Archive for January, 2011

ACLU Files Its Brief in Myriad – Argues DNA Is A Blueprint Without a Name

Friday, January 28th, 2011

On November 30, 2010, the ACLU filed its brief at the Federal Circuit in AMP et al. v. USPTO and Myriad Genetics, Inc. et al. If you have been reading my posts on this suit, you are by now probably tired of reading the same positions repeated over and over by various brief writers and commentators. (My most recent post was on Myriad’s brief, filed October 22d.) There have been more than ten amicus briefs filed for both sides. The Myriad supporters argue that cases like “the adrenaline decision,” Bergy and Chakrabarty indicate that man-made compositions should be broadly patentable, including ones isolated and purified from natural sources that are structurally and functionally distinct from the “native” forms. The ACLU and its supporters cite Funk Bros., American Fruit Growers and the odd 1931 In re Marden CCPA decisions as support that this view would permit patents on gold nuggets panned from a stream or a fallen leaf (see pages 14 and 46 of the ACLU brief for a re-run of this argument) and that DNA is likewise unchanged by isolation from the genome.

However, it is interesting to see how far the ACLU will reach to support its nearly metaphysical argument that DNA is pure information. At pages 42-43, it ratchets up its arguments to the point of scientific absurdity:

“The [Myriad] claims acknowledge that, unlike other chemicals, DNA stores specific information – as dictated by the order of nucleotides – that serves as the blueprint for all of the proteins, cells, and organs that make up the human body. While chemical molecules like water can be described as H2O, HOH, or OH2 because they consist of any two hydrogen atoms and an oxygen atom, DNA is not described according to the sugars and phosphates of its backbone, but by its nucleotide sequence. Because this blueprint is the defining characteristic of DNA and remains the same before and after isolation, isolated DNA has neither a distinctive name, character, and use from naturally-occurring DNA nor markedly different characteristics.”


“Patent Reform Act Of 2011” – Reform Or Regression?

Thursday, January 20th, 2011

Starting from the premise that legislation can raise the quality of patents, Leahy/Hatch/Grassley are poised to introduce this year’s version of Patent Reform. The proposed reforms are extensive, and most have been debated at length. Although the Summary ends by listing supporters of the Act including BIO, IPO, AUTM , AIPLA and several big universities, I still worry that we are “going to Abilene.” In that fable, one member of a country family offhandedly  suggests going on a long dusty drive into town on a hot Sunday. Although almost no one really wants to go, instead of just saying so, each one throws out a thought – we could go to a movie, or get ice cream, or visit old Aunt Ida – until, before they know it, they are all in the car and on the way to Abilene, a place no one really wanted to go in the first place.

The Summary of the Reform Act gives me that impression. If it passes, and it may well this time around, not only will patent applications be attackable during prosecution –anyone will be able to send in prior art and comment on it, but there will also be a nine-month period for opposition following issuance, as well as a streamlined inter partes opposition procedure that will be conducted by a panel of three administrative law judges and permit direct appeal to the Federal Circuit. Opposers must show a reasonable likelihood of success and will be estopped from relitigating issues that reasonably could have been raised during inter partes review that they instituted. Have such standards ever been articulated clearly? There will also be a ”supplemental examination process” to help applicants fix flawed patents. (I have not have time to read this, but isn’t this called reissue?) By the way, the PTO Director can set fees, but must start out by cutting fees paid by small entities and “micro-entities.”

However, even if an applicant operating under a first-to-file system (yes, Red Riding Hood, that Big Bad Wolf is back too) gets his/her “high quality patent” through an obstacle course that could be used on the show “Wipeout,”  enforcement will not be a picnic. Courts are supposed to evaluate the “legal basis for specific damages theories,” willful infringement will be harder to prove, and enhanced damages harder to obtain. Well, I can’t wait to cuddle up on the sofa on a cold Saturday and start into this 99 page thriller!

LHG Patent Reform Act

Patent Reform Summary from Senate Judiciary Staff

Astrazeneca v Apotex – Patent That Label!

Thursday, January 13th, 2011

I recently had a chance to re-read AstraZeneca LP v. Apotex, Inc., Appeal No. 2009-1381, 1424 (Fed. Cir. Nov. 1, 2010) and realized that it is a virtual case note on how to extend patent term by “patenting the label.” The primary patents on budesonide, an anti-asthma drug, had expired and AZ was trying to use two add-on patents (U.S. Pat. Nos. 6598603 and 6899099)claiming the drug administered in a  continuing once-a-day regimen for treating a respiratory disease and a kit containing the drug in a solvent and a label indicating the once-a-day regimen.

Apotex had filed a para. IV notification alleging invalidity and non-infringement but had been required by the FDA to copy AZ’s label which included a statement that the initial dosing, e.g., twice a day, should be titrated downward in some cases. AZ argued successfully that the Apotex labeling would induce infringement because titrating down from the recommended starting dose would necessarily lead to the claimed once-daily dosing regimen.

After interpreting the claims to exclude the drug encapsulated in liposomes (even though the specification of the patents taught this as an option, and no language in the claims excluded liposomal encapsulation—good lawyering Ms. Loring!), the Fed. Cir. agreed that the Apotex labeling would induce infringement. (There is a good discussion of the standards for inducing infringement in the opinion). However, the Fed. Cir. found that the kit claims were invalid, since the labeling packaged with the drug was not “functionally related” to the drug or to the kit: “Our decision In re Ngai foreclosed the argument that simply adding new instructions to a known product creates the functional relationship necessary to distinguish the product from the prior art.” Preliminary injunction affirmed.

Well, one valid “label claim” was all it took to keep a generic off the market, so read those labels when you are designing your client’s or company’s product life cycle management strategy. Conversely, if you are preparing a PIV opinion, watch out for attempts to patent (often obscure) portions of the label.

AstraZeneca v Apotex



Judge Goes Medieval On Spoilating Defendants

Thursday, January 13th, 2011

This summary of Victor Stanley v. Creative Pipe et al., provided by Ron Schutz of Robins, Kaplan, Miller & Ciresi is a cautionary tale for patent prosecutors served with subpoenas (or about to be). If the appropriate steps are not taken to preserve documents or, even worse, if documents are destroyed,  the consequences can be severe.


The Gang That Couldn’t Spoliate Straight (Updated)

Topic: Available sanctions for repeated, egregious, willful spoliation.


Plaintiff  Victor Stanley brought claims for copyright infringement, patent violations, and unfair competition against defendant Creative Pipe and its owner, Mark Pappas.  Despite four specific court orders regarding preservation of electronically stored information (“ESI”), Victor Stanley demonstrated that Pappas had repeatedly and deliberately destroyed extensive quantities of ESI crucial to Victor Stanley’s case.  Exasperated and appalled, Chief United States Magistrate Judge Paul W. Grimm undertook an extensive review of the law of spoliation throughout the circuit courts in order to craft the most effective set of sanctions possible.  The Magistrate’s opinion acknowledges the “collective anxiety” that exists due to a lack of a uniform standard governing the duty to preserve and then attempts to synthesize existing case law in order to provide a cohesive analytical framework for future spoliation disputes.  After reviewing all available sanction options, Magistrate Grimm recommended that the district court enter a permanent injunction and default judgment as to Victor Stanley’s copyright claim. Magistrate Grimm also directly ordered an award of all costs and attorneys’ fees incurred by Victor Stanley in proving spoliation over the course of the litigation as a monetary sanction.  Notably, the acts of spoliation were deemed civil contempt, allowing the magistrate to order that Pappas be jailed for up to two years “unless and until” payment of the ordered sanctions occurs.