Patent Baristas

Gen-Probe Inc. announced today that the United States Court of Appeals for the Federal Circuit has affirmed the summary judgment in favor of Gen-Probe in the patent infringement lawsuit initiated by Enzo Biochem, Inc. The summary judgment was granted in July of 2004 by the U.S. District Court for the Southern District of New York. The District Court ruled that the patent on which Enzo’s lawsuit is based is invalid and dismissed Enzo’s infringement claims against Gen-Probe and its co-defendant, Becton Dickinson. Enzo filed the infringement lawsuit in June 1999. Enzo alleged that Gen-Probe and Becton Dickinson willfully infringed U.S. Pat. No. 4,900,659 through the manufacture and sale of products for the diagnosis of gonorrhea.

Enzo is the assignee of the ’659 patent, which relates to nucleic acid probes that selectively hybridize to the bacteria that cause gonorrhea, namely, Neisseria gonorrhoeae, as well as methods for using those probes to detect the bacteria. The district court’s decision invalidated the ’659 patent for violating the on-sale bar. The trial judge specifically held that “there are no triable issues of fact,” and he granted defendants’ motion for summary judgment. The District Court judge made it clear that his rulings affected all six claims of the patent and held them invalid. Importantly, the trial judge concluded the hearing by asking the parties “if there is anything that I have missed in my rulings that I should rule upon.” Both counsel responded that the court had covered all the issues raised, and Enzo’s counsel indicated that it would appeal the decision. The judge then stated that he would “enter a summary order . . . that will enable you to proceed with dispatch in the Federal Court of Appeals on your rights if I have erred.” Enzo filed a Notice of Appeal and Gen-Probe then moved to dismiss the appeal, arguing that its remaining unadjudicated counterclaim of unenforceability for inequitable conduct rendered the district court’s judgment nonfinal.

Gen-Probe argued that there was no final judgment in this case because there was no adjudication of Gen-Probe’s unenforceability counterclaim, nor had Gen-Probe agreed to a dismissal without prejudice or without a finding of mootness. The district court also did not expressly find that the counterclaim was moot in light of its summary judgment of invalidity.

Gen-Probe did not bring the pending counterclaim to the district judge’s attention when asked whether any issues were outstanding and Enzo contends that the district court believed that the judgment was final, as evidenced by its statements during the summary judgment hearing and the unequivocal direction to the clerk of the court to enter an order closing the case. Second, Enzo asserts that Gen-Probe’s counterclaim for unenforceability is moot because all claims of the patent were held invalid. It argues that the allegations of inequitable conduct would be relevant only to a claim for attorney fees, which Enzo maintains does not render a judgment on the merits nonfinal for appellate review under Federal Rule of Civil Procedure 58(c). Enzo contends that Gen-Probe did not timely move for attorney fees, so it waived any such claim, and its unenforceability counterclaim is therefore moot. Gen-Probe responds that the district court’s belief that the judgment was final is irrelevant to whether jurisdiction is satisfied. It argues that the district court’s pronouncement that an order is final for purposes of appellate jurisdiction is not itself conclusive of finality, and it alleges that the district court had no occasion to address the counterclaim during the summary judgment hearing, which focused on invalidity.

Gen-Probe asserte that the responses by Gen-Probe’s counsel to the district court’s inquiry concerning whether all issues had been resolved did not unambiguously refer to the case as a whole, including the outstanding counterclaims. Gen-Probe asserted that its answer to the district court was in the more specific context of the summary judgment hearings; the affirmative statement by its counsel came at the end of a hearing on invalidity lasting several days and was not intended to waive its unenforceability counterclaim.

The Fed Circuit held:

We agree with Gen-Probe that its pending unenforceability counterclaim renders the district court’s judgment nonfinal for purposes of appeal. … Although it is true that the district court here did make a clear statement that the case was at an end, it was mistaken, because an unadjudicated counterclaim remained. Gen-Probe’s brief to this court, supported by the record, and unrefuted by Enzo, makes that clear. While it is, to say the least, regrettable that a party with a remaining counterclaim that it wishes to pursue, as well as its opponent, leaves a trial judge with the impression that no claims remain in the case, we have no choice but to take cognizance of the nonfinality created by the unquestioned existence of that counterclaim.

… although the district court may have indicated its intent that its order “will enable you to proceed with dispatch in the Federal Court of Appeals,” Summary Judgment Hearing at 35, it did not address at any time Gen-Probe’s unresolved counterclaim of unenforceability. At no time was the counterclaim waived, and, whether through inadvertence or not, the parties should not have let the trial court conclude its deliberations under that false impression. Because Gen-Probe’s counterclaim remains unadjudicated, the judgment is nonfinal.

We also disagree with Enzo that the only issue remaining is Gen-Probe’s claim for attorney fees. Enzo’s argument under Federal Rule of Civil Procedure 58(c) that a pending motion for attorney fees will not render an otherwise final judgment unappealable, is relevant only when all other claims have been adjudicated. More litigation lay ahead than awarding fees. To be eligible for attorney fees on the basis of inequitable conduct, Gen-Probe still has to establish that Enzo actually engaged in such conduct, an issue that remains unresolved in the district court. Despite the jurisdictional defect in the instant appeal, we have held that “a premature notice of appeal ripens upon subsequent action of the district court,” Pause, 401 F.3d at 1295 (citing E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1367 (Fed. Cir. 2003) and Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 830 (Fed. Cir. 2003)). Accordingly, inasmuch as the appeal has been briefed and argued on the merits, in the interest of judicial economy we grant Enzo leave to seek remedial action in the district court and thereafter reinstate the appeal if and when the judgment becomes final.

See the entire holding here.

In a preliminary ruling, the U.S. Patent and Trademark Office (USPTO) has issued a double-patenting rejection on a Genentech patent indicating that the patent, awarded in 2001, covered basically the same invention as an earlier Genentech patent that was set to expire next March. Genentech called the patent examiner’s action “a routine and expected next step in the reexamination procedure.” A final resolution could take months or years and the patent will remain enforceable in the meantime. The request to reexamine the patent was made in May by a Chicago lawyer but it’s not known which company or companies are represented.

The patent, known as the Cabilly patent after the lead inventor, Shmuel Cabilly, covers what Genentech calls “the ‘fundamental technology required for the artificial synthesis of antibody molecules,” which are the basis for many of the best-selling drugs produced by the biotechnology industry. Genentech gets an estimated $300 million a year in royalties on sales of drugs like Enbrel from Amgen, Remicade from Johnson & Johnson and Synagis from MedImmune. The patent claims:

1. A process for producing an immunoglobulin molecule or an immunologically functional immunoglobulin fragment comprising at least the variable domains of the immunoglobulin heavy and light chains, in a single host cell, comprising the steps of:

(i) transforming said single host cell with a first DNA sequence encoding at least the variable domain of the immunoglobulin heavy chain and a second DNA sequence encoding at least the variable domain of the immunoglobulin light chain, and

(ii) independently expressing said first DNA sequence and said second DNA sequence so that said immunoglobulin heavy and light chains are produced as separate molecules in said transformed single host cell.

For background, on March 25, 1983, Celltech filed in the United Kingdom a patent application directed to methods of making recombinant antibodies and antibody fragments, together with vectors and host cells useful in these processes. Celltech filed a related patent application in the United States, which issued as U.S. Patent No. 4,816,397 (“the Boss Patent”). On April 8, 1983, about two weeks after Celltech’s original U.K. filing, Genentech filed a United States patent application directed to similar technology, which issued as U.S. Patent No. 4,816,567 (“the Cabilly Patent”). The Boss Patent and the Cabilly Patent issued on the same day, and both were scheduled to expire on March 28, 2006.

After Celltech’s Boss Patent issued, Genentech copied the Boss Patent claims into a previously-filed Cabilly Patent continuation application. As a result, the United States Patent and Trademark Office declared an interference between Celltech’s issued Boss Patent and Genentech’s Cabilly Patent continuation application to determine who was the first to invent, and therefore which company would be entitled to a patent on, the claimed invention. Seven years after the Genentech-Celltech interference began, the Patent Office determined that Celltech’s inventors, and thus Celltech, were entitled to the patent. Why it took so long isn’t clear – it seems that neither party had sufficient incentive to expedite the process.

Genentech appealed the Patent Office decision by filing a civil action in the United States Federal District Court for the Northern District of California. Following two years of discovery, i.e., more than nine years into the dispute, the District Court denied Genentech’s motions that it was entitled to a patent on the disputed technology. In briefing those motions Genentech and Celltech each argued that the other was not entitled to a patent. Shortly after the District Court ruled on those motions, Genentech and Celltech settled their dispute by entering into an agreement which resulted in the District Court’s issuing an order directing the Patent Office (i) “to vacate the decision in [the prior interference proceeding], (ii) “to revoke and vacate [the Boss Patent],” and (iii) “to grant and issue to Genentech’s inventors … a United States patent [with the same claims as the Boss Patent].”

The USPTO ultimately revoked the Boss Patent and issued a new United States patent, U.S. Patent No. 6,331,415 to Genentech (“the New Cabilly Patent”). All the claims originally issued in the revoked Boss Patent subsequently issued in the New Cabilly Patent. As a result, while the disputed invention was originally scheduled to pass into the public domain in 2006 upon expiration of the Boss Patent, it is now owned exclusively by Genentech until 2018, which is when the New Cabilly Patent is scheduled to expire.

MedImmune is now claiming that Genentech and Celltech conspired improperly to secure for themselves, through 2018, a dominant and exclusive position in the recombinant antibody field. But, it’s too early to try to predict the outcome so it is not clear yet if companies developing recombinant antibody-based products will become free and clear of the Boss Patent and the Cabilly Patent in 2006.

Wherever you look these days, the biotech industry wants more incentives to lure startup companies to this or that state. Ohio, Michigan, Florida, Maryland, California, Wisconsin, Missouri. It seems it would be much easier to just ask which one or two states is not using one type of incentive package or another to get their piece of the elusive high-tech pie.

Now, Floridians for Stem Cell Research and Cures, embryonic stem-cell research advocates in Florida, have drafted a ballot initiative that would put $200 million toward the science over the next 10 years. The measure would mandate that “the Department of Health shall make grants for embryonic stem-cell research using, or using the derivatives of, human embryos that, before or after formation, have been donated to medicine under donor instructions forbidding intrauterine embryo transfer.”

Other states, e.g., New Jersey and Illinois, have allocated money for stem-cell research, but Proposition 71 in California is the only successful effort to amend a state constitution to allow and fund embryonic stem-cell research. Wisconsin is in the game and who wouldn’t want a piece of the Scripps Florida deal where Florida will pay Scripps $310 million to run the center and Palm Beach County is financing the land and construction costs, which already total more than $200 million.

This is not a U.S. phenomenon, of course, as we move to a global economy. In France, venture capitalists have written to Dominique de Villepin, French prime minister, calling on his government to grant tax breaks for investments in small high-tech companies in this year’s finance bill. Their proposals would offer tax breaks to investors buying shares in companies with fewer than 2,000 employees, at least 10 per cent of spending going on research and development, and revenues of less than $184m. Just 10% on R&D? Only 2,000 employees? Wow, that’s not exactly the definition of a struggling, cash-strapped start-up trying to bootstrap itself up from zero.

The idea of tax breaks for high-tech investments is supported by several ministers since the French government is worried about falling behind the US, UK, and Germany. In their letter, 14 specialist high-tech funds wrote that “[T]he stock market does not work in France for these innovative SMEs, great capital consumers and future world leaders.” They don’t explain why the rules need to be different for VC-backed companies.

They only give the example of biotechnology, where France initially had an early lead in Europe, but now has only four listed companies, versus 15 in Germany, more than 50 in the UK and 350 in the US. I find it hard to believe that tax breaks would suddenly rocket France to the top of the biotech ladder.

This also seems questionable given all the reports lately that tax subsidies don’t really deliver all that they promise. In “The Great American Jobs Scam,” Greg LeRoy, details what he sees as a system that enables corporations to extract huge taxpayer subsidies by promising quality jobs – and then lets them fail to deliver. The other benefit often promised – higher tax revenues – often proves false or exaggerated as well. One study of 80 companies that had received “retention” subsidies from New York City found that at least 39 had later announced major layoffs, or they had entered into large-scale mergers or put themselves up for sale – events that usually trigger mass layoffs. A detailed analysis of 10 subsidized companies found they had a total loss of more than 3,000 jobs.

LeRoy claims that schemes like this cost taxpayers an estimated $50 billion a year in total spending by states and cities. The bulk of this comes from the tax breaks granted by states – income, sales, and excise taxes – the least visible, least accountable, and most corrosive means by which states fund job creation. Those granted locally – in particular, property tax abatements and diversions – are especially harmful to schools.

This would all be well and good except that, in general, these have failed to create or retain as many jobs as they said they would. Companies often have laid people off since they got the subsidies while other companies that have gotten paid just to move existing jobs from one place to another, where they are proclaimed to be “new jobs.”

What started as a strategy for economically depressed regions to develop has turned into a national epidemic of job blackmail. Subsidy packages routinely exceed $100,000 per job. And guess who’s getting stuck with the tab. One construction executive admitted during a lawsuit deposition:

“I hate to give the example, but we decided very early in the game we were going to locate somewhere in the Winston-Salem/Greensboro area and narrowed it down to Kernersville rather rapidly; but spent a lot of time in Siler City and Asheboro and other communities hearing their story, primarily to use as a leverage to get all we could out of Winston-Salem. Now I give you that as a local example. But a more recent one – in Dickson, Tennessee, we had about ten west Tennessee municipalities chasing us with all kinds of offers; although we knew through the whole process it was going to be Dickson. And it was unfair and probably, as bad as it sounds, we used the others to get what we could out of where we were going in the first place. . . . you know, I’ve been around it a long time; but to me it’s the process. Usually, you know early where you are going, and you use your leverage.”

Maybe we need political leaders to call a cease-fire in the incentive wars and work together, knowing that companies locate in areas that are desirable to employees. Money might be better spent on education and training initiatives, universities, transportation infrastructure, and public policies supporting technological innovation. We need the kinds of investments that will drive our economy, improve our quality of life and raise incomes for all in the next century.

The Baristas need to look into getting some tax breaks by threatening to move off-shore. The state needs us.

Read more in Greg Le Roy’s new book: The Great American Job Scam: Corporate Tax Dodging and the Myth of Job Creation.

Dr. Bernard Fabre-Teste, a World Health Organization adviser, said the lack of low-cost AIDS drugs was “a key problem” for many developing countries and that countries facing severe HIV and AIDS epidemics should consider using domestic or international trade rules to circumvent patent laws on anti-retroviral drug therapies. Basically, he is referring to a World Trade Organization agreement reached in 2003 that allows countries facing a public health emergency to issue “compulsory licenses” to manufacture generic versions of patented drugs. It also allows those countries to export generic drugs to other countries that have no domestic pharmaceuticals industry.

Although no country has yet to use the WTO provision, earlier this year the Brazilian government threatened to use the WTO provision to break the patent on the AIDS drug Kaletra unless Abbott Laboratories significantly reduced the price of the medication. Kaletra, also known as Lopinavir/Ritonavir, is a protease inhibitor and is expected to bring in $1 billion in sales this year.

In July, Brazil’s health ministry and Abbott said they had reached an agreement for Abbott to keep the government’s annual expenses on Kaletra at current levels for the next six years and that Brazil would not break Abbott’s patent to produce a generic equivalent of the drug. However, less than a week after the agreement was announced, incoming Brazilian Health Minister Jose Saraiva Felipe dismissed the agreement and said the country would continue to negotiate for a lower price and now Abbott says it submitted a revised pricing proposal last week. Officials from Argentina, Brazil and nine other Latin American countries earlier this month reached an agreement with 26 pharmaceutical companies to secure discounts of as much as 66% on antiretroviral drugs. The other countries participating in the agreement include Chile, Bolivia, Ecuador, Peru, Venezuela, Colombia, Mexico, Paraguay and Uruguay. Abbott, GlaxoSmithKline, Merck, Bristol-Myers Squibb, Roche and Bayer were among the companies involved in the agreement, and discounts range from 15% to 66%, depending on the medicine.

Abbott feels that Brazil, with the world’s ninth-largest economy, can afford the “fair price” Abbott is demanding. And it argues that without strong profits from Kaletra and other successful drugs, Abbott would be unable to fund the research that produces such breakthroughs. But Brazilian says Kaletra itself eats up a third of the country’s AIDS spending. Anti-HIV medicines account for a quarter of the Health Ministry’s budget.

Fabre-Teste also said governments should consider taking unilateral steps to allow generic AIDS drugs to be imported from countries that produce them. In 2004, the Malaysian government enacted a law allowing it to import generic versions of AIDS drugs for “noncommercial” or non-profit distribution. Since then, the price of delivering AIDS drugs has dropped by 90 percent and the number of patients receiving treatment increased from 1,500 in 2003 to 3,000 in 2004.

Also, Saraiva Felipe has signed a memorandum of understanding with the Clinton Foundation that will allow the country to obtain generic antiretroviral drugs at lower prices. Under the agreement, the foundation will provide technical support to help the Brazilian government obtain the raw materials necessary to produce generic antiretrovirals. The agreement also will help Brazil purchase diagnostic tests and monitor the spread of HIV.

Finally, Argentina and Brazil have pledged to join forces in producing generic AIDS drugs to cut costs and expand care for people infected with HIV. The nations will begin by sharing information and technology and by bringing experts together. Left unsaid is whether the two countries plan to break international patents.

As we’ve discussed before, nothing in life is free. Drug companies won’t develop drugs unless they can charge for the drugs. This isn’t about a greedy drug company withholding life-saving drugs from the public. They’re available. This is a case of greedy governments not wanting to pay the cost of healthcare for their own citizens. And who wouldn’t want to pay less for any item? I’d like a big discount on every patented item I purchase.

I’m all for furthering discussions on how to share the burden of medical care costs but saying that the burden should fall solely on the patent holder is short-sighted and unfair. Perhaps countries with greater wealth should share more of the burden but breaking patents is not the route to go on this. Let’s get this discussion on the right track.

Like me, I’m sure you are overwhelmed with too many email messages. In a large law firm, we get urgent, breaking-news kind of emails daily like “Does anyone know a good lawyer experienced in riparian rights in Punxsutawney, Pennsylvania?” or “Does anyone have the Pensky file in their office?” So, I’m use to deleting lots of messages that I wish I had never received and always look for good email usage tips to pass along.

Now, from 43Folders, Merlin Mann’s blog about personal productivity, I found some added tips on writing sensible email messages that I’ll try to incorporate into my own writing.

Merlin writes, first: Understand why you’re writing. Before you type anything into a new message, have explicit answers for two questions:

If you can’t succinctly state these answers, you might want to hold off on sending your message until you can. One commenter says you have to write like your recipient has a severe attention-deficit disorder.

Second, write a great Subject line. You can make it even easier for your recipient to immediately understand why you’ve sent them an email and to quickly determine what kind of response or action it requires. Merlin recommends that you avoid “Hi,” “One more thing…,” or “FYI,” in favor of typing a short summary of the most important points in the message:

In fact, consider using just the subject line to relate your message and identify it as such by adding (EOM)—for end of message—at the end of the Subject line. This lets recipients see that the whole message is right there in the subject without clicking to the view the (non-existent) body.

Acronyms that may be useful shorthand in subjects:

1. EOM End Of Message;
2. RR Response required;
3. AR Action Required;
4. ATTACH Contains attachment;
5. PERS Personal;
6. CONT Continued;
7. 411 For Information Only;
8. MSR Monthly Status Report;
9. MEET Meeting; and
10. MINUTES Message contains minutes of meeting.

Finally, make use of the different fields for TO|CC|BCC. Those in the TO field are required to do something (Action) and those in the CC field should NOT do anything (if needed, under separate cover). For an FYI, as no reply is required, all can go in the cc: field. And to avoid reply-to-all brawls, put all recipients in the BCC field.

Update on Our Earlier Story:

France’s State Council, the highest court for administrative affairs, has found that the government’s plan to protect companies in strategic sectors from foreign takeovers may not comply with EU law. According to the council, EU member states may not limit the free circulation of capital among the union unless a deal would disturb public order or security, meaning the government would not be able to protect all the 10 sectors it has identified as strategic. Furthermore, in sectors where the government could prove a risk to security, France could not limit a takeover from another EU member. It could only protect the company from takeover attempts coming from outside Europe.

It remains to be seen if yogurt proves to be a high security risk to France.

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[from 09-14-05]

In a soon-to-be-published decree, raised by ministers after rumors of a PepsiCo Inc. bid for French food company Danone SA, the French government will gain a veto over takeovers in 10 industries deemed “sensitive to national security.”

Sectors on the list include some that most countries retain control, such as arms manufacturing and encryption but it also covers companies with activities in biotechnology, data security, casinos and antidote production — fueling concern that it could lead to a broader kind of protectionism. French Prime Minister Dominique de Villepin, in fact, coined the term “economic patriotism” for the reason for these moves and asked that pension funds, banks, and insurers direct their investments toward his list of “strategic” industries.

EU Internal Market Commissioner Charlie McCreevy told an economic forum in Italy he would “vigorously pursue” breaches of EU law resulting from attempts to thwart foreign takeovers. France’s conservative government, however, is getting criticism even at home as French companies warned the government away from protectionist temptations, likening some of the recent rhetoric to the massive concrete border fortifications that failed to stop Germany’s World War II invasion.

The Finance Ministry said the decree will merely bring ”more precision” to the current law — which allows the state to block investments in any companies deemed sensitive to “public order, public safety or national defense interests.” Yes, we wouldn’t want yogurt falling into the wrong hands.

According to a government official, the draft legislation is not yet finalized and the veto would not apply to bids for entire pharmaceutical companies, for example, but to divisions making antidotes useful against bioterrorist attacks. I’m not quite sure how that would work in real life since companies are not always so neatly organized in discreet packets.

Last year, the government cited Aventis’ “strategic” vaccine operations as it fended off a planned offer from Switzerland’s Novartis AG and instead steering Aventis into an all-French merger with Sanofi-Synthelabo, forming Sanofi-Aventis SA. Novartis cited government intervention in its decision not to bid.

We’ll keep an eye on the progress on this initiative and our safety from Lactobacillus bulgaricus and Streptococcus thermophilus cultures everywhere. More available here.

The USPTO has issued a set of final rules to implement the Cooperative Research and Technology Enhancement Act of 2004 (CREATE Act) that amended Section 103(c) of the Patent Act effective September 14, 2005. As we described in an earlier post, the purpose of the Act is to promote cooperative research, such as between a university and start-up company by excluding prior art from obviousness (103) consideration if the prior art arose from a joint research agreement.

The newly implemented rules do not require a statement of the field of the claimed invention or a statement of the date of execution of the agreement. A processing fee of $130 will be required and the applicant must provide a “statement of compliance.”

The CREATE Act amends 35 U.S.C. 103(c) to provide that subject matter developed by another person shall be treated as owned by the same person or subject to an obligation of assignment to the same person for purposes of determining obviousness if three conditions are met: (1) The claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and (3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. See Pub. L. 108–453, 118 Stat. 3596 (2004). Section 2 of the CREATE Act specifically amended 35 U.S.C. 103(c) to provide that:

(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.

(2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if—

(A) The claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;

(B) The claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(C) The application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

(3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

Section 3 of the CREATE Act provides that its amendments shall apply to any patent (including any reissue patent) granted on or after December 10, 2004.

The CREATE Act provides that its amendments shall not affect any final decision of a court or the Office rendered before December 10, 2004, and shall not affect the right of any party in any action pending before the Office or a court on December 10, 2004, to have that party’s rights determined on the basis of the provisions of title 35, United States Code, in effect on December 9, 2004. Since the CREATE Act also includes the amendment to 35 U.S.C. 103(c) made by § 4807 of the American Inventors Protection Act of 1999 (see Pub. L. 106–113, 113 Stat. 1501, 1501A– 591 (1999)), the change of “subsection (f) or (g)” to “one or more of subsections (e), (f), or (g)” in 35 U.S.C. 103(c) is now also applicable to applications filed prior to November 29, 1999, which were pending on December 10, 2004. 35 U.S.C. 103(c) as amended by the CREATE Act continues to apply only to subject matter which qualifies as prior art under 35 U.S.C. 102(e), (f) or (g), and which is being relied upon in a rejection under 35 U.S.C. 103. If the rejection is anticipation under 35 U.S.C. 102(e), (f), or (g), 35 U.S.C. 103(c) cannot be relied upon to disqualify the subject matter in order to overcome the anticipation rejection. Because the CREATE Act applies only to patents granted on or after December 10, 2004, the recapture doctrine may prevent the presentation of claims in reissue applications that had been amended or cancelled (e.g., to avoid a rejection under 35 U.S.C. 103(a) based upon subject matter that may now be disqualified under the CREATE Act) during the prosecution of the application which resulted in the patent for which reissue is sought. See H.R. Rep. No. 108–425, at 6–7 (2003). The Office published an interim rule to revise the rules of practice in title 37 of the Code of Federal Regulations (CFR) to implement the CREATE Act. See Changes to Implement the Cooperative Research and Technology Enhancement Act of 2004, 70 FR 1818 (Jan. 11, 2005), 1291 Off. Gaz. Pat. Office 58 (Feb. 8, 2005) (interim rule). This final rule further revises the rules of practice in title 37, CFR, to implement the CREATE Act.

The final rule is here.

I was going to write a Friday rant on Britney Spears’ new baby — the one she had with some guy I’ve never heard of — but then I realized how much I didn’t care. I decided instead to write about Renee Zellweger’s marriage — the one she had with some guy I’ve never heard of.

Zellweger has filed for an annulment from her husband after just four months of marriage. In court papers filed Wednesday in Los Angeles County Superior Court, the listed “fraud” as the reason for the breakup with the country music star. Fraud? Really? Like, he pretended they were just going to get fishin’ licenses and “Oops” they got married?

Zellweger tried to clear this up saying the term was “simply legal language and not a refection of Kenny’s character.” But, isn’t that in itself fraud? Fraud generally involves one party misrepresenting some material fact to the other party, and that other party having relied on that misrepresentation as a basis for the marriage.

Usually, to file an action based on fraud, you must have immediately separated from your spouse as soon as you learned of the fraud. This is true for lack of consent circumstances as well. You cannot cohabitate after discovery of the fraud. The longer the marriage continued from the time consent was possible or fraud was discovered, the less likely the court will be to grant your request.

The realm of possibilities that one can imagine here is just too much to resist. He wasn’t of age? He was already married and has eight kids in a housetrailer in Oklahoma? What is it? We can’t wait to find out. We only wish we could be more charitable, like Ms. Zellweger, who’s already demanded that the court rule out the possibility of financial support.