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FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

Federal Circuit Finds That Fetal Diagnosis Claims Survive Written Description Attacks

Stanford University v. The Chinese University of Hong Kong. Federal Circuit Appeal No. 2015-2011. Decided June 27, 2017. In an appeal from the Patent Trial and Appeal Board (PTAB), the Federal Circuit held that claims...more

In Helsinn Healthcare, the Federal Circuit Offers Guidance on the On-Sale Bar under the AIA

The sale of a product prior to filing a patent application, or “on-sale bar,” has long been a potential barrier to obtaining a patent in the United States. Especially in the biotechnology space, which can involve a long...more

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more

Getting the Most from Biotech Patents in Europe Without Breaking the Bank: Selecting the Right Countries for Validation

Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries. Such a decision may have long-term business and legal consequences. ...more

Continental patents a la carte or prix fixe? Biotechnology considerations for the unitary patent in Europe

Unitary patents in Europe - The European unitary patent and Unitary Patent Court (UPC) are slated to go into effect in early 2017. These monumental changes will have a significant impact on the ways patent rights are...more

Cabilly II IPR Update: Sanofi-Aventis U.S. LLC v. Genentech, Inc.

In July of 2015, Sanofi filed petition for an inter partes review (IPR2015-01624) for 15 claims of U.S. Pat. No. 6,331,415 (“Cabilly II”). In the antibody field, the Cabilly family of patents is well known and is believed to...more

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