Patent Baristas

After Amgen tried to get a judgment against Hoffman-La Roche that Roche’s product, MIRCERA®, would infringe Amgen’s five patents if imported into the United States, Roche tried to get the patents invalidated. Amgen v. Hoffman-La Roche (09-1020, -1096).

The patents, U.S. Patent Nos. 5,441,868, 5,547,933, 5,618,698, 5,756,349, and 5,955,422, relate to the production of erythropoietin (“EPO”) protein using recombinant DNA technology. All five patents share a common specification and descend from Application No. 06/675,298, which issued as now-expired U.S. Patent No. 4,703,008.

At the district court, the court entered judgment that the ’868, ’933, ’698, and ’422 patents were infringed and not invalid, and permanently enjoined Roche from marketing MIRCERA® in the United States.

The U.S. Court of Appeals for the Federal Circuit issued a 81-page ruling that gave each side a little of what was requested but, in the end, the appeals court affirmed that Roche’s drug did infringe on some of Amgen’s patent claims.

To produce EPO, Amgen researchers led by Dr. Fu-Kuen Lin made an expression vector carrying the human EPO DNA sequence. Lin injected, or transfected, host Chinese hamster ovary (CHO) cells with the expression vector. The transfected CHO cells use the EPO DNA sequence to form a protein with the 166 amino acid sequence of EPO.

Prior to secretion of EPO from the cell, the final amino acid, or the C- terminal amino acid, of the 166 amino acid sequence is cleaved off, leaving a 165 amino acid protein. Also prior to secretion, carbohydrates are attached to certain sites on EPO by glycosylation, which results in a glycoprotein. Recombinant EPO produced in this manner can bind to the EPO receptor and stimulate erythropoiesis.

In 1986, the PTO subjected Amgen’s ’298 application to a restriction requirement, which identified claims drawn to DNA, cells, polypeptides, and pharmaceutical compositions as each directed to patentably distinct subject matter. (Ed. Note: Today, that would more likely be a 165-way restriction but that’s another issue). Amgen elected to prosecute Group II claims, which were drawn to DNA and host cells. Ultimately, the ’298 application issued.

On October 23, 1987, subsequent to the restriction requirement but before the ’008 patent issued, Amgen prosecuted the claims withdrawn from the ’298 application in continuation applications 07/113,178 and 07/113,179. Eventually, the ’933 patent eventually emerged from the ’178 application, while the ’422, ’349, ’868, and ’698 patents eventually emerged from the ’179 application.

Based on these patents, Amgen has developed two erythropoiesis-stimulating agent (ESA) drugs, EPOGEN® and Aranesp®, to treat anemia and anemia-related diseases. Roche sought to introduce its own ESA drug, MIRCERA®, which it manufactures overseas. The active ingredient of MIRCERA® is continuous erythropoietin receptor activator (CERA). CERA is formed via a chemical reaction that bonds polyethylene glycol (PEG) to recombinant EPO produced by CHO cells. Pegylation of a therapeutic protein, such as EPO, can expand the drug’s life in the body and reduce levels of toxicity, allowing for extended dosing intervals. Id. As a result, MIRCERA® has received FDA approval for once-monthly dosing to anemic patients. Id.

In this appeal, the CAFC looked at issues involving obviousness-type double patenting, anticipation, indefiniteness, and infringement relating to the ’933, ’422, ’349, ’868, and ’698 patents.  The district court granted Amgen summary judgment of no obviousness-type double patenting of the asserted claims of the ’933, ’422, and ’349 patents over the claims of the ’008 patent. Section 121, entitled “Divisional applications,” provides in its third sentence:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

The third sentence of § 121 is a safe harbor provision that protects a divisional application, the original application, or any patent issued on either of them from validity challenges based on a patent issuing on an application subjected to a restriction requirement or on an application filed as a result of a restriction requirement.

The district court concluded that the ’933, ’422, and ’349 patents were entitled to the § 121 safe harbor because they had descended from the ’178 and ’179 applications, both of which had been filed in response to a PTO-imposed restriction requirement. The court observed that “[a]fter the PTO imposed the 1986 restriction requirement,” Amgen “filed two divisional applications, the ’178 and ’179, which ultimately issued as the ’933, ’422, and ’349 patents.”

On appeal, Roche argued that § 121 cannot shield the ’933 and ’422 patents because they issued from solely continuation applications to which § 121 is inapplicable. Roche contends that § 121 applies exclusively to divisional applications and patents issuing therefrom. Roche emphasizes that the statute, entitled “Divisional applications,” requires on its face that the later patent must issue from “a divisional application” or the “original application.” Because the ’933 and ’422 patents issued from the ’178 and ’179 continuation applications, Roche contends they are not entitled to the § 121 safe harbor.

Amgen obviously rejected Roche’s version of reality and argued that the only § 121 requirement at issue is the “divisional application” requirement, and Amgen contends that the ’178 and ’179 applications meet that requirement. Amgen relied on the definition of “divisional application” in § 201.06 of the Manual of Patent Examining Procedure (“MPEP”), which provides:

A later application for an independent or distinct invention, carved out of a pending application and disclosing and claiming only subject matter disclosed in the earlier or parent application, is known as a divisional application or “division.”

The Court of Appeals felt that form should prevail over substance in this matter:

We conclude that, because the ’178 and ’179 applications were filed as continuation—rather than divisional—applications, the ’933, ’422, and ’349 patents do not receive the benefit of § 121. We reach this conclusion in light of our opinion in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). The Pfizer decision addressed whether a patent that issued from a continuation-in-part application—rather than a divisional application—could receive the protection of the § 121 safe harbor. 518 F.3d at 1358–62. Looking first to the statute, the court observed that § 121 on its face refers to “divisional application[s].” Id. at 1360. Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court’s view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude[d] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application.

… Amgen has not presented us with any persuasive reason as to why we should deem the ’178 and ’179 continuation applications divisional applications for purposes of § 121. Amgen does not dispute that it denominated the ’178 and ’179 applications continuations, that it checked the continuation application box on the submitted form, or that its applications met the PTO’s definition of a continuation application in MPEP § 201.07. See Amgen’s Br. 38, 42. Instead, Amgen argues that, because the ’178 and ’179 continuation applications could have been filed as divisional applications, we should treat them as such for purposes of § 121. While this argument convinced the district court to regard the ’178 and ’179 continuation applications as divisional applications, we are not likewise convinced. We decline to construe “divisional application” in § 121 to encompass Amgen’s properly filed, properly designated continuation applications.

For Amgen, it mostly cares that Roche is still blocked from importing MIRCERA considering that Amgen’s two anemia drugs, Aranesp and Epogen, brought in revenue of $4.1 billion in the U.S. for 2008, representing more than 35% of Amgen’s U.S. product sales.

The US Court of Appeals for the Federal Circuit upheld a patent directed to certain fermentation methods used to produce fatty acids such as DHA and reversed the trial court’s interpretation of the term animal to exclude humans in claims directed to methods of increasing the concentration of microbial omega-3 fatty acids such as DHA in an animal. The Federal Circuit concluded that the term animal does include humans and remanded the patent to the trial court for further proceedings consistent with this interpretation.  See Martek Biosciences v. Nutrinova (08-1459, -1476).

Earlier, Martek Biosciences sued Nutrinova Nutrition Specialties and Food Ingredients GmbH Inc for the infringement of a variety of patents related to the production of DHA, an important omega-3 fatty acid. In 2005, Lonza purchased the DHA-business from Nutrinova and Nutrinova and Lonza were held to have infringed certain claims of Martek Biosciences’ patents.

Lonza appealed claiming that the ’594 patent claims are invalid and that Lonza does not infringe the ’281 patent claims. Lonza also fought the district court’s exclusion of its prior inventorship evidence and the district court’s construction of the claim term “non-chloride sodium salt.” Meanwhile, Martek cross appealed the district court’s grant of Lonza’s motion for JMOL that the asserted claims of Martek’s U.S. Patent No. 6,451,567 are invalid and the district court’s construction of the claim term “animal” in Martek’s U.S. Patent No. 5,698,244.

Martek and Lonza make and sell products containing docosahexaenoic acid (DHA), an essential omega-3 fatty acid that plays an important role in the development of organs such as the heart, brain, and eyes, and is reported to have many additional health benefits. They obtain DHA by extracting lipids from fermented microalgae. The patents at issue relate to specified microorganisms that are useful for the commercial production of DHA because they produce high levels of DHA.

Three of the patents at issue are directed to heterotrophic organisms and a process for culturing them for the production of lipids with high concentrations of omega-3 highly unsaturated fatty acids (HUFA) suitable for human and animal consumption as food additives or for use in pharmaceutical and industrial products. The ’244 patent is directed to methods for increasing the concentration of omega-3 HUFA in animals by feeding them microorganisms of the order Thraustochytriales, which includes the Thraustochytrium and Schizochytrium genera, or lipids extracted from such microorganisms.

All asserted claims of the ’244 patent are directed to methods for achieving high concentrations of omega-3 HUFA in an “animal.” The district court construed the claim term animal to mean “any member of the kingdom Animalia, except humans.” Based on the court’s construction, Martek stipulated that Lonza does not infringe the ’244 patent claims, because neither Lonza nor its customers use the claimed methods to provide omega-3 HUFA to non-human animals.

Martek pointed out that the patent’s stated definition of animal would include humans and the court agreed:

When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls. See Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed. Cir. 2005) (en banc) (“[T]he specification ‘acts as a dictionary when it expressly defines terms used in the claims . . . .’”

Here, Martek explicitly defined the term “animal” in the ’244 patent: “The term ‘animal’ means any organism belonging to the kingdom Animalia.” ’244 Patent col.5 ll.11–12. That definition controls. Thus, because it is undisputed that humans are members of the kingdom Animalia, it was error for the district court to limit the claim term “animal” to exclude humans.

Lonza tried to argue that when the ’244 patent specification is considered in its entirety, it clearly limits the claim term animal to non-human animals even while agreeing that humans are members of the kingdom Animalia.

The court reversed stating:

Although the patent contemplates that certain animals are “[p]referred animals from which to produce a food product,” that statement does not disavow human animals because it relates to preferred embodiments only; it does not state that all animals covered by the claims must produce a food product. As we have explained:

[P]articular embodiments appearing in the written description will not be used to limit claim language that has broader effect. And, even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004) (citations and internal quotation marks omitted). Here, the patentee has used no words or expressions that manifestly exclude coverage of humans, and thus, it would be improper to override the patentee’s express definition of “animal” to limit the scope of the claims. Moreover, the patentee’s use of modifying language to specify “[p]referred animals” as “economic food animal[s]” ultimately supports a broad construction of the unmodified term “animal” that includes non-food animals, such as humans.6 In summary, absent a clear intention to restrict the invention to particular members of the kingdom Animalia, we cannot limit the claims to the listed preferred embodiments. See id.

The court held that the ’244 patent does not otherwise contain language that can be fairly interpreted as a clear intention to disclaim coverage of humans. See id.; Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“Absent a clear disavowal or contrary definition in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language.”). For example, the fact that the claims refer to “raising” and “feeding” animals does not clearly disclaim humans.

Circuit Judge Lourie and Rader, dissenting, focused on statements in the patent that allegedly distinguish between humans and other animals:

This case illustrates the unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent. Martek’s attempt at lexicography does not conform to the way in which it otherwise describes its invention.

It is fundamental that we must read a claim term in a manner that comports with the written description of the patent as a whole, see Markman v. Westview Instruments, Inc., 517 U.S. 370, 389 (1996), and not simply with a single sentence, even one purporting to be a definition, that is inconsistent with the remainder of the specification. We have stated many times that the specification of a patent is the “single best guide to the meaning of a disputed term,” and that the specification is to be viewed in its totality. …

Thus, rather than reading in isolation the single line in the specification that Martek argues provides a definition of “animal,” one should review the entire patent to determine the proper construction of the term. Having done so, it is clear that humans should be excluded from the construction of the term “animal” in the ’244 patent.

Starting with the claims, claim 1, which is the only independent claim in the ’244 patent, reads, “A method of raising an animal, comprising feeding said animal material” that contains omega-3 highly unsaturated fatty acids “in an amount effective to increase the content of omega-3 highly unsaturated fatty acids in said animal.” Martek argues that this language applies to humans, since children are “raised” in the sense that they are “reared.” But, as demonstrated by the discussion below, the specification is not directed to raising children; it is directed to raising non-human animals.

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood held a press conference today on the issues facing the biotech industry this fall, namely, the healthcare reform going on and the energy/climate issues.  Greenwood reiterated that the organization’s goal is to relieve suffering across the globe.

BIO emphasized that it worked very hard to make sure that any amendment to create a regulatory pathway for biosimilars by the House Energy and Commerce Committee would contain 14 years of data exclusivity.  See America’s Affordable Health Choices Act (H.R. 3200).  Earlier, the House of Representatives’ Energy and Commerce Committee voted 47-11 in favor of allowing 12 years of data exclusivity for biotech drugs.

In creating a pathway for approval of biosimilars, BIO wants to preserve sufficient incentives for innovator companies and venture capitalists to commit the substantial investments necessary to develop such discoveries into new biologic treatments, as well as to provide a pathway for entry of biosimilars into the market to promote broad, affordable public access to such treatments.

BIO wants to have any final rules include the provisions of the amendments by Rep. Anna Eshoo, which includes key features of H.R. 1548, endorsed by AAU, and the Hatch/Enzi/Hagan Amendment recently adopted by the Senate Health, Education, Labor and Pensions Committee.  These provisions are supported by a wide range of groups including BioOhio and KentuckyBioAlliance (see EIB Supporters Ad).

See also:

• Letter from 160+ stakeholders to the late Chairman Kennedy and Ranking Member Enzi in support of a pathway for biosimilars (pdf)
• Letter cosigned by four HIV/AIDS advocacy organizations to the late Chairman Kennedy in support of a pathway for biosimilars (pdf)
• BIO press release on House Energy & Commerce bipartisan approval of biosimilars amendment to health care reform legislation (pdf)

The Australian Full Federal Court has upheld an earlier decision that the duty to perform research in an employment contract did not give rise to an implied duty to invent, even though the nature of the research was such that inventions could quite likely result.  See University of Western Australia v Gray 9[2009] FCAFC 116 (3 September 2009)).

Here, the University of Western Australia claimed that three families of patents invented wholly or in part by Dr Bruce Gray belonged to the University.  The patents, which relate to the production and use of microspheres for targeted treatment of human tumors, were transferred to Sirtex Medical Ltd. (previously Paragon) in exchange for shares in the company, reportedly valued at A$60-90 million.

The University maintained that Dr. Gray conducted the work leading to the inventions while he was employed by UWA as its Professor of Surgery. Under the terms of his employment contract Dr. Gray was required to teach and to undertake research in his field.

In the end, the Full Court Justices held that the duty to do research in Dr. Gray’s employment contract did not give rise to an implied duty to invent, even though the nature of Dr. Gray’s research was such that inventions could quite likely result. In making this decision, the Full Court noted the distinction between ownership of employee inventions in the University context, in contrast to that in the private sector. Supporting factors in reaching the decision were summed up as:

1. The absence of any duty to invent anything.
2. The freedom to publish the results of his research and any invention developed during that research notwithstanding that such publication might destroy the patentability of the invention.
3. The extent to which Dr Gray, as a researcher and those working with him, were expected to and did solicit funds for their research, including the development of inventions, from sources outside UWA. The relevance of those considerations is not affected by the arrangements under which UWA would administer funding, eg in the case of CSIRO or NH & MRC grants.
4. The necessity, consistent with research of the kind he was doing, to enter into collaborative arrangements with external organisations such as CSIRO.

The court concluded that the University’s Patents Regulations had no significance in this matter.  However, the Patents Regulations’ preamble states:

The purpose of University research is to advance knowledge and to make the benefits of such knowledge available to all. Although it is not the policy of University research specifically to seek patentable inventions, there can arise in the course of research inventions which in the interest of the public, the University and the inventor should be patented. The purposes of the University Patents Regulations are to define the procedures for determining which inventions resulting from University research should be patented, and to establish the procedures for obtaining patents without cost to the inventor and for dealing with them so as to safeguard the interests of the University and of the inventor in a manner consistent with the University’s obligations to the public.

The regulation also states that:

(2) Any person authorised under the preceding sub-regulation to undertake work supported by any outside person or organisation, shall assign to the University such rights as may be necessary to enable it to exercise the inventor’s rights in any invention made or developed with such outside support.

But, the University did not follow its own rules under Regulation 6.1 of the Patents Regulations, which required a person subject to them to inform the Vice-Chancellor immediately of any patentable invention made or developed wholly or in part during the course of the person’s duty or while using UWA’s research facilities. The Patents Regulations required the Vice-Chancellor to refer the matter disclosed to a “Patents Committee” and to act on that Committee’s advice as to whether to exercise UWA’s “rights in the invention” and to inform the inventor accordingly.

The university’s failure to maintain a patent committee mechanism –- deemed a failure to maintain a mechanism on which its rights were dependent – was held to be a non-fulfillment of contingent condition.  While UWA said “Hold on thar, we could have thrown together a committee had we only known” — or something like that — even if there was no formal committee in existence, the court had no mercy:

The last of these propositions is notable for its unreality. Not only was the use of an ad hoc committee not considered (not surprisingly, given it was a creature of the Senate, not of the Vice-Chancellor) but also, and more importantly, UWA had moved down an “alternative pathway” to provide a framework within which inventions could be commercialised: [256]. To put the matter colloquially, the Patents Regulations were no longer part of UWA’s agenda and UWA acted accordingly.

Dr Gray had no duty to invent anything. He had a duty to undertake research and to stimulate research amongst staff and students at UWA. He was working for a university.

The court seemed to make a lot of the fact that at all presently relevant times there was nothing to prevent Dr. Gray from publishing the discoveries he made and details of the technologies he developed. They noted that he was not obliged to protect by non-disclosure the patentability of any invention he developed in the course of his employment making his employment obligations different from those of a person employed by a private commercial entity whose inventions in the course of employment could benefit or affect the business of the employer.

The primary Judge went on to acknowledge that the “contemporary reality” was that most if not all universities (including UWA) engage in commercial activities. Nonetheless, when selecting the research work he would undertake, “Dr Gray was not required to advance a UWA commercial purpose”:

Research of the kind that Dr Gray was engaged to do carried with it the possibility that he would develop inventions capable of attracting patent protection. The duty to undertake research could be discharged in a variety of ways. These were within the discretion of the researcher. One of the ways in which the duty could be discharged was the development and testing of new technologies. It could be said therefore that an invention made in the course of Dr Gray’s research activities as an employee of UWA was an invention made within the scope of his employment and doing what he was employed to do. It does not follow that there was an implied term that the rights to which his invention gave rise belonged to UWA.

In light of this decision, Australian Universities and other research institutions should be concerned about the ownership of intellectual property invented by employees not bound by a specific duty to invent within their employment contracts or where assignments of intellectual property rights have not been made. The question now, when can researchers can be expected to make inventions?

How do you know the government is upset about paying out all its money for health care? When you’re required to pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions.

The U.S. Department of Justice levied the largest criminal fine in U.S. history against Pfizer after accusing the drug company of such things as creating false doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages and wining and dining doctors — including sending sent them on exotic trips — all to get them to prescribe its drugs.

The government claims that Pfizer promoted prescription drugs, such as the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved by the U.S. Food and Drug Administration. The use of drugs for off-label medical conditions is fairly routine but drug companies are prohibited from marketing drugs for uses that have not been approved by the FDA.

According to the press release by the DOJ:

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

Pharmacia and Upjohn, a Pfizer subsidiary, entered an agreement to plead guilty to one count of felony misbranding over the promotion practices for Bextra (i.e., not Pfizer).  Bextra is a Cox-2 inhibitor pain medication that was pulled from the U.S. market due to the risk of heart attack, stroke and death.

Other inappropriate drug promotions involved the nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs, some of which will be shared among the states.

Best tidbit:  Former sales manager Thomas Farina, who is doing six-month of hard home confinement with an electronic ankle bracelet for his role in the case referred to his team as “the Highlanders” — a reference to a movie and TV show about a cult of immortals living secretly among us who must kill or be killed. Farina signed his emails, “There can be only one,” a reference to the motto of the show.

Highlighting that the new Administration is serious about cutting expenses, Associate Attorney General Tom Perrelli noted that:

Because health care fraud is such a significant problem for the public and the federal [budgets], the Justice Department and HHS recently invigorated our longstanding partnership in fighting health care fraud, by launching the Health Care Fraud Enforcement Action Team – or HEAT – earlier this year. This working task force is led by key senior-level leadership in both agencies and has already increased coordination and intelligence data sharing between the agencies and has secured indictments charging dozens of defendants with health care fraud offenses.

In an earlier announcement that helped distract attention from the settlement — and to show it can still obtain world domination — Pfizer announced plans to acquire Wyeth for $68 billion, which is expected to close before the end of the year.

In 1995, Beth Jacobson’s late husband, Dr. Ira Wolmer was diagnosed with multiple myeloma; an incurable blood cancer that develops in the bone marrow. Ms. Jacobson, a lawyer, devoted her efforts to identify treatment options for her husband, which led her to request that he be treated with Thalomid, Celgene’s brand name for thalidomide.

While Dr. Wolmer did not respond to treatment and later died, thalidomide has become a major treatment against multiple myeloma and Celgene has grown into a $24 billion company. Jacobson has now brought a lawsuit against the Celgene Corporation (Jacobson v. Celgene Complaint) based on what she claims is Celgene’s misappropriation of her idea for treating multiple myeloma with thalidomide and she wants $300,000,000 plus 25% of future profits.

Multiple myeloma is the second most common blood cancer after non- Hodgkin’s lymphoma impaired production of normal antibodies, increased susceptibility to bacterial infection, and hypercalcemia. Dr. Wolmer was treated at the Myeloma Institute by a team of doctors, led by Dr. Bart Barlogie.

In Ms. Jacobson’s research on alternative treatments, one researcher told her about Dr. Judah Folkman, a researcher at Harvard Medical School who has theorized that cancer may be treated by retarding angiogenesis, the growth of blood vessels that feed tumors. One of the substances under study in Dr. Folkman’s laboratory was thalidomide.

Ms. Jacobson claims that she suggested the idea of using thalidomide to treat her husband’s multiple myeloma because of the similarities she perceived between leukemia and multiple myeloma and that Dr. Folkman told her that he had never thought of the idea. (other versions say that Dr. Folkman suggested thalidomide but he died last year).

After her conversation with Dr. Folkman, Ms. Jacobson got Dr. Barlogie to treat her husband with thalidomide, which was obtained from Celgene. Dr. Barlogie got FDA approval to administer thalidomide to Dr. Wolmer on an experimental basis. Unfortunately, Dr. Wolmer died despite the treatment.

Later, physicians at the Myeloma Institute used thalidomide to treat another patient and this time, thalidomide worked and the patient had a near complete remission. Dr. Barlogie and others then conducted a clinical trial, the results of which were published in the New England Journal of Medicine and showing that “thalidomide had substantial antitumor activity in patients with advanced myeloma.”

The article was dedicated to the memory of Dr. Wolmer and expressly acknowledged Ms. Jacobson’s idea of using thalidomide to treat multiple myeloma and stated that “We are indebted to Beth Wolmer for her persistence in recommending the clinical evaluation of thalidomide in the treatment of multiple myeloma.” In addition, Celgene’s 1999 Annual Report stated that the 1999 clinical trial for the treatment of multiple myeloma with thalidomide along with its publication in the New England Journal of Medicine was a “seminal event in the commercialization of Thalomid.”

It is interesting that the same drug that caused a catastrophe of the 1960’s with many children born with severe birth defects due to their mothers’ use of the drug, is now a miracle drug, helping to alleviate their suffering of illnesses from AIDS to cancer.

Thalomid (thalidomide) and a related drug, Revlimid, generate $2.2 billion a year for Celgene.  Ms. Jacobson would now like a big pile of cash claiming the idea of treating multiple myeloma with thalidomide was novel and that no one in the medical community was using the drug for this purpose before Ms. Jacobson’s discovery.

The premise behind the claim of misappropriation of ideas is that when a party misappropriates another person’s confidential idea or some other type of property, the law imposes an obligation on that party to pay the other restitution for its improper use.

Generally, the test for determining whether the law will imply an obligation to pay for a confidentially submitted idea is when “a person communicates a novel idea to another with the intention that the latter may use the idea and compensate him for such use, the other party is liable for such use and must pay compensation if:

(1) the idea was novel;
(2) it was made in confidence to the defendant; and
(3) it was adopted and made use of by the defendant in connection with his own activities.

A misappropriation claim, unlike a contract-based claim, only can arise from the taking of an idea that is original or novel because the law of property does not protect against the appropriation of that which is free and available to all. Anyone may use ideas in the public domain freely.

While Jacobson now claims that she disclosed the information to Celgene on a confidential basis, there is no evidence that anyone agreed to keep any information secret or not to use the information.

Even if there was some sort of implied obligation of confidentiality on Celgene, Jacobson’s pleading states that she told another patient about using thalidomide and that patient asked for and received the drug from the Multiple Myeloma Institute’s staff.  Certain the information was available to – if not created in whole or in part by – Folkman and Barlogie.

In addition, all the pertinent information was certainly disclosed on publication of the New England Journal of Medicine article and the Celgene Annual Report. It could be that any novelty of the treatment was lost early on and the information had fallen into the public domain.

We’ll keep you posted on developments.

Calling Emerging Company Presenters
Application Deadline is September 23

Company presentations are one of the features that make Mid-Atlantic Bio unique. These presentations provide company executives with the opportunity to share informed insight into their product and process innovations as well as their growth strategies. The audience of conference attendees comprises prospective investors, scientists, advisors, and professional services firms from the life sciences sector.

Back Again This Year!

2009 Mid-Atlantic Bio Calls Emerging Companies

To apply to present November 4-6, 2009

Apply now – Deadline is September 23

Building on the success of last year’s format, company presentations will again be offered on two tracks. In addition to our main “Showcase” track, we are also featuring a separate “Growth Watch” track for emerging companies. Mid-Atlantic Bio will provide a platform for these selected enterprises to share science or technologies of interest to both strategic collaborators and other alternative investment and partnering organizations in attendance, including patient advocacy groups.

Emerging companies interested in presenting are encouraged to submit their company information through the on-line application, which will be reviewed in a competitive process conducted by industry representatives.

As part of the 2009 Mid-Atlantic Bio program, executives from companies in the Growth Watch track will participate in several pre-conference programs, including an exclusive networking event and a mandatory half-day boot camp session on October 2nd to help prepare for the formal presentations before industry attendees.

To learn more and to apply, visit here.

IAmBiotech, an online hub for showcasing the passion of the researchers, patients, farmers, and other innovators who are finding solutions through biotechnology, is looking for input from the biotech community.

They have launched a survey to see how the biotech community is using social media to connect with one another online.  Do you think Facebook can help your bottom line?  Do you think Twitter is a waste of effort?

The results have been pouring in, and you just have 1 week left to add your input.

Win A Flip Video Camera

Take 5 minutes to complete the Biotech Social Media Survey and you’re automatically entered to win a free Flip Video camera.  Could be worth your time!

Here are some highlights from the responses so far:

• 47% say they use social networking sites several times a day;
• 26% say a lack of familiarity with social media resources is the main reason that many of their colleagues aren’t joining in;
• And, 56% say LinkedIn is the most important online tool for advancing their careers in biotech.

Do you agree?  Have your say.

Click here to voice your opinion.