Publications & Resources in This Practice Area:

  • USPTO and the Federal Service for Intellectual Property, Patents and Trademarks of the Russian Federation (ROSPATENT) Launch Patent Prosecution Highway Pilot Program on September 1
  • Starting September 1, 2010, the United States Patent and Trademark Office (USPTO) and the Federal Service for Intellectual Property, Patents and Trademarks of the Russian Federation (ROSPATENT) will partner in a Patent Prosecution Highway (PPH) pilot program.

  • CAFC Invalidates Patent Covering Methods of Using Gemzar
  • On July 28, 2010, the Court of Appeals for the Federal Circuit (CAFC) upheld a decision of the US District Court for the Eastern District of Michigan in which a US patent covering methods of using Gemzar® (gemcitabine) for cancer treatment was invalidated for obviousness-type double patenting.

  • Supreme Court Renders Decision in Bilski
  • On June 28, 2010 the United States Supreme Court finally released the long-delayed and much anticipated decision in Bilski v. Kappos.

  • Patent Strategy Update: CAFC Invalidates Patents Due to Improper Priority Claim
  • The validity of your patent family could depend upon a proper chain to a desired priority date. In a recent decision, the Court of Appeals for the Federal Circuit upheld a decision in which two US patents were invalidated for anticipation. Although the anticipatory reference was published after the earliest claimed priority date of the patents, the court determined that the patents were not entitled to this date due to an improper priority claim. The case is Encyclopaedia Britannica, Inc. v. Alpine Electronics of America, Inc., et al.

  • USPTO Proposes Changes to Patent Examiner Performance Standards
  • On June 16, 2010, the U.S. Patent and Trademark Office proposed the first significant changes to the patent examiners’ performance appraisal plan (PAP) in 25 years. The changes were drafted by a joint task force of USPTO management and representatives of the patent examiners union, the Patent Office Professional Association (POPA).

  • USPTO Proposes New "Three-Track" Patent Examination Process
  • The U.S. Patent and Trademark Office (USPTO) has proposed a new patent examination initiative that will allow applicants greater control over the speed with which their patent applications are examined. The proposed three-track system includes a prioritized examination track that would provide a first Office action on the merits within 4 months and a final disposition within 12 months of prioritized status being granted to the application.

  • District Court Invalidates Gene Patents
  • On March 29, 2010 in Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (“Myriad”) the United States District Court for the Southern District of New York ruled that the claimed “isolated DNA is not markedly different from native DNA as it exists in nature” and is therefore unpatentable subject matter. We expect this case to be appealed to the Federal Circuit; therefore, it will be some time before we understand whether this case has broader implications for patent claims directed to gene sequences.

  • CAFC Determines Tramadol Formulation Patents to be Obvious
  • On June 3, 2010, 2010, the Court of Appeals for the Federal Circuit (CAFC) upheld a decision of the US District Court for the District of Delaware in which two US patents covering formulations of tramadol, an opioid analgesic used for the treatment of pain, were invalidated for obviousness. The case is Purdue Pharma Products L.P. et al. v. Par Pharmaceutical, Inc. et al.

  • USPTO Announces Expansion of Application Exchange Program to All Applicants
  • The United States Patent and Trademark Office (USPTO) recenlty announced that the application exchange program previously available to small entities will be expanded to all applicants. Under the expanded “Project Exchange,” any applicant with more than one application filed prior to the inception of the program can receive expedited review of one application in exchange for withdrawing an unexamined application. The expanded Project Exchange will give applicants with multiple filings greater control over the priority in which their applications are examined and enable priority applications to be examined on an expedited basis.

  • CAFC Maintains Patent Term Extension for Enantiomer Patent
  • On May 10, 2010, the Court of Appeals for the Federal Circuit (CAFC) upheld the extension of the term of a patent covering an isolated enantiomer of a previously known, and FDA approved, racemic drug form in the decision Ortho-McNeil Pharmaceutical, Inc. et al. v. Lupin Pharmaceuticals, Inc. and Lupin LTD.

  • Supreme Court Declines to Review CAFC's Decision in Yasmin Dispute - Formulation Patent Maintained as Obvious
  • On May 3, 2010, the Supreme Court denied a request to review the Court of Appeals for the Federal Circuit’s (CAFC) decision in Bayer Schering Pharma AG et al. v. Barr Laboratories, Inc. This case focused on U.S. Patent No. 6,787,531, which was directed toward a particular formulation for the birth control drug drospirenone.

  • PTO Announces Revised Procedure for Appeal Brief Review
  • The U.S. Patent and Trademark Office announced a revised procedure for appeal brief reviews, which streamlines the appeal process and creates uniformity in appeal processing. The new procedure is effective as of March 30, 2010.

  • Court Reaffirms Written Description Requirement For Patents
  • On March 22, 2010, in an en banc decision, the U.S. Court of Appeals for the Federal Circuit reaffirmed the requirement that a patent contain a written description of the claimed invention. The Court also reaffirmed prevailing doctrine that the description requirement is distinct from the enablement requirement which requires a patent to enable making and using the invention. The decision ensures that written description law will continue to have a significant impact on patenting technology in the fields of chemistry, pharmaceuticals and biotechnology.

  • Confidentiality Agreements - When "Standard" Is Not So Standard
  • Confidentiality Agreements are generally considered to be some of the simplest and most pervasive of contracts. However, slight changes in wording can create varying degrees of protection, and risk, while still presenting a document that appears “standard.” Thus, do not underestimate these clever little documents; that “standard” document you are holding in your hand may be more pernicious than you think. Here are some tips to help you conduct a more thorough analysis of the next confidentiality agreement that crosses your desk.

  • Patent Strategy Update: Court Curtails Extraterritorial Scope of Method Patents
  • On January 11, 2010 the United States Supreme Court declined to hear the appeal of Cardiac Pacemakers Inc. v. St. Jude Medical, Inc., 576 F.3d 1348 (Fed. Cir. 2009). This leaves standing the en banc decision of the Court of Appeals for the Federal Circuit (CAFC) that 35 U.S.C. § 271(f) does not apply to methods patents and thus, does not afford protection against the practice of a patented method overseas with components supplied from the United States. This interpretation of Section 271(f) could have significant impact on some industries, especially in the biotechnology and IT (software) sectors.

  • Brazil Announces it may Break Patents to U.S. Companies
  • Brazil announced on February 10, 2010 that a forthcoming plan of sanctions against the United States may include a breach of intellectual property rights targeted at US companies. Brazil may break up to US $270 million worth of patents related to US goods, particularly pharmaceutical products. Other targets of the sanctions regime include medical equipment, electronics, cars, cosmetics, ketchup, and chewing gum.

  • USPTO Pilot Program Accelerates the Patent Process for Small Entity Inventors
  • The United States Patent and Trademark Office (USPTO) has announced a pilot program to assist small entity inventors with expediting the patent process. In brief, the program gives small entity inventors having two or more currently pending patent applications the ability to control the priority in which their applications are examined.

  • PCT-Patent Prosecution Highway Pilot Program Begins January 29, 2010
  • PCT-Patent Prosecution Highway pilot program designed to promote faster and more efficient examination of applications begins on January 29, 2010 in the USPTO, EPO and JPO.

  • Wyeth v. Kappos Is Final . . . What Now?
  • The U.S. Department of Justice and the U.S. Patent and Trademark Office announced today (January 20th) that they will not seek further review of the Federal Circuit’s ruling in Wyeth and Elan Pharma v. Kappos, No. 2009-1120 (Jan. 7, 2010). The Wyeth decision rejected the Patent Office’s long-standing method of calculating patent term adjustments (PTAs) under 35 U.S.C. §154(b). The PTA provision of the patent statute allows patentees to extend a patent’s life for certain delays caused by the Patent Office during the examination process.

  • Green Technology Patents to Get Quick Reviews from PTO
  • Under the U. S. Patent and Trademark Office’s recently announced “Green Technology Pilot Program,” the first 3,000 eligible applications in which a proper petition is filed will receive an accelerated review process. Eligible applications include patents relating to energy conservation, environmental quality, development of renewable energy resources or greenhouse gas emissions reductions.

  • U.S. Supreme Court Hears Oral Arguments in Bilski v. Kappos
  • On November 9, 2009 the Supreme Court heard oral arguments in the appeal of the Court of Appeals for the Federal Circuit (CAFC) decision in In re Bilski (now re-named Bilski v. Kappos). The case addresses the scope of patent eligible subject matter under 35 U.S.C. §101.

  • Supreme Court Declines to Review the Federal Circuit's Decision in Plavix Dispute - Enantiomer Patent Upheld
  • On Monday, November 2, 2009, the Supreme Court denied a request filed by generic drug maker Apotex, Inc. to review the Court of Appeals for the Federal Circuit’s (CAFC) decision in Sanofi Synthelabo, Inc. v. Apotex, Inc. This case revolved around the patentability of an isolated enantiomer over a prior patent disclosing the racemic mixture.

  • Controversial Patent Regulations Package Rescinded
  • The U.S. Patent and Trademark Office announced on Thursday, October 8, 2009, that the highly controversial procedural Rules package proposed under the Bush administration will be officially rescinded. The Rules package addressed the number of continuation applications as well as the number of claims that could be filed with each patent application.

  • Are You Ready for Your Next IP Due Diligence
  • Whether you are an investor or company looking to acquire technology or a start-up seeking to leverage your company’s intellectual property (IP) assets towards a financial event, a strategic IP review can ensure that these assets are appropriately valued in the market. No matter which side of the table you sit, an informed assessment of the value and risks presented requires that you have a comprehensive patent portfolio strategy, a strong understanding of the competitive landscape and a sound plan for mitigating risk.

  • Patent Strategy Update: Federal Circuit Further Defines Standard for Establishing Conception of Biological Inventions and Stresses Corroborating Evidence
  • It is firmly established that “[c]onception is the touchstone of inventorship, the completion of the mental part of the invention.” Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994). But when is conception complete? The answer to this question can have far-reaching implications for determining inventorship, and, by extension, ownership, of patent rights. In a recent decision in University of Pittsburgh v. Hedrick (Fed. Cir. 2009), the Federal Circuit has further defined the requirements for demonstrating complete conception of biological inventions.

  • Federal Circuit Will Review Patent Description Requirement
  • On August 21, the U.S. Court of Appeals for the Federal Circuit decided to re-hear the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.

  • Federal Circuit orders an en banc review of Tafas v. Doll case
  • As part of the order, the Federal Circuit vacated their previous opinion, issued on March 20, 2009, and ordered that the en banc appeal be heard based on the previously filed briefs, and any additional briefs directed to the issues addressed in the panel opinion.

  • U.S. Supreme Court Grants Certiorari in Bilski v. Doll (formerly In re Bilski)
  • The Supreme Court has agreed to hear the appeal of the Court of Appeals for the Federal Circuit (CAFC) decision in In re Bilski (now re-named Bilski v. Doll).

  • Patent Strategy Update: Patent Court Limits Scope of Product-by-Process Claims
  • Lahive’s Patent Strategy Updates report on recent developments in patent law and how they may affect your IP strategy.

  • EPO Fee Increase Effective April 1, 2009
  • EPO enforces a new fee structure effective April 1, 2009. These changes relate to the claims fee, excess page fee, and designation fee.

  • Freedom To Operate Presentation
  • Debra Milasincic, Ph.D. and Amy Mandragouras delivered this presentation to the Massachusetts Biotechnology Council's Project Management Committee on January 20, 2009. It provides an overview of Freedom to Operate (FTO), including what, why, when, and how.

  • New Local Rules for Patent Suits in Massachusetts
  • On November 24, 2008, the U.S. District Court in Massachusetts issued a notice enacting new local rules adopted by the Court for patent cases in this District. The new rules will dramatically accelerate the pace of patent litigation in Massachusetts during the first 6-12 months of the case.

  • In Re Bilski Summary
  • On October 30, 2008 the Court of Appeals for the Federal Circuit (CAFC) released its much anticipated decision in In Re Bilski setting forth a new test for determining whether a claimed process or method is drawn to patent-eligible subject matter under 35 U.S.C. §101. The CAFC articulated a “machine or transformation” test that requires an applicant to show that his process/method claim is either tied to a particular machine or transforms an article.

  • New Patent Continuation and Claims Rules
  • On August 21, 2007, the U.S. Patent and Trademark Office (USPTO) published in the Federal Register the Final Rules pertaining to: (1) continued examination filings, (2) examination of claims in patent applications and (3) patent applications containing patentably indistinct claims. The Final Rules will go into effect on November 1, 2007 and are available in the Federal Register. The USPTO’s presentation on the Final Rules is also available at the USPTO's website.

Case studies

 
 
Our Thinking Expands Yours

The client, a software developer that creates unique software for modeling dynamic systems, wanted to protect its flagship product. That product, used for three-dimensional modeling and simulation, has been a huge commercial success, particularly in the automotive sector. » read more

News & Events

USPTO and the Federal Service for Intellectual Property, Patents and Trademarks of the Russian Federation (ROSPATENT) Launch Patent Prosecution Highway Pilot Program on September 1 » read more

Giulio A. DeConti Selected to Best Lawyers in America » read more

CAFC Invalidates Patent Covering Methods of Using Gemzar » read more

December 2, 2010
Peter Dini presents "Antibodies: Overcoming Patentability Hurdles and Claim Drafting Strategies for New Technological Developments" at the ACI Biotech Patents Conference » read more

August 30, 2010
James Velema and Peter Dini present "Patenting of Therapeutic Antibodies" to the NRC Biotechnology Research Institute, Montreal, Canada » read more

August 26, 2010
Brian Trinque presents "Nonobviousness of Chemical Inventions" at 240th ACS National Meeting » read more

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