06/18/2013 - Not a Biotech Company? What Myriad Might Mean For You
You’ve seen all the articles about the Supreme Court’s decision in Assoc. for Molecular Pathology v. Myriad Genetics Inc. and the end of DNA patents, but what does this mean outside the biotech world?

06/06/2013 - Law360 Guest Article: Infringement Liability May Exist For Foreign Manufacturers
Many foreign manufacturers ignore U.S. patents because they wrongly assume they have no real economic risk and are not liable for infringing a patent in another country. But when products are being shipped to the U.S from another country, infringement liability may exist.

05/23/2013 - Monsanto Rounds Up Big Win for Self-Replicating Tech
The Supreme Court’s recent decision has seeded another patent protection feather in Monsanto’s increasingly large cap, in addition to providing guidance on application of the patent exhaustion doctrine in the case of self-replicating technology.

01/30/2013 - The IP Beacon, January 2013
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

11/14/2012 - Step Right Up and Adjust Your Patent Term: Court Finds Improper PTO Calculations
The U.S. Patent and Trademark Office (“PTO”) has been improperly calculating patent term adjustment (“PTA”) for some patents, specifically, in cases where prosecution of the underlying application involved the filing of a Request for Continued Examination (“RCE”) more than three years after the application filing.

10/12/2012 - The IP Beacon, October 2012
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

09/13/2012 - Pharmaceutical Online Guest Column: New And Improved Third-Party Submissions
One of the many opportunities enhanced by the America Invents Act (AIA)patent reform legislation, enacted inSeptember 2011, is the expanded submission of prior art references into pending patent applications of thirdparties, such as marketplace competitors and non-practicing entities.

07/10/2012 - Pharmaceutical Online Guest Column: Patent Reform: What Does it Mean for a Pharmaceutical Enterprise?
The America Invents Act (AIA), enacted in September 2011, has already modified various aspects of U.S. patent law and includes various provisions that phase in this September and March 2013, such as a completely new guiding statute addressing prior art and patentability — 35 U.S.C. § 102. In many ways, however, patenting will continue as usual, particularly for international companies who already prepare patent applications for international use.

04/30/2012 - The IP Beacon, April 2012
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

04/06/2012 - Breaking the Chains of Prometheus: Practical Claim Drafting
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter.

02/14/2012 - Biosimilars: Draft Guidance Documents Issued by FDA
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action.

09/16/2011 - Practice Tips Under the Patent Reform Rules
The long anticipated America Invents Act (the “Act”) was signed into law today. However, given that certain provisions of the Act are now in effect while others do not come online until March 16, 2013, innovating companies and individuals should consider the impact and timing of those provisions on their overall patent strategy.

08/16/2011 - The IP Beacon, August 2011
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

08/16/2011 - Proceed With Caution: Does that Employment Agreement Have a Proper IP Assignment?
The Supreme Court ruled earlier this week that the Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al.

07/26/2011 - Conformity is a Virtue: The U.S. Patent and Trademark Office Proposes Changes to the Duty of Disclosure to Match the Therasense Standard
The U.S. Patent and Trademark Office (“PTO”) has proposed changes to two rules that are designed to streamline the obligations of innovators and their patent practitioners to disclose information to the PTO in patent applications and reexamination proceedings.

06/28/2011 - Patent Reform 2011: It Could Happen to You
On June 23, 2011, the U.S. House of Representatives passed House Bill H.R. 1249 (the “Leahy-Smith America Invents Act”) by a vote of 304-117. This follows on the Senate’s 95-5 passage of bill S. 23 (the “America Invents Act”) back on March 8, 2011.

04/05/2011 - How Much Would You Pay for This Lovely Expedited Examination? USPTO Approves Priority Utility and Plant Patent Application Examination
On April 4, 2011, the U.S. Patent and Trademark Office (USPTO) issued a Final Rule implementing the prioritized examination track (“Track I”) of its new examination timing control procedures.

01/20/2011 - Effective Affidavit Practice

10/01/2010 - The IP Beacon, October 2010

09/08/2010 - "Abbreviated" Biologics Applications: The Reality of Providing Biosimilar Products

06/29/2010 - The Supreme Court Rules on Bilski: Business Method Patents Survive
On June 28, 2010, the United States Supreme Court announced its decision on Bilski v. Kappos regarding what inventions are eligible for patent protection. The decision affirms that business methods are patentable, although the specific business methods at the center of the case are not.

06/28/2010 - Accelerated Patent Examination Plan Extended
Most patent applicants can now accelerate the examination of a select number of patent applications in exchange for abandoning an equal number of unexamined, pending applications, according to an announcement issued by the U.S. Patent and Trademark Office (“PTO”) on June 24, 2010. The PTO’s official notice, titled “Expansion and Extension of the Patent Application Backlog Reduction Stimulus Plan” (the “Plan”), eliminates the requirement whereby only small entity applicants could participate in the Plan.

06/23/2010 - U.S. Patent and Trademark Office Proposes Three-Track Patent Examination Initiative
The United States Patent and Trademark Office (“USPTO”) is seeking public comment on a proposed three-track patent examination initiative that would provide applicants with greater control over the speed at which their applications are examined.

05/27/2010 - The Broken Patent System: A Threat to American Economic Security?
Chief Judge Paul Michel of the United States Court of Appeals for the Federal Circuit recently addressed the examiners of the United States Patent and Trademark Office (“USPTO”)  calling for “an improved patent system” as the “primary engine of American recovery and resurgence,” with a need for “faster, sounder and clearer patents, plus faster, stronger enforcement.”  These remarks seem well-received and are considered to be on-point by many in the innovation community, perhaps because they parallel the recent concerns of both consumers and technology companies.

05/10/2010 - Management (and the Federal Circuit) Torched Our Patent: What Should We Have Done Differently?
Just one day after the U.S. Court of Appeals for the Federal Circuit indicated that it would consider the current state of the inequitable conduct doctrine en banc in Therasense, Inc. v. Becton Dickinson and Co., a split panel of the Federal Circuit issued a decision in the case of Avid Identification Systems, Inc. v. Crystal Import Corp. affirming a lower court’s finding of inequitable conduct.

05/07/2010 - The IP Beacon, May 2010
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

05/04/2010 - Obviousness-Type Double Patenting As An Invalidity Defense

02/22/2010 - Don’t Rely on Reissue to Fix Your Patent Claims
Reissue is a post-issuance procedure that enables the correction of certain limited types of errors in a patent, but cannot be used merely for precautionary claim improvements. The Board of Patent Appeals and Interferences (BPAI) at the U.S. Patent & Trademark Office recently decided in a precedential opinion that reissue cannot be used to add a dependent claim “simply as a hedge against possible invalidity of the original claims.” Ex parte Yasuhito Tanaka, Appeal No. 2009-000234 (BPAI, Dec. 9, 2009) (per curiam).

02/01/2010 - Efficacious and Safe Drug Labeling Strategies - The Access to Affordable Medicines Act
This article discusses U.S. drug labeling strategies used by brand (also referred to as innovator) and generic pharmaceutical companies, including the most recent proposed drug labeling changes in the Access to Affordable Medicines Act (AAMA).

02/01/2010 - Coming to Terms
You've found an investor who's willing to make a substantial investment in your biotech company—that's great news. But after the handshake, the next thing is to negotiate the term sheet outlining the structure of the transaction to ensure a true meeting of the minds.

01/27/2010 - Litigation Risk and Liability Danger from False Patent Marking in View of Forest Group, Inc. v. Bon Tool Co.
In a case arising from the Southern District of Texas, the Federal Circuit recently issued an opinion that highlights the risks associated with marking products with patent numbers. See Forest Group, Inc. v. Bon Tool Co., No. 2009-1044 (Fed. Cir. Dec. 28, 2009) (slip opinion). 

01/19/2010 - The IP Beacon, January 2010
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

01/11/2010 - Zipping Your GreenTech Patent Application Down the Line

01/11/2010 - Maintaining Attorney-Client Privilege When Disclosing Opinion Letters in M&A Transactions

11/30/2009 - Jumpstart Your Patent Application Through Early Examination
The Patent and Trademark Office (“PTO”) published an official notice titled “Patent Application Backlog Reduction Stimulus Plan” on Wednesday, November 25, 2009 that it will now advance applications out of turn for small entity patent applicants on a temporary basis (74 Fed. Reg. 62,285).

10/12/2009 - PTO Seeking Rulemaking Authority Despite Rescinding Proposed Claims and Continuation Rules
The U.S. Patent and Trademark Office (“PTO”) has announced that the director has signed a Final Rule, which has not yet been published, that rescinds the hotly contested proposed claims and continuation rules. These rules would primarily have limited the number of patent applicant filings of: (i) continuation applications, (ii) Requests for Continued Examination (“RCEs”), and (iii) claims without examination support documents (“ESDs”) within a single application. The proposed rules were at the heart of a two-year legal battle that pitted co-plaintiffs Triantafyllos Tafas and GlaxoSmithKline (“GSK”) against the PTO and its director.

10/02/2009 - The IP Beacon, October 2009
The IP Beacon is a quarterly newsletter prepared by the Haynes and Boone Intellectual Property Practice to inform clients and friends of trends and changes in intellectual property law.

09/21/2009 - Double Standards at the Federal Circuit
Generally, “product” claims in a patent define a product in terms of its structure, properties, or composition. A product claim could thus cover a pharmaceutical composition or formulation with a well-characterized compound and useful excipients, a light-weight alloy used in windmill blades for renewable power, or an electrolyte composition for a fuel cell. In contrast, a “product-by-process” claim defines the product partly by how it is made, i.e., the claim recites process or method steps.

07/01/2009 - Living (La Vida Loca) Under Your NDA: Strategies for Ethical M&A Diligence
Dance Fever - Living (La Vida Loca) Under Your NDA: Strategies for Preliminary M&A Diligence, presented to AIPLA as a webinar, July 1, 2009.

03/30/2009 - Patently Complicated New Rules Still in Play: Tafas v. Doll on Interlocutory Appeal
The Federal Circuit in Tafas v. Doll (formerly Tafas v. Dudas) has now had its first review of the new rules proposed by the U.S. Patent and Trademark Office (“PTO”), based on an appeal of a summary judgment ruling.  The PTO has been attempting to implement these new rules relating to the patenting of inventions since November 1, 2007, which would impose fairly strict and burdensome requirements on patent applicants and companies attempting to protect their financial investment and incentive to develop such technology. 

02/26/2009 - The IP Beacon 2009
"The IP Beacon" is a Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

02/11/2009 - Patenting of Industrial Biotechnology: A Gamble That Pays Off
We have come a long way from that one word from “The Graduate.” Plastics, once conventionally manufactured from petroleum, is a field that has drastically expanded to include industrial biotechnology, which relies on micro-organisms rather than merely petroleum to develop biofuels, chemicals, and bioplastics. Enzymes or micro-organisms are essentially miniature biofactories that convert plant sugar, starch, or oil into biodegradable polymers used to make various products, including bottles, carpet, clothing, and cosmetics. With the new focus on renewable energy and resources, industrial biotechnology has enormous and increasing market potential.

02/11/2009 - Publication Clauses and Other Problems Lurking in Sponsored Research Agreements
Industry-sponsored research and clinical trials are the primary means for investigating the efficacy and safety of medical devices and pharmaceuticals. Enormous financial stakes are often involved in the outcome of these studies.
Originally appeared in Life Sciences, Vol. 2, Issue 3, December 2008 (American Health Lawyers Association Newsletter) - reprinted in Haynes and Boone's "The IP Beacon," Winter 2009.

11/24/2008 - To CIP Or Not To CIP? There Is No Question
IP Law360
As an inventor or decision maker for the business, you should know enough to discuss the forest before your patent counsel starts cutting the trees in making significant, irreversible decisions affecting your patent rights. 

11/20/2008 - Fall 2008 Haynes and Boone IP Beacon Newsletter
Intellectual Property articles and news from the Haynes and Boone IP lawyers.

11/12/2008 - Patent Process Claims Impacted by U.S. Court of Appeals for the Federal Circuit
The U.S. Court of Appeals for the Federal Circuit has issued a ruling in In re Bilski that modifies the test of whether a “process” qualifies as patentable subject matter.

10/23/2008 - Diligence in Preliminary Merger & Acquisition Evaluations
AIPLA Annual Meeting, Special Committee on Mergers & Acquisitions
After conducting the initial due diligence using public information to obtain and evaluate the intellectual property rights of a potential merger or acquisition target, you have entered a Non-Disclosure Agreement (NDA) to engage in more intimate discussions with your target to continue the deal process.

10/23/2008 - Living (La Vida Loca) Under Your NDA - PowerPoint Presentation
AIPLA Annual Meeting, Special Committee on Mergers & Acquisitions
Dance Fever - Living (La Vida Loca) Under Your NDA: Strategies for Preliminary M&A Diligence

09/08/2008 - The IP Beacon
A Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

07/24/2008 - Be Careful Where You Save That File
IP Law 360
Inventions are not patentable in the U.S. if they have been publicly disclosed, used, or sold for more than a year before filing an application, according to Section 102(b) of the Patent Act. This rule is based on the principle that an invention in the public domain should no longer be patentable.

07/01/2008 - Preparing for (and avoiding) the Courtroom
Nature Biotechnology
Intellectual property (IP) is often the most valued asset of biotech firms, especially startups. Two IP lawyers offer guidance on avoiding suits altogether, when to settle them and when to fight.

02/13/04 - Product Clearance and U.S. Patent Opinions
A study of certain business risks of launching products and services, and considerations in managing the risk associated with the launch by evaluating competitive patents and obtaining an opinion of counsel if needed.