Patent Baristas

In another update to the preliminary injunction issued August 29 in the Plavix case, the cheeky Apotex has filed an appeal with the Court of Appeals for the Federal Circuit against the preliminary injunction preventing the drug company from selling a generic version of the heart drug Plavix. The request came a day after a federal judge had denied Apotex’s request to postpone his order last week to halt the company’s sales of generic Plavix.

The district court judge had said Sanofi had demonstrated that questions Apotex raised as to the validity and enforceability of its patent were without substantial merit and he also concluded Sanofi would suffer irreparable harm if Apotex were permitted to continue selling the generic while any detriment to Apotex was a result of the company’s own calculated risk-taking. A trial is set for January on the infringement suit.

In its appeal, Apotex claims the court failed to properly consider Apotex’s “massive irreparable harm, including the loss of its enormously valuable exclusivity and the great harm to third parties.” … “The injunction will wreak havoc in the pharmaceutical markets where statutes and insurers require that prescriptions be filled with generic product.”

There will be plenty more to come in this high stakes game. We’ll keep you posted.

I don’t know what it is about wikis but there seems to be a wikification of the patent world. After the U.S. Patent and Trademark Office put out a draft Five Year Strategic Plan outlining their intention to develop a “peer review mechanism” that would enlist volunteers from the public to weigh in on applications, there seems to be a lot of response from the community at large. I’ve been sent info on three new sites in just the past week.

An early adopter is WikiPatents.com. Anyone can join the WikiPatents Community for free and voice concerns, praise, comments, and opinions on any issued patent. The WikiPatents Community was established to allow the community to give feedback on patents (and eventually applications) to ostensibly improve patent quality. By adding and voting on overlooked prior art and submitting public comments on the merits of issued patents, the WikiPatents Community will (theoretically) provides a resource to patent Examiners reviewing related pending applications.

[*Note: As reported by Greg Aharonian’s Internet Patent News Service, Business Week’s Lorraine Woellert has reported that the PTO told its examiners that they could no longer use the controversial online encyclopedia as an accepted source of information.]

Just as eager as the USPTO is to develop a “peer review mechanism” that would enlist volunteers from the public and ease the burden on its own staff, the public is anxious to serve. I have received notice of several other services. One service, Patent Debate, is offered by IP.com.

Patent Debate is described as “a powerful intellectual property tool to pioneer the battle against overly broad patents.” The idea being that anyone who is interested in the outcome of a particular patent application can publicly voice their objection since Patent Debate allows users to freely search, view, and post commentary on any pending U.S. patent application. IP.com already maintains a Prior Art Database for use by companies to publish their technical disclosures (defensive publications) in a searchable database.

Besides at least one other beta project we know of, there is also Patent Quality Index, which seems blank right now, and the Community Patent Project, which is a New York Law School venture backed by IBM, Red Hat, Microsoft and Hewlett-Packard. That project, scheduled for a pilot rollout in January 2007, will allow the public to comment on patent applications and rank one anothers’ comments for quality. The Community Patent Project tries to provide an online system for peer review of patents by a network of experts, which can advise the Patent Office on prior art as well as to assist with patentability determinations.

It claims that by using social software, such as social reputation, collaborative filtering and information visualization tools, we can apply the “wisdom of the crowd” – or, more accurately the wisdom of the experts – to complex social and scientific problems. Apparently, though, they don’t like to be called a wiki declaring that “the technology we will use — and which we are in the process of designing and building with public input — is not a wiki. It is not wikipedia for patents. It is a peer review system that is specially designed with a knowledge and understanding of patent law and practice.” Uhhmm…whatever.

How all of these patent review/comment sites will figure into the patent examination process remains foggy at best. Right now, patent law gives those involved in the patent process a “duty of candor” to share information about prior art, but only if they know about it. Although there’s no obligation to affirmatively go out and search for prior art now, there is concern about such proposals by the USPTO like the one limiting submissions to 20 references and, for additional references, making the applicants point out what part of the document makes it important, to identify specific claims to which a document applies, to clarify how a document adds new information not already considered by the examiner, or explain why the claims are patentable in light of the information provided.

In case you just can’t get enough wiki, these sites allow for easy collaboration: Jot, Wetpaint, PBwiki, Wikispaces, Wiki.com and Wikia.

We think the best idea lately is IP Law in Poetry. Yehuda has rendered both the USC Copyright and USC Patent codes into poetic form for easier (if slightly less accurate) reading.

On April 20, 2006, Amgen filed a lawsuit against Ariad in the U.S. District Court for the District of Delaware seeking a declaratory judgment that each of the claims contained in U.S. Patent No. 6,410,516, covering methods of treating human disease by regulating NF-κβ cell-signaling activity, are invalid and that Amgen has not infringed any of the claims of the ‘516 Patent based on activities related to Amgen’s products, Enbrel® and Kineret®.

The ‘516 patent claims methods of treating disease by regulating a family of molecules known as NF-κβ. While Ariad contends that the patent covers all means for modulating the NF-κβ pathway, Lilly’s contention is that it discovered the drugs in question, Evista and Xigris and disclosed their medicinal properties years before the patentees’ scientists made their discovery. Ariad asserts that the claims of the ‘516 patent cover “methods of treating human disease by regulating NF-κβ activity,” “methods of treating disease by inhibiting NF-κβ,” and “methods useful for treating various disease conditions through modulation of NF-κβ activity.”

On April 4, 2005, Eli Lilly and Company filed an ex parte request in the United States Patent and Trademark Office, or PTO, to reexamine the patentability of certain claims of the ‘516 Patent. In addition, an unrelated third party filed an ex parte request in the PTO on December 2, 2005 to reexamine the patentability of certain claims of the ‘516 Patent. The PTO has granted both of these reexamination requests. On April 4, 2006, counsel for the patentees of the ‘516 Patent filed separate Petitions requesting the PTO to merge these two reexamination requests, which were granted by the PTO on May 4, 2006. Additionally, on April 7, 2006, counsel for the patentees of the ‘516 Patent filed a third ex parte request in the PTO with respect to one claim of the ‘516 Patent, which was denied by the PTO on May 5, 2006. As a result of the PTO orders described above, Lilly’s ex parte request has been merged into a single action to look at the patentability of certain claims of the ‘516 Patent by newly cited references which (i) either inherently or expressly disclose the use of a variety of prior art compounds as reducing NF-κβ activity and resulting gene expression, or (ii) are directed to the use of oligonucleotides having an NF-κβ binding site for reduction of NF-κβ activity (Reexam. C.N. 90/007,503).

The Examiner has now rejected 160 of the 203. In a quite lengthy and detailed 66- page Nonfinal Office Action, the Examiner rejected various subsets of claims as anticipated and/or obvious in light of a long list of prior art references. For example, many claims were rejected over Meichle (J. Biol. Chem. 265 (5/90) 8339-43), which teaches the reduction of NF-κβ activity in induced cells using agents that inhibit protein kinase C. In addition, because Meichle used the HIV LTR in their experiments, this reference anticipates, or alternatively, makes obvious claims drawn to regulating expression of viral genes.

The Examiner contends that the ‘516 claims are drawn to reducing NF-κβ activity in eukaryotic (e.g. claims 1 or 2) or mammalian cells (e.g. claim 11) to effect inhibited expression of a gene under transcriptional control of NF-κβ. For example, NF-κβ activity can be effected by diminishing induced NF-κβ mediated intracellular signaling (claims 6-9) to inhibit associated gene (viral gene such as HIV: claims 1-4) expression of a cytokine protein(claim 5) in a eukaryotic cell. Meichle teaches the use of Protein Kinase Inhibitor H8 (among others) to reduce NF-κβ-mediated gene transcription by reducing NF-κβ activity and reducing the binding of NF-κβ to NF-κβ binding sites.

It is noteworthy that the USPTO states that claim 1’s sole method step is functional, i.e., reducing NF-κβ activity and, therefore, the claims would encompass any in vitro or in vivo, natural (indirect) or man-made (direct) means of reducing NF-κβ activity. The Examiner contends that most of the method steps recited in the patent are purely functional with the exception of claim 7 and dependent claims 81, 83 and 85-87 which require “modifying NF-κβ activity” (which are partially functional) and claim 203 which requires “introducing a nucleic acid decoy molecule into the cell” which requires an active step.

The problem with biochemical pathway patents for generic treatments is that they represent methods of treating disease by modulating a particular pathway in the body without claiming a specific drug or class of drugs that may effect the modulation. While this may provide broad (over)reaching claims, the reverse applies, too. That is, all the Examiner needs to show is that someone, somewhere modulated the pathway – whether they knew it or not.

Prior to the ‘516 patent, there were agents that existed that are now known to act by inhibiting NF-κβ activity, e.g., ibuprofen, which has been around since 1969 even if it’s mode of action wasn’t known until 1998. The mode of action was inherent even if not appreciated. Heck, even vitamin E inhibits NF-κβ activity. There’s just going to be a lot of prior art out there.

Of concern to Amgen, of course, is that claim 69 recites “a method for diminishing induced NF-κβ-mediated intracellular signaling comprising reducing NF-κβ activity in cells such that NF-κβ-mediated intracellular signaling is diminished, wherein reducing NF-κβ activity comprises reducing binding of NF-κβ to NF-κβ recognition sites on genes which are transcriptionally regulated by NF-κβ.” Ariad claims that Evista acts by inhibiting NF-κβ binding to its binding site.

As we’ve said earlier, this is far for over. Given the time for responses and extensions, it could be a year or two before this is settled (if then). We’ll keep you posted as to a response by Amgen.

Dennis Crouch over at patently-o has posted on his great blog the briefs filed in a patent case soon to be heard in the Supreme Court.  The Court and parties believe the issue is whether there is Article III jurisdiction over a declaratory judgment action brought against the licensor of a patent by the licensee where the licensee is still paying royalties, and so on.  There were lots of amicus briefs, and I wrote one in which I argued on behalf of several law professors that Congress had simply not enacted statutes that granted this jurisdiction — the Article III issue isn’t to be reached.  He posted all the briefs, including my brief which focused principally on statutory interpretation.  Others mention the statutory issue, too.  I’m betting that my position wins 5 votes… Stay tuned!

David Hricik
Mercer Law School
(I’m not affiliated with the firm that owns this site)

A new blog I came across is IP Law Daily, listed as a media perils, cyberlaw and patent blawg. It is the latest venture from Kevin Heller of Tech Law Advisor fame. According to the site, IP Law Daily monitors approximately 75 intellectual proeprty related legal weblogs (blawgs) and aggregates all the interesting tidbits of information from these sites, flowing through the tubes of the internet, in one place. A handy site if you don’t use an RSS reader.

I received a note from Lee Thomason, an IP attorney (and ex-FBT’er) at Spalding & Thomason, about his new blawg ISinIP. Described as a weblawg for Innovative Strategies In IP, Lee sums things up thusly:

If your ship must travel a straight course, through still water, then any mate can handle that. If however, rough water or unexpected difficulties may be encountered, then you are better served with a captain who has completed many such voyages before.

And finally, in the non-legal sector, Drug Channels brings expert viewpoints by Dr. Adam J. Fein on the latest pharmaceutical distribution trends affecting manufacturers, wholesalers, pharmacies, PBMs, and payers. Fein provides a lot of insight into what can be done to stop counterfeit drugs.

A pharmacies’ right to compound prescriptions came in jeopardy after the Food and Drug Administration argued that compounding creates new and unapproved drugs. In Medical Center Pharmacy, et al. v. Gonzalez, et al., No. MO-04-CV-130, District Court for the Western District of Texas, a suit was brought by 10 pharmacies against the Food and Drug Administration regarding the practice of pharmacy compounding. The court sided with the pharmacies saying that compounding ingredients to create a drug under a valid prescription does not create a new drug.

Drug compounding, a practice in which pharmacists manufacture prescription drugs from bulk ingredients, is traditionally done for medical reasons, such as when a patient is allergic to an inactive ingredient in the commercially manufactured drug. Typically, if a patient has a condition that off-the-shelf pharmaceuticals cannot meet, then customized compounded medicines are prescribed by physicians and prepared by licensed pharmacists. Every state legislature has authorized the compounding of drugs and state governments continue to regulate the practice.

In this ruling, the court went beyond its earlier finding that the FDA does not have the authority to classify compounded products as new drugs to add that the agency cannot prohibit pharmacists from using bulk ingredients to create customized medications. While the agency has never prohibited the use of bulk ingredients for human prescriptions, it had done so for animal products. Compounding proponents believed that the FDA would soon try to apply this policy to human drugs.

First, the Court ruled that compounded drugs do not fall under the new drug definitions and, therefore, are legal. Judge Junell explained: “If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval … It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner.”

Second, the Court ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless FDA can demonstrate that the pharmacy is not compliant with applicable state laws and does not operate as a retail pharmacy.

Third, the Court ruled that compounding from bulk pharmaceutical ingredients for non-food animals is legal. This is an important issue for animal owners and their veterinarians who prescribe compounded medications to treat a variety of conditions, many of which require medications that are only available by compounding bulk pharmaceutical ingredients. Without them, animals may needlessly suffer or even die. Until now, the FDA asserted that prescribing and preparing these treatments was illegal.

In 1938, Congress passed the Food, Drug, and Cosmetic Act to empower the FDA to require approval of new drugs made by pharmaceutical manufacturers. FDA began arguing in the late 1980’s that Congress intended for that law to apply to compounded preparations in addition to manufactured products. This meant that, according to the FDA, each compounded medicine was a “new, unapproved drug” subject to the same requirements as manufactured products. Because these requirements are inherently impossible for compounding pharmacists to meet, it meant that FDA considered all compounded preparations illegal.

While the FDA asserted that compounded drugs fall within the definitions of new drugs under 21 U.S.C. §§ 321(p)(l) and (v)(l), the term “new drug” is defined as “Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof…”

The court held that compounded preparations are not new, unapproved drugs. Two other issues in the case — the Food and Drug Administration (FDA)’s broad authority to inspect pharmacies’ records and pharmacies’ ability to compound from bulk active ingredients for non food- producing animals (e.g. pets, horses, zoo animals) — are still being considered by the judge.

Now, when you really need that special cocktail of Viagra, Bisquick and the little Purple Pill, you’re good to go.

One of the items that I tend to fall terribly behind in is mentioning other IP sites of interest. I wanted to make up for some of my wanton and willful negligence by highlighting some noteworthy pages.

Joseph Scott Miller, an Associate Professor of Law at Lewis & Clark Law School, launched The Fire of Genius in May 2006 to comment on patent law, i.p. law, creativity, the legal academy, and more. Of special note to litigators is his round-up on injunctions, offering a running list of the patent, copyright, and trademark cases in which courts have applied the eBay four-factor framework to grant or deny injunctive relief.

Another new IP blog is IPEG, by Simmons & Simmons partner Severin de Wit, which covers mostly European patent & technology issues. This site offers some unique insight into EPO practice and is worth a look.

More to come.

Kevin Heller, the Tech Law Advisor and commissioner of the Legal Bloggers Fantasy Football League, is heading up Blawger Bowl III. The league is made up of draft teams managed by 12 law blawgers. Patent Baristas is participating – although how we got talked into this I’m not so sure.

Current Roster:

Anonymous Lawyer
Bizz Bang Buzz
Invent Blog
IPTablog
Knowtime
Loosely Coupled
Patent Baristas
paulfrankenstein.org
Tech Law Advisor
TortsProf Blog
Unbillable Hours

Wish us luck. Our quarterback is Ben Roethlisberger.