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 …

Copyright For Engineered Dna: An Idea Whose Time Has Come?, Christopher M. Holman

Christopher M Holman

The rapidly emerging field of synthetic biology has tremendous potential to address some of the most compelling challenges facing our planet, by providing clean renewable energy, nutritionally-enhanced and environmentally friendly agricultural products, and revolutionary new life-saving cures. However, leaders in the synthetic biology movement have voiced concern that biotechnology's current patent-centric approach to intellectual property is in many ways ill-suited to meet the challenge of synthetic biology, threatening to impede follow-on innovation and open access technology. For years, copyright and patent protection for computer software have existed side-by-side, the two forms of intellectual property complementing one another. Numerous academic commentators …

Protecting Innovation In Computer Software, Biotechnology, And Nanotechnology, Dennis S. Karjala

Dennis S Karjala

In the 1970=s, paying virtually no attention to the fundamental distinction between patent and copyright subject matter, Congress decided to protect computer programs as a Aliterary work@ under copyright law. As a result, a work of technology for the first time was consciously placed under the protective umbrella of a statute designed for art, music, and literature. While the vulnerability of computer program code to cheap and easy verbatim copying supplied a policy basis for Aanti-copy@ protection of code, courts often analogized these congressionally anointed Aliterary works@ to broadly protected novels and plays rather than thinly protected technical specifications and …

Non-Obviousness In Patent Law: Impact Of New Scientific Discoveries On In Re Kubin, Ryan C. Smith

Ryan C Smith

The Federal Circuit made a recent controversial decision in In Re Kubin in applying the KSR v. Teleflex obviousness criteria to the field of biotechnology. As the legal world contemplated the implications of KSR on the field of biotechnology, a new scientific discovery was made which addresses the fundamental logic of an element of Kubin. The impact of the new scientific discovery on In Re Kubin suggests (a) Kubin should be limited to its facts, and (b) the scope of subject matter in the non-obvious “obvious to try” category should be significantly expanded, enabling greater patentability on new biotechnology inventions …

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 …

Protecting Innovation In Computer Software, Biotechnology, And Nanotechnology, Dennis S. Karjala

Dennis S Karjala

In the 1970’s, paying virtually no attention to the fundamental distinction between patent and copyright subject matter, Congress decided to protect computer programs as a “literary work” under copyright law. As a result, a work of technology for the first time was consciously placed under the protective umbrella of a statute designed for art, music, and literature. While the vulnerability of computer program code to cheap and easy verbatim copying supplied a policy basis for “anti-copy” protection of code, courts often analogized these congressionally anointed “literary works” to broadly protected novels and plays rather than thinly protected technical specifications and …

Statutory Stones And Regulatory Mortar: Using Negligence Per Se To Mend The Wall Between Farmers Growing Genetically Engineered Crops And Their Neighbors, Joshua B. Cannon

Washington and Lee Law Review

No abstract provided.

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 …

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 …

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

Faculty Works

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 …

Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman

Faculty Works

The patent eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation …

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

Robin C Feldman