Posts Tagged ‘biotechnology’

Abbvie V. Janssen Biotech –Written Description Requirement Road Map

Monday, July 7th, 2014

The recent decision in Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir. , July 1, 2014) deserves more attention than it has received. (A copy of the decision is available at the end of this post.) The appeal was by Abbvie from a District Court decision entering a judgment of invalidity of Abbvie’s patents on fully humanized antibodies (Abs) to IL-12. Although Abbvie won an interference involving its U.S. Patent No. 6,914,128, a jury found both patents invalid inter alia as failing the written description requirement (“WDR”) of s.112, para. 1.

The “modern” WDR as created in UC v. Lilly and applied in decisions such as U. of Rochester v. Searle and Ariad v. Lilly has been a potent patent-killer, particularly when functional claims are asserted. That is just what Abbvie attempted, e.g.:

Claim 29. A neutralizing isolated human antibody…that binds to human IL-12 and disassociates from human IL-12 with a koff rate constant of 1×10(-2)s(-1) or less, as determined by surface plasmon resonance. See slip. op p.7.


More Questions Than Answers from the PTO

Wednesday, July 2nd, 2014

At the recent BIO International Convention, Deputy Commissioner Andrew Hirschfeld (who chaired the May PTO s.101 Forum) presented seven “Sample Claims” related to biotech/pharma inventions and invited “discussion and feedback” from the interested public. The claims have been posted on the PTO website (and can be found here). I will attempt some commentary on patent-eligibility under the new PTO Guidelines.

6. Antibiotic L, which is expressed by recombinant yeast. (Antibiotic L is secreted by a bacterial species and exhibits antibiotic properties when the bacteria functioning naturally)(Comments in parentheses are my slightly rewritten summaries of the background of the claims provided by the PTO in the slides.)

Patents4Life comments: We know that the Guidelines would require the Examiner to reject a claim to isolated antibiotic L or to a pure strain bacterial culture that would excrete the antibiotic into the medium–both are “natural products.” But in claim 6, a lot more of the hand of man is involved. But wait! This is a product-by-process claim and the PTO ignores process limitations when evaluating the patentability of a compound, and evaluates the compound per se. Now the “answer” turns on whether or not expression from yeast significantly alters the structure of antibiotic L, and we are not told whether or not it does. So the question is unanswerable at this point.



Friday, June 27th, 2014

The deadline for Myriad-Mayo comments has been extended by a month.

Info on the USPTO website and can be found here.


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.”