This Newsletter was originally posted to the articles section of the Harness IP website in January 2015. To receive the most up-to-date BioPharma news and tips, please visit www.harnessip.com and subscribe to our BioPharma emails.

1) Subject Matter Eligibility Update:

The much-anticipated subject-matter eligibility Guidance has been released by the USPTO for public comment. Harness IP attorneys offered perspective on the new Guidance in December 2014.

Meanwhile, subject matter eligibility remains a constantly changing aspect of U.S. patent law. The very day after the new Guidance was released, the Federal Circuit ruled that additional claims belonging to Myriad Genetics were invalid for lack of subject matter eligibility. In re BRCA Cancer Test Litigation, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014). The Federal Circuit not only struck down claims to probes and primers directed to the brca-1 and -2 genes, the court also struck down claims to methods of using these probes and primers to detect mutant alleles. The court offered some limited guidance, however, as to the sort of claim that might yet survive challenge.

Practice Tip:

The Federal Circuit contrasted the invalid claims with another claim (not in the lawsuit) that was limited to a method of detecting ten specific mutations. Therefore, when writing a claim to a diagnostic method or kit, include a claim limited to just a few known disease markers or sequences of which the Applicant is aware at the time.

2) U.S. Biosimilar Update:

We reported the district court decision in the first U.S. lawsuit concerning the application process for biosimilars (Amgen Inc. v. Sandoz Inc.) in the November 2014 Newsletter. The district court ruled that Sandoz had not provided Amgen with a complete application as required by 42 U.S.C.  262(l), but Sandoz appealed. On 8 Dec 2014 the Federal Circuit dismissed the appeal as not yet ripe. Sandoz Inc. v. Amgen Inc., 112 U.S.P.Q.2d 2004 (Fed. Cir. 2014). Although Sandoz is busy amassing data for its expected application to market a biosimilar entanercept, it has not yet filed an application with the FDA. Therefore, the Federal Circuit considered a lawsuit about the expected application to be too speculative to adjudicate at this time.

• Result: We have to wait for another case to see if a complete biosimilar application needs to be provided to the brand owner under §262(l).

3) PTA Update:

On 9 Jan 2015, the final rules were published regarding patent term adjustment (PTA) following the decision in Novartis AG v. Lee 740 F.3d 593 (Fed. Cir. 2014).
Summary of the New Rules:

• Additional “B” Delay (§ 1.703): Even after filing an RCE, “B” delay is accrued between a notice of allowance and issue of the patent.
• New Applicant Delay (§ 1.704): Filing an RCE after a notice of allowance results in a new type of applicant delay amounting to the time from the notice of allowance to the filing of the RCE, unless the RCE is filed only with submission of an IDS with a § 1.704(d) statement.

Practice Tips:

• Timely File Your IDS: Submit necessary patent office communications and references cited therein from a related/counterpart application (foreign or U.S.) within 30 days of receipt with a § 1.704(d) statement to avoid a loss in PTA, especially now if filing an RCE after a notice of
  allowance only for purposes of filing an IDS.
• Review PTA Determination: Double check the USPTO’s determination of PTA. In the past when new PTA rules were implemented, the USPTO’s PTA software lagged in incorporating the rule changes. Thus, many patents were issued with incorrect PTA.
• *For further details regarding the revised rules, please see our blog post.

4) Terminal Disclaimer Update:

In Japanese Foundation v. Lee, Nos. 2013–1678, 2014–1014 (Fed. Cir. 2014), outside counsel mistakenly filed a statutory disclaimer disclaiming the entire term of U.S. 6,194,187 due to a miscommunication between in-house counsel and outside counsel. Subsequently, outside counsel filed a petition to withdraw the statutory disclaimer, but the USPTO denied the petition. The Federal Circuit upheld the USPTO’s decision, holding that:

• 35 U.S.C. §255, governing certificates of correction, does not provide for the withdrawal of a mistakenly filed statutory disclaimer because it is not a “clerical or typographical error;” and
• Since the USPTO determined that miscommunications between the Foundation and its attorney of record did not excuse the actions of the attorney, the court deferred to the USPTO and would not substitute its judgment for that of the USPTO.

Practice Tip:

• After issuance of a patent, you cannot withdraw a mistakenly filed terminal disclaimer once filed. Verify terminal disclaimer instructions before filing.