Expert opinion on therapeutic patents
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Expert Opin Ther Pat · Jan 2015
EditorialTeva Pharmaceuticals v. Sandoz: availability of generic glatiramer acetate and the impact to patent litigation claim construction.
In the upcoming case of Teva Pharmaceuticals v. Sandoz, the U. ⋯ Supreme Court will address how much deference the appellate court should afford to a trial court's claim construction ruling. The effect of this decision will be far-reaching, as how claims are construed can determine whether a patent is infringed or not infringed, valid or invalid.
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Expert Opin Ther Pat · Nov 2014
EditorialBiosimilars lining up to compete with Herceptin--opportunity knocks.
Trastuzumab is a monoclonal antibody developed by Genentech as a treatment for breast cancer and gastric cancer when the cancer cells overexpress HER2, a membrane-bound receptor activated by epidermal growth factor. Now marketed by Roche under the trade name Herceptin, trastuzumab has been readily adopted as treatment for some of the most invasive types of breast cancer. ⋯ As biosimilar manufacturers look for opportunities to market biosimilar trastuzumab products, Roche has positioned itself to protect its market by developing additional anti-HER2 products complementary to Herceptin. The advent of competition from biosimilars should bring some opportunity for cost savings for patients, as well as incentive for continued advancement in development of better treatments to fight breast cancer.
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For over 20 years, the US Patent & Trademark Office (USPTO) has been granting patents to DNA sequences. But on 13 June 2013, the US Supreme Court decided that genomic DNA sequences are unpatentable because they are products of nature. This article discusses the effect that this will have on DNA patents in the Unites States and in other countries.
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Expert Opin Ther Pat · Aug 2013
EditorialStrategic considerations under the Biologics Price Competition and Innovation Act.
The Biologics Price Competition and Innovation Act provides a pathway for regulatory approval of generic drugs and the associated patent challenge. This article reviews strategic considerations during the patent litigation and injunction phases. Considerations during the initial patent litigation phase include when and whether to exchange a paragraph k application and the listing and exchange of patent information during the volley phase.