Brand-name and generic medicines: Both play an important role in health care today
by Larry Lucas
My job representing America’s pharmaceutical research companies requires me to be on the road a lot. As a “road warrior,” I spend a great deal of time in communities across the country talking to patients about the health care issues that matter most to them. Without a doubt, the most common question asked of me is, “Larry, what’s the difference between the generic and brand-name medicines my doctor prescribes?”
First, let’s consider brand-name medicines. New, brand-name medicines are on the cutting-edge of science with each medicine representing an average of $1 billion and 12 to 15 years of research and development. Creating and discovering these breakthrough medicines is complex; the chances of a drug making it from the lab to your medicine cabinet are remarkably small. On average, only five of every 10,000 compounds investigated make it to clinical trials. Of those five, only one is ever approved for patient use.
With the time, money and risk involved with creating and discovering new medicines, some may wonder why we bother. The answer is simple: New medicines help people live longer, healthier lives. A study by the National Bureau of Economic Research noted that new medicines account for 40 percent of the increase in longer life spans. And while new medicines might cost more than older ones, they can help save on overall health care costs. A study by Columbia University economist Frank Lichtenberg found that each additional dollar spent on using a newer prescription medicine (instead of an older one) saves more than $5 in other health expenses.
Each patient is unique in how their bodies respond to particular medications, and there might be instances where your doctor determines an older medicine with a generic equivalent to be your best treatment option. But what is a generic medicine, exactly? The Food and Drug Administration (FDA) defines a generic drug as a copy of a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Generic medicines play an important role in health care today; they currently account for 67 percent of medicines prescribed, according to data from IMS Health. But only your physician can decide if a generic medicine is best for you.
Everyone wants to save money, of course, and taking the generic equivalent of brand-name medicines can be a good way to do that. But generic medicines might not always be the best option for you. First, not every medicine has a generic equivalent. Second, generics may have different dosage requirements. For example, the brand-name version of a medicine may require you to take the medication once daily, whereas the generic version requires you to take it three times per day. This kind of change might not work for you. As with any prescription medicine – generic or brand-name – it’s important to consult your physician about all of your health care options.
The Partnership for Prescription Assistance (1-888-4PPA-NOW or www.pparx.org), a national program sponsored by America’s pharmaceutical research companies, can also help you save on your prescription medicines. This program provides a single point of access to information on more than 475 patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs. So far, the program has already helped nearly 5 million people in need nationwide.
America’s pharmaceutical research companies are committed to helping patients, and that means developing newer, better medicines. One of every five dollars in revenue is poured back into research and development. This investment is making a significant impact on many health conditions that disproportionally affect African Americans; today there are 114 medicines in development to treat cardiovascular disease, 95 medicines in development for diabetes and 67 medicines that target HIV infection. These medicines will go a long way to helping close the health disparity for our community.
Larry Lucas is a vice president for Pharmaceutical Research and Manufacturers of America (PhRMA).
Since the original decision in Ex Parte Bilski, the fate of application 08/833,892 has been a subject of great interest to the patent law community.Last month, the Federal Circuit, on its own initiative, issued an order granting an en banc hearing to the appeal of Bilski’s rejection by the patent office.
Since then, both the patent law community (see, e.g., here, here and here) and the mainstream media (e.g., here and here) have been all atwitter about the possibility of a major shift in patent law and the possible end of business method or software patents (or both).While the excitement is understandable, in this case I think it’s misplaced.
The Federal Circuit asked whether it should reconsider some of its patentable subject matter cases but I think it is unlikely to make any major changes it its existing jurisprudence.Further, to the extent that the Federal Circuit does make changes to its existing jurisprudence, I think it is unlikely that those changes will have much effect on the day to day business of getting patents.My reasons for this can be seen in the questions included in the Federal Circuit’s en banc order.
Question 1:Whether claim 1 of the 08/833,892 patent application claims patent-eligible subject matter under 35 U.S.C. § 101? This is devoted to the narrow question of what to do with a particular claim in a particular patent.The Federal Circuit could answer this question in the negative by simply agreeing with the BPAI and leaving the broader picture of patent law untouched.While I think that’s unlikely to happen, this first question doesn’t indicate that the Federal Circuit is planning on doing away with business methods in general.
Question 2:What standard should govern in determining whether a process is patent-eligible subject matter under section 101?This question, while broader than question 1, is focused on a particular class of patentable subject matter (processes), and is therefore unlikely to have much effect on the practice of “business method” patents.The BPAI’s original rejection of Bilski’s claims was based on the concept that the decisions which are generally recognized as opening the door to software and business method patents, State St. Bank & Trust Co. v. Signature Fin. Group and AT&T v. Excel Communications were limited to the “‘special case’ of transformation of data by a machine.”
Using that distinction, even if the Federal Circuit (contrary to statute) completely eliminates protection for process patents, clever attorneys can still get their “business method” patents past the 101 hurdle by casting them in the form of machines that manipulate data.Indeed, even Amazon’s notorious “1-Click” patent includes claims directed to machines, rather than being limited to process claims.
Question 3:Whether the claimed subject matter is not patent-eligible because it constitutes an abstract idea or mental process; when does a claim that contains both mental and physical steps create patent-eligible subject matter?
Like question 2, the answer to this question (whatever it is) is unlikely to have much practical effect because it is limited to process claims, and, moreover, to process claims which contain both physical and mental steps.However, as the state of the art in programming progresses, more and more steps which are today “mental” will eventually be performed by a machine, thereby allowing their inclusion in claims.Moreover, even if the Federal Circuit rules that any process including a step which could be performed by a human being is unpatentable, it still leaves open the “special case” of writing claims directed to the transformation of data by a machine, which keeps the door for business method and software patents wide open.
Question 4: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? Like questions 2 and 3, regardless of the answer to this question, protection for “business method” type inventions will still be available as long as the invention can be described in terms of data processing.Further, even if that was not the case, requiring that a process be tied to a machine, or result in a physical transformation of an article would do no more than throw up formal barriers which would be easy to overcome.
For example, I can easily tie almost any process I write claims for to a computer, and it would be a trivial task to require that the computers make a physical change in an article (e.g., printing an invoice).Thus, I just don’t see the answer to question 4 really having any significant impact on my (or any other patent prosecutor’s) day to day practice.
Question 5:Whether it is appropriate to reconsider State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998), and AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (Fed. Cir. 1999), in this case and, if so, whether those cases should be overruled in any respect?Unlike the previous four questions, this last question in the en banc order could result in a major shift in the landscape of patent law.However, even if the Federal Circuit completely overruled
State Street
and AT&T, at least for software patents, lawyers would be able to continue based on the Supreme Court’s case of Diamond v. Diehr which stated that When a claim containing a mathematical formula implements or applies the formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies 101’s requirements.As long as that case is good law (and the Federal Circuit doesn’t have the power to overturn it) patent attorneys will be able to use it as shield to protect their software (and likely business method) claims from 101 rejections.
Today’s post comes from Guest Barista William Morriss, a registered patent attorney in Frost Brown Todd’s Cincinnati office and a Contributor to Ephemerallaw.
Johnson & Johnson has sued the American Red Cross, an indisputably highly regarded charitable organization, over ARC’s “commercial” use of the red cross symbol trademark. It seems that the ARC has been licensing others to use the symbol in connection with first-aid type products sold in retail stores. To raise money, of course. That’s generally what charities do in order to fund their services.
Apparently worried about provoking cries of outrage and denouncements of corporate greed, J&J’s lawyers laced the complaint with interesting but mostly irrelevant historical information about ARC’s charter and the utterances of long-dead public figures, to support a suggestion that ARC should only be permitted to use the symbol in connection with its “chartered” (non-”commercial”) purposes. J&J’s people have been busy issuing press releases, too, about J&J’s efforts to be reasonable and seek amicable resolution of the dispute. The complaint has provoked cries of outrage and denouncements of corporate greed.
The complaint alleges an 1895 agreement between J&J and the ARC in which the ARC acknowledged “the exclusive use [by J&J] of a red cross as a trademark”. The complaint also notes J&J’s federal trademark registration for the symbol. Unless J&J amends its complaint at some time in the future, these things, too, seem irrelevant. Why? Because the complaint doesn’t allege claims for breach of contract or trademark infringement.
Instead, it contains only two counts against ARC: First, it alleges a vague claim of “equitable estoppel”, to the effect that because the ARC allegedly said in the past that it would not use the symbol “commercially”, J&J believed it would not do so in the future. In some if not many jurisdictions this would not even be recognized as a valid cause of action. Second, it alleges violation of a 102-year-old federal criminal statute that makes it a crime for anyone to make use of the Greek red cross on a white background (except the ARC and those who were already lawfully using it at the time of enactment — which allegedly includes J&J).
Assuming the ARC has actually violated the statute in some way (how, it is not clear), violation of a criminal statute does not automatically give anyone who objects a private civil cause of action. There has to be an associated, legally recognized civil tort — like trademark infringement — which is not alleged here. You can’t sue me in civil court for parking my car illegally, unless in doing so I am trespassing on your property.
Confused? I am. First, I hadn’t even known that J&J owns or uses “its famous Red Cross design” trademark. No products come to mind. I went to J&J’s web site to look for evidence of use of the mark, and couldn’t readily find any — it may be there somewhere, but I couldn’t find any after 10 minutes. It doesn’t appear on Band-Aids packages. Apparently J&J does use the mark in connection with consumer first aid kits, sold somewhere. But other sellers of first aid kits use cross symbols of varying colors and configurations.
Additionally, the symbol has been widely used to identify sources of medical care, throughout the world. This suggests the possibility that the symbol has become generic, and therefore, unprotectable as a trademark. Perhaps J&J didn’t allege trademark infringement because it is worried about this, or about its ability to succeed in showing that people in the U.S. associate the red cross symbol with any particular organization . . . other than the ARC.
Coupled with this very unclear situation concerning ownership and violation of rights, in an unfortunately typical showing of heavy-handedness, the complaint seeks relief including an injunction, destruction of all of the defendants’ marked goods, packaging and promotional materials, “all profits, gains and advantages derived by Defendants from their unlawful conduct,” “exemplary and punitive damages,” costs, interest and attorneys’ fees. Granted, attorneys routinely put things like this in their pleadings because they think it will instill fear in their opponents, but did J&J consider the perceptions of non-lawyers reading this? Just take a look at some of the blog postings, for example, here.
What is J&J trying to accomplish? Time will tell, but we wonder whether litigation will be a worthwhile endeavor for anyone but the lawyers.
One of the less-noticed items during the Senate Judiciary Committee mark-up of the Patent Reform Bill (Senate Bill S. 1145) was the adoption of Senator Specter’s amendment on venue. Following is an analysis of that amendment:
S. 1145 (before today): Implements venue reform by limiting venue to where (1) either the patent holder or infringer resides (for a corporation, this means the principal place of business or state of incorporation), or (2) where infringer has committed acts of infringement and has a regular place of business.
There was discussion and concerns raised by Senator Cornyn about a change that would limit venue to 3 states (WI, CA, VA) which I believe referred to Leahy’s 2nd manager’s amendment. From an e-report:
*Cornyn: “The manager’s amendment already fixes the problem. I oppose abusive forum shopping. But I fear the Specter provision would effectively limit patent litigation to WI, CA, and VA. There would be an inadvertent backlog in patent litigation.”
The 2nd manager’s amendment was adopted (which included venue among them), then Senator Specter’s amendment on venue was adopted, superseding the manager’s amendment. The limitation to three states does not appear to be in the Specter Amendment. However, in my opinion, its effect is worse.
S. 1145 (after today):
(1) prohibits patent holders from “manufacturing venue” by assignment/incorporation to establish venue for a specific district (e.g., companies setting up shells in ED Texas to invoke that venue); [probably ok]
(2) expands venue restrictions to apply not just to claims for infringement as well as declaratory judgment actions [outrageous result when considered with changes below — DJ filers (infringers taking a preemptive strike) can file suit and take advantage of the subsequently described venue restrictions];
(3) Provides that venue for a US infringer will be (a) where infringer resides (the principal place of business or state of incorporation) or (b) where infringer has committed “substantial” acts of infringement and has a “regular and established physical facility”. [note the expansion of limitation from “regular place of business” to “physical facility of significance”];
(4) Provides that venue for a foreign infringer will be (a) the foreign corp’s residence, which is where its main U.S. subsidiary is located or (b) where the foreign corp. has committed “substantial” acts of infringement AND has a “regular and established physical facility” [this is an *outrageous* result — (a) provides LESS jurisdiction over a foreign corp than a U.S. corp. by limiting the jurisdiction only to where the U.S. subsidiary is located, and it gives incentive for a foreign corp with a U.S. subsidiary to “locate” in the most infringer friendly forum of their choosing; and (b) provides no jurisdiction over those foreign corporations without a U.S. subsidiary who do not meet the criteria of a “regular and established physical facility” in the U.S.]
(5) Provides a “safe harbor” for universities from venue reform restrictions by allowing venue for university plaintiffs to be where the university resides [nice nod to universities on its face, but universities (a) are, at best, reluctant plaintiffs, and (b) have no protection for their tech-transferees, which means that the incidences of universities having to be plaintiffs will rise, their tech-transferees will be further disadvantaged, and ridiculous accusations and controversy of further “commercial” activity and Bayh-Dole abuse by universities be further fed.];
(6) provides a safe harbor for individual inventor plaintiffs who qualify as a micro-entity by allowing venue where the individual resides [again, nice on its face, but any individual inventor who has $4.5 million necessary to litigate will be highly unlikely to qualify for micro-entity status].
Finally, the inclusion of the safe harbors for universities and individual inventors highlights the most outrageous component of this amendment: that which is missing and removed. The original language of S.1145 provided jurisdiction where either the infringer *or* patent holder resides (for a corp, this means the principal place of business or state of incorporation).
The amendment eliminates jurisdiction where the patent holder resides for all but universities and micro-inventors! This means 99% of aggrieved patent holders who need to turn to litigation to defend their patent rights will now be forced to seek recourse against U.S. based accused infringers only on the infringer’s “home turf” with friendly jury pools predisposed to the substantial local business operations of the accused infringer. Worse, an aggrieved patent holder who needs to enforce his rights against a foreign patent holder will have even more restrictive avenues, and in some cases, will have NO recourse where a “regular and established physical facility” of a foreign corp. cannot be established.
This means that the traditional rule that the plaintiff chooses the forum is eliminated for most all constitutionally protected patent holders. Worse, it also means that *neutral* sites are eliminated as forums which have jurisdiction over patent suits. The only jurisdiction where patent infringement remedies can be brought for most all patent infringement cases is based upon the forum which, if at all, is that which is most favorable to the accused infringer!
India’s leading Para IV challenger – Dr. Reddy’s Laboratories (DRL) has finally zeroed down to settle its pending Para IV patent litigation with GlaxoSmithKline (GSK) over the blockbuster anti-migraine drug, Imitrex, generically known as Sumatriptan Succinate which is worth around US $ 890 million in sales in the U.S. market. GSK, under the terms of agreement, has agreed to grant an authorized generic (AG) status to DRL for its Imitrex tablets in the U.S. market which would eventually allow DRL to launch its authorized generic in the last quarter of 2008 ahead of the expiration of the pediatric exclusivity on the U.S. Patent # 5,037,845. After Merck’s blockbuster drugs, Zocor & Proscar, Imitrex is third in a row to fall in DRL expanding authorized generic portfolio. As far as DRL is concerned, it is undoubtly a win situation, both on strategic and financial frontier. This settlement strategically gives DRL an advantage over other generic manufacturers and financially reduces DRL’s legal burden of fighting expensive patent litigations. But what made GSK to go about settling it?
Sumatriptan Succinate and Orange Book Status
Sumatriptan succinate is broadly covered by the U.S. Patent No. 4,816,470 (the genus patent) within the Markush Structural Formula I and in particular claimed by the U.S. 5,037,845 (the species patent). The genus patent was subject to 35 U.S.C. § 156 and received an extension of the patent term for the period of 275 days, extending the original expiration date from March 28, 2006 to December 28, 2006. Both genus and species patents also received additional six months pediatric exclusivity, extending patent validity period till June 28, 2007 (genus patent) and February 06, 2009 (species patent). In addition to genus and species patents, Orange Book also lists three more U.S. patents for pharmaceutical compositions and method of treating migraine running out patent protection from September 2012 to July 26, 2016 (including six months pediatric exclusivity). These patents are as follows.
U.S. Patent # 5,863,559 (the ‘559) directed to a pharmaceutical composition for oral administration comprising a compressed film-coated tablet comprising a tablet core containing 25 to 200mg of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide succinate (1:1) salt as active ingredient, and a pharmaceutically acceptable carrier or excipient and a film coating on said tablet core wherein the film coating is applied to the tablet core in an amount of from 2 to 5% w/w of the tablet.
U.S. Patent # 6,020,001 (the ‘001 patent) directed to a pharmaceutical composition for oral administration comprising a film-coated tablet containing 3-[1-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide succinate (1:1) salt as active ingredient, and a pharmaceutically acceptable carrier or excipient.
U.S. Patent # 6,368,627 (the ‘627 patent) directed to a method of treating or prophylactically treating a human suffering from migraine which comprises oral administration of a pharmaceutical composition comprising a film-coated solid dosage form of 3-[2-dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide or a pharmaceutically acceptable salt or solvate therefore as active ingredient.
DRL Eyes Sumatriptan!
In December 2003, DRL filed an abbreviated new drug application (ANDA) with U.S. FDA seeking marketing approval for its generic version of Imitrex tablet, along with Para IV certification on four of the five O.B. listed patents for Imitrex tablets. After receiving notification for DRL, GSK subsequently sued DRL and filed patent infringement lawsuit in the U.S. District Court for the Southern District of New York alleging patent infringement of the species patent. Later six other generic companies also filed ANDAs for Imitrex but of those only Cobalt Pharmaceuticals certified Para IV certification for the species patent, challenging its validity. GSK filed infringement suit against Cobalt in the U.S. District Court for the Southern District of New York. In February 2005, GSK also filed a patent infringement suit against Spectrum Pharmaceutical in the U.S. District Court for the District of Delaware, alleging infringement of the species patent. However, Spectrum filed ANDA for marketing approval for sumatriptan injection.
GSK’s Unexpected Move
In the meantime, GSK made a surprising and unexpected move by filing Disclaimer and Dedication with the USPTO for the ‘559, ‘001 and ‘627 patents under 35 U.S.C. § 253 and thereby dedicating to the public the entire term of the said patents. The dedication was filed on August 16, 2004 and subsequently notified in Official Gazette on November 02, 2004.
It is expressly provided under 37 CFR § 1.321(a) that “a patentee owning the whole or any sectional interest in a patent may disclaim any complete claim or claims in a patent. In like manner any patentee may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted. Such disclaimer is binding upon the grantee and its successors or assigns.” This is furthermore a right that is guaranteed by U.S. patent statute as provided under 35 U.S.C. § 253 that “a patentee, whether of the whole or any sectional interest therein, may, on payment of the fee required by law, make disclaimer of any complete claim, stating therein the extent of his interest in such patent. Such disclaimer shall be in writing, and recorded in the Patent and Trademark Office; and it shall thereafter be considered as part of the original patent to the extent of the interest possessed by the disclaimant and by those claiming under him. In like manner any patentee or applicant may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted or to be granted.”
GSK also asked the U.S. FDA to delist the ‘559 and ‘627 patents from the Orange Book but the FDA refrained from delisting the said patents in the light of petitions filed by Ranbaxy and Ivax against the delisting of Orange Book listed patents for Simvastatin. Moreover, referring USPTO ‘Patent Maintenance Fees’ section, the ‘627 patent has already expired on April 10, 2006 due to non-payment of maintenance fees.
Who Played Smart Enough?
Considering that GSK already dedicated the ‘559, ‘001 and ‘627 patents to the public under 35 U.S.C. § 253 and likely to run-out patent protection for its species patent in February 06, 2009, it seems to be that GSK has made a smarter move than DRL. By allowing DRL to launch Imitrex as an authorized generic in the last quarter of 2008, GSK has well avoided a DRL attack on the validity of the species patent.
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) today announced that they received court decisions on ANDA-related summary judgement motions for Aciphex® (Active Ingredient Name: rabeprazole sodium, Product Name in Japan: Pariet®) on October 6, 2006 (U.S. Eastern time). Eisai won summary judgement for patent validity in its lawsuit against Teva and Dr. Reddy’s over generic Aciphex (rabeprazole). Eisai looks forward to the trial and will vigorously defend its Aciphex® patent in order to protect the company’s interests.
Aciphex is a proton-pump inhibitor indicated for the treatment of ulcers and had sales of $1.2 billion last year. Aciphex® has been shown to have a rapid onset of action and a reliable inhibitory effect on acid secretion related to duodenal ulcers and gastroesophageal reflux disease, which are confirmed in clinical studies. Aciphex® was launched in the U.S. in 1999 and is currently marketed worldwide. Aciphex® has a well-established safety profile. The most common side effect possibly related to Aciphex® is headache.
The opinion by Judge Gerard E. Lynch of the Southern District of New York granted Eisai’s summary judgement motion confirming the validity of the Aciphex® composition of matter patent in its ruling. The judgement states that Eisai’s U.S. Patent No. 5,045,552, would not have been obvious because there was no teaching, suggestion, or motivation to combine three prior art references. The Southern District Court reserved ruling on the enforceability arguments until after trial.
Motion for summary judgement is a request made by the defendant in a civil case. Asserts that the plaintiff has raised no genuine issue to be tried and asks the judge to rule in favor of the defense. Typically made before the trial. “Each element must be supported in the same way as any other matter on which the plaintiff bears the burden of proof” i.e., with the manner and degree of evidence required at the successive stages of the litigation.” Id. In order to defeat a summary judgement motion, the nonmoving party may not simply rely on his pleadings but must present some evidence on every material issue for which he will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986).
Like any motion, a motion for summary judgement educates the opponent. Education is for the classroom, not in the courtroom. Unless the purpose is to inform the court of the law in advance of trial, motion practice is only successful if the defendant or the movant wins. This is true because filing motions informs the opponent about the intricacies, theories as well as the strategies behind the case. If the movant for motion for summary judgement loses the motion, the opponent enjoys the advantage of knowing what your defenses or theories are, and how you intend to implement them. But there is another reason: filing motions informs the court and opposing counsel of the strengths and weaknesses of the case.
If one is trying to settle the case, then bringing the motion may be justified. But if that’s not the case, then showing weaknesses may cause the litigation to drag on. It is often better to say nothing than to say something in an unconvincing fashion. Weaknesses are better left for the spontaneity of trial, as opposed to the deliberative process inherent in motion practice. An affirmative defense can achieve much more than a failed summary judgement motion or a motion to dismiss. The burden of proof in a summary judgement motion initially centers on the burden of production rather than the risk of non-persuasion. In other words, the thing which matters the most is… what facts you are required to muster to establish you are entitled to judgement as a matter of law.
What this means to the person seeking summary judgement is that, as the movant, he must anticipate what the other party’s proof will be. In move for summary judgement, one should show that the uncontradicted facts entitle you to judgement as a matter of law. On the other hand, one should presume that the opponent will attempt to create a disputed fact issue. Therefore, the movant need more than pleadings to win a summary judgement motion (i.e., requests to admit, depositions, affidavits). Once the party seeking summary judgement produces the evidence necessary to establish entitlement to judgement as a matter of law, the burden of production shifts to the party opposing the motion, who may not merely rely on the pleadings, but is required to come forth with some facts which create a material disputed issue of fact. At this point, with respect to summary judgement, it depends whether you are a plaintiff or defendant. If you are the former and opposing the motion, you must provide some factual basis that arguably contradicts the pleadings and affidavits of your opponent as well as shows the elements of your cause of action which would, if believed, entitle you to judgement as a matter of law. If you don’t produce such evidence, you are going to lose the motion.
Summary judgement can be an early demise for an unsuspecting litigant. Its primary function is to let a trial court fathom whether there is any question of material fact to be tried by the court or a jury and, if not, whether your client is entitled to judgement as a matter of law. At the same time, if utilized carelessly, this procedure can give an early view to an opponent’s case, theory(ies), and strategy. The utilization of, and responses to, motions for summary judgement should be undertaken with thoughtfulness, care and a command of the discovery rules that can make summary judgement a reality for your clients.
Today’s post comes from Gautam Bakshi and Ashu Gautm Bakshi, registered patent agents with the Government of India. Manager - IPR, Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India (Gautam.Bakshi - at - intasbiopharma.co.in).
Authorized generics — brand pharmaceutical products masquerading as generics — are an increasingly common brand tactic aimed at discouraging generic companies from challenging questionable brand patents. With GlaxoSmithKline (GSK) and Dr. Reddy’s having settled their litigation over generic Imitrex™, and the parties agreeing that Dr. Reddy’s will sell an authorized generic version of Imitrex™ in late 2008, before GSK’s patents on Imitrex™ expire in February, 2009, the issue of authorized generics is in the forefront once again. The effect of the same on the health of the Generics market structure in US and its ramifications pertaining to Anti-trust laws in US are to be seen in due course of time. The controversies and issues surrounding the very concept of authorized generics seem far away from melting down easily.
Imitrex, is a selective 5-hydroxytryptamine1 receptor subtype agonist and is used to treat headaches. It had sales of $890 million last year. Dr. Reddy’s can sell an authorized generic version of Imitrex tablets in doses of 25 mg, 50 mg and 100 mg respectively. Dr. Reddy’s Laboratories Ltd. though has settled a patent litigation with GlaxoSmithKline PLC (GSK.LN), but the Indian pharmaceutical company’s financial gains from the deal are likely to be limited. Under the deal, Dr. Reddy’s will be allowed to sell exclusively an authorized generic version of Glaxo’s migraine medication Imitrex, or sumatriptan succinate, in the U.S. before the patent expires in February 2009. The settlement of Dr. Reddy’s challenge of the Imitrix patent is subject to government approval. The Indian company’s foothold on the generic version of Imitrex, which had sales of $890 million in the U.S. in the year ending June 30, may be short-lived. Other companies have also challenged the Imitrex patent and, if they win their cases, Dr. Reddy’s won’t be able to sell the drug exclusively. Also the addition won’t significantly boost Dr. Reddy’s bottom line as this will not add any value, it is just marketing the drug…bottom line (net profit) accretion will not be higher than $7 million to $10 million in fiscal year 2009. But it will provide Dr Reddy’s with a steady stream of revenues in the months before the patent expires. (Source: MarketWatch).The Indian drug maker expects to start selling sumatriptan succinate tablets in the U.S. in the fourth quarter of calendar year 2008, the notice said. The settlement of the dispute is mild positive for GlaxoSmithKline, because it should provide reasonable time to switch patients to a newer product, Trexima.
Authorized generic (AG) is a pharmaceutical product that was originally marketed and sold by a brand company, but is relabeled and marketed under a generic product name. One problem with AGs is that they do not have to abide by the 180-day market exclusivity provision granted by the Hatch-Waxman Act to the first generic on the market. AGs could thus undercut the public policy rationale underlying the Hatch-Waxman Act, and have the potential of threatening the generic industry as a whole. An AG, also known as “authorized copy” or “brand-in-bottle,” may be marketed by the brand company itself or through a subsidiary, or the brand company may license the product to another company for marketing in return for royalties. The AG is sold at a lower cost, and as an alternative, to the branded product. The brand companies may choose to launch an authorized generic for a variety of reasons, including settling patent litigation with a generic company by partnering with it, to participate in the generic market once generic competition starts, or to maintain manufacturing capacity for the drug substance or the drug product. For example, of the 57 largest selling drugs in the United States, more than 30 are scheduled to loose patent protection by 2008, representing total sales of more than $60 billion. The launching of AGs allows the branded companies to maintain cash flow, albeit at a lowered rate, once generic competition starts. Similarly, generic companies may choose to partner with the brand company to launch an AG to settle litigation, to market a product they otherwise might not have been able to enter, or to increase their product portfolio.
The economic and other tangible benefits of the six-month exclusivity are significantly reduced by the introduction of the authorized generic products. The entry of a second generic reduces the revenues of the first generic company by about 80%. The introduction of AG during the 180-day exclusivity period is similar to two generic companies competing for the same market, and reduces the benefit to the paragraph IV ANDA filer.
The fact that authorized generics may compete with ANDA generic products, even during the 180-day exclusivity period was affirmed by the U.S. District Court for the District of Columbia in Teva Pharmaceuticals v. FDA (D.D.C. December 23, 2004), and by the U.S. Court of Appeal for the District of Columbia Circuit (June 3, 2005). The generic company will have to show that the introduction of AG is a willful anti-competitive conduct that prevents the generic from fairly competing in the relevant market for the drug. Factually, AGs do not prevent a generic version from being introduced into the market; AGs decrease the revenues and the profits of a generic during the exclusivity period. The generic company is thus able to enter the market, but will likely not reap the economic and non-tangible benefits of being a paragraph IV filer. The launch of every paragraph-IV generic expected to be a blockbuster has been met with the availability of an AG since the fall of 2003. This has financially hurt the generic companies, and could work against the public policy of the Hatch-Waxman Act by removing the economic incentive from challenging the validity and enforceability of weak patents.
In February 2006, a federal law closed another loophole that brands use to benefit from authorized generics. The new law contains a provision that will require brand pharmaceutical companies to include authorized generics in the “best price” calculation that is provided to the Centers for Medicare and Medicaid Services. Due to an ambiguity in the current law, some brand companies were not required to include authorized generics in their best price calculation, diverting government and taxpayer savings. According to some estimates, the new provision could save taxpayers $150 million over five years. The change will go into effect in January 2007. (Source: Generic Pharmaceutical Association (GPhA))
Today’s post comes from Gautam Bakshi and Ashu Gautm Bakshi, registered patent agents with the Government of India. Manager - IPR, Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India (Gautam.Bakshi - at - intasbiopharma.co.in).
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).
Posted October 19th, 2006 by Stephen Albainy-Jenei in Guest Post | | Comments Off
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My job representing America’s pharmaceutical research companies requires me to be on the road a lot. As a “road warrior,” I spend a great deal of time in communities across the country talking to patients about the health care issues that matter most to them. Without a doubt, the most common question asked of me is, “Larry, what’s the difference between the generic and brand-name medicines my doctor prescribes?”
