scholarly journals Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies

2014 ◽  
Vol 20 (3) ◽  
Author(s):  
Stefan Michael Miller

With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a “first-inventor-to-file” system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.

2017 ◽  
Vol 23 (2) ◽  
Author(s):  
Craig Robert Smith

Biotechnology companies rely on patents to protect their most valuable inventions.  Patent protection helps support billions of dollars in research and development of life-saving drugs and treatments.  Protecting biotechnology inventions has become more difficult in the last few years, however, because legal trends have created uncertainty regarding what subject matter is eligible for patent protection.  Specifically, courts have narrowed the scope of what is patentable and have increasingly invalidated patents because they claim abstract ideas or laws of nature.  As biotechnology companies wait for more clarity on the scope of patentable subject matter, they face a dilemma of whether to patent their inventions or keep them secret.  Keeping inventions secret offers some benefits to companies, but may not be sufficient to protect the significant investment made in research and development.  The biotechnology industry will continue to grapple with this dilemma until the courts, the Patent Office or new legislation clarifies the boundaries of what subject matter is patentable.


2016 ◽  
Author(s):  
Mark Lemley

Inherency is a puzzle that runs throughout patent law. Patents are basedupon descriptions of technology. However, technologies may have qualitiesthat are unappreciated or unidentified in a patent description, but whichare nonetheless present. The law refers to these unknown attributes asinherent in the product or process. What should be done about suchcharacteristics or qualities of a technology that exist but are notexplicitly described, either through ignorance or inadvertence? Thisproblem is explicitly presented in at least five different patentdoctrines: anticipation, the on-sale bar, priority disputes,double-patenting, and enablement; and it casts its shadow across the lawgoverning subject matter, infringement, and obviousness.Inherency is also perhaps the most elusive doctrine in all of patent law.The cases appear to flatly contradict each other, are often accompanied bydissents, and in the last three years alone have triggered one abortive enbanc rehearing and strong calls for a second. In particular, the courtshave split sharply over whether an element can be inherent in a prior artreference even if people of ordinary skill in the art do not appreciate theexistence of that element.In this Article, we argue that this confusion is largely unnecessary. Whilemany courts have recited as gospel the idea that inherency requiresknowledge or appreciation of the inherent element, in no case does theapplication of the inherency doctrine actually turn on knowledge of theelement. Rather, the inherency cases are all ultimately about whether thepublic already gets the benefit of the claimed element or invention. If thepublic already benefits from the invention, even if they don't know why,the invention is inherent in the prior art. If the public doesn't benefitfrom the invention, there is no inherency.In Part I, we examine the main thread of inherency cases, those arising outof the novelty and statutory bar provisions of the Patent Act. We explainhow the courts got off track in their focus on knowledge, and why a focuson benefit clearly and consistently explains the doctrine. In Part II, weconsider inherency in a different context, one in which the inventor mustshow possession of the claimed invention, either to prevent a new matterrejection or to establish priority of invention. Finally, in Part III, wediscuss the broader implications of this rule, including what the inherencydoctrine may mean for patents on DNA sequences and patents on drugs derivedfrom traditional knowledge. A proper understanding of the inherencydoctrine may offer a logical explanation for the product of nature cases,undermining the last significant exception to patentable subject matter.


Author(s):  
L. Bently ◽  
B. Sherman ◽  
D. Gangjee ◽  
P. Johnson

This chapter deals with patentable subject matter and the ways in which it is regulated under the Patents Act 1977 and the 2000 European Patents Convention (EPC). More specifically, it discusses five criteria that an invention must satisfy to be patentable, including the requirement that it must be capable of ‘industrial application’, and that patents are not granted for immoral inventions. The chapter also considers two different approaches that are used when deciding whether an invention falls within the scope of section 1(2)/Article 52(2): the ‘technical effect’ approach in the UK and the ‘any hardware’ approach applied by the European Patent Office. Finally, it examines how the law deals with a number of specific types of invention and looks at possible reforms, particularly in relation to computer programs and computer-related inventions.


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