Shifting Sands? The Intellectual Property Basis of Biotechnology
By Mark C. Rogers, MD MBA

Journal editor Mark Rogers writes that in addition to the consequences of proposed patent reform, court rulings and agency policy making impact intellectual property and patents. He discusses the recent Myriad ruling’s long term implications and recent NIH and the National Cancer Institute’s proposed changes to IP agreements that will complicate questions of ownership in inventions developed with selected public funds.

"Without the ability to patent discoveries in an understandable and predictable fashion, the financial investments in discoveries would not be available to convert them from ideas to demonstration projects and ultimately to economically potent companies."

Patent Reform: Effects On Medical Innovation Businesses
By Renee Kaswan, David Boundy and Ron Katznelson

The guest editors assembled a panel of expert contributors to give a "state of the patent system" overview, discuss the potential effects of patent reform broadly or in relation to a specific portion of the proposed legislation as well as alternatives to legislative reform and venture capital perspectives on the reforms.

"We as the editors of this special issue, are deeply concerned that the Patent Reform Act will severely harm medical and small company innovation."

Venture Capital - The Buck Stops Where?
By Gary Lauder

Venture capitalist Gary Lauder expresses his concerns that patent reform could spell the end of venture capital funding for innovative startups in America. In his feature article for MIBJ's special Patent Reform issue, Lauder tackles three proposed changes under proposed reform that he feels will have long-term detrimental effects on the U.S. economy.

"The main provisions of Patent Reform are uniformly adverse to small companies, and consequently to venture capital. The U.S. has the most innovative economy in the world, yet this bill threatens to materially harm it to solve 'problems' that are not really problems."

What is a Bad Patent?
By Patrick Doody

In his article, Mr. Doody discusses the difficulty of defining "bad" patents that critics accuse the U.S. PTO of issuing. Without an adequate definition, Doody asks how a solution can be posed to the alleged problems caused by the alleged "bad" patents.

"The patent itself is not 'bad' rather, it is either the party that is asserting the patent or the overzealous enforcement of the claims against third parties, either through licensing or litigation, that is bad."

Patent Reform's Weakened Grace Period: Its Effects On Startups, Small Companies, University Spin-Offs and Medical Innovators
By David Boundy and Matthew Marquardt

The authors show how redefining the grace period under S.515 and H.R.1260 could seriously impact small companies as R&D resources are diverted to file early patents on questionable inventions.

"Patent Reform's weak grace period directly impairs an inventor's ability to discuss the invention with third parties-investors, strategic partners, and the like-with disastrous consequences for small companies' abilities to turn ideas into practical realities."

Would Derivation Proceedings Be The Same As Derivation Interferences?
By Charles Gholz

Mr. Gholz discusses significant differences between derivations proceedings under proposed reform legislation and existing derivation interferences that would substantially change outcomes for both parties.

"The theory is that the interference determined which party or parties is or are not entitled to a patent, not that either party is entitled to a patent. However, that may not be the case when an applicant wins a derivation proceeding."

Post-Grant Review - Our Next Nightmare? VC Perspective
by John Neis

Venture capitalist John Neis shares his views on the expanded post-grant review provisions of proposed patent reform. In particular, he is concerned that venture capital investment in early stage innovation will dry up if patent rights are no longer assumed valid and enforceable.

"For startups, a patent on a key technology gives investors a necessary degree of confidence that new discoveries can be protected, and a competitive position maintained, throughout a lengthy development process."

Post-Grant Review of U.S. Patents: Will Past Be Prologue?
By Dr. Kevin Noonan

Dr. Noonan expresses his concerns about potential abuse of the proposed Post Grant Review process. Because the reexamination process itself casts doubt on the validity of a patent, the author fears that proposed expansion will result in decreased investment in innovation and harassment of patentees.

"Reexamination under current U.S. law has not reduced patent litigation as expected; instead reexam can be detrimental to attracting venture capital that is vital to the existence of start-up companies."

The Gatekeeper Patent Damages Compromise of S. 515
By Philip Johnson

Johnson & Johnson's Chief Intellectual Property Counsel addresses the proposed "gatekeeper" role of the court in damage awards and explains how unfounded fear of runaway jury awards has hindered the adoption of meaningful patent reforms over the last few years.

"While in three prior Congresses, patent damages reform had been the sticking point preventing progress on reform, this logjam was broken with the development of this gatekeeper compromise."

The Proposed Interlocutory Appeals Provision of Patent Reform - Is It Dead Yet?
By Edward Reines and Nathan Greenblatt

The authors discuss their opposition to H.R.1260's proposed allowance of interlocutory appeals of claim construction orders. Reines and Greenblatt assert that this approach is the wrong solution to the wrong problem that could ultimately inundate the courts in a wasteful cycle of reviews and re-reviews.

"The proposed tampering with the basics of our appellate process is hasty, unnecessary and unwise."

Conversations with Two Chief Judges
By Matthew Dowd

In this rare interview, Dowd speaks with retiring and incoming Chief Judges Paul Michel and Randall Rader of the Federal Circuit. Both Chief Judges share their frank appraisals of the role of the courts in the patent process, proposed Patent Reform legislation, and the pitfalls and successes of the U.S. patent system.

"That's the genius of the common law system. Circumstances change, technology changes, business changes, litigation tactics and arguments change, and the courts can continue to adjust to those changes in a way that legislation can't."

Adequately Funding the USPTO: A Critical Problem That Must Be Solved
By Nicholas Godici

The author, a former Commissioner of Patents and Acting Director of the Patent and Trademark Office, details how funding issues at the USPTO could be resolved to address the growing backlog of patent applications, shortage of trained examiners and outdated IT systems.

"Let's not allow the patent system to suffer from inadequate funding when it could easily be self-supporting."

Patent Reforms Must Focus On The U.S. Patent Office
By Dr. Ron Katznelson

Dr. Katznelson asserts that any reform efforts should be focused on USPTO operations and correction of long-term failure to invest in the patent office as well as dysfunctions in patent processing and administrative law compliance. The author critiques patent office performance metrics as misguided and skewed toward rejection.

“USPTO's rulemaking attempts over the last few years were no less than frontal assaults on patentee's rights and the rule of law... Fundamental reforms in the Office's core practices are also long overdue."

Attenuated Judicial Review of Patent and Trademark Office Decisions: "Technical Amendment," or Stacking The Deck Against Inventors?
By Charles Miller and Daniel Archibald

In their article, Miller and Archibald question why the USPTO supports reform legislation that would remove the District Court as an avenue of redress for patentees who disagree with patent office rulings. They believe that the ultimate goal of the USPTO is to insulate BPAI rulings from meaningful review.

"Because the PTO is now attempting to circumvent current statutory provisions by abolishing civil actions in ex parte reexaminations altogether through legislation that will have catastrophic consequences, such legislation should be stricken from the current Manager's Amendment of S.515."