Posts Tagged ‘biotechnology law’

USPTO issues post- Alice examination guidelines

Thursday, June 26th, 2014

A copy of the guidelines can be found here:


I will comment on this later.


“We Don’t Need No Stinkin’ Patents” – Antibiotic and Antifungal Drugs Gain Non-Patent Exclusivity

Monday, June 23rd, 2014

Posted on the FDA Law Blog by Kurt Karst on June 19, 2014.

After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms to account for new non-patent marketing exclusivities.  First there was the addition of “NCE*” exclusivity, defined as “NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT),” that FDA created after the approval of NDA No. 204168 for FETZIMA (levomilnacipran) Extended-release Capsules, 20 mg, 40 mg, 80 mg and 120 mg (see our previous post here).  Then there was the addition of “RTO*” and “RTO**” exclusivities, defined as “OTC USE FOR WOMEN AGES 15 AND 16” and “OTC USE FOR WOMEN 14 AND BELOW,” respectively, that FDA created to account for various supplemental approvals under NDA No. 021998 for PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (see our previous post here).  Now that FDA has approved the first drug product designated as a Qualified Infectious Disease Product (“QIDP”), the Agency has once again added to the Orange Book list of exclusivity terms.  The term “GAIN” was added to the Orange Book Cumulative Supplement last week in relation to NDA No. 021883 for DALVANCE (dalbavancin HCl) Lyophilized Powder for Injection, 500 mg.  FDA approved DALVANCE on May 23, 2014 in the treatment of acute bacterial skin and skin structure infections.  With a period of NCE exclusivity that expires on May 23, 2019, but that is extended under the Generating Antibiotic Incentives Now Act (“GAIN Act”) by an additional 5 years to May 23, 2024, the GAIN exclusivity FDA granted for DALVANCE is the latest expiring period of non-patent exclusivity ever listed in the Orange Book (not to mention the longest period of exclusivity that FDA has granted for a drug product in decades – see FDC Act § 505(j)(5)(F)(i)).

To see the full post, go to the FDA Law Blog.

Gone Judge – Judge Randall Rader To Resign

Monday, June 16th, 2014

Before stepping down as Chief Judge of the Fed. Cir. on May 30th, Judge Rader had sent a letter to his colleagues on the court apologizing for sending an email to an attorney who had appeared before the court a number of times, praising his work and encouraging him to circulate the email to his associates. (A copy of the letter is available at the end of this post.) The letter was dated May 23, 2014, and was clear about the error of his ways:

“I realize in retrospect that the email constituted a breach of the ethical obligation not to lend the prestige of the judicial office to advance the private interests of others. I apologize for that error, which may have led to the perception that the attorney in question was in a position to influence me in my performance of judicial duties….Working with the court, I have taken steps to remedy the breaches for which I was responsible by recusing in cases as to which a question might be raised as to my impartiality. I am committed to adhering carefully to the requirements of the Code of Conduct for United States judges in making any necessary recusal decisions. I am truly sorry for the lapse and will work diligently to ensure that it does not recur….”


Consumer Watchdog v. Wis. Alumni Res. Foundation – Plaintiff Lacks Standing To Appeal Reexamination Loss

Wednesday, June 4th, 2014

In Consumer Watchdog v. WARF, App. No. 2013-1377 (Fed. Cir., June 4, 2014) the Fed. Cir. found that the Watchdog can bark, but it can’t get a second bite. (A copy can be found at the end of this post.)

Consumer Watchdog lost an inter partes reexamination that it initiated to challenge the validity of WARF’s stem cell patent, U.S. Pat. No. 7,029,913. (A copy can be found at the end of this post.) Although the statute facially gives reexamination losers the right to appeal, in this case, the panel found that Watchdog lacked the requisite “actual or imminently threatened injury” required under the Constitution’s Art. III to appeal the adverse decision. Watchdog was not an “actual or prospective competitor of WARF or a licensee” but simply alleged general harm to taxpayer-funded research in California, due to WARF’s licensing efforts or that the patent completely preempted all uses of human embryonic stem cells.

The panel found that the “injury” requirements apply “with equal force to appeals from administrative agencies, such as the [PTO], to the federal courts.” Article III standing was stated not to be a requirement “to appear before an administrative agency” as in a reexamination proceeding, but “once a party seeks review in a federal court, ‘the constitutional requirement that it have standing kicks in’[{citing Sierra Club v. E.P.A]…the ‘requirement for injury in fact is a hard floor of Article III jurisdiction that cannot be removed by statute.’”

This all makes perfect Constitutional law sense, but I can see the posters now: “Who will protect the (potential) fetuses from ‘injury’?” If for a moment, this seems far-fetched, go to Amazon and search for “Should Trees Having Standing.”