House Patent Reform Bill Filed – Document Link

The House Patent Reform Bill has been filed.

The House Judiciary Committee also held a hearing on the Senate Bill and submitted testimony is available.

Stay tuned for BIO’s press release on the House Patent Bill.

Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation

Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation (March 24, 2011)
BIO joined with 97 other manufacturers, scientists, researchers, academic institutions, and businesses to urge the U.S. House of Representatives to enact patent reform into law in order to strengthen our country’s patent system which will help get breakthrough products to market faster, maximizing our opportunities for job growth.
Read the letter (120 KB PDF)

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Smith To Introduce House Patent Ahead of Next Week’s Hearing

Article from Tech Daily Dose in the National Journal stating:

House Judiciary Chairman Lamar Smith, R-Texas, will introduce his own version of patent reform legislation next week, possibly as early as Monday.

BIO’s Amicus Brief: Microsoft v. i4i

The Biotechnology Industry Organization, along with AUTM and CropLife International, filed an amicus brief in the Microsoft v. i4i Supreme Court case.

This case is widely viewed as one of the most fundamental and important patent cases to reach the Supreme Court in probably a decade. Most basically, this case is about the level of certainty a jury or judge must have before finding a patent invalid in litigation. Historically, the law has required a high level of proof, “clear and convincing evidence,” before a patent that has been examined and issued by the US Patent and Trademark Office can be declared invalid by a court. In the Microsoft v. i4i case, the Supreme Court is now being asked to adopt a lower burden of proof, under which patents can more easily be found invalid by a lower “preponderance of the evidence.”

In our joint brief, BIO, AUTM and CLI explain that the current high burden of proof has deep historic roots in Supreme Court law, and has been consistently applied by the lower courts for many decades. Under the current standard, issued patents benefit from a clear and meaningful presumption of validity that cannot be easily overcome. In this way, patents play their intended role as enduring legal instruments that confer real rights, and that developers and investors can rely on for investment and product development decisions. The importance of being able to rely on patent rights is illustrated very clearly in the biotech industry, which would not be able to make large investments over very long development times without assurances that the fruits of their investments are protected by robust patent rights. Lowering the standard for patent validity would frustrate decades of investment-backed reliance interests and would negatively impact biotechnology innovation going forward. Our brief explains that the existing high burden of proof to invalidate a patent is entirely consistent with other instances where the law imposes high burdens of proof to protect the public’s reliance on existing property rights.

In our brief, we also point out that Congress permits patents to be invalidated on a lower burden of proof only by the expert Patent Office, and then only on certain kinds of reliable evidence. Litigants who prefer to argue to a lay jury or generalist judge, or who want to use less reliable evidence, can do so only under a higher burden of proof. Any change to this carefully-crafted balance would have to be made by Congress, not the courts.

The United States’ brief in this case forcefully argues against changing the current standard of patent validity.

BIO’s Intellectual Property Counsels Committee Seattle Meeting Topics

Join us for BIO’s Intellectual Property Counsels Committee Meeting in Seattle April 13-15.  You can find the session topics below.

Whose Rights Are They, Anyway? Implications from and a Discussion on Stanford v. Roche

The pending Supreme Court review of Stanford v. Roche has brought out multiple perspectives on the disposition of ownership rights in federally funded inventions under Bayh-Dole. This session will explore the different interpretations of the Act’s provisions, and their practical implications for small business grantees or biotech companies who wish to collaborate with federal grantees.

A Landmark Case: The Aftermath of Myriad

This session will provide an update on the status of the case and the arguments that have been made by the various amicus groups, with particular emphasis on the US Government’s brief. We will also explore the impact of “gene patents” on up-and-coming technologies, especially whole genome/whole exome testing.

The Business Case for International Humanitarian Approaches to IP Management and Collaborations

Guest Speaker:

Erik Iverson, Associate General Counsel, Global Health, Gates Foundation

 

Best Practices in Research Collaborations: Joint Inventorship Pitfalls and Ethical Issues in Joint Representation

Don Ware of Foley Hoag will lead a discussion of pitfalls that may arise from prosecuting joint inventions conceived in the course of research collaborations among multiple institutions, including companies, universities and hospitals. Irene Pleasure, Associate General Counsel and Director of Patent Law at Genentech, will provide the in-house perspective on managing patent issues in research collaborations. David Hricik, Professor of Law at Mercer University School of Law and co-author of the treatises Patent Ethics – Prosecution (2009) and Patent Ethics – Litigation (2010), will address the professional responsibilities of patent attorneys involved in the prosecution of jointly-owned patent applications.

How to Stay in the Frying Pan and Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys

Professor David Hricik and Barbara Fiacco of Foley Hoag will present on developments in ethics law for in-house IP counsel, including law firm conflict issues, how to protect the attorney-client privilege, ethical dilemmas created by 21st century social media, in-house counsel ethical pitfalls, and recent developments in IP malpractice law. The game-show format of this panel will be thought-provoking and fun, and will encourage audience participation. CLE Ethics credit is being requested.

Learn How to Navigate IP Landscape in Emerging Markets

BIO members have indicated a strong desire to hear about challenges and key developments in emerging markets such as Korea, China, Brazil and India. Specific challenges, lay of the land, how to negotiate better in these markets.

Double Patenting

This panel will include new developments on the Boehringer Ingelheim Federal Circuit Case, collaboration of multiple parties/how to avoid double patenting rejections and possible coverage of the Sun v. Lilly case.

The Next Chapter: Biosimilars Beyond the Health Care Reform Act

Will Policy Issues Slow the Pace of Implementation? Will the FDA Look to Europe for Guidance on Antibody Biosimilars? Emerging Markets, Emerging Strategies? The panel will cover recent developments in biosimilar, including policy issues based on move to repeal healthcare reform, the recent FDA public hearing on biosimilars, further debate on the meaning of exclusivity, the necessity of clinical trials, the possibility of interchangeability, and developments in Europe with respect to antibody biosimilars.

Biotech, Gates Foundation, and Global Health

Great interview by Gene Quinn with Erik Iverson, Associate General Counsel with the Bill & Melinda Gates Foundation.  A summary article is on BIOtech Now and the full interview can be found on IPWatchdog.com.

 Highlights:

Iverson told me in no uncertain terms, “[A] fundamental premise at the foundation is that we absolutely respect intellectual property rights.  We recognize their importance and we certainly recognize the importance of companies and their involvement in developing products and having them commercialized both in developed and developing countries.”  But how can the Gates Foundation balance the intellectual property rights of those who create live saving technologies and treatments while at the same time ensuring the humanitarian mission? 

According to Iverson, this requires a different approach to each situation taking into consideration the unique factual circumstances involved, such as the disease at issue, the marketability that may exist in developed countries and the need to incentivize the desired outcome.  Iverson explained, “[T]he life science community is all about helping people and saving lives… [we are] trying to figure out how to balance them to push the development of products that well, very few people historically have put much effort into…”

Patent Reform Bill good for Biotech

Patent Reform Passes the Senate and Moves to the House

 

Posted by Roy Zwahlen, manager of intellectual property and technology transfer policy at BIO.

On March 8th, the Senate approved the America Invents Act (S. 23) by an overwhelming vote of 95-5.  BIO supports this bipartisan, consensus-oriented bill, formerly known as the Patent Reform Act of 2011.  Once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.

Patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers.  The improvements made by the America Invents Act would benefit the biotechnology industry, and indeed all sectors of the U.S. economy, by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system.

Increased Resources for the PTO

The America Invents Act contains two provisions that would provide greater resources and operational flexibility for the Patent and Trademark Office (PTO).  First, it would end the diversion of fees collected by the PTO in excess of its budget, and would permit the PTO to retain such fees for use in either the current or future budget years.  It would also give the PTO the authority to set and adjust fees for patent applications, while requiring discounts in fees for small businesses.  These measures will help the PTO improve its long-range budgeting and planning for capital and human resources, hire more examiners to process the more than 350,000 patent applications it receives annually, and reduce the current backlog of more than 700,000 pending applications.

Improvements to PTO Re-Examinations

The America Invents Act would create new and improved proceedings for interested members of the public and the patent owner to seek review of issued patents by the PTO.  The new procedures would result in a more transparent and efficient system of patent quality review. Importantly, patent owners would have a new procedure under which they could go back to the PTO whenever they find new information that might affect the validity or scope of their patent claims without fear of later being accused of concealment or misrepresentation in court by an alleged infringer under the much-maligned inequitable conduct doctrine.  These new procedures would create more business certainty, less risk in investment in biotechnology products, greater assurances in licensing rights, and greater enforceability of patents.

False Patent Marking Litigation

False patent marking litigation occurs when a manufacturer labels a product with an incorrect or expired patent number.  Current law allows any member of the public to sue and sets the fine at $500 per falsely marked article, which has spawned a cottage industry of law firms using this law to shake down industry for settlements in return for promises to drop the lawsuits.  Historically, this was not of great concern until 2009 when the number of these lawsuits greatly increased.  The America Invests Act would require that, in order to sue, someone must have suffered a competitive injury.  This utilizes a common legal principle to ensure that those actually injured are receiving compensation, while excluding those trying to take advantage of a statutory loophole for personal gain.

First Inventor to File

One of the most hotly debated provisions of the America Invents Act would change America’s first to invent system to a first inventor to file system.  This system is embedded in international patent practice, with the United States as the only exception.  While some argue that America’s first to invent system is superior, it is inherently fraught with uncertainties, and problems arise when biotechnology companies try to protect their inventions here and abroad. This bill would remove these uncertainties, while providing adequate protections against misappropriation of an invention by someone other than the true inventor.

Additional Benefits

The America Invents Act would provide several additional benefits for the biotechnology industry, including making it easier for the actual owners of the invention to file patent applications and eliminating the “best mode” requirement as a defense in infringement litigation.  Generally, the removal of subjective elements of patent law helps to create a more equal playing field for all interested parties of an invention.

Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA), and the other members of the Senate Judiciary Committee are to be commended for their tireless efforts to build bipartisan consensus on this legislation, which resulted in wide support of its passage in the Senate.

 

We look forward to working with the House Committee on the Judiciary as it continues its consideration of patent reform, and hope to see meaningful patent reform signed into law later this year.

 

President of the EPO says Unitary Patent Still on Track

Before answering this question, I must say that one thing has always astonished me: while Europe, or at least quite a number of EU Member States, was able to adopt a common currency after a relatively short period of negotiation considering the importance and sensitivity of the issue, it seems much more difficult to obtain a common patent with a single litigation system even though this is an absolute economic and legal necessity.

First came the opinion of the European Court of Justice regarding the patent litigation system on 8 March. One could have been disappointed that the Court concluded that the project was incompatible with the EU Treaty and have feared this result could negatively impact the discussions about the further Unitary Patent. But happily this has not been the case as the EU Council, with a group of 25 Member States, took a landmark decision pushing the enhanced cooperation for the Unitary Patent, on 10 March.

This decision represents a major step forward for European innovative industry, particularly the SME’s! Of course, to respond to the ECJ concerns, policy makers will have to be creative and a transitory solution for the litigation system will certainly have to be found. From the EPO side, I can assure you that all the necessary steps will be duly prepared in order to allow the rapid implementation of the Unitary Patent.

Benoît Battistelli

President

Full EPO Blog Post

U.S. Inter-Agency Group takes on Counterfeit Pharmaceuticals

The Office of the Intellectual Property Enforcement Coordinator released an Inter-Agency report partnering with the Food and Drug Administration, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, and the Departments of Justice, State, and Commerce and USAID.

The report highlights the Administration’s efforts to combat counterfeit pharmaceuticals listing various Department initiatives and in some cases providing actual budget numbers (State Department budgets $1.3 million in 2011 to combat counterfeit pharmaceuticals). 

Finally, the report provides the Vice President and Congress some legislative fixes they deem appropriate to help combat counterfeit pharmaceuticals.  Recommendations include mandatory disclosure by importers and manufacturers when they discover counterfeit drugs or medical products, the adoption of a “Track-and-Trace” system, and the group recommends increasing penalties for counterfeiters.

BIO Hails Senate Passage of America Invents Act

BIO Hails Senate Passage of America Invents Act

Bipartisan, consensus-oriented approach will strengthen nation’s patent system and spur innovation, job creation

Washington, D.C. (March 8, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the passage today of the America Invents Act (S. 23) by the U.S. Senate:

“BIO commends the Senate for its overwhelming passage of the America Invents Act by a vote of 95-5.  We appreciate the dedication of Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA) and the bill’s other cosponsors for their tireless efforts to build bipartisan consensus on the legislation.  Once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.

“Patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers.

“The improvements made by the America Invents Act would benefit all sectors of the U.S. economy by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system. 

“BIO encourages the House of Representatives to consider patent reform without delay, and we look forward to working with Chairman Lamar Smith (R-TX) and the members of the House Committee on the Judiciary.  We are committed to ensuring that patent reform legislation preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country.”