The U.S. Court of Appeals for the Federal Circuit gave a high-five to settlement agreements between a patent holder and a generic manufacturer saying it doesn’t violate antitrust laws under the Hatch-Waxman Act.  In re Ciprofloxacin Hydrochloride Antitrust Litigation (08-1097).

The agreements in question involved a reverse payment from the Bayer to Barr, but did not involve the 180-day exclusivity period.  This is not small change as the payments from Bayer to Barr totaled $398.1 million, which Barr shared with HMR.

The District Court granted Bayer’s motion for summary judgment, holding that any anti-competitive effects caused by the settlement agreements between Bayer and the generic defendants were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.

Note that the Agreements were entered into before the 2003 amendments to the Hatch-Waxman Act, requiring a patent holder and a first Paragraph IV ANDA filer who settle their patent litigation to file their agreement with the Federal Trade Commission and Department of Justice for review, and if the agreement is found to violate the antitrust laws, the first ANDA filer loses its right to the 180-day exclusivity period.

Bayer’s patent relates to quinoline- and napthyridine-carboxylic acid compounds with antibacterial properties and methods of administering the compounds to combat bacterial illnesses.  (U.S. Pat. No. 4,670,444).  Specifically, it covers ciprofloxacin hydrochloride, the active ingredient in Cipro®.  The patent expired on December 9, 2003 but the FDA granted Bayer an additional six months of pediatric exclusivity.

Barr filed an abbreviated new drug application (ANDA) for a generic version of Cipro including a Paragraph IV certification on the grounds that the patent was invalid and unenforceable based on obviousness under 35 U.S.C. § 103 and obviousness type double patenting under 35 U.S.C. § 101, and unenforceable due to inequitable conduct.

Under the Hatch-Waxman Act, the first filer of a Paragraph IV ANDA is automatically entitled to a 180-day period of market exclusivity, which, in the version of the Act in effect at the time, begins to run either on the date that the first ANDA filer begins to market its drug or on the date of a final court decision finding the patent to be invalid or not infringed, whichever is earlier.  Thus, as the first Paragraph IV ANDA filer, Barr was entitled to the 180-day exclusivity period.

After Bayer sued Barr for patent infringement, Bayer, Barr, HMR, and Rugby entered into agreements providing that Barr, HMR, Rugby, Apotex, and Bernard Sherman would not challenge the validity or enforceability of the ’444 patent, Barr agreed to convert its Paragraph IV ANDA to a Paragraph III ANDA, thus certifying that it would not market its generic version of Cipro until after the ’444 patent expired, and Bayer agreed to make a settlement payment to Barr of $49.1 million.

Indirect purchasers of Cipro and various advocacy groups appealed a summary judgment of federal antitrust claims and dismissal of their state antitrust claims against patent holders and brand-name manufacturers, Bayer AG and Bayer Corp. and the generic manufacturers, Barr Labs, Hoechst Marion Roussel, The Rugby Group, and Watson Pharmaceuticals.

They alleged that the district court erred in its determination that the Agreements did not constitute an unreasonable restraint of trade in violation of section 1 of the Sherman Act: (1) by not finding the Agreements to be per se unlawful, or at least applying a proper rule of reason analysis; (2) by finding the Agreements to be lawful because they fell within the “exclusionary zone” of the ’444 patent; (3) by not considering the law of the regional circuits and government agencies in evaluating the Agreements; (4) by failing to appreciate the effects of the Agreements on other generic manufacturers; and (5) by not considering evidence showing that the Agreements preserved Barr’s claim to the 180-day exclusivity period.

The Sherman Act provides that “[e]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several States, or with foreign nations, is declared to be illegal.”  15 U.S.C. § 1.  Although by its terms, the Act prohibits any “restraint of trade,” the Supreme Court “has long recognized that Congress intended to outlaw only unreasonable restraints.”  Only agreements that have a “predictable and pernicious anticompetitive effect, and . . . limited potential for procompetitive benefit” are deemed to be per se unlawful under the Sherman Act.

The Court of Appeals held that the district court correctly applied a rule of reason analysis, a three-step process: First, the plaintiff bears the initial burden of showing that the challenged action has had an actual adverse effect on competition as a whole in the relevant market.  Then, if the plaintiff succeeds, the burden shifts to the defendant to establish the pro-competitive redeeming virtues of the action.  Should the defendant carry this burden, the plaintiff must then show that the same pro-competitive effect could be achieved through an alternative means that is less restrictive of competition.  The Court agreed:

Contrary to the contentions of the appellants, the court did undertake a full rule of reason analysis.  It first determined that the relevant market is ciprofloxacin and that Bayer had market power within that market.  Cipro II, 363 F. Supp. 2d at 523.  It then determined that there was no evidence that the Agreements created a bottleneck on challenges to the ’444 patent or otherwise restrained competition outside the “exclusionary zone” of the patent.  Id. at 540.  Thus, the court concluded that the plaintiffs had failed to demonstrate that the Agreements had an anti-competitive effect on the market for ciprofloxacin beyond that permitted by the patent.

The appellants argued that Bayer is seeking not simply to enforce its patent rights, but to insulate itself from competition and avoid the risk that the patent is held invalid.
The Court of Appeals shot this down saying:

Pursuant to the Agreements, the generic defendants agreed not to market a generic version of Cipro until the ’444 patent expired and not to challenge the validity of the ’444 patent, and Bayer agreed to make payments and optionally supply Cipro for resale.  Thus, the essence of the Agreements was to exclude the defendants from profiting from the patented invention.  This is well within Bayer’s rights as the patentee.  Furthermore, there is a long-standing policy in the law in favor of settlements, and this policy extends to patent infringement litigation.

The Second Circuit, in In re Tamoxifen, similarly concluded that the validity of the patent need not be considered in the analysis of whether the settlement agreement violates the antitrust laws unless the infringement suit was objectively baseless …

We conclude that in cases such as this, wherein all anti-competitive effects of the settlement agreement are within the exclusionary power of the patent, the outcome is the same whether the court begins its analysis under antitrust law by applying a rule of reason approach to evaluate the anti-competitive effects, or under patent law by analyzing the right to exclude afforded by the patent.  The essence of the inquiry is whether the agreements restrict competition beyond the exclusionary zone of the patent.

[In] the absence of evidence of fraud before the PTO or sham litigation, the court need not consider the validity of the patent in the antitrust analysis of a settlement agreement involving a reverse payment.

Posted October 31st, 2008 by Stephen Albainy-Jenei in Antitrust, Generic drugs, IP Litigation
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The Court of Appeals for the Federal Circuit handed down the long awaited en banc decision on In re Bilski (07-1130) in which the court looked at the question of when does a claim that contains both mental and physical steps create patent-eligible subject matter and whether a method or process must result in a physical transformation of an article or be tied to a machine to be patent-eligible subject matter under section 101.

Here, the court looked at an abstract idea or mental process.  But, what about where a claim contains both mental and physical steps to create patentably eligible subject matter?  Must a method claim need to result in physical transformation of an article or be tied to machine under 101?

The court ruled that the patent application did not meet the standards for patentability stating “We hold that the applicants’ process as claimed does not transform any article to a different state or thing.”

Astonishingly, the court seems to be making its own new law of patentability setting out that a software or business method patent is valid only if it (a) is tied to a particular machine or apparatus, or (b) transforms a particular article into a different state or thing. (Diamond v. Chakrabarty)

Despite the fact that Congress had earlier noted that “anything” created by humans deserves patent protection, the Federal Circuit decided that software and business methods have a new, higher standard.  Now, software or business method patents that are neither tied to a specific machine nor change something into a different state are not patentable. It is possible that a certain number of software and business method patents could now be at risk.  More likely, most such patents will have some claims that do, in fact, include some type of apparatus or transformation.

To be fair, the Committee Reports accompanying the 1952 Act show that Congress intended statutory subject matter to “include anything under the sun that is made by man” but refer to such only in the context of the four specific categories of Section § 101:  process, machine, manufacture, or composition of matter.  Section § 101 has no limits. Laws of nature, physical phenomena, and abstract ideas have been held not patentable.

But software is not a law of nature.  Business methods do not spring forth without human intervention.  So why do they warrant special requirements?

To be fair, the present case was really decided on the basis of the algorithm in question having no uses other than those that would be covered by the claims (i.e., any conversion of BCD to pure binary on a digital computer).  Therefore, the claims pre-empted all uses of the algorithm and thus they were effectively drawn to the algorithm itself.

The court noted:

The question before us then is whether Applicants’ claim recites a fundamental principle and, if so, whether it would pre-empt substantially all uses of that fundamental principle if allowed.  Unfortunately, this inquiry is hardly straightforward.  How does one determine whether a given claim would pre-empt all uses of a fundamental principle?  Analogizing to the facts of Diehr or Benson is of limited usefulness because the more challenging process claims of the twenty-first century are seldom so clearly limited in scope as the highly specific, plainly corporeal industrial manufacturing process of Diehr; nor are they typically as broadly claimed or purely abstract and mathematical as the algorithm of Benson.

The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself.  A claimed process is surely patent-eligible under § 101 if:  (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

A claimed process involving a fundamental principle that uses a particular machine or apparatus would not pre-empt uses of the principle that do not also use the specified machine or apparatus in the manner claimed.  And a claimed process that transforms a particular article to a specified different state or thing by applying a fundamental principle would not pre-empt the use of the principle to transform any other article, to transform the same article but in a manner not covered by the claim, or to do anything other than transform the specified article.

The question before the court then became whether Applicants’ claim 1 satisfied the transformation branch of the machine-or-transformation test:

We hold that the Applicants’ process as claimed does not transform any article to a different state or thing.  Purported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances.  Applicants’ process at most incorporates only such ineligible transformations.  …  Thus, claim 1 does not involve the transformation of any physical object or substance, or an electronic signal representative of any physical object or substance.  Given its admitted failure to meet the machine implementation part of the test as well, the claim entirely fails the machine-or-transformation test and is not drawn to patent-eligible subject matter.

Not everyone agreed.  In the dissent by Judges Newman, Rader and Mayer, they argue that the court has imposed a new restriction on the kinds of inventions that are eligible to participate in the patent system:

The court achieves this result by redefining the word “process” in the patent statute, to exclude all processes that do not transform physical matter or that are not performed by machines.  The court thus excludes many of the kinds of inventions that apply today’s electronic and photonic technologies, as well as other processes that handle data and information in novel ways.  Such processes have long been patent eligible, and contribute to the vigor and variety of today’s Information Age.

This exclusion of process inventions is contrary to statute, contrary to precedent, and a negation of the constitutional mandate.  Its impact on the future, as well as on the thousands of patents already granted, is unknown.
This exclusion is imposed at the threshold, before it is determined whether the excluded process is new, non-obvious, enabled, described, particularly claimed, etc.; that is, before the new process is examined for patentability.  For example, we do not know whether the Bilski process would be found patentable under the statutory criteria, for they were never applied.

See the entire 132 page opinion here.

See also:  How Did We Get to Bilski and What Can We Do About It?

Posted October 30th, 2008 by Stephen Albainy-Jenei in Prosecution, IP Litigation
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According to biotechTransfer week, the IRS set to look over the financial statements of public and private colleges and universities for unrelated income sources like tech transfer.

The Internal Revenue Service is looking to gather information from hundreds of US colleges, universities, and affiliated organizations such as foundations and academic medical centers about their financial practices, including those related to technology licensing, investments, and corporate sponsorship, according to the agency.

Last week, the IRS’ Exempt Organizations Compliance Unit began sending compliance questionnaires to approximately 400 U.S. colleges and universities as part of the agency’s focused effort to study key areas in the tax-exempt community.  The EOCU addresses areas of noncompliance of exempt organization. 

The college and university questionnaire will focus on unrelated business income, endowments and executive compensation practices.  The questionnaires are being sent to a cross-section of small, mid-sized and large private and public four-year colleges and institutions.  Private nonprofit universities are generally exempt from tax under Internal Revenue Code section 501(c)(3) and, like state universities, are subject to unrelated business income tax.

Among other things, the questionnaire will gather information from the schools about how they report revenues and expenses from their trade or business activities, classify their activities as exempt or taxable activities, and calculate and report income or losses on taxable activities.  The questionnaire also will gather information regarding how the organization invests and uses its endowment funds and determines compensation of certain highly paid individuals.

The IRS said the voluntary questionnaire is part of an effort by the agency to better understand tax-exempt organizations and perhaps more intently scrutinize what it considers key areas in the tax-exempt community.  The questionnaire is not an audit and schools will not be penalized for refusing to participate.  But, the IRS reserves the right to open an investigation whether or not the universities participate.

In looking at technology-transfer, the questionnaire asks for information on the nature and amount of unrelated business income in categories such as other royalties, commercial research, patents, and copyrights and trade names or trade secrets.  These are potential sources of unrelated-business income and revenues and expenses from taxable trade or business activities must be reported on Form 990-T, Exempt Organization Business Income Tax Return.

The 33-page-long questionnaire is similar to one that it sent out in 2006 to approximately 600 hospitals, which may have given the EOCU a good insight on reviewing such activities.  The IRS said it expects to receive most of the responses within the next several months, analyze the results of the compliance questionnaire and conduct examinations of a sample of the organizations.  The IRS said it expects to issue a report on the project in 2009.

Let us know if you’ve received a questionnaire and whether or not you intend to reply.

See here for the Compliance Questionnaire - Colleges and Universities.

Posted October 27th, 2008 by Stephen Albainy-Jenei in Biotech, Technology Transfer
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John J. Doll, Commissioner for Patents, US Patent & Trademark Office, talked today at the BIO Intellectual Property Counsel Committee’s Fall Conference and Committee Meeting, a group with a very keen sense of the importance of patents.

He livened up the discussion in extolling that “We [the Patent Office] don’t have a standard so we’d allow every application if it meets the requirements.  Your [Applicants and Attorneys] job is to get all that the applicant is entitled to.”

This is certainly true.  The patent statutes state that “A person shall be entitled to a patent unless” the patent statutes preclude the grant (35 USC 102).  However, the Commissioner’s statements didn’t sit too well given that these came immediately after he described the plummeting allowance rate at the Patent Office.

In describing the Patent Offices Strategic Plan, Commissioner Doll explained the the two major points are to: (1) improve the quality of examination, and (2) improve the efficiency of system.  This is to be accomplished through the four basic principals of quality, timeliness, cost and effect.

In describing Quality, the Commissioner explained that in order to enhance patent quality, the USPTO implemented an improved Quality Assurance Program.  One important component of the improved program is expanding the quality review of work products, through a “second-pair-of-eyes” program in areas of identified need.  The Office of Patent Quality Assurance (OPQA) administers a program for reviewing the quality of the examination of patent applications. The general purpose of the program is to improve patent quality and increase the likelihood of patents being found to be valid.

The Quality Assurance Specialists re-examine a randomly selected sample of allowed applications to determine whether any claims may be unpatentable. Reviewed applications may be returned to the examining TCs for consideration of the reviewer’s question(s) as to adequacy of the search and/or patentability of a claim(s).

The Commissioner pointed out that the review is not just to find allowances of patents that should not be allowed but to look for rejections that shouldn’t have been made.  He did not present any statistics for how many of the latter type of error occurred.

However, in a session entitled “Constructive Ideas on Managing USPTO’s Workload,” the Commissioner showed that in 2008, the USPTO found a 3.7% allowance error rate, which is historically relatively low.  The target error rate for the USPTO is 4%.  So, technically, they’re under goal but they get to decide the target and they decide what constitutes an “error” or not.  With no independent review, is it any surprise that they hit their goal?

In the biotechnology examination group (TC 1600), the allowance error rate is higher at 4.2%.  Generally, the <quote> error <unquote> is that the Examiner gave the claims too narrow of an interpretation thereby allowing a claim that should have been rejected in light of the overlap with the prior art.

The most striking chart displayed by the Commissioner is one that showed the allowance rate for patents over the past twenty-three years.  After remaining fairly steady over decades, allowance rates have now plummeted from over 70% in 2000 to an allowance rate of 44.3 % in 2007.  Not surprising to anyone in the field, the allowance rate in TC 1600 was just 33.6% (click on the graph at left to see the data).

It is noteworthy that the Commissioner revealed that the number of original applications has remained rather constant.  The explosion in filed application numbers (441,637 applications in FY2007) comes from Request for Continued Examination (RCE) filings.  With RCE filings are up up 80% in FY2008, it’s no surprise that the backlog in filings is now over 800,000 applications.

This, despite the fact that — as we can see from the steep slope of the graph — we clearly haven’t hit the bottom of the allowance rate decrease.  Just how low will the allowance rate have to go before there is an uprising among applicants?

Graph of USPTO Patent Allowance Rate

Posted October 22nd, 2008 by Stephen Albainy-Jenei in Liveblogging, Conferences, Biotech
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In a session on Case Law Updates, a panel discussion at the the BIO Intellectual Property Counsel Committee’s Fall Conference and Committee Meeting brought up that there was previously a lot of attention on infringement but lately it has been off radar except for joint joint infringement.

Joint infringement comes up as a big issue in method claims and devices.  Medical device inventions often have critical method claim that involve a combination of steps by more than one of :

1. Device company;
2. Doctor; and/or
3. Patient.

It had generally not been necessary for the acts that constitute infringement to be performed by one person or entity. When infringement results from the participation and combined action(s) of more than one person or entity, they are all joint infringers and jointly liable for patent infringement.

The basic principal being that infringement of a patented process or method cannot be avoided by having another perform one step of the process or method. Where the infringement is the result of the participation and combined action(s) of one or more persons or entities, they are joint infringers and are jointly liable for the infringement.

In MuniAuction v. Thomson, a case involving a patent directed to electronic methods for conducting “original issuer auctions of financial instruments,” the case stands for the premise that where the difference in claims over the prior are was “do on the internet,” it is clear that merely doing something over internet instead of in reality, not a patentable distinction over land-based activities.

But, the case also showed that one needs one party to infringe or, if two parties, one party must control the other party.  The question that comes up is would technological control be enough?

It is a Vicarious liability standard where a mere arms length cooperation will not give rise to direct infringement.  The claim is directly infringed only if one party exercises “control or direction” over the entire process such that every step is attributable to the controlling party i.e., the evil mastermind standard.

The Federal Circuit stated thusly:

The control or direction standard is satisfied in situations where the law would traditionally hold the accused direct infringer vicariously liable for the acts committed by another party that are required to complete performance of a claimed method.

The law would traditionally hold the accused direct infringer vicariously liable for the acts committed by another party that are required to complete performance of a claimed method.  But, often incredibly difficult to prove direct infringement.  Now, need to show vicarious liability.

How avoid this result?  Try to get infringement of at least one claim without requiring multiple parties to come up with infringement.  One way is to try to have what amounts to a system claim.

In RIM v. NTP, NTP had system claims.  Since the Blackberry relay was all in Canada, the court said the method claims were not infringed for that reason.  But, NTP had system claims and the court looked at 35 USC 271, which states:

[W]hoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

So, although the system was out of US, the beneficial use of the system is within the US.

Therefore, while joint infringement can be established where one party performs some/most of the steps of a patented process and the other steps are performed at the first party’s direction, the recommendation now is to ensure you at the very least have a claim drafted in a manner that all of the steps of the claimed method can be performed by a single infringer.

Posted October 21st, 2008 by Stephen Albainy-Jenei in Liveblogging, Conferences, Biotech
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In a session on Case Law Updates at the the BIO Intellectual Property Counsel Committee’s Fall Conference and Committee Meeting, Chad Shear led a panel discussion with John Dragseth and Dr. John Garvish through a discussion of Bilski and how we got to Bilski.  The case, involved a patent application seeking exclusive rights to a method of using hedge contracts to reduce the risk that a commodity’s wholesale price might change.  In re Bilski raises the question of whether business methods and other inventions devoid of technology can be patented.

Section 101 of the Patent Act defines what types of inventions are patentable as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” The Supreme Court construed this section broadly, stating it includes “anything under the sun that is made by man” with three exceptions of “laws of nature, natural phenomena and abstract ideas.”

In State Street Bank v. Signature Financial Group, the Federal Circuit held that ideas about how to conduct business aren’t always unpatentably abstract. So, any business method that produces a “useful, concrete and tangible result” can be patented as a “process” under Section 101.

In re Nuijten

Our problems start back at In re Nuijten (en banc denied 2008), a case that looked at whether a transitory propagating signal is proper patentable subject matter.  Here, the court looked at patent claims to signals and ruled that signals are “just too transient” to be patentable subject matter  because it does not fit within any of the four statutory categories of process, machine, manufacture, or composition of matter.  This case is an example of the court parsing technological differences as a politician would, not as a scientist would.

In re Comisky

We continue on to In re Comisky where the courts looked at claims directed to a method and system for mandatory arbitration involving legal documents, such as wills or contracts.

The Court concluded that the independent method claims “claim the mental process of resolving legal disputes between two parties by the decision of a human arbitrator[,]” and are therefore, “directed to an abstract idea itself rather than a statutory category” and are unpatentable. However, two independent system claims in Comisky’s application did incorporate various modules and a database as part of the system and were found to contain patentable subject matter for purposes of section 101. The Court explained that “[w]hen an unpatentable mental process is combined with a machine, the combination may produce patentable subject matter[.]” 

As a result of this decision, applications involving mental processes will be required to combine a particular technology such as a computer with such mental processes for the subject matter to meet the statutory requirement of patentable subject matter.  

In re Bilski

Finally, we get to In re Bilski, in which the Federal Circuit looked en banc at when does a claim that contains both mental and physical steps create patent-eligible subject matter and whether a method or process must result in a physical transformation of an article or be tied to a machine to be patent-eligible subject matter under section 101.

Here, the court looked at an abstract idea or mental process.  But, what about where a claim contains both mental and physical steps to create patentably eligible subject matter?  Must a method claim need to result in physical transformation of an article or be tied to machine under 101?

For the biotech industry, to see the possible effects it’s important to also look back at LabCorp v. Metabolite for determining patentably eligible subject matter under section 101, which looked at whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to “correlat[e]” results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.

The application claimed a method for detecting a deficiency of cobalamin or folate by assaying homocysteine and correlating elevated level with a deficiency.  The Supreme Court declined to weigh in but we know that Justice Breyer wanted this decided and said that the Court should invalidate as “claim 13 is invalid no matter how narrowly one reasonably interprets” the claim.

The problem here is that anyone performing the test for other reasons can’t avoid infringing if do test and “think” about the correlation knowing it exists.

The panel wrapped up stating that the consequences of LabCorp and Bilski for the biotech business is the impact on:

• Mechanism of action claims
• Pro-drug claims
• Diagnostic tests
• Adverse effects or other clinical trial/regimen claims

Clearly, claims will need to rely on more than “mental steps” and claims should always be included that tie the steps to physical materials or transformation.

To see the courts movement on invalidating methods on natural phenomenon see the pending case of Classen Immunotherapies v. Biogen, awaiting an appellate decision. This case, a rseemingly do-over of the Metabolite case, involves patents involving a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules.

The district court held that the claims were invalid as an attempt to patent the idea of a correlation between vaccine schedules and immune mediated disorders (natural phenomenon).

Posted October 21st, 2008 by Stephen Albainy-Jenei in Liveblogging, Conferences, Biotech
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Editor-in-Chief Barista, Stephen Albainy-Jenei, will be live-blogging the BIO Intellectual Property Counsel Committee’s Fall Conference and Committee Meeting on Oct. 20-22, 2008, at the Hard Rock Hotel at Universal Orlando, Orlando, Florida.

The Conference should be an excellent opportunity for BIO members to hear, listen, and learn about current and projected topics related to biotechnology IP.  So, why not get a free gift?

Since we ended up having some iPod Shuffles left over from the BIO2008 International Convention, in San Diego, Calif., after running the Patent Baristas’ iBarista contest, I thought I’d give everyone a shot at picking up the last remaining iBarista iPod.

Basically, all you have to do to win is be the first person to find me at the Fall Conference and ask for the iBarista iPod. That’s it.  (Don’t forget to see all the iPod Giveaway Terms and Conditions here).

Otherwise, if you’d like to meet up during the conference, drop me a note and we’ll schedule some time to have coffee together.

Posted October 19th, 2008 by Stephen Albainy-Jenei in Light Roast, Conferences
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It’s a well-known fact that drug industries pursue patents with a zeal that few possess – after all, a patent in the hand is worth millions in the bank and a relative monopoly over the pharmaceutical market. They lobby for political support to push these patents through, even if they know that the drugs have not been tested thoroughly for their efficacy and safety.

This ardent rush and the intense lobbying done to be the first on the medical scene with a new, breakthrough wonder drug that turns out to be the goose that lays the company’s golden eggs is “simply unacceptable”, in the words of Thomas Pogge, Professor of Philosophy and International Affairs at Yale University. The academic, who spoke at length on the subject in his lecture titled, “Advanced Medicines: Must We Exclude the Global Poor?” at the Federation of European Pharmacological Societies (EPHAR) 2008 Congress hosted by the British Pharmacological Society at the University of Manchester and sponsored by AstraZeneca, said that the current patent system followed by the pharmaceutical industry and the tactics used by the industry to protect the system were not morally acceptable because they “violate the human rights of the poor by denying them access to vital medicines.”

In a humanitarian effort to bring down the mortality and morbidity rates found among the poor all over the world, the professor proposes an alternative licensing system which he has named the “Health Impact Fund” (HIF). The HIF seems to be more of an accessory than an alternative, with Prof. Pogge wanting governments across the globe to bankroll this initiative and offer the patent holder of any new medicine annual payments that are directly proportional to the global health impact of the medicine. In short, the more effective the drug is at alleviating the health problems of the world’s poor, the more lucrative it will be for the manufacturer.

While this is an altruistic model that also has the potential to be profitable for drug manufacturers, there’s just one major drawback – the assumption that drug companies are willing to even consider that there’s a moral aspect to their trade. All they seem to be looking for is instant and immense profits, and the larger their monopoly, the more the money they make before any side effects are found and a public outcry and subsequent pull-out ensue.

Prof. Pogge states that his model is bound to be both humanitarian and profitable for the drug companies, but the latter will not be willing to wait for the efficacy of their drug to be proved before they receive the windfall they think they deserve. Rather, they are all for pressurizing experts in the medical field to testify to the wonders that their drug can work, especially when it comes to controlling the symptoms of lifestyle diseases. We’ve seen and heard of cases where experts who wrote glowing testimonials of a cholesterol-lowering drug were found to have vested interests in the profitability of the drug since they themselves were shareholders in the company.

So you see, when it’s a question of a patent in the drug industry, man proposes and the big Pharma disposes!

This post was contributed by Guest Barista Kelly Kilpatrick, who writes on the subject of the top ten pharmacy schools. She invites your feedback at kellykilpatrick24 at gmail dot com.

Posted October 17th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, Guest Post, Patent News
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