Patent Baristas

You couldn’t swing a dead cat at the BIO2008 conference today without smacking at least one governor out pressing the flesh and showing their state’s support for the biotech industry.

Joining Wisconsin Governor Jim Doyle in announcing initiatives for biosciences and stem cell research, Colorado Governor Bill Ritter gave a talk today on Colorado’s growing biotech and bioscience economic sector, representing over 400 bioscience companies in the state.

Gov. Ritter just signed a bill putting $26.5 million investment in the industry through the new Colorado Bioscience Discoveries Grant Program. Gov. Ritter noted that private research is increasing and that venture capital funding is improving.

When asked about the outlook for bioscience research funding, Gov. Ritter said that the change in administration will most certainly bring a change in the mindset within the government. He felt both candidates would support increased research and noted that Sen. Barack Obama has a belief in biotech as a 21st century economy.

The Governor said that there will not only be additional research funding with a change in the administration but that he also foresees a different mindset at the FDA, which will lead to increased efficiencies in the drug approval process.

Also on tap later today, California Gov. Arnold Schwarzenegger.

The BIO 2008 Convention was in full swing this week as over 20,000 attendees all crushed together gathered in the San Diego Convention Center.  With everything from a golf swing analysis to an oxygen bar, attendees are being treated to an all-out marketing blitz.

With a new billion-dollar initiative seemingly announced daily, the stakes certainly are high. Wisconson noted it spends $250,000 per conference saying that this is Main Street for biotech and if you want the business, you need to have a storefront on Main Street.

You can follow my coverage, as well as many other bloggers, at Bio On The Road — similar to last year’s BIO Voice.  If you’re attending BIO this week, drop me a note and we’ll meet up.  And don’t forget, I’m giving away some iPods from Patent Baristas while I’m hanging out around the Exhibition floor (see details here).  In the meantime, be sure to check out the BIO Party List – Ohio’s reception is tonight at Buster’s Beach House.

Wisconsin Governor Jim Doyle held a press conference this afternoon on why Wisconsin is way more than cheese.  Announcing that the Genetics Policy Institute picked Wisconsin as the host of the World Stem Cell Summit 2008, Gov. Doyle laid out how the state is on pace in building the Wisconsin Institutes for Discovery at the Biotechnology Industry Organization (BIO) conference in San Diego.

The Institutes are twin institutes, one public and one private, to be constructed in the heart of the UW–Madison campus as a hub for interdisciplinary research.  These will be the largest outside the coasts in the U.S. and they represent a potential $5 billion opportunity for Wisconsin.

When asked how any new administration would impact stem cell research and commercialization, Gov. Doyle said that both candidates have indicated that they will broaden stem cell research.  The governor predicted that Sen. Barack Obama, if elected, would totally lift the ban on stem cell research and that either candidate would likely make critical research available and set strong ethical rules for development.  The National Institutes of Health (NIH) would assure that any recipient institutions operate under the correct scientific and ethical standards.

“I don’t think we’ll see another false, arbitrary standard where limits on research are based on the date the president happened to give a speech, ” said Gov. Doyle.  He indicated that science, not politics, should set the standards.

It was three up and three down for the as rejected the claims of its patents on human embryonic stem cells.

Embryonic stem cells, as their name suggests, are derived from embryos that develop from eggs that have been fertilized in vitro. Embryonic stem cells possess two properties that make them valuable for cell therapy. First, because embryonic stem cells are at a very early developmental stage (pluripotent), they retain the ability to become any one of the more than 200 cell types that make up the human body. A second feature of embryonic stem cells is their ability to remain in an undifferentiated state and to divide indefinitely.

Earlier, the U.S. Patent and Trademark Office (USPTO) announced it would re-examine patents covering embryonic stem cell discoveries made by University of Wisconsin researchers. The patents, US Pat. Nos. 5,843,780, 6,200,806, and 7,029,913, cover all embryonic stem cell research in the U.S. and are owned by the Wisconsin Alumni Research Foundation (WARF).

WARF has made free licenses and cells available to more than 300 academic research groups but charges companies $75,000 to $400,000, depending on their size and the terms of the license.  WARF also claims royalties from products produced using the patents.

Now, if only we could figure out why Wisconsin is called the Badger State.

See related items here:
Ding! WARF Wins Round 2 As Stem Cell Patent Upheld
WARF Stem Cell Patents Knocked Down in Round One

I’m excited to be attending BIO2008 Conference in San Diego this week where I’ll be participating as an on-site blogger via the BioOnTheRoad (at bioontheroad.org/) blog — similar to last year’s BIO Voice — the blog of the BIO2008 conference.

It’ll be fun to see an up-to-the-minute review of some of the sights and sounds at BIO’s gathering of professionals with over 20,000 attendees and 2200 exhibitors, from over 70 countries.  From blogging to pictures to Tweetering (Is that a word?), this effort is going to bring you an up-to-the-minute multimedia stream.

I’m looking forward to working with all the other BioOnTheRoad bloggers including returning BioVoice veteran Adam Rubenstein of Colorado Life Science Deal Flow and Canadian Darren Fast of Solalta Advisors.  I’m also looking forward to meeting up with people I can only see at this event. No word, though, on whether or not I’ll get to meet California Gov. Arnold Schwarzenegger, when he delivers Wednesday’s keynote address.

If you want to discuss anything from news tidbits to interview opportunities, please track me down so we can chat over a cup ‘o joe.  Feel free to talk up your own exhibit or product, from biofuels to stem cells.   You can find me at:

Web site  Patent Baristas
Email stephen@patentbaristas.com
Twitter patentbaristas
LinkedIn patentbaristas
Text 5138856188

And don’t forget, I’m giving away some iPods from Patent Baristas while I’m hanging out around the Exhibition floor (see details here).  In the meantime, be sure to check out the BIO Party List.  See you in San Diego!

Also attending:

•  Lisa Dry from Down to Earth

(Let me know if you’re attending)

Lewis & Clark Law Review’s latest issue and it features a business forum on the Supreme Court’s recent patent decision in KSR v. Teleflex. If you want to talk KSR, this is your stop.  There are eleven action-packed articles related to this decision and this is a great way to get your fill of opinions.

Not to be missed is the article by Joseph Scott Miller, of Fire and Genius, which looks at how the Supreme Court’s KSR decision transforms the way we think about patent law’s ordinary artisan. If you remember, the Supreme Court states that the ordinary artisan “is also a person of ordinary creativity, not an automaton.” That’s why they get paid the big bucks.  Looking through the history of nonobviousness, Prof. Miller shows that the modern “level of skill” inquiry can comfortably rely on evidence of long-felt, unmet need in the art and the failure of others to meet that need.

In Creativity, Innovation, and Obviousness, Psychologis R. Keith Sawyer discusses how creativity research could help resolve the unanswered questions of KSR: (1) the role of prior art in invention; (2) the distinction between ordinary and exceptional innovation; and (3) the relative importance of proper posing of a problem and the combination that results in the solution.

Links to each article, along with abstracts, are at the current issue page.

“Biotechnology is not merely a set of technologies, but also an underlying philosophy of entrepreneurship, risk-taking and long-term vision.”  ~BioSynergy

Students at the Massachusetts Institute of Technology (MIT), Stanford University and the University of Toronto have launched a new biotech magazine called BioSynergy.  Their stated goal is to “[C]atalyze the birth of the next generation of biotech’s pioneers by conveying its ideas through the stories of biotech’s luminaries and the exciting technologies they are creating to students and executives across North America.”

Targeted at those with a background in the life sciences, executives and students alike, the magazine features contributions from luminaries including James Watson, Nobel Prize Winner and co-discoverer of the double helix, and Daniel Vasella, CEO of Novartis. The inaugural theme is biology’s transition to a quantitative discipline.

Thirty thousand print copies are to be distributed at BIO2008 and ten biomedical campuses across North America. The group is also planning an entrepreneurship competition and a case-study workshop to occur alongside the BIO2009 Convention in Atlanta, Georgia.  They are also looking for campus partners.  If you are a biotech club somewhere in the world, you can mail info@biosynergyonline.com and they’ll send some print copies of BioSynergy your way.

BioSynergy is a non-profit magazine originally founded by students at the University of Toronto that aims to be the leading source of inspiration and excitement for entrepreneurship in the life sciences.

We’ll be looking for their team at BIO2008.  See more on-line here.

Generic drug maker Mylan got some good news from the U.S. Court of Appeals for the Federal Circuit in a patent litigation related to its heartburn treatment Omeprazole, the generic version of British drug maker AstraZeneca’s Prilosec, when the court affirmed a District Court ruling that Mylan’s 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe AstraZeneca’s patents.  In re Omeprazole Patent Litigation (07-1476, -1477, -1478).

To say the least, AstraZeneca expressed disappointment with the ruling of noninfringement regarding it’s U.S. Patents 4,786,505 and 4,853,230.

Omeprazole is the generic name for Prilosec®. Omeprazole inhibits the production of gastric acid when, after absorption, Omeprazole transforms into its active species in the parietal cells (acid-producing cells in the stomach lining) and inhibits acid production. However, omeprazole degrades in acidic and neutral environments. Therefore, it must be protected from contact with gastric juices while traveling to the parietal cells. Thus, an omeprazole formulation needs a protective enteric coating around the core containing the active alkaline reacting compound (ARC) and a separating layer between that core and the coating.

Astra developed an oral dosage form of omeprazole that overcomes those formulation problems.  They developed an oral formulation that includes a core containing omeprazole and an alkaline reacting compound (ARC), a water soluble subcoat, and an enteric coating.

Astra brought suit against Mylan and Esteve, along with several other generic defendants, alleging infringement under the Hatch-Waxman Act.  Mylan’s products consist of (1) an inert sugar/starch sphere; (2) an active coating of omeprazole, talc, and hydroxypropyl methylcellulose (HPMC) (Film Coating No. 1 or active drug layer); (3) a subcoating of HPMC, talc, and titanium dioxide (Film Coating No. 2); (4) a second subcoating of HPMC and ethylcellulose (Film Coating No. 3); and (5) an enteric coating of methacrylic acid copolymer, triethylcitrate, and talc (the enteric coating).

The district court determined that Mylan/Esteve did not infringe either of the asserted patents and that Astra failed to show that Mylan/Esteve’s omeprazole products met the limitations of paragraph (a) of claim 1 of the patents in suit.  In particular, the court found that Astra failed to prove by a preponderance of the evidence that Mylan/Esteve’s products contained an ARC.  The court rejected Astra’s assertion that carbonates in either the talc or the HPMC, or the triethylamine in the omeprazole, satisfied the ARC and effective amount requirements of the asserted claims.

The issue on appeal was whether the district court erred in concluding that Astra failed to prove the presence of an ARC in Mylan’s products. In order to infringe the patents in suit, the accused products must contain an ARC in the active core region.  Previously, in Omeprazole I, the Federal Circuit had already affirmed the district court’s construction of an ARC, which was construed as:

(1) a pharmaceutically acceptable alkaline, or basic, substance having a pH greater than 7 that (2) stabilizes the omeprazole or other acid labile compound by (3) reacting to create a micro-pH of not less than 7 around the particles of omeprazole or other acid labile compound.

At trial, Astra argued that the talc used in the active drug layer of Mylan’s products, Microace® talc, was alkaline and that the source of alkalinity was carbonates.  More specifically, Astra argued that carbonates that are introduced into the active drug layer through the talc, and not the talc itself, are ARCs as that term is used in the patents in suit.

The district court considered and rejected Astra’s assertion.  The court primarily rested its conclusion on its finding that Astra failed to prove the presence of carbonates in Mylan’s products.  In doing so, the court considered the evidence proffered by both parties relating to the presence or absence of carbonates in the talc.

The court found that those tests indicated that Mylan’s talc contained no detectable amount of carbonates.  After weighing the competing evidence, the court found that Astra failed to prove the presence of carbonates in the talc of the accused products.  Since the determination is based on the district court’s fact findings, it cannot be overturned unless the Federal Circuit finds them to be clearly erroneous, and didn’t.

Astra argued that the district court was wrong to require conclusive evidence that carbonates were present in the talc, rather than preponderant evidence.  The Federal Circuit, however, pooh-pooh that idea saying the district court knew what it was doing.

See also:  Recognizing a Novel Characteristic After the Fact Doesn’t Make a Known Composition New Again

The U.S. Patent and Trademark Office (USPTO) published some new rules that will improve (their word, not ours) the process of ex parte appeals before the USPTO’s Board of Patent Appeals and Interferences (BPAI). The rules are supposed to help to streamline the appeal process and lead to more timely Board decisions.  We’ll see.

The final rule requires examiners to put forward their reasons for the rejection earlier in the appeal process. Examiners will no longer provide a response to the reply brief, and new grounds of rejection are no longer permitted in examiners’ answers. In addition, supplemental examiners’ answers are no longer permitted in response to a reply brief. These changes will result in increased efficiency in the appeals process.

Under the new rules, requirements for a complete brief are clearly set forth, making it easier for applicants to ensure compliance. Briefing requirements that were not necessary for the appeal—such as the “summary of the claimed subject matter”—are no longer required. The facts and arguments required in the brief are focused on distilling the issues of the dispute and establishing where the examiner erred in the rejection. Finally, page limit requirements ensure concise and clear arguments. Supposedly, these new requirements will result in some appeals being resolved before they reach the Board and will help foster timely decisions for the others.

The final rule reflects changes made after receiving public comments. For example, initial page limits set for the appeal brief and reply brief were increased by five pages to 30 and 20 pages, respectively. In addition, the evidence appendix no longer requires the submission of duplicative records beyond that required by the current rules.

David Boundy, of Cantor Fitzgerald LP, was appalled at the way the Response to Comments misparaphrases the comments, rather than fairly addressing the comment.  He was also appalled at the Board’s willingness to be loose with facts.  For example, several comments pointed out that preparing a Table of Authorities using MS Word takes hours.  The Board says, with no identified factual basis, that it takes “10 to 15 minutes” to generate Table of Contents and Authorities with no identification of what tool generates a Table of Authorities in 8 minutes.  Several comments pointed out that the Federal Circuit permits skipping page numbers in order to make it tractable to prepare the appendix.   The Board declined to adjust the page numbering rule.

Boundy went on to elaborate:

Several comments pointed out that the Federal Circuit permits skipping page numbers in the Appendix in order to make it tractable to prepare the appendix and refer to the page numbers in the body of the brief.   The Board declined to adjust the page numbering rule, and instead insists that page numbers begin at 1 and continue consecutively through the appendix.  God help the appellant who needs to insert an additional page in the last few days before filing the brief.

Several people raised substantial issues under Paperwork Reduction Act and Executive order 12866.  The PTO simply brushed the issues aside with no comment, except to baldly assert that the Appeal Rule imposes zero cost of compliance and zero sacrifice of rights, with no identified basis.  The PTO’s certification to Office of Management and Budget of “not significant” allowed the PTO to evade review under Executive Order 12866.  Even on the best possible view of the facts presented in the Final Rule notice, the PTO concedes that the burden of this rule is at least above the threshold for “significant,” and the PTO failed to reply to comments showing that it is likely “economically significant,” the highest category of burden.   This failure to reply to public comments violates both the spirit of the Executive Order and the Administrative Procedure Act.

The new Appeal Rule 41.39(b) provides “No new ground of rejection. An examiner’s answer shall not include a new ground of rejection.”  First of all, this is illegal – it is not a “logical outgrowth” of the rule as published in the Notice of Proposed Rule Making (recall this is one of the grounds on which Judge Cacheris preliminarily enjoined the PTO’s Continuations and Claims rules in October).  Second, this was the rule during the period 1998-2004.  However, the Board refused to enforce the rule during the time it was in effect, Ex parte Brissette, 2002 WL 226585 (BPAI May 19, 2000); Ex parte Deacon, 2002 WL 226993 (BPAI 2000), so as a practical matter, examiners were free to throw in new grounds of rejection at any time, and applicants were constrained in their ability to reply

Since 2001, the PTO has regarded rules of procedure as expendable, to be ignored when constraining PTO action but enforceable when applicable to constrain applicants, and Due Process is something for dewey-eyed foreigners.   This Notice of Final Rulemaking appears to continue the trend.

The final rule will go into effect six months from today (December 10, 2008), and will apply to all appeals in which an appeal brief is filed on or after the effective date.

The full text of the new rules are available here.

Don’t forget to review the public comment letters on the Markush rule now up on the USPTO website.