court Report - August 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al. 1:14-cv-01004; filed July 31, 2014 in the District Court of...more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Court Report - August 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Glycobiosciences Inc. v. Dara Biosciences, Inc. et al. 1:14-cv-01281; filed July 28, 2014 in the District Court of the...more

Court Report -- Part II: August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicines Company v. Accord Healthcare, Inc. et al. 1:14-cv-00626; filed July 24, 2014 in the Middle District of North...more

Examination of Myriad-Mayo Guidance Comments -- ACLU

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Court Report - August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roche Molecular Systems, Inc. v. Cepheid 3:14-cv-03228; filed July 16, 2014 in the Northern District of...more

Court Report -- Part III

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC 1:14-cv-00914; filed July 11, 2014 in the District Court of...more

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