Patent Baristas

Biovail Corp., Canada’s largest publicly traded drugmaker, announced that it has settled with the United States Department of Justice (DOJ) regarding criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem LA. The DOJ alleges that prior management’s actions in 2002 and 2003 in respect of the Cardizem LA clinical experience program, titled PLACE (Proving L.A. through Clinical Experience).

Cardizem LA (diltiazem) is a long-acting drug and part of a group of drugs called calcium channel blockers, which work by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. In 2003, an administrative inquiry reported that Biovail planned to offer doctors $1,000 to write 15 prescriptions for Cardizem LA, then complete a report on each patient.

Under the terms of the agreement, Biovail Pharmaceuticals, Inc. (BPI), would plead guilty to charges relating to making payments to induce purchasing or ordering of Cardizem(R) LA in 2003 and would pay $24.6 million to fully settle this matter.  As part of the agreement, Biovail expects to get full releases for all matters related to the DOJ’s investigation.

The agreement eliminates any criminal liability for Biovail Corporation arising from this matter, and preserves the Company’s ability to conduct business in the United States. Without this agreement, the Company was at risk of being excluded from doing business with any health program sponsored by the U.S. federal government. The agreement is subject to approval at a court hearing.

Cardizem LA had $10.2 million in revenue in the first quarter, down 57 percent from $23.9 million a year earlier. In December, the company agreed to pay $138 million to settle a securities fraud class-action suit brought by investors who claimed the company’s officers and directors lied about the effectiveness of Cardizem LA when it was introduced in 2003.

This comes as many groups are starting to ban give aways to doctors. Earlier, Vanderbilt Medical Center and Stanford joined other institutions in banning gifts, meals and toys from drug reps as part of a new conflict of interest policy. The policy, to be phased in by July 1, will also preclude most employees from accepting free meals.

See more about Biovail’s previous administration under former Chairman and CEO Eugene Melnyk where the Securities and Exchange Commission charged the corporation and its former CEO, former CFO, and two current senior executives with engaging in a number of fraudulent accounting schemes and making a series of misstatements to analysts and investors.  (see complaint here)

See also: NIH Scientist Could Get Prison and $100K Fine

Pfiscal Responsibility

Pfizer announced that it has posted a list of U.S. medical, scientific and patient organization grants and charitable contributions made in the first quarter of this year, part of an ongoing drive throughout the company to increase transparency. 

Of a total $9.97 million in grants and charitable contributions reported for the first quarter of 2008, the largest grant – $3,420,318 – was made to the California Academy of Family Physicians in March for a three-year national health care professional education campaign to reduce the number of U.S. smokers.  Detailed descriptions of the types of support provided are available here. (via World Pharma News)

In re Bilski

The U.S. Court of Appeals for the Federal Circuit, in a 12-judge en banc hearing, asked for help in figuring out what to do with methods of doing business.  Among the questions presented in In re Bilski, the court was asked: “What standard should govern in determining whether a process is patent-eligible subject matter under section 101?”

In the polarizing case, which covers a covers a method of managing risk in selling commodities, the court received 44 amicus briefs (see Patently-O blog for many of the documents) as various entities took sides on how to define the patentability of business methods after the State Street decision.

The patent office argued that the Bilski method is ineligible for patent protection because it fails to claim a machine and because it does not involve a physical transformation. Pointing out that a change in trajectory could constitute a physical transformation, Judge William Bryson asked “Is a curveball patentable?” (via Law.com)   The court seemed to even question what it means to apply its own test for business method patentability (that the method produces a useful, concrete and tangible result).

Examining the Examiners

The new USPTO Examiners website (slogan: We Examine the Examiners) is a message board where practitioners can rate patent examiners.  While offering the disclaimer that posted messages are simply opinions of the message drafters,” the site seemed to offer as many — if not more — accolades as disparaging remarks. The post “This Examiner is a Stud!” sure catches your eye.

Frighteningly, it also allows patent examiners to rate practitioners so excuse us while we go check to see if we’ve been targeted…   (via Peter Zura’s 271 Patent Blog)

Red Cross Won’t Have to Change to Red Polygon

The American Red Cross can continue to use its mark (a red, well…cross) after a federal court ruled against Johnson & Johnson. J&J, which also uses the symbol, filed suit in an attempt to prevent the Red Cross and its licensees from using the “Greek red cross on a white ground,” claiming that it is a trademark violation and that the humanitarian group was barred from using it for commercial purposes.

But U.S. District Judge Jed Rakoff disagreed, noting that the American Red Cross had used the emblem for more than a century and was authorized to do so by various Geneva Conventions and the U.S. Congress. In his 34-page decision, Judge Rakoff said the “real question” was whether the permission given by U.S. statute to the American Red Cross to use its logo included commercial purposes. The judge ruled the answer was yes.

The judge left a part of the suit intact wherein J&J contends the American Red Cross purposefully interfered with its business relationship with two of the four companies. (via Pharmalot)

Where’s My &%$#@! 3G iPhone?

Rumors about Apple (finally) releasing a 3G iPhone are coming fast and furious with everyone pretty much confident that “the 3G iPhone will be unveiled in the coming weeks.”  Which means nobody knows anything for certain. But, those who read the tea leaves say everything now is looking towards Apple’s Worldwide Developers Conference in San Francisco starting June 9 and keynoted by Steve Jobs.

The worldwide 3G iPhone Watch has ramped up significantly after the current model iPhone sold out at Apple’s web site with no sign of restocking.  Added rumors say that the new model will come in 3 colors — black, silver and white — and sport GPS.  All I can say is that the 3G needs to be in my hands when I hit the ground in San Diego for BIO 2008. (via iPhone Buzz)

See the biotechnology industry’s global reach next month. The BIO International Convention, hosted by the Biotechnology Industry Organization (BIO), will take place June 17-20, 2008 at the San Diego Convention Center in San Diego, Calif. Not a small, intimate affair with attendance at more than 22,000 in 2007, with representatives from 68 countries — international attendance now makes up more than 30% of the attendees. The convention features more than 175 breakout sessions along with over 220,000 square feet of exhibition space.

The 2007 BIO International Convention in Boston saw double-digit percentage growth in attendees from Spain, Malaysia, Canada, German, India, and the United Kingdom. In 2008, more growth is expected from Asia and Latin America. There has also been a significant increase in attendance of international public officials from 45 in 2005 up to 72 during the Boston event. Notable leaders in attendance have included the Deputy Prime Minister of Malaysia, the Deputy Director General of the China State Food and Drug Administration, India’s Director of the Department for Biotechnology, and South Africa’s Minister of Agriculture.

The BIO International Convention features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities including Craig Venter of the J. Craig Venter Institute (JCVI), Governor Arnold Schwarzenegger of California and General Colin L. Powell, USA (Ret.). Past speakers include President George W. Bush, President Bill Clinton, Michael J. Fox, and Her Majesty Queen Noor of Jordan (I still have a crush on her even though she banished the media from her talk). The convention also includes hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition – the BIO Exhibition.

The 2008 BIO International Convention will feature leading industry experts and government officials from around the world debating key issues that dramatically influence the biotechnology industry including follow-on biologics/biosimilars, biomarker research, genomics and the ever-changing global biotechnology business landscape. The convention will highlight how biotechnology, the life sciences, investments, policy, and the international community work together to heal, fuel, and feed the world.  Expect to see heavy emphasis on global intellectual property property protections, follow-on biologics/biosimilars, international networking for research and development of neglected diseases and sustainable agriculture.

If you’d like to meet up during the conference, drop me a note and we’ll schedule some time to have coffee together.   It looks like the Securing Innovation guys along with the Patent Docs will be there — maybe there can be an IP blawger get-together on the USS Midway?  Send me your suggestions.

See here for more information on the 2008 BIO International Convention and registration.

Note to regular readers:  Check back next week for details on my BIO2008 daily giveaway.

The Palm Beach Post reported that the Scripps Research Institute has started issuing home loans — I guess they heard about the sub-prime bonanza and decided to jump on the bandwagon. Despite sounding like they’ve branched into some wildly diversified operations, the loans come as a bribe an incentive to get top scientists to move to the Institute. One top recruit snagged a $1 million mortgage for an oceanfront condo that cost $850,000.  A good deal if you can get it.

Scripps won’t say why the mortgage exceeds the condo’s purchase price, or whether the loan was derived from a $310 million state grant used to attract the biomedical research powerhouse here in 2003. In the past year, five Scripps recruits were provided with mortgages totalling $1.4 million. The terms of the loans are being kept under wraps and Scripps will only say that the state’s agreement gives the institute “broad authority” to use grant money for employee compensation and benefits.

The million-dollar mortgage recently was filed in the public record. After The Palm Beach Post asked about it, Scripps notified the Scripps Florida Funding Corp., which oversees Scripps’ grant.

Scripps claims that the intense competition for scientists and the added housing troubles have led it to up the ante with housing loans. Scripps indicated that the main reason for the incentive packages is to recruit scientists who bring in big grants and intellectual property. This is an interesting case of using grant money to lure scientist into moving and bringing along more grant money.

This begs the question:  Are such incentives a good idea?

more at twiigs.com…

See also:  Are Tax Breaks for Biotech Worth the Price?

Planet Eureka!

In the category of solutions looking for problems to solve, Planet Eureka! is a new on-line marketplace for patents and other intellectual property rights by Eureka Ranch Technologies in Cincinnati, Ohio.

Planet Eureka! Offers the USA National Innovation Marketplace as a way to bring together buyers and sellers of intellectual property. The Marketplace offers a place where inventors, patent holders, and intellectual property owners can post ideas in search of partners, buyers, and licensees.

Access is free to sellers and buyers but future plans include charging for consulting and other services. This site is from Doug Hall of American Inventor infamy.

InnoCentive

Another site, InnoCentive, provides a way for companies, nonprofits, and government agencies looking for solutions to problems to find the people and organizations that have answers. Charges $15,000 to post a problem as well as 40% commission on amount paid to the solution provider.

InnoCentive’s Open Innovation community is a way to get large numbers of members to try to solve some of the problems facing the world today. Those who are successful can win cash awards of up to $1,000,000 for solutions to Challenges. The site is a spin-off of Eli Lilly.

WikiPatents Community

Yet another patent marketplace is WikiPatents Community, which claims to contribute to the US patent system by reviewing issued patents and pending patent applications. WikiPatents features a wiki-like interface to review, rate, and discuss patents — plus free patent PDF downloads, file histories, and advanced patent searching.

The site also offers WikiPatents Marketplace, where companies can list patents for sale. IP is listed using various package deals ranging from $89/month to $1999/year.

What’s not clear is how members are able to vote on the value of any particular invention. The numbers for estimated value, royalty rate, market share and market size seem to be pulled from thin air. My favorite is U.S. Patent 7,095,126, entitled “Internal energy generating power source,” which claims:

1. A system for generating energy such that a portion of the generated energy supplies power to the system that generated the energy comprising: an electric motor capable of producing electric energy; a power source for supplying an initial amount of power to said electric motor; an alternator power source connected to said initial power source and said electric motor for continuously supplying power to said electric motor; a first inverter system connected to said electric motor, said inverter having an input through which said inverter system receives energy produced by said electric motor, said first inverter system also having one output through which said first inventor supplies power back to said electric motor to supply said electric motor with power; a load connected to said first inverter system via an inverter system output to alter the electric current traveling from said first inverter system such that the current feeding into the electric motor 30 is not purely inductive.

I think I’ve seen this perpetual motion machine before. Expect many of these to show up on Geekologie.

A relatively new blog that’s getting some attention is the Green Patent Blog, a site “dedicated to discussion and analysis of intellectual property issues in clean technology.”  I have to admit, I’ve become a little skeptical of all the greenwashing that’s been going on in the world so I sometimes roll my eyes at any effort that seems to spend more time and money telling you their green than actually goes towards being green.

But the Green Patent Blog is no wash job. Featuring patent items on everything from Carbon Sequestration to Fuel Cells, this blog highlights many interesting patents and developments in clean technology.

One noteworthy item highlights the Eco-Patent Commons, an initiative by IBM, Sony, Pitney Bowes and Nokia to share patented technology that (purportedly) protects the environment.  Each company has donated at least one patent to the Commons, which is administered by the World Business Council for Sustainable Development (WBCSD), a Geneva-based organization that promotes sustainability in business. 

Members of the Eco-Patent Commons (known as “pledgers”) sign a nonassert pledge promising not to enforce the donated patents against those who use the patented technology to achieve an environmentally beneficial result (known as “implementers”).   

But, in an effort to make it confusing,  depending on whether or not the implementer asserting its patent against the pledger is another pledger, the pledger may, at its option, terminate the nonassertion against you if:

(a) you are a member of the Commons and you (or someone acting in concert with you) assert an unpledged patent against that pledger’s infringing components where such components alone (or when included in a product or service) reduce/eliminates natural resource consumption, reduce/eliminate waste generation or pollution, or otherwise provide environmental benefit, or (b) you assert any patent against that pledger and you are not a Member of the Commons.

Got that?

We think you’ll like the Green Patent Blog and look forward to more good stuff.

Senate Reform Bill

It appears that the Senate has pulled the plug on the Patent Reform Act (S. 1145) after Senate Majority Leader Harry Reid pulled the bill from the floor schedule. This is not a huge surprise given the interests against it. (via ars technica)

A problematic area was a proposed change to the award of damages under the provision for Reasonable Royalty Damages. Currently, courts generally consider the value of the entire product when any part of it infringes a patent. The proposed changes would allow judges to base damages only on the “economic value properly attributable to patent’s specific contributions over the prior art.” Opponents of the legislation say it would make it easier for large companies to infringe the patents of small companies or individual inventors.

No indication when the bill will be re-started but expect it back after the new administration comes in.

See also: Coalition for Patent Fairness Thinks Patent Reform Is Near

Tafas v. Dudas

On the other end, the Patent Office is forging ahead with its attempt to force rule changes onto the public whether it has the authority or not (via Patently-O).  The USPTO has filed an appeal with the Court of Appeals for the Federal Circuit in the Tafas v. Dudas case reported earlier.

Dr. Triantafyllos Tafas filed suit against the proposed U.S. Patent Office continuation rules for being void for exceeding the PTO’s authority and won a permanent injunction prohibiting the USPTO from putting the new rules changes into effect.

The court held that, under the existing patent, system an applicant may file an unlimited number of continuation or continuation-in-part applications, RCEs, and claims. As far as continuation and continuation-in-part applications go, 35 USC 120 provides that there is no statutory basis for fixing an arbitrary limit to the number of continuing applications that may be filed and that retain the benefit of the priority date.

See also: No Joke, Court Smacks Down New Patent Rules

K&L Gates is hosting a free lunchtime webinar featuring John J. Doll, U.S. Commissioner for Patents.

U.S. patent law and practice is in its most dynamic period in recent memory. The landscape of patent laws and regulations is being modified by the Courts, Congress and the USPTO. Recent changes in case law, the Patent Reform Act of 2007, and proposed rules changes combine to make this a unique and challenging time for patent stakeholders.

Hear the U.S. Commissioner for Patents, John Doll, comment on current developments in patents, most especially those occurring at the U. S. Patent and Trademark Office, and participate in questions and answers.

Moderator: Stephen C. Glazier, K&L Gates, Washington, D.C. office

Registration is complimentary; however, virtual seating is limited, so please register as soon as possible here.

Webinar log-in instructions will be circulated via email prior to the program.

For further questions, e-mail Nancy Feldman or call 617.951.9257.

Tuesday, May 13, 2008, 12:00 – 1:00 p.m. (EDT)

Webinar Schedule:  Log-in opens: 11:45 a.m.  Program: 12:00 – 1:00 p.m.