The Return Of The Magnificent Prosecution Specialists Or Just More “QA”?

The USPTO recently announced the creation of an ombudsman program to resolve applicant/examiner logjams in all of the Tech Centers. This is a move that the Office (and practitioners) have needed badly for a number of years, ever since the demise of the “Strong” Patent Prosecution Specialists in the pharma/biotech groups (1600/1800). Patent Prosecution Specialists like Richard Schwartz, Brian Stanton (now at NIH), and Margaret Parr were given real power to move stalled applications forward by mediating amendments acceptable to both sides or, in some cases, by simply telling the Examiner that he/she was wrong and to allow the claims in question. However, if this is simply a return to the “Weak” QA Specialist program that was no more than window dressing on the no-Patent Office, why bother? We need change we can believe in, not a PTO where Examiners are encouraged to just say “No”!

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FYI

LES Spring Meeting — Boston, MA – May 19-21, 2010

I will be part of a Workshop entitled “A Shot Across the Bow – The Process Behind the Making and Responding to Demands to License Patented Technology” scheduled for May 21st at 930AM. The other speakers will be Robert Sloss of Farella Braum & Martell, Ted Chan of Biovail and Susan Stoddard of the Mayo Foundation. The short title of this workshop could be “Fending off the NPE’s,” but, of course, not all “license seekers” are Trolls and sometimes, it is better to flee to the shelter of a reasonable license than it is to push your gladiator (read “litigator” ) into the ring.

Schwegman Lundberg & Woessner Ranked High On “Patent Scorecard”

Schwegman Lundberg & Woessner is approaching its 17th anniversary with about 80 attorneys in three offices and 12 satellite locations. The firm has remained unique in both not having a litigation department and in not maintaining a large incoming “foreign” docket. As a result, most of the patents that we draft and prosecute originate with U.S. clients. That leaves us pretty far down on the list of firms when rankings come out based only on total number of attorneys or number of patents issued per year.

However, it was heartening to see the “’Patent Scorecard” published in the April 2010 issue of Intellectual Property Law Today. Schwegman Lundberg & Woessner ranked second of the 25 firms ranked. The rating and ranking system was developed by The Patent Board and “is complied with natively-filed patents, excluding those with a foreign priority…since patents with a foreign priority have usually been drafted according to the requirements of a specific foreign jurisdiction.”

The total Technological Strength Score accorded to a firm was based on metrics named Current Impact, Science Linkage, and Innovation Cycle Time, but you can guess that using “natively- filed” patents as a starting point eliminating the monster patent-issuers like Oblon Spivak, Sughrue, Birch Stewart, and Oliff & Berridge, all of whom obtained over 2000 patents in 2009. So it was particularly gratifying to rank so high on a list mostly made up of older, better known firms, when we “only” issued 808 natively-filed patents in 2009. (Just based on the number of such patents, we were ranked 5th.) Of course, I agree with the summary of the Patent Board: “In this difficult economy, Patent Analytics offer a vital perspective that can help maximize returns on investment for clients and law firms alike.” Write on!

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Is The “Golden Rule” Of Biological Drugs At Hand?

I just finished speaking on IP issues involving biomarkers at a Q1 Conference in the Bay Area. Before the conference started, I spoke to the head patent counsel of a well-known bio/pharma company. He said, to my initial shock, that he thought new drugs based on small molecules were on the way out as commercial products. He was mostly focused on the difficulty he was having in getting claims allowed in the PTO, but his comments resonated with the comments of the first speaker, who pointed out, as did others, that it takes about 14.5 years from preclinical work to launch a new drug (small molecule or biological).

Now, taking that as a good estimate, and considering that a patent filed in the U.S on a drug at the beginning of the development period will have only about 5.5 years of life left when the product launches – less if it is filed in the pre-clinical stage – I jotted some quick notes from the speaker’s timeline. Patent term extension based on her figures for clinical trials and FDA approval delay would yield a patent term extension of only about 3.5-4.5 years. So the innovator only has about ten years to make a profit on its investment. The innovator will get five years of data exclusivity when the drug is approved, but the patent has more life than that, so the NCE exclusivity doesn’t add to the “product life cycle.” Also, the innovator can extend only one patent, so the generics have a clear target to zero in on via para. IV filings.

Of course, this is not the entire story, as the innovator can file add-on patents, including “label patents,” but these are both increasingly difficult to obtain post-KSR and easier to attack (e.g., via reexamination). Contrast this with the situation for a new biological drug, as set forth in the Obama Health Care Bill. No matter how long the development period, the innovator gets 12 years of data exclusivity from product approval/launch. Now there is no patent-based exclusivity for the generic company to attack or, I should say, attacking the patents won’t get the generic approved. So they are pretty much stuck in neutral. (See my recent post on the biologicals rules in the Health Care Bill.)

The FDA just announced an NIH-sponsored trial dubbed I-SPY 2 that will use genetic markers from patients’ tumors to identify which of five cancer drugs they will receive. The trial will evaluate the effectiveness of five investigational drugs from Abbott, Amgen, and Pfizer. Guess what? The names given in the post (fdanews.com) all end in “mab” or “nib.” So which business would you rather be in today, if drug discovery and development is your thing?

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Patenting Genes – The Conversation Myriad Needs To Start

I watched “60 Minutes” last night, during which Kevin Noonan got about 30 seconds to justify “patenting genes” and the Myriad BRAC1-2 assays. He did as well as could be done, speaking about the good the patent system does in incentivizing investment in medical advances. However, “big bad” Myriad declined to be interviewed, so all the viewer saw was a few shots of their posh-looking headquarters. Arguments about economics are not going to make a big impression as compared to two cancer patients who claim they can’t afford the assay or have no place to go for a second opinion, and Chris Hanson, the ACLU attorney, who likens patenting genes to patenting gold nuggets panned from a stream – a product of nature, no more no less. No one should get a patent on something like that!

I read all of Judge Sweet’s opinion and could see that Myriad was trying hard to convince the court that “isolated and purified DNA” is obtained by chemical and physical processes that necessarily alter the chromosomal DNA after it is purified, and that it is not just “purified” from a cell, but they have to try harder. I have little doubt that the Federal Circuit will reverse this decision, but the ACLU and the plaintiffs are swinging for the fences. Go back and listen to the July podcast “debate” between Chris Hansen and me that is in the archives of this blog. His arguments are reflected in the decision almost verbatim.

The Supreme Court may have taken quite a few patent appeals of late, but Pioneer Hi-Bred vs. J.E.M., which affirmed the patentability of plants and approved of Chakrabarty, was not a biotech case, and Chakrabarty did not involve patenting human genes. So the “transformation” vs. “isolation” debate will soon be re-run, I fear. I feel that our conversation with the “concerned public” has to go more like this:

“Mr. or Ms. Patient: No one owns your genes. No drug company with a gene patent is going to come up to you and say, ‘I have a patent on one of your genes, so you must pay me or you can’t use it anymore.’ The gene that the drug company has in that test tube is not the gene as it exists in your cells. It has been removed from the biological jungle of the human body by reactions that are something like decoupling a string of 15 freight cars from a freight train that is 1000 cars long. The bonds, or couplings, that kept the 15 cars with the train were chemically decoupled, and the 15 cars were put on a siding, where they can be cleaned, inspected to see what they carry, and perhaps put into the middle of a different train, using new couplings.

“Another way to think of a gene or DNA that can be patented is to consider biodiesel. It is the result of a chemical reaction carried out on fats or “triglycerides.” Your blood contains triglycerides, but no one has tried to patent blood containing triglycerides. The triglycerides used to make biodiesel are purified from animal or plant materials and then subjected to a chemical reaction that splits them into biodiesel, which will fuel a car, and glycerol, which is used to make candy. In much the same way. the DNA that Myriad has patented has been split out of the purified chromosome that it was part of. Your chromosome was not patented; a very small very useful part of it was.”

I don’t know if these analogies will help at all, but maybe it is time to start talking about what patents don’t let us do, rather than what patents let us control or bring to a stop.

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