Law Commons^™

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

What About Know-How: Heightened Obviousness And Lowered Disclosure Is Not A Panacea To The American Patent System For Biotechnology Medication And Pharmaceutical Inventions In The Post-Ksr Era, Yi-Chen Su

Marquette Intellectual Property Law Review

In KSR International Co. v. Teleflex, Inc., the Supreme Court rejected the Federal Circuit's rigid application of the teaching, suggestion, or motivation test (TSM test), and replaced it with an expansive and flexible approach, in determining the question of obviousness. Nevertheless, an expansive and flexible approach to obviousness may not be consistent with the international norms of practice if it is applied literally. The U.S. Patent and Trademark Office's literal application of the decision has essentially created another set of inflexible rules, which is contrary to the Supreme Court's intent. The Federal Circuit's recent decision in In re Kubin cautiously …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

The Intellectual Property Landscape For Ips Cells, Robin C. Feldman

Robin C Feldman