The America Invents Act (AIA) ushered in a new era for patent law and procedure at the United States Patent and Trademark Office. Among the changes that took effect were the much-debated shift away from the first-to-invent standard and to a first-to-file standard that is far more consistent with the rest of the world, although not identical.
Philosophically, the shift to a first-to-file system represents a major shift, but in truth, the U.S. had a de facto first-to-file system already. It had been years since a small entity (i.e., a company with 500 or fewer employees) had been able to prevail by demonstrating that they invented before another party filed a patent application. For the most part, much of the focus on first-to-file has done nothing more than divert attention from the most significant change from the patent owners perspective….
There is little doubt that the largest change ushered in by the AIA was the creation of administrative patent trials, namely Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) Review.
On November 13, 2015, the United States Court of Appeals for the Federal Circuit decided to take a case en banc that will require the court to resolve issues relating to the on-sale bar of pre-AIA 35 U.S.C. § 102(b).
The case is The Medicines Company v. Hospira, Inc., which was decided by Judges Dyk, Wallach, and Hughes on July 2, 2015. The original panel decision, which was authored by Judge Hughes, has been vacated and the appeal reinstated.
The Medicines Company filed a combined petition for panel rehearing and rehearing en banc. The petition was considered by the panel that heard the appeal and thereafter referred to those judges on the full court who are in regular active service (i.e., judges on senior status who did not participate in the panel hearing do not participate in en banc petitions). A response was invited by the court and filed by defendant/cross-appellant Hospira, Inc.
Recently, IPWatchdog.com has published a series of articles relating to Mark Cuban’s activities and views relative to the patent system. (See here, here and here.) Cuban is no stranger to the patent policy debate, and has gone on the record numerous times explaining that he thinks software patents should be abolished. In fact, he famously donated $250,000 to the Electronic Frontier Foundation for the creation of the Mark Cuban Chair to Eliminate Stupid Patents.
In the comments to the aforementioned articles, Mark Cuban engaged in a spirited back and forth with readers, and with me. I invited him to do an interview with me. He agreed and we conducted an e-mail interview. To read the full interview, please see A patent conversation with Mark Cuban.
The United States Patent and Trademark Office (USPTO) recently published a short Federal Register notice titled Change in Practice Regarding Correction of Foreign Priority Claims.
The USPTO has required that any correction of the application number in a domestic benefit claim after the time period for filing a priority or benefit claim be via a petition to accept an unintentionally delayed benefit claim. Notwithstanding, the USPTO has not historically required a petition with respect to the correction to a foreign priority claim after the time period for filing a priority or benefit claim. This dissimilar treatment of the correction of foreign priority claims and domestic benefit claims results in the publication of a corrected patent application publication reflecting the accurate domestic benefit claim information whenever an applicant corrects the application number in a domestic benefit claim in a pending application, but not whenever an applicant corrects the application number of the foreign application in a foreign priority claim.
Trade partners negotiating the Trans-Pacific Partnership trade deal have reached an agreement, although it may be months, or even more than a year, before the Obama Administration submits the deal to Congress for approval. The agreement details have not been officially released, and likely will not be for at least a month, perhaps longer.
The New York Times, POLITICO and others are reporting that, in order to reach an agreement, the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently, the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years.
A leaked version of the TPP from WikiLeaks, if indeed an accurate representation of the TPP, confirms that data exclusivity for 5 years was agreed to by the Obama Administration. Specifically, Article QQ.E.16.1(a), which relates to data protection for pharmaceutical test data, reads as follows:
If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar product on the basis of:
(i) that information; or
(ii) the marketing approval granted to the person who submitted such information
for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.
Article QQ.E.20(1) on biologics reads:
With regard to protecting new biologics, a Party shall either:
(a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic62,63, provide effective market protection through the implementation of Article QQ.E.16.1 and Article QQ.E.16.3 mutatis mutandis for a period of at least 8 years from the date of first marketing approval of that product in that Party; or alternatively
(b) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:
(i) through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;
(ii) through other measures; and
(iii) recognizing that market circumstances also contribute to effective market protection
to deliver a comparable outcome in the market.
Thus, the TPP will offer different data exclusivity for pharmaceuticals (at least five years) and biologics (at least 5 years, but perhaps as long as 8 years).
While the term of data exclusivity is not one and the same with the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.
According to POLITICO, some countries viewed 12 years of data protection as prohibitively expensive as they search for ways to offer such treatments to their population. The U.S. government, specifically the Obama Administration, has also long wanted a more limited term for data exclusivity.
Stay tuned as the official agreement is released and debate in Congress begins.
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