IP Law Bulletin

Summary: The USPTO announced a year-long program aimed at reducing the backlog of pending ex parte patent appeals. An ex parte patent appeal is an appeal to the Patent Trial and Appeal Board typically made by applicants after receiving a final rejection from an examiner and failing to reach agreement on the allowability of the patent application. Currently, the average time to receive a final decision on an ex parte appeal is between 2 to 3 years. Under the new program, an applicant/appellant can have one appeal finally decided within 6 months of entering the program if the applicant willingly withdraws a second appeal. The applicant can contemporaneously file an RCE for the withdrawn appeal to keep the subject matter of the application alive.

On April 13, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of the Center for Diseases and Radiological Health’s (CDRH) final guidance document entitled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” This 44-page final guidance outlines the FDA’s new Expedited Access Pathway (EAP) program for select medical devices that demonstrate the potential to address life-threatening or irreversibly debilitating, unmet medical needs. The FDA stated that the EAP program will “… help patients have more timely access to these medical devices by expediting their development, assessment and review, while preserving FDA’s statutory standard for PMA approval (reasonable assurance of safety and effectiveness) and the statutory standards for granting de novo requests.”

On May 13, 2015, the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs will go into effect in the United States. The Hague system will, in effect, introduce a design patent analog to the current Patent Cooperation Treaty (PCT) international patent application and Madrid Protocol international trademark registration systems. Rather than filing for design patent protection in foreign jurisdictions individually, applicants will be able to file a single application at the USPTO to pursue protection in multiple jurisdictions. Other participating countries at the time of writing include the European Union and South Korea. Japan will adopt the agreement on the same date as the U.S., and Canada, China, and Russia are all said to be exploring the possibility of participation.

On January 20, 2015, the United States Supreme Court decided the case of Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., which presented the question of the proper standard of review for factual findings by district courts during patent claim construction. The CAFC has long held that claim construction rulings, including underlying factual findings, are reviewed de novo (that is, without deference to the district court). The Supreme Court has now partly upended that rule, holding that determinations of fact made by district courts must be reviewed for abuse of discretion, which is more deferential to the district court. The Court left alone, however, the existing de novo standard of review for the ultimate legal determination of patent claims' meanings.

In mid-January, the USPTO published a notice that its Extended Missing Parts Pilot Program would continue through the end of 2015. Originally introduced in 2010, the Extended Missing Parts Pilot Program allows applicants to delay the payment of fees required for examination (i.e., the search fee, examination fee, any excess claims fees, and surcharges for late fee payment) by up to 12 months, allowing a sort of “extension” to the term of a provisional patent application. To take advantage of the program, applicants must submit a certification and request to participate when filing a nonprovisional or plant application that validly claims the benefit of a provisional application (applicants also must not have filed a nonpublication request). The Extended Missing Parts Pilot Program can be an effective tool to further delay costs associated with filing and prosecuting a patent application, thereby allowing funds to be put toward commercial development. However, the program does not affect the 12-month priority period for foreign filing under the Paris Convention, so applicants should be careful to complete any desired foreign filings within 12 months of their provisional application filing date.

Click here to read the Federal Register notice regarding the Extended Missing Parts Pilot Program.

Following on the heels of the Supreme Court’s decision in Alice v. CLS Bank, the United States Patent and Trademark Office (USPTO) issued subject matter eligibility guidelines for determining whether a patent claim amounts to “significantly more” than an abstract idea. The agency has now issued follow-on guidance in the form of eight fact patterns intended to demonstrate the abstract idea analysis in further detail. The fact patterns highlight some familiar themes that have emerged in the case law both pre- and post-Alice.

The United States Patent and Trademark Office (USPTO) released final rules on January 9, 2015 implementing changes to the way in which Patent Term Adjustment (PTA) is calculated in view of the recent Novartis v. Lee case.

On December 16, 2014, the United States Patent and Trademark Office (USPTO) published long-awaited guidelines intended to help examiners determine the patent eligibility of a wide range of inventions from isolated genetic materials to computer-implemented methods. The new guidelines revise those published by the office earlier this year (discussed here), which drew heated criticism from some in the patent community as too vague with respect to examination of certain inventions and too onerous with respect to others.

On March 28, 2012, the Food and Drug Administration (FDA) published its first-ever guidance document on the risk-benefit analysis that forms the cornerstone of medical device approval.¹ The 2012 guidance addressed considerations governing pre-market approval (PMA) and de novo submissions, but notably absent from the final version of the 2012 guidance was an explanation of the risk-benefit analysis for premarket notifications [510(k)]. On July 15th of this year, more than two years later, and amid a flurry of FDA guidance documents,² the FDA released a draft guidance document specifically focused on the risk-benefit analysis for devices undergoing the 510(k) process. Although remarkably similar to the 2012 guidance, the 2014 guidance includes a handful of subtle differences that may be important for device manufacturers to keep in mind when making any type of submission.

Currently, the average time a patent applicant waits to receive a first Office Action from the United States Patent and Trademark Office (USPTO) is 18.9 months. The total pendency for a patent application before a final disposition is achieved (e.g., Notice of Allowance issued, Request for Continued Examination filed, or application is abandoned) is 27.5 months. This number jumps to 37.9 months when applications in which RCEs are filed are included. These long delays can be frustrating for patent applicants. Start-up companies looking to secure patent protection to attract investors can find this long delay at the USPTO detrimental to the company’s ability to survive. Further, applicants looking to use information from U.S. patent prosecution to make decisions about which countries to enter following the filing of a Patent Cooperation Treaty (PCT) patent application may be left making expensive foreign filing decisions without much information about the likelihood of securing a patent.