Patent Baristas

In Pfizer v. Mylan Labs (02cv1628) a patent infringement action was brought by Pfizer under U.S. Pat. Nos. 4,572,909 and 4,879,303, which cover an amlodipine besylate product sold under the trade name Norvasc®.

Mylan filed an Abbreviated New Drug Application (“ANDA”) for approval to sell generic amlodipine besylate. Mylan certified pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4) (paragraph IV certification) that it was seeking approval to market its generic copy of Norvasc® prior to the expiration of the ’909 and ’303 patents. The application stated that to the best of Mylan’s knowledge neither the ’909 nor the ’303 patents would be infringed by the manufacture, use or sale of the proposed generic amlodipine besylate.

Pfizer sued Mylan for infringement of both patents and sought “[a]n order preliminarily enjoining and permanently enjoining [Mylan] from making, using, selling, offering to sell, or importing into the United States the Mylan Amlodipine Tablets described in ANDA No. 76-418 until after the expiration of the ‘909 patent term, . . ., and after the expiration of the ‘303 patent term . . .”

Mylan argued that Pfizer’s claims for inducing infringement and infringement of the ‘909 patent should be dismissed for lack of subject matter jurisdiction. According to Mylan, since the ‘909 patent expired on July 31, 2006, there is no longer a case or controversy with respect to the ‘909 patent. Pfizer responded that the district court retains jurisdiction over a patent infringement case when the patent has expired but the period of pediatric exclusivity remains at issue. Because the ‘909 patent expired on July 31, 2006, the court found that the rights secured by the patent are no longer protectable and entitlement to injunctive relief becomes moot because such relief is no longer available.

Pfizer had sought to continue to include the ‘909 patent in the litigation in an attempt to reinstate pediatric exclusivity as to Mylan. The FDA has confirmed that Mylan was the first generic company to file on all strengths of Norvasc(R) Tablets and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the pending litigation between Pfizer and Mylan.

In Ortho-McNeil Pharmaceutical v. Mylan Laboratories (04-cv-01689), Ortho (a subsidiary of Johnson & Johnson) claimed that its U.S. Pat. No. 4,513,006 was infringed by Mylan. The claims of the ’006 patent cover the drug topiramate, pharmaceutical compositions containing topiramate, and a method of using topiramate to treat convulsions. Ortho holds an approved New Drug Application (“NDA”), under Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 335(a), for topiramate tablets and topiramate capsules, which are marketed in the United States as the anticonvulsant Topomax®.

In 2001, Mylan filed an Abbreviated New Drug Application (“ANDA”), pursuant to Section 505(j) of the FFDCA, to market topiramate before the expiration of the ’006 patent claiming that the ’006 patent is invalid. Ortho then filed a motion for a preliminary injunction to enjoin Mylan from marketing or selling topiramate.

To get a preliminary injunction, a plaintiff must show: (1) a reasonable likelihood of success on the merits of its claims; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction’s favorable impact on the public interest. In order to demonstrate a likelihood of success on the merits on a particular claim of patent infringement, Plaintiffs must show that (1) Defendants likely infringe the patent, and (2) the claims of the patent will likely withstand Defendants’ challenges to validity. The court found that Ortho has demonstrated a likelihood of success in establishing that Mylan would infringe the ’006 patent and that the infringed claims of the ’006 patent will likely withstand Defendants’ challenges to validity.

In arguing that claim 1 of the ’006 patent (the only independent claim) is invalid as obvious, Mylan relies entirely on the expert opinion of Dr. Laurens Anderson. The court held that:

The approach espoused in Anderson 1 has significant problems that lead this Court to conclude that, in relying on it, Mylan has not raised a substantial question of obviousness. To begin with, as Ortho contends, Dr. Anderson has merely followed the path of development that Dr. Maryanoff claims to have followed. (See New Product Conception Record, Harth Conf. Decl. Ex. Q.) Dr. Anderson begins with the problem he believes Dr. Mayanoff was attempting to solve, follows the path he believes Dr. Maryanoff took, and ends up with topiramate. This is a hindsight-based obviousness analysis. The Federal Circuit has made clear that the inventor’s chosen path is irrelevant: “[T]he path that leads an inventor to the invention is expressly made irrelevant to patentability by statute. . . [T]his inquiry, as a matter of law, is independent of the motivations that led the inventors to the claimed invention.” Life Techs., Inc. v. Clontech Lab., Inc., 224 F.3d 1320, 1325 (Fed. Cir. 2000). Rather, § 103 requires that the obviousness inquiry must be performed from the perspective of one of ordinary skill in the art. 35 U.S.C. § 103(a).

…

Furthermore, applying the “motivation-suggestion-teaching” test, this Court finds significant gaps in the path Dr. Anderson follows: 1) Dr. Anderson implies that knowledge of Thomas “inspired” the idea of substituting a sulfamate group for a phosphate group. (Anderson 1 at 12.) This leaves unexplained, however, how knowledge that replacing a part of 5′-AMP with a sulfamate group produces an antibiotic would motivate the idea of sulfamoylation of a fructose derivative to produce a FBPase inhibitor. Furthermore, Dr. Danishefsky contends that the research on 5′-AMP and nucleocidin should not be considered to be part of the analogous prior art. (Danishefsky Decl. 19.) Even if it were shown to be relevant prior art, Dr. Anderson does not explain how knowledge of modifications to produce antibiotic potency would motivate modifications to produce gluconeogenic enzyme inhibition. 2) Dr. Anderson states that Dr. Maryanoff selected the “well-known” 2,3:4,5-di-isopropylidene fructose (“DPF”). (Anderson 1 at 17.) Dr. Anderson gives no explanation of what would have suggested DPF to one of ordinary skill in the art. Dr. Anderson states that Dr. Maryanoff “suggested that the desired inhibitory properties might be present in fructose derivatives . . .” (Id. at 12.) Dr. Anderson’s statement that it was Dr. Maryanoff himself, and not something in the prior art, that suggested researching fructose derivatives for enzyme inhibitors raises the inference that Dr. Anderson’s ideas in this regard may have been original and inventive. Certainly, Dr. Anderson has not pointed to anything that would have suggested the use of fructose derivatives to Dr. Maryanoff. This is a crucial gap in the theory, since Dr. Anderson proposes that by choosing a particular fructose derivative (DPF), and then choosing to sulfamoylate it, one ends up with topiramate. There is no basis to infer that one of ordinary skill in the art would have been motivated to select DPF to sulfamoylate.

Ortho argued that the claimed invention would not have been obvious based on four categories of objective evidence of non-obviousness: (1) Unexpected results; (2) Commercial success – Topamax® is the top-selling branded neurology product in the US.; (3) Copying – FDA has received nine ANDA applications for topiramate formulations; and (4) Industry recognition.

Overall, the Court found that all four factors in the preliminary injunction analysis weigh in favor of granting Ortho’s motion for a preliminary injunction.

Earlier, Eli Lilly and Company lost a jury trial in the U.S. District Court of Massachusetts in the case of Ariad Pharmaceuticals et al. v. Eli Lilly and Company. The jury awarded the plaintiffs approximately $65 million in back royalties and a 2.3 percent royalty on future U.S. sales of Evista and Xigris until the patent’s expiration in 2019.

The Jury decided that U.S. Pat. No. 6,410,516, owned by Harvard, the Massachusetts Institute of Technology, and the Whitehead Institute and licensed to Ariad Pharmaceuticals, was valid and infringed by Lilly’s sale of Evista® and Xigris®.

The ‘516 patent claims methods based on the discovery of a naturally-occurring biological pathway, the NF-kappaB pathway. While Ariad contends that the patent covers all means for modulating the NF-kappaB 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.

We don’t think Ariad will be spending that $65 million any time soon. This decision goes against long-standing patent practice in that one cannot get a patent that would remove known materials from the public. In addition, it has always been the case that one may patent a drug without knowing how it works.

This case begs the question of if a researcher discovers a drug without ever knowing the drug acts on a patented pathway or before the pathway is understood, does that constitute infringement? If the drug was acting on the pathway before the pathway was discovered, does the existence of the drug invalidate the patent on the pathway by rendering it not “new“? This could also give rise to an ever-increasing number of conflicting patents.

A separate bench trial with the U.S. District Court of Massachusetts was held in August based on Lilly’s contention that the patent is unenforceable and will also consider the patent’s improper coverage of natural processes.

This bench trial addresses patent validity and enforceability issues different from those considered in the jury trial. Lilly contends that the asserted claims of U.S. Pat. No. 6,410,516 are invalid for including non-statutory subject matter, for being obtained through inequitable conduct, and are unforceable due to prosecution laches.

Lilly argues, and of course Ariad disputes, that the claims cover unpatentable naturally-occurring phenomena, that Ariad withheld critical documents from the patent examiner not only to get the patent issued, but to avoid the risk of losing 13 years of patent term.

Of these, the patent term argument is probably the most compelling. In any case, particularly in light of the parallels with the Court of Appeals for the Federal Circuit decision in University of Rochester v. G. D. Searle et al., the likelihood that Ariad’s victory will survive the bench trial and the inevitable appeal(s) is quite low.

See the following court documents (these are large files so only download if you need them):

Pre-Trial Brief by Ariad Pharmaceutical.

Supplemental Pre-Trial Brief by Ariad Pharmaceutical.

Pre-Trial Brief by Eli Lilly & Co.

Motion to Supplement Trial Exhibit PTX 2 in Order to Complete the PTO Prosecution File of U.S. Patent No. 6,410,516 by Eli Lilly & Co.

Motion to Preclude a Claim Construction That is Barred by Judicial Estoppel by Eli Lilly & Co.

Opposition re Motion to Preclude a Claim Construction That is Barred by Judicial Estoppel filed by all plaintiffs.

Proposed Findings of Fact by all plaintiffs.

Response by Eli Lilly & Co. to Proposed Findings of Fact.

More on Ariad v. Lilly to come.

Blawg Review has the insane task of hosting both Carnival of the Capitalists and Blawg Review #80 today. Given the problems they had crashing their server after it choked on all the links, I think you should give them the honor of your presence by visiting this week’s Review.

Besides learning all about early marijuana laws, you can learn the Four Simple Steps to Becoming a Billionaire from Long or Short Capital:

1. Take outrageous risks with extremely high upside.

2. Be the 1 out of 500 million for whom it pans out. This one is key so focus on it.

3. Attribute your wealth creation to your own hard work, your own genius and the power of your business plan. Be sure to stress how your wealth was singularly made possibly by your unique endowment of elbow grease, street smarts, common sense, all of which your competitors obviously lacked (proven by how poor they are compared to you).

4. Buy a mega yacht and/or athletic team.

There is now a website that pays doctors to post medical observations, including reports on side effects and off label uses. Needless to say, this has raised some eyebrows. Sermo Inc. runs a website, sermo.com, as a password-protected private forum where raw postings by doctors can be viewed, for a fee, by Wall Street investment firms. I have to admit, a site where doctors are paid to post thoughts about drugs and side effects makes me a little squeamish. Even the tag line (“Who Else Knows?”) seems a little Orwellian.

Founder Daniel Palestrant says the site will serve as an early-warning system about potentially dangerous drug reactions. The site will also be a forum for doctors to share information about off-label uses of drugs. Off-label use of an approved drug refers to a use that is not included in the approved label. Off-label use does not imply an improper use. The practitioner who prescribes a drug is responsible for deciding which drug and dosing regimen the patient will receive and for what purposes. This decision is made on the basis of the information contained in the drug’s label or other data available to the prescriber. The off-label use of a drug should be based on sound scientific evidence, expert medical judgment, or published literature.

Admittedly, the FDA, which is charged with monitoring drug safety, can’t be on the front lines every day and has come under criticism for failing to respond to reports of drug side effects. Still, some may not feel comfortable about the ability of someone, even if that someone is a doctor, being able to make anonymous postings about perceived side effects.

Sermo pays doctors $30 to $50 to post observations and says it already has “several hundred” credentialed contributors. Once doctors are credentialed and accepted to the Sermo site, their medical observations are ranked for noteworthiness and credibility by other doctors, who also get paid for their observations. The site lists the amount paid to date as $132,145.00.

Public Citizen, a Washington nonprofit consumer advocacy group, said companies should not attempt to supplant the FDA’s watchdog role. The FDA already gathers specific side-effect information that doctors and companies submit in a government-mandated format. Sermo is an open bulletin board where doctors post about anything anonymously and seems to be designed to help investors more than patient.

Sermo charges subscription fees to its largest subscribers but doesn’t disclose the size of the fees. The company said big subscribers are Wall Street investment companies looking for preliminary information that might help them anticipate swings in a drug company’s stock.

An admitted key factor is how to separate the wheat from the chaff. Sermo uses a set of credibility-ranking systems where peers support (or not) any observations. It’s designed to prevent any exaggerated or inflated claims from spiraling out of control, there’s no way to really prevent any over-reactions from going nuclear.

Also, there doesn’t seem to be any mechanism to prevent stock fraud by pumping up (or sounding the alarm on) a certain drug and then trading ahead of the crowd. I don’t know how Sermo could prevent collusion among several doctors who agree to make a drug look particularly valuable or dangerous knowing that the information is being fed straight to big investing firms. And even if it all is legit, it still feels unnerving that Wall Street houses will get an early, inside look ahead of common investors.

The company closed on $3 million in capital from Longworth Venture Partners and looks to raise another $8 million to $10 million.

Conflicts of interest in the pharmaceuticals area have been in the news quite a bit lately. I don’t think that it indicates any new trend or that the world going to hell in a handbasket. I think if you want to know the root of the issue, you need look no further than the bottom line for drug sales. The global pharmaceutical market is forecast to grow to $842 billion in 2010. Just the top 16 new blockbuster drugs in 2005 generated combined sales of $18.1 billion. These eye popping numbers can put a lot pressure on the marketplace – some innocent, some not so innocent.

The Regulations

Federal doctors now say drug maker Eli Lilly & Co. subtly influenced the development of medical guidelines for treatment of sepsis (an often fatal blood infection). Guidelines are meant to reflect independent medical opinion but too much corporate influence could lead to corporations trying to guide health care in ways that benefit them directly.

Doctors at the National Institutes of Health claim in the New England Journal of Medicine that Lilly worked through medical societies to influence standards for treating sepsis where its drug, Xigris, was incorporated into the guidelines. The sepsis guidelines urge that very ill patients at risk of dying get the novel anti-clotting drug Xigris, the only medicine approved for the disease. A $6,800 treatment can help protect organs destroyed by the bacterial infection, once called blood poisoning. About 750,000 cases occur in the United States each year, and nearly one-third prove fatal. The U.S. Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee.

Lilly acknowledged hiring a marketing firm and paying doctors and ethicists to launch a campaign about choosing which patients to treat in the intensive care unit. But the company said its efforts were educational and had the goal of making sure only the appropriate patients were treated with Xigris. Experts disagree as to whether Lilly’s role was improper in this case since the money was given in an arms-length transaction and the doctors were free to reach their own conclusions.

The Regulators

But, money always has a way of finding its own conclusions. Ex-FDA Commissioner Lester Crawford pleaded guilty on Tuesday to two charges resulting from his ownership of stock in companies the agency regulated. Crawford, who resigned from the FDA last year, admitted to making false statements on financial disclosure forms and violating conflict-of-interest laws. Each count carries a maximum fine of $100,000 and up to one year in prison.

According to DOJ prosecutors, government ethics officials told Crawford in 2002 that he and his wife needed to sell shares in 12 companies that were regulated by FDA. The couple sold shares in nine of the companies — which included Johnson & Johnson, Merck, Boston Scientific, Pfizer, Medtronic and others — but kept shares in three companies: food and beverage maker PepsiCo; food distributor Sysco; and Kimberly-Clark, which makes some consumer health care products, DOJ said. In addition, Crawford’s wife held shares in Wal-Mart, which also is regulated by FDA, but Crawford did not include those holdings in his 2002 financial disclosure, DOJ said. Crawford also failed to disclose that he held options to buy 41,500 shares in Embrex, an FDA-regulated poultry biotechnology company on whose board he once served.

From August 2003 through June 2004, Crawford and his wife owned 1,400 shares of PepsiCo stock worth at least $62,000 and 2,500 shares of Sysco worth at least $78,000, according to court documents. It doesn’t help that that the Crawfords continued to hold the PepsiCo, Sysco and Kimberly-Clark shares despite being told by ethics officials at the Department of Health and Human Services (HHS) that they had to be sold. In 2004, an HHS ethics official inquired about Crawford’s ownership of Sysco and Kimberly-Clark stock. Crawford’s wife also retained shares in Wal-Mart Stores Inc., also regulated by the FDA, prosecutors said

The Regulated

According to a study of doctors published in the Journal of Medical Ethics, one in three doctors believe that their decisions on which drugs to prescribe have been affected by receiving drug samples from pharmaceutical sales representatives. Nearly all of the doctors, 94 percent, distributed samples to patients based on financial need. Sixty-three percent of the time they said effectiveness in treating patients was the reason. In 2003, the pharmaceutical industry spent $25.3 billion on drug promotion, including distributing $16 billion in free drug samples to doctors, the study said.

Noteworthy was that 92 percent of doctors felt that it was more acceptable to take drug samples than any other “incentive item,” such as a free lunch or a position as a paid consultant. Almost 60 percent of doctors distributed samples to “build a good relationship with the patient,” and almost 90 percent said they distributed the samples because they were available.

In recent months, several academic medical centers, including Yale University and the University of Pennsylvania, have barred drug-company sales reps from bringing free lunches to staff physicians. And on Sept. 12, Stanford University announced that its physicians will no longer be able to accept gifts of any size from any type of vendor, including biotech companies and medical-device makers.

With the expiry of patents for the blockbuster molecules looming large, the camps of big pharma giants are in disarray. The brain-storming strategies and policies pertaining to evergreening of these patents may be seen in the days to come.

Some of the big names in the game include the likes of Pfizer Inc., Merck & Co. Inc.’s, Bristol-Myers Squibb Co.’s and last but not the least AstraZeneca PLC’s.

These pharma giants own the drugs called as statins which lower the Low-Density-Lipoproteins (LDL) or bad cholesterol in the body. Statins are competitive inhibitors of HMG CoA reductase, the rate-limiting step in cholesterol biosynthesis. They occupy a portion of the binding site of HMG CoA, blocking access of this substrate to the active site on the enzyme. Currently available statins in the United States include lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin and rosuvastatin.

The global statin market in 2001 was valued at around $19bn led by Zocor and Lipitor. These two drugs generated total global sales of $12bn and accounted for approximately 70% of the global statin market. In 2002, AstraZeneca’s third generation statin, Crestor (rosuvastatin), received its first approval by the Medicines Evaluation Board (MEB) in the Netherlands. This approval initiated the arrival of the new “superstatins” into this maturing market. The withdrawal of Bayer’s Baycol (cerivastatin) has heightened awareness of the adverse effects of statins and has meant that considerable emphasis has been put on the safety concerns surrounding high doses of rosuvastatin and pitavastatin. Therefore, the lack of long-term safety data for third generation statins limits their uptake.

Patent expirations of three blockbuster statin drugs — Zocor, Pravachol and Lipitor between 2006 and 2015 will slash down more than half of the $27-billion (U.S.) annual market for lipid lowering drugs, of which 85 per cent was generated by statins, as a treatment to prevent cardiovascular disorders such as heart attacks and stroke. (By: British market research firm Datamonitor PLC)

Lipitor is one of them which need no introduction…thanks to Ranbaxy-Pfizer litigations worldwide with court decision(s) still pending around. Rest of the statins due to expire in the line are Merck & Co. Inc.’s Zocor and Bristol-Myers Squibb Co.’s Pravachol.

Innovative – Strategies of Innovators to keep generics at bay:

PLAN A) New Drug Development:

The most promising development is Pfizer’s CETP-inhibitor drug torcetrapib, which is being tested in combination with Lipitor, the world’s best-selling drug, with sales last year topping $12- billion. Torcetrapib works in the body by raising the levels of “good” cholesterol or HDL along with lowering of the LDL levels thereby arming the medical fraternity to deal with cardiovascular problems in a dualistic manner. But despite its promising efficacy, some analysts remain cautious because the Pfizer medicine can also raise blood pressure.

Pfizer’s plans to launch the new drug by 2009 as lipid lowering cocktail along with its winning horse Lipitor. Later it may sell torcetrapib on its own. But with generic Zocor around, it may eat away the profit margins of existing Lipitor as it is cheaper and an equally potent alternative in some cases.

Earlier this year, AstraZeneca claimed that its Crestor drug has the ability to reverse plaque buildup. Previous studies indicated that statins can only slow or halt plaque buildup.

Further it’s suspected that Merck has been testing its own CETP-inhibitor drug, even though the company has declined comment. AstraZeneca also paid $50-million to AtheroGenics Inc. last year to license its atherosclerosis drug candidate AGI-1067, which is now in late-stage clinical trials, with promises of another $950-million if the drug wins regulatory approval.

PLAN B) Over-the-counter (OTC) Switch:

It’s not long before AstraZeneca uses this weapon to fend off the generics with its money-spinner molecule omeprazole. The same can be speculated for the class of lucrative statins. Pharma experts are of the view that statins are a complex product because regular office visits are required to monitor cholesterol levels while being treated. Industry observers say that Merck’s Mevacor and Bristol-Myers Squibb’s Pravachol applications for OTC status were initially rejected because of these complexities. However with many blockbuster statin products approaching patent expiration, the industry will likely increase its OTC efforts.

State efforts for the OTC switch are driven by the growing statin market size. While the FDA previously refused to approve statins for OTC use, the administration has now signaled that it may be willing to reconsider its previous decision.

Future of statins:

It is estimated that around 10 million patients in the US are on statins, and recent federal guidelines estimate that as many as 30 million Americans may need to take a cholesterol- lowering agent to reduce the risk of heart attacks.

Today’s post comes from Gautam Bakshi, Manager – IPR, Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India (Gautam.Bakshi – at – intasbiopharma.co.in).

In Apotex v. Pfizer (Sup. Ct. 05-1006), the Supreme Court said that it will not hear a case brought by generic pharmaceutical company Apotex that was trying to have Pfizer’s Zoloft patent invalidated. Zoloft (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) used to treat depression.

Earlier, Pfizer sent Apotex an unconditional covenant not to sue Apotex with respect to U.S. Pat. No. 5,248,699. It also announced that Teva Pharmaceutical had begun marketing its generic version of Zoloft®, starting the 180-day exclusivity period that Apotex sought to trigger with a court judgment. Therefore, any future court judgment regarding the ’699 patent would no longer have any effect on the exclusivity period.

In its supplemental brief, Pfizer argued that the case is now moot and requested that Apotex withdraw its petition for a writ of certiorari. Apotex, however, said that it did not consider the case moot and that it would not withdraw the petition. The Court had asked the Solicitor General to offer the views of the U.S. on the merits of the declaratory judgment jurisdiction question.

While Pfizer unconditionally promised that Pfizer will not sue or otherwise enforce the ‘699 patent against Apotex in connection with the manufacture, sale, offer for sale, use, or importation of Apotex’s proposed generic sertraline hydrochloride drug product, that is the subject of ANDA No. 76-882, it did not constitute any kind of license so Apotex would still need to wait out the 180-day exclusivity period.

A generic company that is first to break a branded drug’s patent is awarded a 180-day period of exclusivity over other generics. But an authorized generic can compete in this period. Generic companies are mad about the Teva deal because it means they don’t get a 180-day period of market exclusivity. Teva inherited the rights to generic Zoloft through its acquisition of Ivax Corp. earlier this year.

Ivax received FDA approval in December 2004 to sell a generic version of Zoloft after the patent expires and 180 days of marketing exclusivity upon launch. However, the exclusivity period does not apply to authorized generics. By launching their own generic products, branded companies hope to hang on to a bigger portion of sales from the drugs they developed and discourage generic companies from making patent challenges.

Now, Pfizer’s covenant not to sue can leave the status of the patent unresolved and create uncertainty for a generic drug company, since the brand-name company could later sue for patent infringement once the generic firm begins manufacturing and selling the drug. This threat can prevent generic companies from proceeding in the first place.

In Teva v. Pfizer, the CAFC had held that the court does not have declaratory judgment jurisdiction over a case between an ANDA filer and the patent holder unless the patent holder at least threatens suit stating that a listing in the Orange Book listing alone does not create a reasonable apprehension of suit.

In the present case, Apotex faces the same issue and Apotex argued that the unsure situation should give the generic a right to pursue declaratory relief. The FTC has argued that this is anticompetitive under antitrust laws.

Patents Drive the Economy

A Special Report in the Toledo Blade newspaper points out that Ohio’s economy is closely tied to innovation. Manufacturing job loss doesn’t explain why the economy is lagging in certain states, like Ohio. A study by the Cleveland Federal Reserve Bank concluded that patents per-capita were the source of Ohio’s wealth. They cite a decrease in patents as the cause of the real cause of the state’s economic slump.

In looking at key statistics in several areas, including tax rates, government spending, education levels, and climate over 75 years, they found that tax levels and highway spending did not affect state income growth significantly. Also, a state’s concentration of industry, such as Ohio’s reliance on manufacturing, mattered only a little. What mattered most was a states’ patents per-capita. Ohio ranked sixth in the nation in per-capita patent generation in 1954. It fell to 11th in 1988. By 2001, Ohio fell to 20th, passed by new tech hubs such as Wisconsin, Utah, and Idaho. The reason given is that patents improve existing products and generate new ones that attract investors, profits and (ultimately) jobs.

What’s the World’s Fastest Supercomputer Used For?

Blawg Review Editor tipped us off about the newest $9 million supercomputer. RIKEN’s MDGrape-3 is the first machine to break the petaflop barrier — that’s 1 quadrillion calculations (floating-point operations, to be specific) per second — and it’s three times faster than the currently ranked fastest computer in the world, IBM’s BlueGene/L. MDGrape-3 isn’t officially the world’s fastest supercomputer – it can’t run the software that the official rankings demand. MDGrape-3 is designed for one thing, pharmaceutical research. More specifically, molecular dynamics simulation used in developing drugs. It can analyze tens of thousands of chemical compounds to find out how they’ll affect the protein-bonding structures in the human body. This is a good example of how biotech is driving computing. Experts believe that all the demand from biotech is going to boost our supercomputing power the same way the space race helped spur the development of the mainframe computers that were revolutionary for their time.

Biotech Deals Perk Up

The Boston Globe reported that after a quiet year for biotechnology, a sudden wave of mergers and buyouts has sparked interest in biotech. Gilead Sciences said it would buy drug developer Myogen Inc. of Colorado for $2.5 billion. Millennium Pharmaceuticals is in a half-billion-dollar bidding war against Genzyme over Canadian cancer-drug maker AnorMed Inc . And, Merck KGaA announced a $13 billion takeover of Serono SA , a Swiss biotech firm. The action is critical given that most biotechnology companies never turn a profit. Most new biotech companies depend on mergers and acquisitions to cash out.

About Biotech Guide Steps Down

After seven and a half years of running About Biotech, Yali Friedman, Ph.D. has decided to move on to concentrate on his full-time job with New Economy Strategies and to have more time to devote to his book, Building Biotechnology, and generally enjoying life in Washington DC. We will miss Yali for all he’s done, including bringing us Building Biotech, Biotech Blog, BioEconomy, DrugPatentWatch, Think Biotech and even the Send a DNA-o-Gram where you can send your message encoded as DNA sequencing.